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Hulapop HulapopINTERGOVERNMENTAL MEETING OF EXPERTS (CATEGORY II)
RELATED TO A DRAFT RECOMMENDATION ON THE ETHICS OF
NEUROTECHNOLOGY
RÉUNION INTERGOUVERNEMENTALE D’EXPERTS (CATÉGORIE II)
RELATIVE AU PROJET DE RECOMMANDATION SUR l’ÉTHIQUE DES
NEUROTECHNOLOGIES
Room/Salle XI, UNESCO Headquarters/Siège de l’UNESCO, Paris, France
12-16 May/mai 2025
SHS/IGM-NEURO/2025/MAY/INF.2.REV
10 April/Avril 2025
Original: Multilingual/Multilingue
COMPILATION OF COMMENTS RECEIVED FROM MEMBER STATES
ON THE FIRST DRAFT OF THE RECOMMENDATION
COMPILATION DES COMMENTAIRES REÇUS DES ÉTATS MEMBRES
SUR L’AVANT-PROJET DE RECOMMANDATION
ATTENTION: PLEASE NOTE THAT THE ENTIRE DOCUMENT
CONTAINS 843 PAGES.
This document is a compilation of comments received
from Member States and observers on the first draft of
the Recommendation on the Ethics of Neurotechnology
(CL/4483). All comments are included in this document in
the original language(s) in which they were submitted to the
Secretariat. The table of contents below can be used to go
directly to the comments submitted by a specific Member State
or permanent observer.
ATTENTION : VEUILLEZ NOTER QUE L'ENSEMBLE DU
DOCUMENT CONTIENT 843 PAGES.
Ce document est une compilation des commentaires reçus des
États membres et observateurs sur l’avant-projet
de Recommandation sur l'éthique des neurotechnologies
(CL/4483). Tous les commentaires sont inclus dans ce document
dans la ou les langues originales dans lesquelles ils ont été
soumis au Secrétariat. La table des matières ci-dessous peut
être utilisée pour accéder directement aux commentaires soumis
par un État membre ou observateur permanent spécifique.
TABLE OF CONTENT/TABLE DE MATIÈRES
by alphabetical order of Member States and Permanent Observers that submitted comments
par ordre alphabétique des États membres et Observateurs permanents ayant soumis des commentaires
ARMENIA/ARMÉNIE........................................................................................3
AUSTRALIA/AUSTRALIE ................................................................................5
AUSTRIA/AUTRICHE.....................................................................................38
BAHRAIN/BAHREÏN ......................................................................................74
BULGARIA/BULGARIE..................................................................................75
BURKINA FASO ...........................................................................................146
CANADA ......................................................................................................150
CHINA/CHINE ..............................................................................................187
COLOMBIA/COLOMBIE ...............................................................................211
CÔTE D'IVOIRE ...........................................................................................219
DENMARK/DANEMARK...............................................................................220
FINLAND/FINLANDE....................................................................................221
FRANCE.......................................................................................................251
GERMANY/ALLEMAGNE .............................................................................289
INDIA/ INDE .................................................................................................351
JAPAN/JAPON .............................................................................................354
JORDAN/JORDANIE ....................................................................................383
LITHUANIA/LITUANIE ..................................................................................433
MALAYSIA/MALAISIE...................................................................................442
NORWAY/NORVÈGE...................................................................................636
PALESTINE (STATE OF)/PALESTINE (ÉTAT DE)........................................448
PERU/PÉROU ..............................................................................................449
REPUBLIC OF KOREA/RÉPUBLIQUE DE CORÉE......................................465
RUSSIAN FEDERATION/FÉDÉRATION DE RUSSIE ...................................497
SLOVAKIA/SLOVAQUIE...............................................................................631
SPAIN/ESPAGNE..........................................................................................635
SWEDEN/SUÈDE.........................................................................................636
SWITZERLAND/SUISSE ..............................................................................711
THAILAND/THAÏLANDE ...............................................................................756
TÜRKIYE......................................................................................................758
UNITED KINGDOM/ROYAUME-UNI............................................................790
UNITED STATES OF AMERICA/ÉTATS-UNIS D’AMÉRIQUE......................794
URUGUAY....................................................................................................843
PERMANENT OBSERVERS/OBSERVATEURS PERMANENTS
HOLY SEE/SAINT-SIÈGE..............................................................................853
2
ARMENIA/ARMÉNIE
COMMENTS OF THE REPUBLIC OF ARMENIA
CONCERNING THE PRELIMINARY REPORT ON THE FIRST DRAFT OF THE
RECOMMENDATION ON THE ETHICS OF NEUROTECHNOLOGY
The complex nature of neurotechnologies and the societal, economic and moral changes
associated with their progress require a new understanding of the values of human civilization
and life itself.
While at first glance, neurotechnologies seem promising as they have the potential to
improve human life, the widespread dissemination and expanding scope of neurotechnologies
raise serious concerns, particularly regarding security, privacy, and a host of other critical
bioethical issues.
Throughout history, medical science has recorded many new achievements; however,
they have never given rise to such confused and conflicting moral debates as they do today.
Despite the potential benefits of neurotechnology, the associated risks are substantial and
may outweigh the rewards. Therefore, we have a moral duty to carefully guide its development
to ensure it is ethical and beneficial for society.
As aptly stated in the proposed program, the fundamental criterion for regulation in the
field of biotechnologies should be the preservation of the spiritual integrity of the person. The
development and application of modern neurotechnologies must be guided by a strong ethical
framework. This framework must prioritize the fulfillment of human spiritual needs while
ensuring the utmost respect for individual sovereignty, self-determination, dignity, and
fundamental rights and freedoms.
Neurotechnologies are developing at a rapid pace. The volume of public and private
investments in this sector is steadily increasing. The significant potential of neurotechnologies is
manifested not only in the treatment of a wide range of diseases and disorders of the nervous
system, but also in various scientific studies aimed at improving human nature in general.
However, the uncontrolled use of these technologies can lead to disastrous consequences in terms
of preserving fundamental human freedoms and autonomy.
Currently, the ethical regulation of the development of science and technology lags
behind the development process itself, as it is based on a simple response mechanism to specific
situations caused by existing or even widely used technologies.
The introduction of transformative technologies like neurotechnologies will undoubtedly
have profound societal impacts, including unintended consequences. International organizations,
such as UNESCO and its advisory body, the International Bioethics Committee, play a crucial
role in addressing these challenges. The work conducted by the Committee's expert groups,
including the development of draft recommendations, is an essential step in the challenging
process of establishing moral and legal frameworks for this rapidly evolving field.
We especially emphasize the definition of the concept of "neurorights" and the
clarification of their scope. These rights are based on the recognition of the right to physical and
mental integrity, privacy of personal data, freedom of thought, free will, and access to scientific
progress of all people without discrimination, and the need to protect and promote these rights.
They also include the right to make free, autonomous and responsible decisions about the use of
neurotechnologies without any discrimination, coercion or violence.
1
3
The Republic of Armenia shares the concerns related to the introduction of
neurotechnologies and is ready to adopt relevant regulations on the protection of mental health
at the state level, as well as ensuring the protection of neurodata, treating it as a category of
sensitive personal information, based on the recommendations of the presented draft.
At the same time, we would like to emphasize that there is almost no mention of the
application of neurotechnology in the military field. The development of brain-computer
interfaces for rehabilitating wounded soldiers (e.g., prosthetics for limb loss) and treating
conditions like post-traumatic stress disorder represent a more benign application. Meanwhile,
the potential of these technologies extends far beyond such humanitarian uses. The
weaponization of neurotechnologies presents profound ethical, psychological, political, and
security challenges. For instance, the use of devices that directly monitor and potentially
manipulate the behavior of soldiers raises serious concerns. These technologies could blur the
lines of moral and legal responsibility, potentially leading to an increase in the brutality of
warfare and expanding the scope of war crimes.
Neurotechnologies can also bring hybrid warfare to a new level. While modern
battlefields already witness the influence of electronic media propaganda, the emergence of
neurowarfare raises the specter of technologies that could directly manipulate the cognitive
processes of individuals, both combatants and civilians beyond the frontlines, with a massive
impact on the political and social fabric of states.
The responsible development and application of neurotechnologies necessitate close
collaboration among scientists, legal experts, and ethicists. When developing neurotechnologies,
it is also important to take into account the needs and concerns of the people who will be their
direct consumers. Therefore, public awareness of what neurotechnologies are and what
consequences can be expected from their development and use, should be a core mission of
relevant authorities and organizations.
UNESCO, with its extensive expertise in bioethics, plays a crucial role in navigating the
ethical complexities of emerging neurotechnologies.
It is both logical and encouraging that the presented draft incorporates the foundational
principles outlined in the UNESCO Universal Declaration on Bioethics and Human Rights
(2005).
4
AUSTRALIA/AUSTRALIE
PRELIMINARY REPORT ON THE FIRST DRAFT OF THE RECOMMENDATION ON THE
ETHICS OF NEUROTECHNOLOGY
This preliminary report on the draft Recommendation on the Ethics of Neurotechnology, was prepared
in accordance with Article 10.1 of the Rules of Procedure concerning recommendations to Member
States and international conventions covered by the terms of Article IV, paragraph 4, of the
Constitution.
INTRODUCTION Commented [LM1]: We suggest including some
discussions on how generative AI impacts the ethics of
1. Within the general advancement of scientific knowledge and technology, the disciplines that neurotechnology. With the rapid advancement of
study the brain and mind have made significant progress. According to UNESCO, during the last generative AI, neurodata is no longer exclusively
generated by humans—it can now also be produced by
decades, neuroscience has been one of the most dynamic areas of research and innovation, with
AI models/systems or a mixture of human-generated and
an increasing number of patents (from less than 500 in 2000 to over 12,000 in 2020), scientific AI-generated. This raises significant ethical questions:
publications (reaching 1.2 million in 2021) and investments (the neurotechnology devices market is How should existing ethical frameworks apply to AI-
expected to reach USD24.2 billion by 2027) 1 . This progress has substantively advanced our generated neurodata? What new ethical principles or
understanding of the nervous system, offering the possibility to intervene on the brain and address considerations are necessary to guide the creation,
many unmet medical needs, related especially to neurological disorders and mental health. It is also a interpretation, and use of such data? These questions
major source of ethical challenges deeply interconnected with human rights and human dignity, as the call for a deeper understanding of the unique ethical
challenges associated with AI-generated neurodata,
nervous system is the coordinating centre of behaviour and mental processes enabling the exercise of including issues of authenticity, accountability, and its
self-determination, the capacity to act as moral agents, to exert responsibility, cooperate with others, implications for decision-making processes.
deliberate about individual or collective decisions and develop one's own personality. Considering the
major impact of these developments and their significance for the human rights framework, this debate For example,
falls clearly within the scope of UNESCO's mandate to advance the ethics of science and technology. •Unlike human-generated neurodata, where ethical
principles typically focus on consent, privacy, and
2. Neurotechnology refers to devices, systems, and procedures that directly access, monitor, data ownership, AI-generated neurodata often lacks a
analyse, predict or modulate the nervous system to understand, influence, restore, or anticipate its clear source or subject. This raises critical issues
regarding data ownership, responsibility for its
structure, activity, function, or intentions. Historically, neurotechnology tools have been developed for generation, and appropriate regulation. Ethical
laboratory research, such as observing the brain activity of patients or healthy volunteers. These tools frameworks may need to be adapted to address
have been used in the clinic for decades as diagnostic tools or to mitigate the impacts of neurological situations where a "data subject" does not exist, as the
and neurodegenerative disorders such as Parkinson's disease by stimulating targeted brain areas and data is entirely fabricated by AI.
partially restoring brain functions. The convergence of neurotechnology with other scientific and •Moreover, managing the biases and inaccuracies
technological developments, particularly artificial intelligence, has opened the door to more powerful, inherent in AI-generated neurodata is essential to
precise, and ready-to-use applications. mitigate risks for downstream applications. How can
we develop strategies to reduce, detect, and address
these biases to ensure ethical and responsible use of
3. Consequently, neurotechnology is being mobilised in a growing number of settings and such data?
situations, and it is expected to increase its footprint. Besides the medical field that keeps expanding, •Also, should AI-generated neurodata be evaluated
new application domains emerge, including in education, the workplace, and the direct-to-consumer differently from human-generated data in terms of
market for entertainment or personal use. reliability and validity? How can we ethically
differentiate between these two types of data to
4. In this context, the ethical challenges raised by neurotechnology go beyond those linked with the ensure trust and fairness in applications like
medical or research field, that are usually well framed in many countries, bringing new challenges for healthcare, neuroscience, and broader societal
decision-making? These are vital questions in the
human rights. In some instances, neurotechnology may pose new threats to human dignity and ongoing development of neurotechnology.
integrity, and challenge fundamental freedoms such as freedom of thought and pose new threats to
human dignity and integrity. With its power to modify our nervous system, neurotechnology can
Commented [LM2]: 'Human dignity’ and ‘integrity’ are
shape the lives of persons, and the developments that may bring positive impact could also be concepts, whereas fundamental freedoms are legally
misused or have unintended negative consequences. Tools interfering with the brain might challenge enforceable human rights). Edits are for distinction
our ability to make free decisions. It raises also critical concerns over issues of manipulation in the between the two.
political domain, in marketing, in the recreational domain, and in other areas outside the medical
realm, as well as concerns over threats to democracy, especially if one considers the convergence of
neurotechnology with artificial intelligence. Data about the structure, activity and function of the
nervous system (neural data) can be processed to provide information related to the health and
mental states of the person. The right to privacy may be
Figures from the UNESCO report Unveiling the Neurotechnoloqy Landscape: Scientific Advancements, Innovations
and Maior trends, 2023
5
threatened, as some aspects of inner life that are naturally concealed - private thoughts that relate
to us intimately and personally - might be disclosed when neural data is processed or combined with
other data. The global circulation of data, which is a hallmark of contemporary science, makes this
issue even more pressing and difficult to handle.
5. The risks to human rights, fundamental freedoms and human dignity are real, and concern
everyone, from patients persons with severe disabilities to a larger population of potential technology Commented [LM3]: We strongly recommend using
users of different applications, such as children whose developing brains are very sensitive. In the language compliant with international human rights law.
context of increasing healthcare inequalities, neurotechnology development and commercialisation The UN CRPD doesn’t categorise disability by strength
or severity, nor does it refer to persons with disabilities
can challenge the principles of justice and solidarity. There are millions of patients with unmet medical as patients (even in a health context).
needs and the potential benefits of neurotechnology for healthcare are enormous. At the same time,
there are also prospects of healthy individuals who can access the latest technological developments
to enhance their cognitive functions (e.g., attention, memory) at the detriment of others such as in
educational settings or in the workplace. In this context, an international and coordinated effort is
required to steer an ethical development of neurotechnology to mitigate its impacts on human rights Commented [LM4]: The need for mitigation of impacts
and for the benefit of humankindpresent and future generations and mitigate its impacts on human on human rights should be referenced ahead of the
rights. possible benefit.
Commented [LM5]: We suggest using language from
6. Under the leadership of UNESCO's Director-General, and parallel to other normative work of the Pact language, ‘for the benefit of present and future
UNESCO, the need to tackle the challenges imposed by neurotechnology was based on the research generations’.
conducted by the International Bioethics Committee (IBC) of UNESCO, whose experts prepared a
report on the Ethical Issues of Neurotechnology in 2021, and the mandate for the elaboration of a
Recommendation on the Ethics of Neurotechnology as provided by the General Conference (42
C/Resolution 29).
7. The United Nations Secretary-General report on "Our Common Agenda" (2021) mentioned
neurotechnology as a frontier human rights issue, and Secretary General Antonio Guterres
established a working group at the Assistant Director-General level, co-led by UNESCO and the
Executive Office of the Secretary-General. The working group included other international
organizations, such as the Office of the United Nations High Commissioner of Human Rights and the
Organisation for Economic Co-operation and Development (OECD). The Working Group convened
two interdisciplinary expert consultation meetings in 2021 and 2022 to present key findings and
recommendations of the work done in the system (particularly the UNESCO- IBC reports) and to
advance a coordinated United Nations-wide system approach to the governance of neurotechnology.
Given its work in this field UNESCO was entrusted with the lead of this workstream.
8. UNESCO organised several events throughout this process, including a seminar for
Ambassadors and permanent delegates (April 2023) and an international conference in July 2023.
To inform the International Conference, UNESCO launched top notch research, based on machine
learning, mapping the technological developments, innovation and patents of neurotechnology,
(Unveiling the Neurotechnology Landscape: Scientific Advancements. Innovations and Major Trends,
2023) filling a gap in the understanding of the research, investments and innovation trends, as well
as the distribution and access to knowledge on neurotechnology all around the world. UNESCO also
prepared an overview of the risks and challenges of neurotechnologies for human rights.
9. At the same time, initiatives providing normative guidance for neurotechnology development
have been burgeoning at the international and national levels. Some countries have updated their
laws or are engaged in processes to do so. Soft law instruments and declarations at the international
level have been published recently, such as the Inter-American Declaration of Principles on
Neuroscience, Neurotechnologies, and Human Rights by the Inter-American Juridical Committee or
the EU Le6n Declaration on European Neurotechnology at the EU inter-ministry level, both published
in 2023. Other initiatives include guidelines for stakeholders and producers of the technology, such
as the OECD Recommendation on Responsible Innovation in Neurotechnology (2019) or the French
Charter for the responsible development of neurotechnology (2022). A European charter is now
under consideration by major scientific societies in this domain. The Council of Europe is also
currently leading a discussion on neurotechnology and human rights. UNESCO has been working
in close collaboration with the Office of the United Nations High Commissioner for Human Rights
6
and the United Nations Human Rights Council. The latter has launched a consultation process
analysing the human rights implications of neurotechnology. The different initiatives were reflected in
UNESCO's Towards a draft text of a Recommendation on the Ethics of Neurotechnology: working
document, April 2024).
10. The frameworks mentioned above vary depending on their respective areas of application and
approaches. Given the increased activities in this domain, UNESCO has mapped these initiatives
and coordinated with them. The specific mandate on the ethics of science and technology as well as
its capacity to develop global standards with universal membership, position UNESCO well to
develop a global and pluralistic process, and to establish a platform for dialogue, bringing together
both developed and developing countries, different cultural perspectives, as well as various
stakeholders within the public and private sector. UNESCO has acted as a bridge between Member
States, civil society, the research community, academia, and the private sector, building on its record
of multi-stakeholder consultation and consensus building.
PROCESS
11. In line with 42 C/Resolution 29, on the basis of Member States proposals, and top experts
identified by the Secretariat of the Social and Human Sciences Sector (SHS) of UNESCO, an Ad
Hoc Expert Group (AHEG) was established by UNESCO's Director-General to prepare a first draft
text of a Recommendation on the Ethics of Neurotechnology. The AHEG is composed of 24
independent experts from all UNESCO regions, appointed on a geographical and gender balance
basis and bringing complementary disciplines. The first AHEG meeting was held at UNESCO's
Headquarters from 22 to 26 April 2024 and was opened and attended by the Assistant Director
General for SHS and supported by the Bioethics Section. The AHEG elected a Bureau with members
from all UNESCO regions, including two co-chairs (from the United States of America and France)
and a rapporteur (from Kenya). The AHEG drew on its own expertise and the work and reflection
already conducted at UNESCO to advance its work on the first draft of a Recommendation.
12. To collect feedback on the first version of the draft Recommendation, SHS, with the support of
field offices, conducted a multi-stakeholder consultation process on the first version of the draft
Recommendation from 6 June to 12 July 2024. The consultation process was based on three
components: (i) a global public online consultation, which collected over 7000 comments
demonstrating high interest in the topic despite its highly specialised nature; (ii) 25 regional, sub
regional and national online and in person consultations co-organised with host countries, institutions
and/or National Commissions for UNESCO in all of UNESCO's regions, involving some 800
participants from over 100 countries; and (iii) coordination with other international agencies, including
at the United Nations level, was conducted through the Inter-Agency Working Group on Artificial
Intelligence (IAWG-AI) as well as through the United Nations Inter-Agency Committee on Bioethics
(UNIACB).
13. The consultations generated a rich conversation that raised awareness and triggered regional
and sub-regional debates. The consultations have clearly shown the need and the strong appetite
to have an ethical framework on neurotechnology. Beyond the encouraging comments and positive
feedback collected during the regional and sub-regional debates, the consultation process provided
also concrete figures on the overall support to the document, with a majority of respondents
endorsing the choices made in the first draft. Many comments referred to the vocabulary and
language used in the draft, from fundamental concepts such as the definition of neurotechnology and
neural data to terms related to human rights and ethics of science. Thanks to the consultation, points
in need of clarification and passages requiring improvement were identified. Useful suggestions were
numerous, sometimes including concrete wording for some passages. The need to revise the
structure of the document to better reflect the articulation between human rights, values, ethical
principles, human rights, and policy actions, was also recognised. The consultation process fostered
also global discussions on the issue of consent and self-determination, the impact of
neurotechnology on children and the rising inequalities worldwide.
7
14. The Bureau of the AHEG accompanied by the Secretariat prepared a preliminary revision of
the Recommendation draft taking into consideration the most relevant comments. A new structure
as well as many improvements in the text were suggested. The AHEG convened again during a
meeting week on 26-30 August at UNESCO Headquarters and finalised the first draft
Recommendation based on the feedback of the consultations and on its further discussions, and to
include the implementation and follow up section. As such, the first draft of the Recommendation is
transmitted to Member States, for their comments, together with this preliminary report.
THE FIRST DRAFT OF THE RECOMMENDATION
15. The AHEG decided to focus on the impacts of neurotechnology on humankind and human
rights. Given the spectrum of current and future applications of neurotechnology (from research and
clinic to education, workplace, entertainment) and the diversity of populations possibly affected by
these technological developments, the ambition was to produce a framework as comprehensive and
agile as possible. The discussion put the emphasis on recurring themes, such as the protection of
brain data collected by neurotechnology, the need to safeguard the self-determination of persons
while intervening on their brain, the respect for the principle of justice in neurotechnology
development and use, the need for techniques to work for the benefit of humanity as a whole, and
the desire to refuse any practice of discrimination, unconsented standardisation and alignment with
a dominant pattern.
16. One of the first tasks of the AHEG was the identification of critical ethical and human rights and
ethical challenges as well as deciding on the scope of the Recommendation and providing specific Commented [LM6]: While ethical considerations are
definitions that could capture the complexity of the subject matter. During the first meeting, different important, protecting human rights are a state
working groups were established to advance specific parts of the agenda, and to cover various obligation. Suggested re-order to reflect this distinction.
aspects and drafting chapters. During the second meeting week, the AHEG debated only in plenary
session while the Bureau worked on the integration of the outputs of the plenary discussion into draft
proposals.
17. Significant methodological choices were made with regard to definition and scope. Although
the definition of neurotechnology adopted in the draft Recommendation follows a classical distinction
between observational (those that collect and analyse data from the nervous system) and
interventional tools (modulation of brain and neural activity), defining neurotechnology is a delicate
exercise that has sparked many debates within the AHEG and elicited many comments in the
consultations. While the group wanted the definition to be as broad as possible so that it can apply
to a wide range of neurotechnology tools even in the future, the draft Recommendation provides also
some examples of current technologies for clarity. One notable aspect of the adopted definition by
AHEG is that attention should be put on the nervous system, beyond the brain (that is, consider the
peripheral nervous system along with the central nervous system). Indeed, neurotechnology can be
mobilised to restore function in cases of paralysis or motor disorders via stimulation of the spinal
cord. The AHEG was also aware of the fact that neurotechnology in a strict sense (recording of
signals or stimulation of neurons and nerves) is often combined with other tools and other data, such
as biometric data more generally (physiological measurements) and the processing of this data will
often involve artificial intelligence. The latter is crucial in many neurotechnology applications today.
This convergence of tools and data contributes increased power and efficacy when it comes to
observe, predict and modify mental states. As a consequence, it was decided that the
Recommendation should embrace a broad scope. It includes what the AHEG called "cognitive
biometric data", that is, data collected by non-neural biometric technologies that can be processed to
infer mental states: Consistent with this wide-ranging approach, it was decided that neurotechnology
ought to be considered in its whole lifecycle, from the early stages of mining for materials, prototyping,
research, design and development to deployment and use, including maintenance, operation, trade,
financing, monitoring and evaluation, validation, end-of-use, disassembly, termination, disposal and
recycling. It also considers the intersection with other converging technologies, such as artificial
intelligence.
8
18. The draft Recommendation relies on an extensive list of values and ethical principles that are
detailed in a dedicated chapter. Given the success and the record of UNESCO's work on Artificial
Intelligence, the discussion among the experts started from the values already established in the
Recommendation on the Ethics of Artificial Intelligence, which were further discussed and refined to
fit the specificity of neurotechnology. The following values principles were put forward: the respect,
protection and promotion of fundamental universal human rights and, fundamental freedoms; Commented [LM7]: This is a redline edit. Human
mindingand respect for human dignity; promoting human health and well-being; ensuring and rights are not a value. They are legally binding legal
respecting diversity and fairness; consideration for cross cultural perspectives on human knowledge concepts. As a subjective term, ‘human dignity’ is a
concept separate from human rights.
and its sharing; commitment to peace, fairness and justice in society; global solidarity and
international cooperation; sustainability; integrity and responsibility. The values principles were Commented [LM8]: Dignity should be separated out
developed according to into ethical principles and human rights and other issues at stake in from human rights and fundamental freedoms which
come with legal obligations to respect, protect and
neurotechnology: beneficence, proportionality and do no harm; self-determination and freedom of promote. Human dignity is inherent.
thought; protection of neural and cognitive biometric data for mental privacy; non-discrimination and
inclusivity; accountability; trustworthiness and transparency; epistemic justice, inclusive engagement Commented [LM9]: This is a redline edit. Human
rights are not a value. They are legally binding legal
and public empowerment; best interests of the child and protection of future generations; global and concepts.
social justice, enjoying the benefits of scientific progress and its applications.
19. The AHEG delineated several areas of policy action and proposed concrete courses of action
by domain, including those that are less regulated up to now such as educational settings, labour
and employment, and the direct-to-consumer and commercial domains. It calls on Member States to
actively enforce policies that can protect human rights against possible infringements violations and
abuses related to neurotechnology development and use. Furthermore, the Recommendation Commented [LM10]: This is a high priority edit.
recognises that data about the structure, activity and function of the nervous system (neural data) Human rights are violated (by the state) and abused
should be considered sensitive data, particularly when collected outside of the medical context. This (by non-state actors).
element will likely have deep implications for informed consent procedures and data processing in
various settings, as only data collected within the medical context is systematically recognised
sensitive in most jurisdictions today. A full list of actions directed at neural and cognitive biometric
data policy, intellectual property, and cybersecurity is provided. Attention is drawn to the end users
of neurotechnology that deserve special consideration, such as children, older persons, persons with
physical disabilities and persons with mental health conditions. Provisions on gender equality are
also included. For each population, the Recommendation provides a series of policy actions.
20. An implementation plan is included in the draft Recommendation. It proposes a UNESCO full
fledged program on the ethics of neurotechnology, based on the successful program established for
the implementation of the UNESCO's Recommendation on the Ethics of Artificial Intelligence (2021).
Such a program could include a Readiness Assessment Methodology to assist Member States in
identifying their status at specific moments of their readiness trajectory and a methodology for Ethical
Impact Assessment of neurotechnology based on rigorous scientific research and grounded in
international human rights law. These tools would be backed up by a research program on the ethics
of neurotechnology gathered in a UNESCO observatory with the aim of becoming a shared pool of
knowledge and awareness of good practices and innovations. Another key element would be the
creation of a collaborative platform fostering meaningful exchanges and facilitating collaboration
among Member States and among stakeholders to promote a global policy dialogue, including at
Ministerial level in the context of a Global Forum on the Ethics of Emerging Technologies, combining
the current Global Forum on the Ethics of Artificial Intelligence, and its annual edition, with this other
platform that would deal with developments in neurotechnology. A network of experts on the ethics
neurotechnology with balanced representation of all UNESCO's regional groups could be established
to support this effort.
NEXT STEPS
21. To be effective, the Recommendation needs to be accompanied by policy and support in
building national capacities for its implementation and transformation into concrete guidelines for
neurotechnology actors, legal and governance frameworks. As such, UNESCO will bring its 30 years
expertise in dealing with the ethics of emerging technologies, including bioethics and more recently
artificial intelligence, to assist Member States in fulfilling the provisions outlined in the
Recommendation once adopted. The comprehensive implementation programme mentioned above
9
will be instrumental in that regard. The Recommendation will also provide a solid foundation for the
entire United Nations system in its collective response to the human rights challeng,es raised by
neurotechnology.
22. Member States are now invited to submit their comments and observations, in English or
French, on the first draft of the Recommendation annexed hereto, no later than 31 December 20242.
Responses should be addressed to Gabriela Ramos, Assistant Director-General for the Social and
Human Sciences, at the following email address: [email protected]. A final report containing
a draft text of the Recommendation will be prepared based on those comments and observations
and communicated to Member States by Spring 2025. The final report shall be submitted to the
intergovernmental meeting of a special committee (category 11 meeting) in Spring 2025 for finalization
and eventual adoption by UNESCO's General Conference at its 43rd session.
2 The first draft of the Recommendation is available in Arabic, Chinese, English, French, Russian and
Spanish on the following website:
https://www.unesco.org/en/ethics-neurotech/recommendation?hub=83294
10
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
PREAMBLE
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health conditions,
along with the profound suffering they cause for individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better
preventive and therapeutic treatments for millions, benefitting humanity as a whole and providing
opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
self:-determination, privacy, personal identity, freedom of thought, risk of discrimination, inequality
and challenges to democracy, and that justice, trust and fairness must be upheld so that no country
and no one should be left behind, either by having fair access to neurotechnology and enjoying their
benefits or in the protection against their risks, while recognizing the different circumstances of
different countries and respecting the desire of some people not to take part in all technological
developments, Commented [LM11]: This is a bit ambiguous. We
would not want this to be interpreted that countries or
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security people can develop technologies outside of an ethical
framework.
by promoting collaboration among nations through education, the sciences, culture, and
communication and information, in order to further universal respect for justice, for the rule of law and
for the human rights and fundamental freedoms which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human rights
and human dignity, as well as gender equality, social and global justice and development, physical
and mental well being and health, diversity, interconnectedness, global solidarity, fairness, non-
discrimination, inclusiveness, and environmental and ecosystem protection, can guide
neurotechnology in a responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to countries in special situations, low- and middle-
income countries (LMICs), including but not limited to least developed countries (LDCs), landlocked
developing countries (LLDCs) and small island developing States (SIDS), as they have their capacity Commented [LM12]: We prefer following UN
but have been underrepresented in the development and access to neurotechnology, conventions and using agreed groupings of countries in
special situations (LDCs, LLDCs and SIDS).
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and Commented [LM13]: Suggest deleting for redundancy
enables the realization of the full potential of neurotechnology, while addressing the ethical with 'global cooperation’.
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development and
policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General "to prepare a standard-
11
setting instrument on the ethics of neurotechnology in the form of a recommendation", which is to be
submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration on
the Responsibilities of the Present Generations Towards Future Generations (1997); the Universal
Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on the Rights of
Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate Change (2017);
the Recommendation on Science and Scientific Researchers (2017); the Recommendation on the
Ethics of Artificial Intelligence (2021); the Recommendation on Open Science (2021); the Human
Rights Council's resolution on 'The right to privacy in the digital age" (NHRC/RES/42/15) (2019); the
Human Rights Council's resolution on "New and emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), and the UN Guiding Principles on Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to Al-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX
day of November 2025;
2. Recommends that Member States, with the support of UNESCO's Secretariat, apply
the provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other measures may be required, in conformity with the constitutional
practice and governing structures of each State, to give effect within their jurisdictions
to the principles and norms of the Recommendation in conformity with international law,
including international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound scientific research as well as
ethical analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
1.1 SCOPE
This Recommendation:
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1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing and on the enjoyment of human rights.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (OTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to animals
in research.
4. Approaches neurotechnology ethics as a systematic normative reflection, grounded in human
rights, based on a holistic, multicultural, multidisciplinary, pluralistic and evolving frameworks of
interdependent values, principles, and actions that can guide societies in dealing responsibly with
the impacts of neurotechnology on human beings, societies, and the environment and ecosystems.
(a) It considers human rights ethics as a basis for the normative evaluation and guidance
of neurotechnology, with human rights, human dignity, well-being, and the prevention
of harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from human rights
and other disciplines including neuroscience, medicine, engineering, psychology,
ethics, human rights, law, sociology, anthropology and others disciplines.
5. Covers the measurement, recording, and modification of the human nervous system, the
handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because the
highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to be
responsible for actions, cooperate with others, deliberate about collective decisions and develop
personality.
7. Further recognizes that humans develop and flourish in their interaction with other human
beings and a nurturing material and cultural environment, highlighting that autonomy is not just
individual but also relational, as it arises from and impacts one's interactions and belonging with
the community.
8. Addresses the ethical and human rights and ethical concerns that arise from the rapid
developments and the convergence of neurotechnology with other technologies such as spatial
computing, extended reality (XR), artificial intelligence (Al), sensors and semi-conductors. Notably,
other biometric data when processed to infer sensory, motor, and mental states raises similar
ethical concerns. Therefore, this Recommendation applies to both neurotechnology and the use
of cognitive biometric data, ensuring that ethical principles and practices are consistently applied
across these domains.
9. Further addresses the integration of Al with neurotechnology, which can enhance precision
and predictive capabilities, such as improving processing speed, reducing cost, optimizing
neurotechnology systems. However, it also magnifies ethical threats, including cybersecurity
concerns, lack of transparency, the potential for algorithmic bias, and risks to autonomy, mental
privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications of
neurotechnology. Calls on all concerned to act responsibly with regard to neurotechnology.
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1.2 DEFINITIONS
11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include cognitive,
affective, and conative states), and supports consciousness, sleep and the experience of pain.
The nervous system activity and structure provide information inherent to all human beings and
the community, regardless of gender, ethnicity, language, or religion. The nervous system activity
is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures
encompassing both hardware and software-that directly access, monitor, analyze, .predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity,
function, or intentions (speech, motor). Neurotechnology combines elements of neuroscience,
engineering, and computing, among others.
13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction with the
nervous system or by interfacing it with devices and systems. It includes but is not limited to:
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical, optical,
magnetic and/or mechanical), chemical and biological signals associated with the
structure of and functional signals from the nervous system. These may be used to
identify, record, and/or monitor properties of nervous system activity, understand how
the nervous system works, diagnose pathological conditions, or control external
devices (brain machine interfaces (BMI), often referred to as brain computer interfaces
(BCI)). Of note, both open-loop (i.e., fixed-parameter brain stimulation) and closed
loop systems (i.e., state dependent stimulation) introduce complex ethical issues.
(i). Examples include but are not limited to Electroencephalography (EEG),
Magnetoencephalography (MEG), Magnetic resonance imaging (MRI),
Functional Magnetic resonance imaging (fMRI), Positron emission tomography
(PET), Functional Near-infrared spectroscopy (fNIRS), Implanted
microelectrodes, Optogenetics, Optical imaging, Diffusion weighted imaging,
Calcium imaging, Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for example,
to restore sensory input, such as hearing (i.e., cochlear implants) or Deep Brain
Stimulation (DBS) to treat tremors and other pathological conditions. They are meant
to either modulate the functions of the nervous system and/or send signals directly to
the nervous system by applying acoustic, electrical, magnetic or optical stimulation
and/or inhibition of the peripheral or central nervous system.
(i). Examples of this neurotechnology are implanted microelectrodes, BMI, DBS,
Optogenetic optical stimulation, Transcranial electrical stimulation (tES),
Transcranial Magnetic Stimulation (TMS) or Neuropharmacological infusion.
14. Of note, several sensor technologies collect data indirectly informing about neural activity.
Even if they are not neurotechnology per se, they raise similar ethical and human rights issues as
neurotechnology when used to infer mental states. They include but are not limited to eye-tracking,
Video Oculography, Typing dynamics, Voice recognition and analysis, Gait analysis, Skin
conductance, Heart rate variability, Sleep movement monitoring, Blood pressure measurement, or
facial- emotion recognition systems.
15. Neural data. Neural data are qualitative and quantitative data about the structure, activity
and function of the nervous system. They encompass data relating to a nervous system's activity,
14
including both direct measurements of neuronal structure, activity and/or function (i.e., neuronal
firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e., blood flow
in fMRI and fNIRS). At the neurobiological level, neural data are the most direct correlates of
mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non-neural biometric
technologies can be processed to infer mental states, which this Recommendation refers to as
"cognitive biometric data".
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining for
materials, prototyping, research, design and development to deployment and use, including
maintenance, operation; trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology includes
its convergence with other technologies and the diversity of actors who are involved in every stage.
11. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the development and use
of neurotechnology in ways that are ethical, safe and effective for the good of humanity, individuals,
communities, societies, the environment and ecosystems, and to prevent harm in the present and
the future based on international law, in particular the Charter of the United Nations and
international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms; respect for, human dignity and equality, including gender equality, and to
respect and cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities, institutions,
private sector companies and every other relevant actor to ensure the embedding of
ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable and
reproducible;
(d) to provide a universal framework that not only articulates values and principles, but
also translates into concrete policy recommendations and effective implementation to
guide Member States in their engagement with neurotechnology in its whole lifecycle,
consistent with their obligations under international law, including international human
rights law and other international standards; Commented [LM14]: We note Australia has
international obligations outside of international human
(e) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and consensus rights law which would also be relevant to the subject
matter in the draft Recommendation. While we note the
building about ethical issues relating to neurotechnology;
draft Recommendation states that nothing in the
Recommendation ‘may be interpreted as replacing,
(f) to promote justice and equitable access to developments and knowledge in the field altering or otherwise prejudicing Member States’
of neurotechnology and the sharing of benefits; obligations or rights under international law’ (paragraph
167), we recommend this be reflected in the objectives
of the Recommendation.
(g) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.
15
111. VALUES AND PRINCIPLES
111.1 VALUES
111.1.1 Respect, protection and promotion of universal human rights and,
fundamental freedoms and human dignity
20. The inviolable and Universal Declaration on Human Rights posits that the inherent dignity of Commented [LM15]: Delete ‘inviolable’ - as per the
every human being is the foundation of universal human rights and fundamental freedoms. preamble of the Universal Declaration of Human
Respect, protection, and promotion of human dignity, as established by international human rights Rights.
law is, are essential in the whole lifecycle of neurotechnology. Dignity encompasses the
recognition of the intrinsic and equal worth of each person. Neurotechnology must never be used
in ways that objectify, exploit individual vulnerabilities, or undermine the dignity or rights of any
individual, including people living in vulnerable situations.
111.1.2 Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical, mental,
and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the largest
number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
111.1.3 Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of neurotechnology.
Special consideration should be given to neurodiversity, minority groups, Indigenous Peoples, and
underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban well
resourced sector, specific attention to underserved and marginalised people is crucial to prevent
bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological assimilation,
or using technology as a tool of colonisation (a term the Recommendation refers to as
"technological colonialism"), can threaten cultural diversity and heritage, therefore must be
protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its benefits Commented [LM16]: It is not clear how equitable
are accessible to all, regardless of socioeconomic status or geographical location. Special access would be facilitated. Suggest further revisions
attention must be given to low- and middle-income countries, resource-constrained settings, and to help clarify.
marginalised communities, including the specific needs of different groups, ages, segments,
cultural systems, languages, communities, and marginalised and vulnerable populations, people
with disabilities, neurological disorders, and mental health conditions.
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided that
these choices are made in ways that respect the rights of others.
111.1.4 Consideration for cross-cultural perspectives on human knowledge and its sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
16
28. It is essential that any research and development involving diverse groups and communities
is done with their permission and guidance, and conducted with their full prior and informed
consent and partnership in ways that serve their interests and respect their traditional knowledge
and epistemic contributions.
111.1.5 Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of thought
especially in situations where refusal to use the technology could lead to competitive disadvantage.
Such interferences include but are not limited to the use of force, threats, undisclosed access,
manipulation, or any scenario where consent is compromised, including as a result of power
imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that segregate,
objectify or subordinate individuals or communities, reduce social cohesion by exacerbating pre
existing inequalities or generating novel inequalities that divide and antagonize individuals against
each other, and thereby threaten the coexistence between humans, other living beings and the
natural environment.
111.1.6 Global Solidarity and International Cooperation Commented [LM17]: Global solidarity and
international cooperation are the same thing – deletion
31. The Recommendation should guide all actors in the development, deployment and use of to remove redundancy.
neurotechnology to act in solidarity and call for accountability in instances where neurotechnology
may be misused in ways that threaten human rights.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use to
prevent abuse and uphold global ethical standards.
111.1.7 Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used with a
deep respect for environmental stewardship, prioritizing the minimisation of ecological harm
throughout the lifecycle of the materials used, including, for mining extraction, data processing and
storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP), requires should be upheld so that neurotechnology,
through its whole lifecycle, be is guided by a profound respect for Indigenous rights, ensuring that
their lands (including during mining), knowledge, communal rights, and privacy are honoured in all
activities, including those related to resource extraction. Commented [LM18]: We recommend amendments to
this paragraph (i.e., deletion of the term ‘requires’) to
111.1.8 Integrity and Responsibility avoid the implication that UNDRIP is a binding
instrument (when it is a non-binding instrument), and in
light of the fact that mining and resource extraction are
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with ethical not explicitly referenced in UNDRIP.
steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align with
both professional standards and societal values.
37. Integrity includes a commitment to taking responsibility for one's actions and being
accountable for their outcomes. This involves not only acknowledging successes but also owning
up to mistakes and taking corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-based,
objective and transparent research practices. It ensures that all scientific endeavours are
17
conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant for
neurotechnology.
111.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human rights-based-centred approach through
fundamental ethical principles including but not limited to self-determination, agency, freedom of
thought, privacy, cognitive liberty, personal and collective identity, trustworthiness, respect,
reciprocity, and justice. Furthermore, it incorporates the respect, promotion and protection of
human rights.
111.2.1 Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and well-being, and empower individuals to make
informed decisions about their nervous system and mental health while fostering a better
understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally. The "do
no harm" principle must guide the whole lifecycle of neurotechnology, ensuring that the quality of
life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only unexpected
damage to the nervous system, but also to amplified inequalities within society.
43. Any restrictions to human rights must meet all applicable requirements under human rights
law, including the principles of legality, legitimate aim, reasonableness, necessity and
proportionality. Commented [LM19]: While under international human
rights law certain rights are absolute, reasonable limits
44. The principles of proportionality, balance and legitimacy should govern the use of may be placed on most rights and freedoms. However,
any measure seeking to limit rights must conform to
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional
specific criteria to be permissible:
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon the •it needs to be prescribed by law; and
foundational values of this document; (c) appropriate to the context and target user group; (d) •it needs pursue a legitimate objective and be
based on safety principles and rigorous scientific evidence. reasonable, necessary and proportionate.
111.2.2 Self-determination and Freedom of Thought Edit for completeness of full requirements under human
rights law.
45. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the rights
of freedom of thought, and self-determination must be secured.
46. Individuals have the right should be able and empowered to make free, informed, and
voluntary decisions about their engagement with neurotechnology throughout the whole lifecycle,
in accordance with international human rights law and other international standards, including the
right to refuse or withdraw from its use, at any time, ensuring their autonomy and respect for their
decision-making capacity is upheld and where surrogate consent is used, the best interests of the
affected.individual are considered. Individuals who are enrolled in research should be informed of
potential side effects and given the opportunity to disclose if they have any contraindications for
the procedures used. Informed consent procedures should be affirmative, dynamic, and require
opt-in, comprehensive and transparent providing detailed information about the purposes, risks,
benefits, alternatives, and possible outcomes of the technology in all its application domains,
ensuring that consent is voluntary and that individuals fully understand the implications for their
privacy, autonomy, and well-being. Commented [LM20]: We note there is no general right
to make free, informed, and voluntary decisions in
47. Neurotechnology should never be used to exert undue influence or manipulation, whether relation to engagement with neurotechnology under
relevant binding international human rights law
through force, coercion, or other means that compromise self-determination and freedom of
instruments.
thought. This protection covers both the internal processing of thoughts and their external
expression, ensuring freedom from any interference.
18
111.2.3 Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct and indirect data about the nervous system
that is uniquely sensitive because they can be processed and analysed to provide deep insights
into the processes that underpin our mental states and behaviour, including self-awareness and
introspection. As it becomes increasingly difficult to anonymize data, there remains persistent risks
of misuse of this data by revealing neurobiological correlates of diseases, disorders, or general
mental states without the authorization of the person from whom data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural data must be conducted
with free and informed consent, in ways that respect the ethical and human rights and other ethical
considerations principles outlined in this Recommendation.
50. There should be clear safeguards against the misuse or unauthorised access of neural and
cognitive biometric data, including affirmative consent, data minimization and purpose
specification, autonomy over data rights (such as rights including to access, correct and delete
data), and data securityprotection, particularly in contexts where such data might be aggregated
with other sources. Commented [LM21]: We note there is no standalone
right to the protection of personal data under
111.2.4 Non-Discrimination and lnclusivity international law.
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface with
other technologies like Al, must commit to upholding universal human rights and other ethical
principles that prevent discrimination, stigmatisation, targeting, or exploitation of any individuals or
groups, particularly those in vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or mental
characteristics, or other any grounds protected under human rights law. Commented [LM22]: We suggest aligning language
with other binding international human rights
53. Non-inclusive technological development and standardisation may drive a trend toward instruments regarding discrimination. Further, it is not
immediately clear that neurological or mental
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural characteristics fall within a protected ground of non-
and collective identity. discrimination under the International Covenant on Civil
and Political Rights (ICCPR) (articles 2 and 26).
54. Garnering the trust and acceptance of communities in the whole lifecycle of neurotechnology
requires transparent engagement with the public, seeking their input and validation to align these
technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or discrimination
against older persons.
111.2.5 Accountability
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology requires all
actors to promote and protect human rights, and adhere to the highest ethical standards, remain
open to feedback, be committed to adjusting practices in response to new evidence or ethical
concerns, and be held accountable for their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and a duty
to anticipate and address potential harms-whether short-term, long-term or arising from unintended
use and impact.
19
59. A commitment to accountability requires global, governmental, societal and collective action
to ensure those harmed by neurotechnology have access to justice and an effective remedy, and
that those responsible for wrongdoing are required to take meaningful steps to identify, prevent,
mitigate and account for how they address and redress their adverse human rights impacts,
including through corrective actions and reparations. Commented [LM23]: We suggest an addition to align
with Article 2(3) of the ICCPR, regarding right to
111.2.6 Trustworthiness and Transparency effective remedy for those subject to human rights
violations.
60. All actors throughout the whole lifecycle of neurotechnology must To guarantee the respect,
promoteion and protection universal of human rights and fundamental freedoms. They should also
ensure , all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international principles
of responsible conduct and scientific integrity. This includes preventing the replication or
amplification of biases, ensuring that neurotechnology is traceable and explainable, its capacities
and limitations are accurately portrayed, the conditions for accountability are clearly defined,
adhering to ethical guidelines in research and development, including the registration of trials, fair
participant selection, and approval by independent ethics committees.
111.2.7 Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about neurotechnology,
including recognizing diverse ways of knowing, and that all individuals and communities can
participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community engagement,
to ensure diverse populations can gain and exchange knowledge about nervous system
functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and
identity, to respect different ways of knowing and understanding. This respect for diversity ensures
that the knowledge and perspectives of diverse communities are valued and included in decision
making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may be
marginalized or excluded from knowledge production and dissemination.
65. All communities should have a voice in decisions that affect them, particularly when it comes
to the development and use of neurotechnology.
111.2.8 Best Interests of the Child and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right of
children and adolescents to participate in decisions that affect them. Technology should be
rigorously assessed to ensure it serves the best interests, well-being and healthy development of
children, as they grow into autonomous individuals and safeguard the rights of future generations
by ensuring that today's decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology for
early diagnosis, instruction, education, and continuous learning, it is equally important to make a
commitment to the holistic development of the child. This includes nurturing their social life,
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and
physical activity.
20
111.2.9 Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must be
shared equitably among all contributors to that research and development, with a particular focus
on ensuring global distribution that promotes fairness and reduces disparities, in accordance with
their international obligations. Commented [LM24]: It is unclear to whom the content
in this paragraph is directed, noting the mandatory
69. Neurotechnology developments should be leveraged to reduce global health inequities. language it contains (‘must’). To the extent it is directed
to Member States, we note that Australia has existing
These technologies should serve as catalysts for improving the quality of life, particularly in international IP obligations including under the World
resource-limited settings. Trade Organization (WTO) Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS
70. Research, development, and trials in neurotechnology must adhere to the highest ethical Agreement).
standards, ensuring the non-exploitative participation of all individuals involved. This includes
safeguarding the rights and well-being of participants, and patients and their caregivers, as well
as ensuring the ethical collection and use of data. Special attention should be given to ensure that
those contributing to research and development have their fair share of the benefits and do not
bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never take
advantage of, the lack of necessary technological or medical infrastructure, education and skills,
as well as ethical-legal frameworks, particularly in LMICs, LDCs, LLDCs and SIDS, affecting
communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive recipients
of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
promotes and protects individual and collective human rights. This commitment should include
funding for interdisciplinary research that not only advances neurotechnological innovation but also
studies the ethical, legal, social, environmental and cultural implications of these technologies, and
supports the implementation and clinical translation of technological prototypes. Particular attention
should be given to the development and implementation of adequate technical, institutional,
procedural and other safeguards to ensure that they equitably benefit society and that human rights
are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology in
contexts thatto violate individual and collective human rights. Member States should conduct human
rights due diligence, including regular, comprehensive human rights impact assessments,
concerning neurotechnology that they develop, design, deploy, use, sell, operate or procure, in
order to prevent and mitigate their adverse human rights impacts. Specifically, neurotechnology
should not be used for purposes such as non-consensual interrogation in law enforcement, criminal
and civil justice, development or deployment of weapons targeted at the nervous system, social
control, attempts at coercive behavioural conformity based on personal beliefs or thoughts, political
or other opinion, gender identity or sexual orientation, or surveillance of mental states, among
others. Governments should adopt legislation that ensures neurotechnology is deployed
responsibly, and based on human rights, with robust oversight mechanisms to enforce adherence
to these restrictions and protect mental privacy and freedom of thought for all individuals. These
policies should be developed in consultation with diverse actors, including civil society, end-users,
21
neurotechnology experts, ethicists, and human rights advocates, to ensure broad consensus and
respect for global human rights norms.
75. Member States should ensure transparency and accountability in their support, oversight,
and regulation of neurotechnology, particularly in publicly funded initiatives such as brain research
and development programs. While recognizing the limitations in disclosing certain sensitive
information, governments should require government sponsored neurotechnology projects to
publicly disclose the objectives, methodologies, intended uses, and societal impacts of their
neurotechnology initiatives wherever possible. This transparency is crucial for fostering public trust
and ensuring that neurotechnology advances are aligned with ethical standards and human rights.
76. Member States should apply a comprehensive approach to regulatory and policy measures
to protect against human rights harms related to neurotechnology developed, marketed, operated
or used by the private sector. This includes legislative and regulatory measures and accompanying
guidance, incentives, and transparency requirements. This comprehensive approach should also
require human rights due diligence, ensuring that businesses identify, prevent, mitigate, and
account for their adverse human rights impacts through context-dependent processes, including
human rights impact assessments, meaningful public and community engagement, and
transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in human rights, be implemented
in according with robust scientific evidence, be implemented ethically in accordance with human
rights, and be aimed at promoting public safety while protecting the rights and dignity of all those
involved. This requires respect for fundamental universal human rights, such as human dignity, Commented [LM25]: This is a redline edit. Human
bodily integrity, confidentiality of personal data, due process and fair trial rights, including the dignity is not a human right, but the foundation of
presumption of innocence, and the right against self-incrimination, as well as freedom from torture human rights - see Universal Declaration of Human
Rights (preamble, first para).
and other cruel, inhumane or degrading treatment or punishment ill-treatment, the right to privacy,
and the right to freedom of thought. Commented [LM26]: Suggest the following
amendments to align language with relevant
78. Member States should establish comprehensive incentive structures, such as tax incentives, international human rights instruments. The ICCPR and
Convention Against Torture both refer to ‘cruel,
grants, and awards, with a particular focus on encouraging the construction and development of
inhuman or degrading treatment or punishment’ rather
manufacturing, computational resources, and data analytics capabilities within public research than ‘ill treatment’.
institutions and small and medium enterprises (SMEs). Member States should also incentivize and
support partnerships that leverage the computational resources and data analytics capabilities of
private firms to advance public research goals. These incentives should prioritize rewarding
transparency, participatory development processes, and contributions to societal benefits, aiming
to foster an environment where public institutions and companies innovate responsibly and align
with human flourishing goals.
79. Member States should establish a coordinated, cross-sectoral approach to assessing the
impacts of neurotechnology across the whole lifecycle. This approach should include, but is not Commented [LM27]: We suggest this should consider
limited to: the global harmonisation approach to medical device
regulation.
(a) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology. The process should ensure that
neurotechnology respects and promotes human rights, with particular attention to
people in vulnerable situations. HRIAs should involve meaningful public and
community engagement to incorporate diverse perspectives Commented [LM28]: Human Rights should be the
overarching consideration. Paragraph moved from
(a)(b) Economic Impact Assessments: Conducted by relevant national bodies responsible below.
for economic and labor policies to assess how neurotechnology impacts economic
growth, jobs, social justice, and environmental sustainability;
(b)(c) Benefit-Risk Assessments: Managed by entities responsible for public health, medical
research, and consumer protections, these assessments should rigorously evaluate
the risks and benefits associated with the development, deployment, and use of
22
neurotechnology, including research, clinical applications, and consumer products.
The process should include thorough documentation, ethical oversight, and continuous
monitoring to ensure the safety, well-being, and equitable treatment of all individuals
involved;
23
(c)(d) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these assessments
should evaluate and mitigate risks to individuals' mental privacy posed by
neurotechnology. This includes ensuring that appropriate safeguards are in place to
protect neural and cognitive biometric data in compliance with national and
international privacy standards, and the data policy practices discussed herein;
(d)(e) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology. The process should ensure that
neurotechnology respects and promotes human rights, with particular attention to
vulnerable people and people living in vulnerable situations. HRIAs should involve
meaningful public and community engagement to incorporate diverse perspectives.
80. Member States should promote equitable access to neurotechnology worldwide. To achieve
such goals, efforts should be made to support the reduction of final costs for end users, pursue the
development, adoption and continuous support of non-proprietary software solutions, and explore
reimbursement strategies or subsidisation commensurate with conventions in local jurisdictions, in
sectors of crucial potential benefits.
81. Member States should adopt agile regulatory frameworks, including the use of regulatory
sandboxes-controlled environments for developing, testing, and evaluating neurotechnology-in
response to rapid advancements in neurotechnology and its convergence with other technologies
such as Al, spatial computing, and immersive technologies. These sandboxes should be used to
explore innovative applications, particularly in workplace settings, with appropriate ethical
oversight provided by regulatory bodies or national authorities. These frameworks should facilitate
innovation, ensure ethical data processing, and safeguard rights by incorporating mechanisms for
regular monitoring, evaluation, and dynamic policy adjustments in line with technological and
ethical developments. Commented [LM29]: This paragraph is quite
prescriptive. We would like to seek further refinement
IV.2 DATA POLICY to ensure that member states can adapt these
recommendations within existing regulatory
frameworks.
82. Member States should develop a robust regulatory and legal framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data grounded
in international human rights law. This and existing frameworks should recognize this data to be Commented [LM30]: We affirm the criticality of
stringent safeguards to protect neural and cognitive
both personal and sensitive data in medical and non-medical contexts. biometric data. This includes affirmative consent, data
minimisation, purpose specification, data rights (such
83. Member States should ensure that their existing privacy policies comprehensively cover as access, correction, and deletion), and robust data
stringent safeguards for individuals' neural and cognitive biometric data. If current policies do not security measures.
adequately address these areas, Member States should adopt targeted legislation or regulatory
We note that with the increasing availability of portable
frameworks to secure these protections. These safeguards should for example include affirmative and affordable neuro devices (e.g., EEG helmets and
informed consent, data minimization and purpose limitation, data rights (including the right to wearable sensors), neural data collection is no longer
access, correct, and delete data), and stringent data security protection measures, such as limited to specialized research labs—it is now happening
advanced cybersecurity protocols to prevent unauthorized access and breaches. Such legislation in homes, schools, and workplaces. This shift raises
or frameworks should prohibit the practice of tying access to goods or services to the disclosure of important ethical concerns about privacy, security, and
neural and cognitive biometric data, require explicit opt-in for any data sharing, and forbid the use informed consent, particularly in uncontrolled
environments. The growing accessibility of open-source
of such data for targeted advertising without the individual's explicit, affirmative informed consent. tools and DIY neuro devices allows individuals to build
and use their own systems, which introduces new ethical
84. Member States should develop and implement specific policies to reduce the ecological challenges distinct from those associated with devices
footprint of neurotechnology, particularly in relation to large-scale data centers and computing made by manufacturers. How can ethical guidelines for
resources used for processing and storage of neural and cognitive biometric data. These policies neurotechnology be effectively applied to open-source
should emphasise data minimisation, ensuring that only the necessary amount of data is collected tools and DIY neuro devices?
and processed, and promote the proportional use of neurotechnology, aligning its deployment with
genuine needs and minimising unnecessary environmental impact. Measures should include
optimising energy efficiency, using renewable energy sources, promoting the recycling and
24
sustainable disposal of neurotechnology-related equipment, and ensuring the rehabilitation of
affected environments.
85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, such· as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy and
ethics by design, requiring the incorporation of privacy-preserving technologies as default features
in their devices. Commented [LM31]: We encourage the inclusion of
“secure-by-design” into these relevant paragraphs so
87. Member States should encourage ethical data sharing by establishing safe, secure, data that the integrity of the technologies themselves are as
secure as possible from interference. This includes
repositories for neural and cognitive biometric data used in research. These repositories should
understanding the relevant supply chains and data
be in compliance with international law, meet stringent cybersecurity, data privacy, and ethical use repositories involved and whether there are Foreign
standards (including data minimisation and purpose limitations), tiered access and other privacy- Operation, Control or Interference risk that may
enhancing approaches. Appropriate funding mechanisms should be established for the curation undermine the principles outlined in paragraph 74.
and maintenance of data and data governance processes streamlined.
Commented [LM32]: Australia believes the language
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing in of this paragraph should be strengthened, to include
neurotechnology research, working towards greater alignment of data protection standards, more caveats for the safe use of data and references to
international law.
particularly concerning neural and cognitive biometric data, by establishing clear protocols for data
transfer that ensure safe, secure and compliant data exchanges across borders, and standards for Commented [LM33]: We kindly request clarification or
interoperability of data, including governance frameworks for data sharing, while taking into re-drafting of ‘compliant data exchanges’. It is unclear
account existing mechanisms and guidelines for privacy protection and data governance. what these would be compliant with? Suggest this
should be international law.
89. Member States should consider specific guidelines for the ethical use of neural and cognitive Commented [LM34]: We note there are several other
biometric data in Al development and research, including consent procedures for uses of neural initiatives currently being developed by the United
Nations system, regional and international
and cognitive biometric data in training and application of Al models, ensuring transparency and organisations, as well as other stakeholders, in relation
respecting individual and community rights. to data governance including by the United Nations
Statistical Commission and the Commission on
IV.3 INTELLECTUAL PROPERTY (IP) Science and Technology for Development. Australia
believes this UNESCO report should note and take into
consideration these ongoing processes so efforts are
90. Member States should adopt policies to ensure that neural and cognitive biometric data, as not duplicated or pre-empted.
individual human activity derivatives, are not subject to proprietary rights. IP protection should only
apply to original data compilations (created through a process of aggregation, organization, or Commented [LM35]: We affirm the criticality of
stringent safeguards to protect neural and cognitive
selection, resulting in a new dataset) that meet strict and ethical criteria. biometric data. This includes affirmative consent, data
minimisation, purpose specification, data rights (such
91. Member States should collaboratively establish clear, harmonised guidelines for IP rights as access, correction, and deletion), and robust data
applicable to neurotechnology on an international scale. These guidelines should address the security measures.
patentability of Al-generated inventions and the ethical implications of IP laws, ensuring they Commented [LM36]: This wording could be
promote global accessibility and innovation. interpreted to mean that the only form of IP protection
available for neurotechnology are those associated
92. Member States should ensure that all actors adopt IP management strategies that with original compilations of data (which appears to be
reflecting the intellectual creations pursuant to article
encourage innovation and avoid overly restrictive patent use, fostering an open innovation 10 of the TRIPS Agreement). Given that IV.3 expressly
ecosystem. This approach should continuously adapt to the evolving landscape of contemplates patent use (for example, in paragraph
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously 92), and that the definition of neurotechnology in
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility. paragraph 12 is broad enough to attract other forms of
intellectual property protection, such as those afforded
to patents, we recommend the removal of the word
93. Member States should foster an environment of co-creation in neurotechnology, by ‘only’, for clarity.
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors.
94. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing. Particularly
with the convergence of digital technologies and the increasing concentration of those
25
innovations in industry sectors, this balance is crucial to ensure that IP protection mechanisms do
not hinder scientific research, innovation, and the wide dissemination of knowledge and new
technologies. As a basic rule of equitable partnership, when Indigenous Peoples are involved in
neurotechnology research and development, open science processes, IP management strategy,
should be developed in collaboration with them from the beginning.
IV.4 CYBERSECURITY Commented [LM37]: We suggest referring to
standards developed in multi-stakeholder forums like
95. Member States should collaborate internationally to establish comprehensive standards for the International Organisation for Standardisation
(ISO), as well as the Joint Technical Committee 1, a
cybersecurity across all neurotechnology domains. These standards should encompass hardware,
collaboration between the ISO and the International
software, and data security protection measures to protect against potential cyber threats. By Electrotechnical Commission (IEC). This is to ensure
implementing uniform cybersecurity standards, Member States should ensure the integrity, that the necessary technical/professional expertise are
confidentiality, security, and availability of neural data, as well as enhance user trust and being considered to address issues relating to ethics
confidence in neurotechnology devices. Additionally, these standards should evolve in tandem and ethical use of these technologies.
with technological advancements and emerging cyber threats to maintain robust protection against
evolving risks.
96. Member States should employ red-teaming exercises-adversarial challenges to test the
efficacy of security systems-as a proactive measure to assess and enhance the safety, security,
and resilience of neurotechnology systems. By conducting regular red-teaming exercises, Member
States should proactively identify and address security gaps, test incident response procedures,
and strengthen the overall safety and cybersecurity posture of neurotechnology devices.
IV.5 COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
98. Member States should collaborate with international organizations, educational institutions,
and private and non-governmental entities to develop and disseminate accessible and engaging
educational materials tailored to diverse audiences to bridge knowledge gaps, particularly in
underserved regions about the nervous system and mental health functioning, as well as the
benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies' functionality, safety, efficacy, and societal impact, empowering
individuals to make informed decisions and to enable their ethical reflection about their use of
neurotechnology.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a wide
array of actors. The aim of these engagements should be to inform policy development, shape
ethical guidelines, increase public awareness and understanding, align investment priorities, and
ensure that neurotechnology deployment aligns with public interests and values. Special attention
should be given to involving groups traditionally underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation of accurate, precise, and accessible
language and terminology for discussing neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is inclusive, non-stigmatizing, and accurately
reflects the technologies' capabilities and limitations. Member States should establish regulatory
frameworks that require clear and ethical communication standards for neurotechnology. These
frameworks should require evidence-based reporting of capabilities, risks, and limitations across
all applications to avoid exaggeration of claims, including but not limited to applications in sleep,
attention, memory, and emotional regulation. Within these frameworks should be specific
26
guidelines for ethical marketing and protocols for responsible communications about early-stage
research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user and
for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that evaluate
the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit and explicit coercion
to use neurotechnology. Member States should pay attention to the autonomy of children and
adolescents through informed consent and assent that is adapted to and respectful of age and
decision-making capacity.
105. Member States should fund research and development grants focused on creating user
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children, adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed to
teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
106. Member States should ensure research involves strict oversight and close follow-up of all
neurotechnology research involving children and adolescents. This oversight is crucial during the
developmental phases of childhood to address and mitigate any unforeseen long- term effects.
Such research must include comprehensive monitoring protocols and periodic evaluations to
ensure the ongoing safety and well-being of young participants, taking into account their unique
developmental needs and vulnerabilities. In the framework of research, involving children and
adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring units), special
attention will be given to consent and assent, particularly considering particular aspects of research
(time, iterations) to prevent any form of instrumentalization.
107. Member States should enact specific regulations that prohibit the use of marketing
techniques-such as neuromarketing, biometric emotional analytics, immersive advertising, and
virtual or augmented reality advertising-that rely on sensitive neural and cognitive biometric data
collected from children and adolescents. Recognizing the heightened vulnerability of children and
adolescents in digital environments, these regulations must explicitly forbid any practices that use
such data to influence or exploit children and adolescents.
27
IV.7 OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by funding and
implementing evidence-based programs that integrate neurotechnology into routine care. These
programs should involve the entire support ecosystem, including family, caregivers, and medical
teams, to enhance quality of life. Priority should be given to developing and implementing tools
that prevent, delay, and treat age-related health conditions, impairments, and neurodegenerative
diseases. Member States should ensure that access to these neurotechnology programs is
equitable and does not exacerbate socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making for
older people using neurotechnology for sensorimotor and cognitive support. The consent process
should accommodate potential cognitive challenges faced by older adults, ensuring that consent
is informed, ongoing, and adaptable to changing health conditions. Policies should be in place to
ensure that assistive neurotechnology recognize changing cognitive capacities over time and
respect users' preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such as
robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8 WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive gender-responsive policies that
promote and respect gender equality and diversity in the whole lifecycle of neurotechnology. The
policies should prioritize inclusive research for addressing women and gender specific needs and
differences, require targeted gender-disaggregated data collection and analysis, include education
and training programmes on inclusive research practices, ensure public and community
engagement with women and gender health experts and advocacy groups and, incentivise gender
responsive technology design, to meet the needs and conditions specific to women, girls and people
of diverse gender identities and gender minorities. Affirmative action policies are necessary to close Commented [LM38]: We do not support this
gender gaps in these fields, increase representation, engagement and leadership. language. We have made edit that reflects preferred
language through section IV.8
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are Commented [LM39]: It would be good to reflect the
inclusive, representative and supportive, particularly for women, girls and people of diverse gender importance of women’s full, equal and meaningful
identities and gender minorities, and safeguard against harassment and discrimination. This representation, participation and leadership in all
workplaces if possible
should include robust mechanisms for reporting and addressing incidents of harassment, and
discrimination and violence, ensuring accountability and support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women, girls and people of diverse
gender identities’'s and gender minorities' participation in neurotechnology. This includes funding
and other policies that prioritize ethical and equitable research and innovation, but also affirmative
action initiatives to support the participation and leadership of women, girls and people of diverse
gender identities and gender minorities in neurotechnology through targeted education programs,
employment opportunities, entrepreneurship support, and leadership development within the
sector. Member States should also provide support systems such as mentorship programs,
networking opportunities, and resources to help women, girls and people of diverse gender
identities and gender minorities overcome barriers to participation and succeed in the
neurotechnology field.
28
IV.9 PERSONS WITH PHYSICAL DISABILITIES Commented [LM40]: We kindly ask UNESCO to
consider whether this subsection could be expanded to
115. Member States should adopt policies that harness the potential of neurotechnology by include ‘all persons with disabilities’. The potential
benefits and risks of neurotechnology apply to all
removing barriers experienced by persons with physical disabilities and providing support thereby persons with disabilities, not just those with physical
contributing to achieving equal enjoyment of human rights. They should implement regulatory disabilities.
frameworks that require accessibility assessments for all new neurotechnology products to ensure
these products do not perpetuate existing disabilities or health disparities. These frameworks
should include protocols for testing with diverse groups of persons with disabilities to ensure
technology meets a wide range of needs and does not unintentionally exclude or disadvantage
any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their quality of life and functional
independence. These programs should include tax incentives for companies investing in assistive
neurotechnology research and development, grants for research institutions focusing on
neurotechnology for disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living assistance, and innovation
prizes for breakthroughs in affordable, accessible neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential neurotechnology
devices, such as neuroprosthetics, for persons with physical disabilities. They could encourage
public-private partnerships to make advanced neurotechnology affordable and integrate
neurotechnology coverage into national health insurance and other reimbursement schemes for
persons with physical disabilities. A national database of available neurotechnology resources and
support services should be developed to facilitate access and information sharing.
IV.10 PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to address
the increasing prevalence and special needs of people with mental health conditions, including
victims and survivors of trauma and violence, and the relevance of neurotechnology for these
communities.
119. Member States should allocate funding for long-term advocacy and efficacy studies, post
market oversight, and tiered scrutiny with special attention to invasiveness and reversibility of
neurotechnology interventions. It is important to ensure that people with mental health conditions
are well-informed and have reasonable expectations about the process.
120. Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
29
123. Member States should build and maintain international solidarity cooperation to address
global health risks and uncertainties, and ensure that their implementation of healthcare for the
nervous system is consistent with international law and rigorous human rights obligations. This
could involve creating international forums for sharing best practices in the implementation of
neurotechnology in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and mental
health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results. Commented [LM41]: This may overreach and
intercept negatively with the existing robust regulatory
125. Member States should consider the significant cost and impact associated with pathologies frameworks already in place for medical devices. We
suggest further refinement of this paragraph.
related to the nervous system, as well as the potential benefits of early diagnosis and access to
preventive and assistive neurotechnology. Public policies should prioritize the promotion of access
to these technologies and ensure health cost coverage for individuals in need.
126. Member States should promote the development of reliable and durable neurotechnology
for healthcare applications. This includes encouraging the design of devices and systems that
require minimal maintenance, ensuring they remain functional and effective under everyday
conditions. Regulatory bodies or designated authorities should oversee the enforcement of
rigorous standards for quality, safety, and longevity, thereby reducing the burden on users and
enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States should ensure the development or strengthening of existing comprehensive
neurotechnology medical device reporting systems that track and address adverse effects. In
contexts where such systems do not exist, Member States should establish them. Where systems
are already in place, they should be updated to specifically include neurotechnology. These
systems should be interoperable and contribute to a centralised, public, and transparent
international database, managed in collaboration with international organizations, to ensure that
global standards are met and accessible for public knowledge, international oversight and
research.
IV.12 RESEARCH ETHICS Commented [LM42]: We note that many of the
concerns regarding vulnerable populations and
128. Member States should reinforce the ethical frameworks governing neurotechnology research concerns on research ethics may already be addressed
in existing policy frameworks, such as the World
to ensure robust protection of human participants. Member States should adopt clear guidelines Medical Association’s Declaration of Helsinki – Ethical
or policies that define the qualifications to ensure that research is conducted by professionals with Principles for Medical Research Involving Human
appropriate knowledge about the nervous system structure and function in addition to brain Participants
disorders and is performed in adequate research settings. Furthermore, research protocols, public
or private, in the medical as well as the non-medical domain, should be carefully evaluated by
registered ethics boards (ethics committees) and specific attention dedicated to individuals with
special situations regarding vulnerability such as diminished capacity to consent or to make
decisions. Member States should ensure that all research institutions have mandatory ethics
training for researchers.
129. Member States should encourage multicentre international research that involves various
cultures and ethnic groups. Member States should promote international cooperation to develop
common reporting standards and protocols for interoperability, particularly for implantable
neurotechnology devices. This cooperation should aim to enhance the comparability and utility of
research globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered in
the design of a clinical trial, including policies to protect patients in case of cessation of activities
of the trial sponsor or promoter. Member States should establish requirements for clinical trials to
be included in relevant nationally or internationally approved registries, and encourage registration
30
with community and patient registries. Also, clinical trials should report on appropriate medical
device reporting systems developed within Member States.
131. Technology developers should ensure that the validation of Al algorithms in neurotechnology
research include rigorous testing for biases, as well as measures to enhance explainability and
transparency, including the provenance of training datasets. Suitable techniques should be
employed to mitigate any biases present in Al models used in neurotechnology applications.
132. Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual's subjective
experience, agency and personal identity. Understanding how neurotechnology may impact
aspects of self-perception, consciousness, and identity is essential for addressing ethical concerns
and ensuring the well-being of individuals using these technologies. •
133. Member States should ensure those engaged in research implement regular auditing and
monitoring of research practices to ensure adherence to ethical standards. This should include
evaluating the adequacy of informed consent, particularly concerning data reuse and the potential
commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings to
participants. These protocols should ensure that such findings are conveyed promptly, respecting
participants' rights and autonomy. Additionally, Member States should mandate that researchers
provide the necessary support and coordination with healthcare providers to address any health
concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those_ with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants' right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13 EDUCATIONAL SETTINGS
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is grounded in human rights, and is evidence-based and aligned
with the education goals and complements traditional learning methods. Emphasis should be
placed on promoting the holistic development of students, focusing not just on academic
performance but also on mental health, well-being, and overall interests. To ensure inclusivity,
Member States should develop age appropriate guidelines for neurotechnology use across
different educational stages and learning styles. Regular assessments of neurotechnology's impact
on student development, including mental health, should be conducted, with ethical review
processes established to oversee deployment. The primary focus should be on fostering critical
thinking, creativity, and emotional intelligence rather than solely enhancing academic performance.
137. Member States should adopt policies ensuring the voluntary deployment of neurotechnology
in education, grounded in fully informed consent. These policies must include clear, age
appropriate information about the technology's purpose, benefits, and risks, with adequate
consideration periods. Considering the increased complexity of obtaining voluntary consent in this
context, consent and assent procedures should involve children, adolescents, parents, guardians
and all actors necessary to obtain approval required for minors. Ethical oversight mechanisms
should be established, including regular consent renewal and immediate cessation of
31
neurotechnology use upon withdrawal, and ensure anonymous feedback channels. Policies must
prohibit undue incentives or academic penalties for non-participation and take measures to avoid
creating or reinforcing inequalities among students. Additionally, Member States should support
student involvement in decision-making about neurotechnology integration and fund training
programs on its ethical use, empowering educators and students to critically assess its application.
138. Member States should establish a unified, robust oversight mechanism for neurotechnology
use in educational settings, incorporating regular audits, public and community feedback, culturally
appropriate and according to local conventions, and strict adherence to safety and ethical
standards, including an assessment of reversibility on the nervous system. Continuous research
should be funded to assess the long-term psychological and cognitive impacts of these
technologies. Oversight should involve periodic reviews based on empirical evidence to adjust
neurotechnology usage as needed, ensuring it serves student development and addresses risks
like dependency or de-skilling. This comprehensive approach will help maintain the safety,
effectiveness, and alignment of neurotechnology with best practices for student well-being and
learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations throughout
the neurotechnology whole lifecycle. This training should include ethical design, human rights law,
and societal impact assessment, preparing the next generation of technologists to critically
evaluate the implications of their work.
IV.14 LABOUR AND EMPLOYMENT
140. Member States should establish workplace policies and incentives that prioritize the health
and well-being of employees in the use of neurotechnology. These policies should ensure that any
deployment of neurotechnology is evidence-based, with a focus on applications that have been
scientifically validated to promote employee well-being, such as reducing stress or enhancing
workplace conditions (i.e., adaptive and responsive environments that adjust workloads based on
cognitive load). Deployment must be on a voluntary basis and employees must have the option to
opt out of using neurotechnology without facing any negative consequences or discrimination.
Under no circumstances should these technologies be used for punitive measures, mental
surveillance, or in ways that could compromise employee health.
141. Member States should require employers to clearly provide employees with comprehensive
information about how neurotechnology used in their workplace works, the benefits it offers,
transparency about what data are collected, how it is used, and who has access to it, and clearly
disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring fatigue
in commercial drivers or tracking attention in air traffic controllers). To respect employees' mental
privacy, employers should be prohibited from unauthorized access to neural and cognitive
biometric data that may be collected incidentally during routine workplace monitoring. Employers
should be prohibited from using neural and cognitive biometric data for any non-consented
purposes, particularly those that could negatively impact an employee's job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation and
secure storage of neural and cognitive biometric data, ensure that data is stored securely, with
access limited to authorised personnel only, is deleted once its intended purpose has been fulfilled.
Additionally, upon an employee's departure, all related records should be fully deleted or individual
data released to the employee, ensuring that no data is retained after the termination of
employment.
32
144. Member States should ensure that when employees are issued multifunctional devices (i.e.,
earbuds or headphones that also include neural sensors) that can be used at work or at home,
employers should be prohibited from collecting neural and cognitive biometric data outside of
workplace settings and working hours and ensure that any data collected during work is used
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right ofallow employees to obtain
a copy of any neural and cognitive biometric data collected about them, along with any
interpretations drawn from it in an accessible and comprehensible manner. To use these tools Commented [LM43]: We note there are no binding
without consent constitutes a breach of trust, undermining the value they would otherwise create. international laws regarding the rights of employees vis
a vis their biometric data
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and not
for enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should develop
stringent regulations against using neural and cognitive biometric data for profiling in the
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive
biometric data to discriminate against candidates, particularly neurodiverse individuals, ensuring
hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or maintaining
employment, to limit such use where such neural and cognitive biometric data are directly relevant
to the specific requirements of the job.
IV.15 CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a regulatory framework that balances innovation
in the recreational and commercial domains with protecting individual rights and well-being. This
framework should be dynamic, allowing for timely updates as technology evolves and new insights
are gained about its impacts on society. This includes providing adequate oversight to ensure that
neurotechnology does not cause harm, are used consensually, and include robust mechanisms
to protect users from potential psychological distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include clear
labelling on commercial neurotechnology products, detailing their effects, limitations, and risks to
prevent misleading claims and ensure transparency. This also includes prohibiting practices of
"tying" or requiring the disclosure of neural and cognitive biometric data as a condition to access
goods or services, and prohibition about third party data sharing or the uses of this data without
affirmative opt-in option.
151. Member States should foster an environment that ensures all claims about consumer, non
medical technologies are supported by robust scientific evidence. They should, by regulation,
require that any products claiming to treat, prevent, or diagnose diseases or medical conditions be
validated through rigorous safety and efficacy testing, including clinical trials where necessary, and
be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and transparent
across all neurotechnological interventions, ensuring that participation is fully voluntary and
respects the privacy and autonomy of individuals. This principle should apply uniformly in various
domains such as sports, arts, where robust standards should safeguard against coercive use and
respect athletes' and artists' individual autonomy, community interests, and IP rights.
33
153. Member States should steer the use and development of neurotechnology in the arts toward
ensuring the enhanced learning and cultural appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of consumer
technology, especially neurogaming and other devices that exploit the dopamine reward system
or seek to induce problematic and unhealthy use and overconsumption. Such regulations should
mandate clear labeling of risks, disclosures on their effects on the nervous system, enforce game
design standards and safety, privacy and age-appropriate design standards that prevent taking
advantage of a person's physical, mental and emotional vulnerability to lead to compulsive use or
addiction of gaming or digital recreational platforms combined with neurotechnology, to promote
healthy, balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that 'opt-out' features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding self-determination,
consent, privacy, and the potential for manipulation raised by neurotechnology that arise in the
contexts of recommender systems, priming and nudging, marketing during sleep and dream,
neuromarketing, and closed-loop environments by adopting comprehensive policies and
regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive biometric
data in recommender systems for manipulative or deceptive purposes, including in
political context. These regulations should require that any use of such data within
these systems be based on explicit, informed opt-in consent from users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging-subtly
influencing individuals' decisions or behaviours, often without their explicit awareness.
This is particularly critical in sensitive areas such as political messaging, commercial
advertisement, and healthcare. These frameworks should require explicit, informed
consent for any use of such data to influence decisions or behaviour, the right to opt
out of these systems, and transparency and clear disclosures at the point of data
collection, with strict limitations on using data for purposes beyond those explicitly
disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that influences
or manipulates individuals during sleep, such as marketing during sleep and dream.
Regulations should strictly prohibit commercial, marketing, or political applications that
target individuals during sleep, using neurotechnology or neural and cognitive
biometric data. Additionally, robust oversight mechanisms should be required to
ensure that any research or application of such technologies prioritizes the well-being,
privacy, and autonomy of individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in neuromarketing,
including by requiring comprehensive disclosures to ensure that all neuromarketing
activities are conducted transparently, with participants' explicit informed consent. This
includes ensuring that participants in neuromarketing research or campaigns are fully
aware of methods, risks, and intentions and affirmatively opt-in to participation. The
use, storage, and potential reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and use
34
of closed-loop environments-such as immersive computing devices that adjust
experiences based on detected neural and cognitive biometric data. These policies
should require clear and accessible disclosure about how neural and cognitive
biometric data are used in these environments, prohibit real-time behavioral
modification or manipulation without explicit, informed consent, and implement
safeguards specifically designed to prevent abuses such as unauthorized surveillance,
manipulative interventions, and practices that could influence voting behavior, political
opinions, or exploit psychological and emotional vulnerabilities in real-time.
IV.16 ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human mental
performance outside of the medical context introduces complex ethical, social, and legal
challenges, which can create new kinds of disparities in the global world. When neurotechnology
is used in these contexts, it raises crucial questions about equity, consent, individual and
community autonomy, and the nature of enhancement of the nervous system itself. Member States
should ensure that any policies, law and regulatory frameworks that govern the use of
neurotechnology in these contexts do not exacerbate social inequalities or lead to discrimination,
address the potential risks (including to reversibility, invasiveness, and risks to self-determination)
and fully comply with human rights and dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in this Recommendation should respect,
promote and protect the ethical values, principles and standards related to this Recommendation,
and should take all feasible steps to give effect to its implementation.
159. Member States shall, according to their specific contexts, governing structures and
constitutional provisions, credibly and transparently advance the ethics of neurotechnology, in line
with the UNESCO Recommendation. Member States shall monitor and evaluate policies,
programmes and mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance
with national and international standards, and ensuring that data and insights from different
regulatory domains are shared effectively to inform decision-making and policy development.
These bodies should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions in respect of this
Recommendation, by cooperating with all relevant national and international governmental and
non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector's interests and therefore
UNESCO needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
35
advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shall contribute by developing a full-fledged program with the following elements: Commented [LM44]: We recommend this work refers
to standards developed in multi-stakeholder forums like
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States in the International Organisation for Standardisation
(ISO), as well as the Joint Technical Committee 1, a
identifying their status at specific moments of their readiness trajectory along a
collaboration between the ISO and the International
continuum of dimensions; Electrotechnical Commission (IEC). We want to ensure
that UNESCO has the necessary technical/professional
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of neurotechnology expertise to address issues relating to ethics and
based on rigorous scientific research and grounded in international human rights law, ethical use of these technologies.
along with specific guidance for its implementation in the whole neurotechnology
lifecycle, and capacity-building tools and materials to support Member States' efforts
to train government officials, policy-makers and other relevant actors on the
methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and the
efficiency of the policies for the ethics of neurotechnology and incentives against
defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of knowledge and awareness of good
practices and innovations available to all Member States and actors, in the form of
research reports, data, and statistics regarding policies for ethics of neurotechnology.
The research program should take into consideration the converging developments of
neurotechnology with other technologies such as artificial intelligence and quantum
technology, work to be conducted in collaboration with other relevant UNESCO
initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global policy
dialogue, including at Ministerial level in the context of a Global Forum on the ethics
of Emerging Technologies. Supporting this effort, UNESCO shall establish a network
of experts, with balanced representation of all UNESCO's regional groups, on the
neurotechnology.
165. Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, under-represented, vulnerable people or people in vulnerable
situations and ensuring social, cultural and gender diversity. The monitoring and assessment of
the impact of neurotechnology and related ethics policies and practices should be carried out
continuously in a systematic way proportionate to the relevant risks. This should be based on
internationally agreed frameworks and involve evaluations of private and public institutions. Data
collection and processing should be conducted in accordance with international law, national
legislation on data protection and data privacy, and the values and principles outlined in this
Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a whole, and the foundational values and
principles are to be understood as complementary and interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
36
prejudicing Member States' obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or perform
any act contrary to universal human rights and, fundamental freedoms; and other concerns for,
human dignity, and concern for and the environment and ecosystems.
37
AUSTRIA/AUTRICHE
General comments by Austria
UNESCO First Draft of a Recommendation on the Ethics of neurotechnology
1. We appreciate the opportunity to comment and would like to offer the following
general observations, supplemented by specific comments and proposed
amendments to the First Draft, as outlined in Doc SHS/BIO/AHEG-Neuro/2024/2
(hereinafter referred to as the “First Draft”). This contribution is the result of a
multistakeholder consultation involving experts and stakeholders from government,
the private sector, research institutions, academia, and civil society groups in Austria
and beyond.
2. Austria welcomes the initiative to undertake global and inclusive ethical reflections
on the enormous implications of neurotechnology. These implications touch on
international peace and security, human rights, democracy, the rule of law,
sustainable development, health, science, education, labour markets, the economy
and society, if not humanity, at large.
3. We commend the Ad Hoc Group for their dedicated efforts in drafting a
comprehensive document. The text, however, would benefit from greater focus and
streamlining, as well as clearer definitions and conceptual clarity. We advocate for a
strong, effective, precise and operational instrument that avoids details, which could
detract from addressing the most urgent and critical leverage points requiring joint
action. In addition, granular specificity across interdisciplinary domains makes it
difficult for the intergovernmental committee to achieve consensus within a limited
timeframe. We suggest revising the text accordingly, in particular the areas
dedicated to policy action.
4. The current First Draft mixes ethical language with human rights terminology. It is,
however, essential to achieve conceptual clarity, particularly in distinguishing ethical
concepts from established human rights. To maintain clarity in the application of
international law, we suggest consistently distinguishing between ethical goods
(which are not legally enforceable rights) and universally recognized human rights;
or, as applicable, international humanitarian law. We have applied this principle
throughout our proposed amendments to the First Draft. Additionally, we
recommend consistently referring to "international human rights law" and using the
term "law" rather than broader terms like "norms" (e.g., point 74).
5. In this regard, we are concerned about the introduction of new concepts, such as
"mental privacy," which appear to be framed as emerging human rights but are
better understood as ethical considerations. Austria recommends avoiding any
impression that this instrument intents to create new rights, as this could
inadvertently undermine the existing human rights framework. The existing legal
concept of the “right to privacy”, as set out in international human rights law, fully
accommodates “mental” (or internal) aspects of privacy, thus making the concept of
“mental privacy” at best superfluous; at worst it suggest that current law does not
cover these concerns (and therefore new rights are needed).
6. A notable example of this lack of clarity arises in the chapter on Self-determination
and Freedom of Thought. It is unclear whether “self-determination” refers to an
ethical value, such as autonomy in decision-making or free will, or to the” right of
peoples to determine their political, economic, social, or cultural development” as
defined under international law, in particular Art 1 of the UN-Charter and the two
human rights convenants. We propose therefore a different wording.
38
7. We also recommend refining the text's definitions. The current definition of
“neurotechnology” refers broadly to activities relating to the brain, but also includes
tools that measure physical, chemical, and biological signals associated with the
nervous system’s structure and function. Similarly, the definition of “cognitive
biometric data” appears overly narrow, as mental states can also be inferred from
affective or conative states. To ensure alignment with the broad definition of
neurotechnology, we propose removing “cognitive” and adopting a more inclusive
term to reflect the full spectrum of related activities and data. The further
specification of “cognitive biometric” is problematic in our view because it does not
differentiate between “emotional biometric” and “cognitive biometric” data, which is
by no means purposeful or conducive. If one were to differentiate further, there is a
need to define a range of biometric data, such as “emotional biometric”, “intentional
biometric”, “cognitive biometric” and “intentional biometric”, ‘motivational
biometric’, etc. In light of this, we would propose to use the more general definition
“biometric data”.
8. As for the definition of “biometric data”, we would like to propose the following
definition: “personal data resulting from specific technical processing relating to the
physical, physiological or behavioural characteristics of the natural person, which
allow or confirm the unique identification of that natural person, such as facial
images or dactyloscopic data”. (cf. Biometric Recognition and Behavioural Detection
Assessing the ethical aspects of biometric recognition and behavioural detection techniques
with a focus on their current and future use in public spaces | Think Tank | European
Parliament)
9. Another example of a lack clarity is paragraph 79, which addresses various impact
assessment tools. The current text implies multiple options, making it overly complex
and impractical. Aligning with existing assessment frameworks would simplify these
tools and enhance their applicability.
10. While we recognize the potential benefits of neurotechnology in the health sector,
we are concerned about the largely unregulated domain of commercial applications
for healthy individuals, in particular what is discussed under “human enhancement”.
We therefore deeply regret that insufficient attention is being given to “neuro-
enhancement,” an area where risks remain largely unregulated and much of the
current hype occurs. It is unclear why the chapter on enhancement was so
significantly reduced compared to earlier drafts. Given the increasing prevalence of
devices promising better sleep, improved performance, and other augmentations,
this topic demands more robust representation in the Recommendation. Previously
included sections on policies, autonomy principles, research support, and safety
testing respectively effective safeguards have been omitted entirely. Now is the time
to define appropriate recommendations. We strongly encourage reinstating the
missing paragraphs to ensure adequate coverage of these critical issues.
11. Furthermore, of particular concern are the exaggerated expectations fuelled by the
vested interests of industries promoting commercial, non-medical neurotechnology
devices. We believe the First Draft should address the risks associated with these
issues more explicitly. Exaggerated expectations distort public understanding of the
current state of the science, fostering false expectations across society. While these
“hypes” may attract investments and drive market decisions, they also risk
concentrating resources in a few dominant companies, leading to unhealthy
dependencies. At worst, these inflated expectations could trigger a "neurotech
39
winter," similar to what AI research has experienced during cycles of hype and
subsequent disillusionment, resulting in reduced funding and interest.
12. A related and underexplored issue is “neuro-enchantment,” a phenomenon rooted
in the high regard for neuroscience as a discipline and the persistence of so-called
“neuromyths” – widely held yet scientifically inaccurate beliefs about the brain. This
phenomenon fosters an uncritical acceptance of neurotechnology products that
claim to measure, stimulate, or interact with the brain. The allure of these promises
diminishes critical thinking and amplifies susceptibility to manipulation. Evidence
demonstrates how neurotechnology can profoundly influence human perception,
agency, and the sense of free will. We recommend further research into these risks, a
need that should be reflected in the First Draft.
13. Moreover, a misplaced trust in neurotechnology can have severe consequences, inter
alia, in sensitive fields such as law enforcement and justice. Neurotechnology devices
have been deployed despite insufficient evidence of their reliability and practical
impact. We, therefore, commend the clear articulation of “red lines” in paragraph
73 and strongly advocate for their retention.
14. We are equally concerned about the lack of global discussions regarding the
application of neurotechnology in the military and security domain, particularly
when combined with other advanced technologies such as Artificial Intelligence and
quantum technologies. We feel strongly that a lack of attention to “dual-use
concerns” is not justified in view of the risks. We propose wording that makes clear
that states have a duty to ban applications that are not compatible with international
humanitarian law and / or international human rights law.
15. The First Draft disproportionately emphasizes the individual level while neglecting
societal and environmental dimensions. Neurotechnologies are already shaping new
societal norms, where self-optimization takes precedence over broader
organizational and institutional goals. This raises questions about how these
technologies co-construct societal understandings of disability. Furthermore, the
assumption that identities and personalities are “stable” and “fixed” that is
underpinned by many neurotechnological developments ignores the complexity of
human dynamics and emotions. Neurotechnologies also categorize emotions and
mental states as “desirable” or “unacceptable” in various societal contexts, shifting
the responsibility for managing these states onto individuals. This trend encourages a
focus on personal performance at the expense of systemic considerations.
16. Policymakers should also critically examine how market concentration and the
dominance of a few tech companies are gaining disproportionate power across
societal domains, potentially threatening social cohesion and democracy as well as
equitable access to these innovations for public benefit.
40
Comments and amendments put forward by Austria Formatiert: Links
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
PREAMBLE
Recognizing the enormousprofound and dynamic impacts of neurotechnology on human
mindhealth, lives andhuman flourishing, and societies, human rights, the environment, and
ecosystems, Kommentiert [RC<UP1]: Alignment with Art 1.
Considering the major and growing global prevalence of neurological and mental health
conditions, along with the profound suffering they cause for individuals and societies worldwide,
Given Acknowledging the potential of neurotechnology to record and interfere with activity of the
nervous system,
Acknowledging that neurotechnologies offer innovative solutions and deliver better preventive and
therapeutic treatments for millions, benefitting humanity as a whole and providing opportunities for Kommentiert [RC<UP2]: From our perspective, this
health improvements in all countries, statement is not sufficiently reliable and “for millions”
should therefore be deleted, as it suggests an
Considering that neurotechnology developed for health purposes can be used infor unintended expectation of salvation.
mannerspurposes, and that realising responsible innovation in neurotechnology will require concerted action
across governmental levels and across the public and private sectors, including academia and civil society,
and that the principles set out in this Recommendation are accordingly relevant to actors in all of t hese
settings;
Anticipating the risks and danger of abuse of neurotechnologies, such as surveillance and,
cognitive and emotional manipulation
1. Recommending a critical appraisal of the emergence of sources of bias like neuromyths and
neuroenchantment,, as well as adverse impact of excessive market concentration that give rise Kommentiert [RC<UP3]: See Explanation General
to profound questions about our collective vision for education, work, and social relationships, Comments - The term neuroechantment describes an
overwhelmingly positive bias towards
as well as equitable access to these innovations for public benefit neurotechnologies that informs attitudes, decision
making and public communication. Since
,. neuroenchantment perpetuates neuromyths, better
Also considering that neurotechnology raises fundamental questions related to human dignity and understanding of its mechanisms through independent
research is required.
human rights, such as right to privacy, freedom of thought, as well as the right to equality; as well
as to fundamental ethical, legal, societal issues , such as for instance regarding self-determination,
autonomy, privacy, personal identity, democracy, freedom of thought, risk of discrimination,
inequality and challenges to democracy, and that justice, trust and fairness must be upheld Kommentiert [RC<UP4]: The amendments aim to
make, on the one hand, a dogmatic distinction between
Reaffirming that so that no country and no one should be left behind, either by having fair access human rights law as universally recognized in the
to neurotechnology and enjoying their benefits or in the protection against their risks, while human rights treaties; and to refer to the broader ethical
recognizing the different circumstances of different countries and respecting the desire of some values and society objectives such as democracy,
people not to take part in all technological developments, social cohesion, justice, fairness etc. on the other
Kommentiert [RC<UP5]: The principle of “no one left
behind” is a different principle than a human right or an
ethical value, but a political commitment that states
have made in the Declaration on Sustainable
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security Development: it is important to set it apart and make the
by promoting collaboration among nations through education, the sciences, culture, and political commitment stronger ie “reaffirming”
communication and information, in order to further universal respect for justice, for the rule of law
and for the human rights and fundamental freedoms which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human rights,
as well as gender equality, social and global justice and sustainable development, physical and
mental well-being and health, diversity, interconnectedness, global solidarity, fairness, non-
41
discrimination, inclusiveness, and environmental and ecosystem protection, can guide
neurotechnology in a responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
Guided by the purposes and principles of the Charter of the United Nations, Kommentiert [RC<UP6]: The amendment aims to
reajust the structure to bring the legal elements together
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law, in
particular international humanitarian and human rights law. Kommentiert [RC<UP7]: This amendment is meant to
ensure that international law applies in general, and
Noting that ethical guidelines, frameworks and open science promote innovation, development and specifically for situation where IHL and human rights
policies aligned with international human rights law, apply.
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General “to prepare a standard-
setting instrument on the ethics of neurotechnology in the form of a recommendation”, which is to
be submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
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Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration
on the Responsibilities of the Present Generations Towards Future Generations (1997); the
Universal Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on
the Rights of Indigenous Peoples (2007); the United Nations General Assembly Resolution on Transforming
our world: the 2030 Agenda for Sustainable Development (A/RES/70/1) (2015); the Declaration of Ethical Kommentiert [RC<UP8]: Important reference work
Principles in relation to Climate Change (2017); the Recommendation on Science and Scientific (also included in the Ai ethics Recommendation
Researchers (2017); the Recommendation on the Ethics of Artificial Intelligence (2021); the
Recommendation on Open Science (2021); the Human Rights Council’s resolution on “The right to Formatiert: Hervorheben
privacy in the digital age” (A/HRC/RES/42/15) (2019); the Human Rights Council’s resolution on
“New and emerging digital technologies and human rights” (A/HRC/RES/41/11) (2019), and the UN Kommentiert [RC<UP9]: Update needed
Guiding Principles on Business and Human Rights (2011), Pact for the
Future (Resolution A/RES/79/1) Kommentiert [RC<UP10]: Relevant in this context
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to AI-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX day
of November 2025;
2. Recommends that Member States, with the support of UNESCO’s Secretariat, apply the
provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other measures may be required, in conformity with the constitutional practice
and governing structures of each State, to give effect within their jurisdictions to the
principles and norms of the Recommendation in conformity with international law, including
international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development and
use of neurotechnology are guided by both sound scientific research as well as ethical
analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
I.1. SCOPE
This Recommendation:
1.2. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing, on societies and on the enjoyment of
human rights, the environment and ecosystems. Kommentiert [RC<UP11]: Alignment with Preamble
2.3. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (DTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
Kommentiert [RC<UP12]: In line with para 7
3.4. Focuses on the impact on humans and societies only but acknowledges important Kommentiert [RC<UP13]: “environment” so that it
considerations that apply to animals and the environment in research. matches the next paragraph and is consistent.
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4.5. Approaches neurotechnology ethics as a systematic normative reflection based on a
holistic, multicultural, multidisciplinary, pluralistic and evolving framework of interdependent
values, principles, and actions that can guide societies in dealing responsibly with the known and
unknown impacts of neurotechnology on human beings, societies, and the environment and
ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the
prevention of harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from
neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology and other disciplines.
5.6. Covers the measurement, recording, and modification of the human nervous system,
the handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive mental states. Kommentiert [RC<UP14]: Includes cognitive &
affective and is therefore more comprehensive. The text
6.7. Recognizes that interventions involving the nervous system are very sensitive because itself always refers to mental states. Should be made
the highly complex human nervous system is the coordinating centre of behaviour and mental consistent
processes. It enables the exercise of individual autonomy, including the freedom to make one’s Formatiert: Hervorheben
own choices self-determination, the capacity to act as moral agents, to be responsible for actions, Kommentiert [RC<UP15]: We will explain below why
cooperate with others, deliberate about collective decisions, as well as oneself and develop we feel the term “self determination” can be
personality. misunderstood and thus propose to introduce clear
legal language that is already used in international law,
7.8. Further recognizes that humans develop and flourish in their interaction with other concretely in Art 3 of the Convention on the Rights of
Persons with Disabilities. There we speak of :
human beings and a nurturing material and cultural environment, highlighting that autonomy is a.“(…), individual autonomy including the freedom to
not just individual but also relational, as it arises from and impacts one’s interactions and make one's own choices, (…);
b.The term “autonomy” is even mentioned clearly in
belonging with the community. para 44 (and no further mention of “self-
determination”.
8.9. Addresses the ethical and human rights concerns that arise from the rapid
developments and the convergence of neurotechnology with other technologies such as spatial
computing, extended reality (XR), artificial intelligence (AI), sensors and semi-conductors. Formatiert: Hervorheben
Notably, other biometric data when processed to infer sensory, motor, and mental states raises
Formatiert: Hervorheben
similar ethical concerns. Therefore, this Recommendation applies to both neurotechnology and
the use of cognitive biometric data, ensuring that ethical principles and practices are consistently Kommentiert [RC<UP16]: The further specification of
applied across these domains. “cognitive biometric”
is problematic in our view because it does not
9.10. Further addresses the integration of AI with neurotechnology, which can enhance differentiate between “emotional biometric” and
“cognitive biometric” data, which is by no means
precision and predictive capabilities, such as improving processing speed, reducing cost, purposeful. If one were to differentiate further, there is a
optimizing neurotechnology systems. However, it also magnifies ethical threats, including need to define a range of biometric data, such as
“emotional biometric”, “intentional biometric”, “cognitive
cybersecurity concerns, lack of transparency, the potential for algorithmic bias, and risks to
biometric” and “intentional biometric”, ‘motivational
autonomy, the right to mental privacy and of manipulation. biometric’, etc. In light of this, we would propose to use
the more general definition “biometric data”.
I.2. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical, legal, societal, security and human rights challenges risks and threats
that come with the military and security applications of neurotechnology. Calls on all Kommentiert [RC<UP17]: Here we should be talking
concerned to act responsibly with regard to neurotechnology. about the human right to privacy as laid down in Art 17
ICCPR
I.2. Kommentiert [RC<UP18]: That thought should be in
the Preamble, therefore see new PP5.
I.3. DEFINITIONS
10.11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include cognitive,
affective, and conative states), and supports consciousness, sleep and the experience of pain.
The nervous system activity and structure provide information inherent to all human beings and
the community, regardless of gender, ethnicity, language, or religion. The nervous system activity
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is also instrumental in social and cultural interactions.
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11.12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures—
encompassing both hardware and software—that directly access, monitor, analyze, predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity,
function, or intentions (speech, motor). Neurotechnology combines elements of neuroscience,
engineering, and computing, among others.
12.13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction with the
nervous system or by interfacing it with devices and systems. It includes but is not limited to:
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical,
optical, magnetic and/or mechanical), chemical and biological signals associated
with the structure of and functional signals from the nervous system. These may
be used to identify, record, and/or monitor properties of nervous system activity,
understand how the nervous system works, diagnose pathological conditions, or
control external devices (brain machine interfaces (BMI), often referred to as brain
computer interfaces (BCI)), Neurofeedback (NF)B. Of note, both open-loop (i.e., Kommentiert [RC<UP19]: With NF, unlike BCI, no
fixed-parameter brain stimulation) and closed-loop systems (i.e., state dependent external devices are controlled, but feedback is
received about the user's own brain activity with the aim
stimulation) introduce complex ethical issues. of adapting it to a desired goal. This results in other
fields of application (especially in the area of
(i). Examples include but are not limited to Electroencephalography enhancement), other opportunities and possible
(EEG), Magnetoencephalography (MEG), Magnetic resonance consequences that need to be considered.
imaging (MRI), Functional Magnetic resonance imaging (fMRI),
Positron emission tomography (PET), Functional Near-infrared
spectroscopy (fNIRS), Implanted microelectrodes, Optogenetics,
Optical imaging, Diffusion weighted imaging, Calcium imaging,
Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for
example, to restore sensory input, such as hearing (i.e., cochlear implants) or
Deep Brain Stimulation (DBS) to treat tremors and other pathological conditions.
They are meant to either modulate the functions of the nervous system and/or
send signals directly to the nervous system by applying acoustic, electrical,
magnetic or optical stimulation and/or inhibition of the peripheral or central nervous
system.
(i). Examples of this neurotechnology are implanted microelectrodes,
BMI, DBS, Optogenetic optical stimulation, Transcranial electrical
stimulation (tES), Transcranial Magnetic Stimulation (TMS) or
Neuropharmacological infusion.
13.14. Of note, several sensor technologies collect data indirectly informing about neural Kommentiert [RC<UP20]: Allows for a broader scope
activity. Even if they are not neurotechnology per se, they raise similar ethical and human rights
issues as neurotechnology when used to infer mental states, regardless of whether these are
made possible by combinationsthe convergence of several technologies or by individual
technologies. They include but are not limited to eye-tracking, Video Oculography, Typing
dynamics, Voice recognition and analysis, Gait analysis, Skin conductance, Heart rate variability,
Sleep movement monitoring, Blood pressure measurement, or facial- emotion recognition
systems.
14.15. Neural data. Neural data are qualitative and quantitative data about the structure,
activity and function of the nervous system. They encompass data relating to a nervous system’s
activity, including both direct measurements of neuronal structure, activity and/or function (i.e.,
neuronal firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e.,
blood flow in fMRI and fNIRS). At the neurobiological level, neural data are the most direct
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correlates of mental states.
15.16. Cognitive Biometric Data. personal data resulting from specific technical processing relating
to the physical, physiological or behavioural characteristics of the natural person, which allow or confirm
the unique identification of that natural person, such as facial images or dactyloscopic data Neural data,
along with data collected by non-neural biometric technologies can be processed to infer mental
states, which this Recommendation refers to as “cognitive biometric data”. Kommentiert [RC<UP21]: We propose a more
comprehensive definition Mental states are not only
16.17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining cognitive, but also affective (also mentioned conative
for materials, prototyping, research, design and development to deployment and use, including above), so cognitive biometric data alone does not
include everything. As explained, we feel the
maintenance, operation, trade, financing, monitoring and evaluation, validation, end-of-use, introduction of the term "cognitive biometric data" in text
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology is unpersuasive. Conceptually, this newly coined
category feels disconnected from the draft's objective
includes its convergence with other technologies and the diversity of actors who are involved in
and its title ‚Recommendation on the Ethics of
every stage. Neurotechnology‘.
II. AIMS AND OBJECTIVES
17.18. This Recommendation has been created with the aim of guiding the development and
use of neurotechnology in ways that are ethical, safe, trustworthy and effective for the good of
humanity, individuals, communities, societies, the environment and ecosystems, and to prevent
harm in the present and the future based on international law, in particular the Charter of the
United Nations, the Universal Declaration of Human Rights and international human rights law.
18.19. The objectives of this Recommendation are: Kommentiert [RC<UP22]: This statement is in our view
not entirely correct. Studies have shown that a more
(a) to ensure the protection, promotion and respect of human rights and fundamental reliable, accurate and direct correlate is rather
freedoms, human dignity and equality, including gender equality, and to respect manifested behavior from which mental states can be
inferred . We therefore propose to delete this sentence.
cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities,
institutions, private sector companies and every other relevant actor to ensure the
embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable
and reproducible;
(d) to provide a universal framework that not only articulates values and principles,
but also translates into concrete policy recommendations and effective
implementation to guide Member States in their engagement with
neurotechnology in its whole lifecycle, consistent with their obligations under
international law, in particular international humanitarian and human rights law and
other international standards;
(e)(d) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and
consensus building about ethical issues relating to neurotechnology;
(f)(e) to promote justice and equitable access to developments and knowledge in the
field of neurotechnology and the sharing of benefits;
(g)(f) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.values and
principles, as set forth in this Recommendation Kommentiert [RC<UP23]: amendment aims to make
clear what “standards” we are talking about
III. VALUES AND PRINCIPLES
III.1. VALUES
III.1.1. Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
19.20. The inviolable and inherent dignity of every human being is the foundation of universal
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human rights and fundamental freedoms. Respect,
- protection, and promotion of human dignity
and human rights ,
as established by international human rights law, are essential in the whole lifecycle of
neurotechnology. Dignity encompasses includes the recognition of the intrinsic and equal worth
of each person. Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including people living in
vulnerable situations.
III.1.2. Promoting human health and well-being
20.21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical,
mental, and social well-being.
21.22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the
largest number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
III.1.3. Ensuring and respecting diversity and fairness
22.23. Respect for diversity and fairness, must be upheld in the whole lifecycle of
neurotechnology. Special consideration should be given to neurodiversity, minority groups,
Indigenous Peoples, marginalized and underrepresented voices.
23.24. Given that widely recognized neurotechnological innovation largely occurs in the urban
well-resourced sector, specific attention to underserved and marginalised people is crucial to
prevent bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological
assimilation, or using technology as a tool of colonisation (a term the Recommendation refers to
as “technological colonialism”), can threaten cultural diversity and heritage, therefore must be Kommentiert [RC<UP24]: This is the only reference in
protected against. the text, we therefore recommend to delete it.
24.25. Equitable access to neurotechnology should be prioritized globally, ensuring that its
benefits are accessible to all, regardless of socioeconomic status or geographical location.
Special attention must be given to low- and middle-income countries, resource-constrained
settings, and marginalised communities, including the specific needs of different groups, ages,
segments, cultural systems, languages, communities, and marginalised and vulnerable
populations, people with disabilities, neurological disorders, and mental health conditions.
25.26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided that
these choices are made in ways that respect the rights of others.
III.1.4. Consideration for cross-cultural perspectives on human knowledge and its sharing
26.27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
27.28. It is essential that any research and development involving diverse groups and
communities is done with their permission and guidance, and conducted with their full prior and
informed consent and partnership in ways that serve their interests and respect their traditional
knowledge and epistemic contributions.
III.1.5. Commitment to peace, fairness and justice in society
28.29. The use of neurotechnology should be used to promote, not undermine freedom of
thought, especially in situations where refusal to use the technology could lead to competitive
disadvantage. Such interferences include, but are not limited to, the use of force, threats,
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undisclosed access, manipulation, or any scenario where consent is compromised, including as
a result of power imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that Formatiert: Listenabsatz, Einzug: Erste Zeile: 0 cm,
segregate, objectify or subordinate individuals or communities, reduce social cohesion by Nach: 0,63 cm, Abstand Vor: 5,85 Pt., Zeilenabstand:
exacerbating pre-existing inequalities or generating novel inequalities that divide and antagonize Mehrere 1,15 ze, Nummerierte Liste + Ebene: 1 +
Nummerierungsformatvorlage: 1, 2, 3, … + Beginnen bei:
individuals or communities against each other, and thereby threaten the coexistence between
1 + Ausrichtung: Links + Ausgerichtet an: -1,12 cm +
humans, other living beings and the natural environment. Einzug bei: 0,39 cm, Tabstopps: 1,89 cm, Links
31. Furthermore, neurotechnology is already shaping new societal norms, where self-optimization
takes precedence over broader organizational and institutional goals. This raises questions about how
these technologies co-construct societal understandings of disability. By overlooking the complexity of
human dynamics and emotions and assigning value to certain emotions and mental states this trend
shifts the responsibility for managing these states onto individuals encouraging a trend on personal
performance at the expense of systemic considerations.
29. Formatiert: Einzug: Erste Zeile: 0 cm
III.1.6. Global Solidarity and International Cooperation
30.32. The Recommendation should guide all actors in the development, deploymen,t and use
and evaluation of neurotechnology to act in solidarity and call for accountability in instances
where neurotechnology may be misused in ways that threaten international law, in particular
international humanitarian and human rights law .
31.33. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use
to prevent abuse and uphold global ethical standards, as set forth in this Recommendation.
III.1.7. Sustainability
32.34. Considering that sustainability requires that neurotechnology be developed and used
with a deep respect for environmental stewardship, prioritizing the minimisation of ecological
harm throughout the lifecycle of the materials used, including, for mining extraction, data
processing and storage, recycling and disposal practices.
33.35. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
34.36. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP), requires that neurotechnology, through its whole
lifecycle, be guided by a profound respect for Indigenous rights, ensuring that their lands
(including during mining), knowledge, communal rights, and privacy are honoured in all activities,
including those related to resource extraction.
III.1.8. Integrity and Responsibility
35.37. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with
ethical steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align
with both professional standards and societal values.
36.38. Integrity includes a commitment to taking responsibility for one’s actions and being
accountable for their outcomes. This involves not only acknowledging successes but also owning
up to mistakes and taking corrective actions when necessary.
37.39. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-
based, objective and transparent research practices. It ensures that all scientific endeavours are
conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant
for neurotechnology.
III.2. ETHICAL PRINCIPLES AND HUMAN RIGHTS
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38.40. This Recommendation embraces a -human rights-based and human-centred approach
through fundamental ethical principles including but not limited to self-determination, agency,
freedom of thought, privacy, cognitive liberty, personal and collective identity, trustworthiness,
respect, reciprocity, and justice. Furthermore, it incorporates the respect, promotion and
protection of human rights, including freedom of thought, freedom of expression and the right to
privacy. Kommentiert [RC<UP25]: important to make the
distinction between ethical values and the established
III.2.1. Beneficence, Proportionality and Do No Harm framework of human rights law.
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39.41. Neurotechnology should promote health and well-being, and empower individuals to
make informed decisions about their nervous system and mental health while fostering a better
understanding of themselves.
40.42. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally. The
“do no harm” principle must guide the whole lifecycle of neurotechnology, ensuring that the
quality of life is protected and promoted.
41.43. Embracing neurotechnology for enhancement may lead to the risk of not only
unexpected damage to the nervous system, but also to amplified inequalities within society.
42.44. Any restrictions to human rights must meet all applicable requirements under human
rights law, including the principles of legality, legitimate aim, necessity and proportionality.
43.45. The principles of proportionality, balance and legitimacy should govern the use of Kommentiert [RC<UP26]: It is not clear whether we
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional talk about the same principles. Is this going beyond the
standard human rights test ?
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon the
foundational values of this document; (c) appropriate to the context and target user group; Kommentiert [RC<UP27]: The right to self-
(d) based on safety principles and rigorous scientific evidence. determination refers to a collective ie group right by
virtue of which they freely determine their political status
III.2.2. Self-determination and Freedom of Thought and Expression; Individual Autonomy and freely pursue their economic, social and cultural
development. Is “self-determination” meant by this or
rather the right to think freely as explained further in
a. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the rights para 44? If the latter meaning is meant the term “self-
determination” would be a tautology and thus
of freedom of thought and expression , an as well as individual dautonomy, including the
superfluous because the right to freedom of thought is
freedom to make one's own choices self-determination must be secured. already defined as “All persons have the right to think
freely, and to entertain ideas and hold positions based
on conscientious or religious or other beliefs.” . If the
44.46. Individuals have the right to make free, informed, and voluntary decisions about their purpose was to say that people have the right to think
engagement with neurotechnology throughout the whole lifecycle, in accordance with what they want to think and freely express it, it would be
international human rights law and other international standards, including the right to refuse or more appropriate to talk about freedom of thought and
expression. In the para it is even explained as : “This
withdraw from its use, at any time, ensuring their autonomy and respect for their decision-making protection covers both the internal processing of
capacity is upheld and where surrogate consent is used, the best interests of the affected thoughts and their external expression, ensuring
freedom from any interference.”
individual are considered. Individuals who are enrolled in research should be informed of
potential side effects and given the opportunity to disclose if they have any contraindications for
Kommentiert [RC<UP28]: To avoid the problem of the
the procedures used. Informed consent procedures should be affirmative, dynamic, and require term “self-determination” in the context of a right to
opt-in, comprehensive and transparent providing detailed information about the purposes, risks, freedom of though as explained above, we propose the
term “individual autonomy” – This term has been
benefits, alternatives, and possible outcomes of the technology in all its application domains, acknowledged in Art 3 of the Convention on the Rights
ensuring that consent is voluntary and that individuals fully understand the implications for their of Persons with Disabilities which reads:
rights to privacy and the right to, freedom of thought and expression as well as the principle of c.“(…), individual autonomy including the freedom to
make one's own choices, (…); The term “autonomy”
individual autonomy, and well-beingflourishing. is even mentioned clearly in para 44.
45.47. Neurotechnology should never be used to exert undue influence or manipulation,
Kommentiert [RC<UP29]: Definition problems – the
whether through force, coercion, or other means that compromise self-determination andand the definitions could be streamlined and clearer. Biometric
freedom of expression and freedom of thought. This protection covers both the internal data covers cognitive, behavioural and affective data,
processing of thoughts and their external expression, ensuring freedom from any interference. including neural data.
Kommentiert [RC<UP30]: Data Protection is simpler
III.2.3. Data Protection of Neural and Cognitive Biometric Data forand the Right to Mental and clearer in legal termins
Privacy
Kommentiert [RC<UP31]: Again, we ask for clarity in
46.48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the respect of the distinction between ethical value or a
right to privacy due to their increasing ability to collect direct and indirect data about the nervous human right. There is no human right of “mental
privacy”. It is simply the right to privacy as stipulated in
system that is uniquely sensitive because they can be processed and analysed to provide deep Art 17 of the ICCPR which covers the right to be
insights into the processes that underpin our mental states and behaviour, including self- protected against harm tp both psychological, mental
and physical integrity. Introducing “mental privacy” as a
awareness and introspection. As it becomes increasingly difficult to anonymize data, there new human rights concept would suggest that the inner
remains persistent risks of misuse of this data by revealing neurobiological correlates of (mental, psychological) component of integrity is not
protected by existing human rights law. But courts all
diseases, disorders, or general mental states without the authorization of the person from whom
over have clarified this for many years. In the following
data are collected. para it is clearly set out that we talk about “the right to
privacy” .
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agency. The collection, processing, modification,
- and sharing of neural biometric data must be
conducted with free and informed consent, in ways that respect human rights law and the ethical
and human rights principles outlined in this Recommendation. Kommentiert [RC<UP32]: In order to make a clear
distinction between the two
48.50. There should be clear safeguards against the misuse or unauthorised access of neural
and cognitive biometric data, including affirmative consent, data minimization and purpose
specificationlimitation, data rights (such as rights to access, correct and delete), and data Kommentiert [RC<UP33]: We propose to replace with
security, particularly in contexts where such data might be aggregated with other sources. ‚purpose limitation‘ as it is a more comprehensive term,
including that data is collected for specified, explicit, and
III.2.4. Non-Discrimination and Inclusivity legitimate purposes.
49.51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface
with other technologies like AI, must commit to upholding ethical principles and human rights law
that prevent discrimination, stigmatisation, targeting, or exploitation of any individuals or groups,
particularly those in vulnerable situations.
50.52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or
mental characteristics, or other grounds protected under human rights law.
51.53. Non-inclusive technological development and standardisation may drive a trend toward
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural
and collective identity.
52.54. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their input and
validation to align these technologies with societal values and the common good.
53.55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
54.56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or
discrimination against older persons. Kommentiert [RC<UP34]: A restriction to elder people
would not make sense. We have a whole chapter on
III.2.5. Accountability that particular group. In order to avoid a singling out of
one group only we prefer a deletion of this . Alternative
55.57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology one could say discrimination against any other group
requires all actors to adhere to the highest ethical standards and human rights law, remain open protected by human rights law.
to feedback, be committed to adjusting practices in response to new evidence or ethical
concerns, and be held accountable for their actions.
56.58. Accountability is grounded in responsibility, clear and transparent communication, and
a duty to anticipate and address potential harms—whether short-term, long-term or arising from
unintended use and impact.
57.59. A commitment to accountability requires global, governmental, societal and collective
action to ensure those harmed by neurotechnology have access to justice, and that those
responsible for wrongdoing are required to take meaningful steps to identify, prevent, mitigate
and account for how they address and redress their adverse human rights impacts, including
through corrective actions and reparations.
III.2.6. Trustworthiness and Transparency
58.60. To guarantee the respect, promotion and protection of human rights and fundamental
freedoms, all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international
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principles of responsible conduct and scientific integrity. This includes preventing the replication
or amplification of biases, ensuring that neurotechnology is traceable and explainable, its
capacities and limitations are accurately portrayed, the conditions for accountability are clearly
defined, adhering to ethical guidelines in research and development, including the registration of
trials, fair participant selection, and approval by independent ethics committees.
III.2.7. Epistemic Justice, Inclusive Engagement and Public Empowerment
59.61. Ensuring fair and equitable distribution and creation of knowledge about
neurotechnology, including recognizing diverse ways of knowing, and that all individuals and
communities can participate in its creation, sharing, and applications.
60.62. Promoting open and accessible education, along with public and community
engagement, to ensure diverse populations can gain and exchange knowledge about nervous
system functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
61.63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and Kommentiert [RC<UP35]: The comma makes all the
identity, to respect different ways of knowing and understanding. This respect for diversity difference. It needs tob e deleted otherwise the
sentence does not make sense
ensures that the knowledge and perspectives of diverse communities are valued and included in
decision-making processes, and respects self-determination. Kommentiert [RC<UP36]: As explained above, self
determination in this context could refer to the right to
62.64. Grounding education in human rights ensures that the knowledge shared and produced self determination which is a political right for special
respects the rights of all individuals and communities, preventing epistemic injustice where certain groups. If the content is needed – I don’t think it adds
value – then an alternative could read: “ and respects
groups may be marginalized or excluded from knowledge production and dissemination. their decision-making autonomy.”
63.65. All communities should have a voice in decisions that affect them, particularly when it Kommentiert [RC<UP37]: Such as indigenous peoples
comes to the development and use of neurotechnology.
III.2.8. Best Interests of the Child and Protection of future generations
64.66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve their rights, including their right to privacy,
freedom of thought and self-determinationright to be heard and the right of children and
adolescents to participate in decisions that affect them. Technology should be rigorously Kommentiert [RC<UP38]: The amendments bring the
assessed to ensure it serves the best interests, well-being and healthy development of children, language into line with the Convention on the Rights of
the Child (CRC). We would propose that language is
as they grow into autonomous individuals and safeguard the rights of future generations by aligned to the legal rights so as to underline that this are
ensuring that today’s decisions promote their future wellbeing. enforceable rights and not just ethical values. The right
to be heard - Art 12 CRC - is the corresponding right to
65.67. From an ethical perspective, while recognizing the potential benefits of neurotechnology “self-determination and the right to …participate in
decisions that affect them. It would be better not to
for early diagnosis, instruction, education, and continuous learning, it is equally important to make
make a distinction between children and adolescents.
a commitment to the holistic development of the child. This includes nurturing their social life, Under the CRC, “child” is a person under 18 years. We
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and understand “adolscents” as persons from 13-19.
physical activity.
III.2.9. Global and social justice, enjoying the benefits of scientific progress and its
applications
66.68. Access to and benefits arising from research and development in neurotechnology must
be shared equitably among all contributors to that research and development, with a particular
focus on ensuring global distribution that promotes fairness and reduces disparities.
67.69. Neurotechnology developments should be leveraged to reduce global health inequities.
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings.
68.70. Research, development, and trials in neurotechnology must adhere to the highest
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ethical standards, ensuring the non-exploitative participation of all individuals involved. This
includes safeguarding the rights and well-being of participants, and patients and their caregivers,
as well as ensuring the ethical collection and use of data. Special attention should be given to
ensure that those contributing to research and development have their fair share of the benefits
and do not bear disproportionately the risks.
69.71. Efforts, including international cooperation, should be made to overcome, and never
take advantage of, the lack of necessary technological or medical infrastructure, education and
skills, as well as ethical-legal orand legal frameworks, particularly in LMICs, LDCs, LLDCs and
SIDS, affecting communities.
70.72. The development and impact assessment of novel neurotechnology should consider the
implementation of human rights-based and human-centred paradigms in which end-users are
not merely passive recipients of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1. GOVERNMENT INVESTMENT, USE AND REGULATION
71.73. Member States, private actors and international institutions should actively support the
research, development, and deployment use of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
promotes and protects individual and collective human rights. This commitment should include Kommentiert [RC<UP39]: Covers both, avoids a
funding for interdisciplinary research that not only advances neurotechnological innovation but dogmatic discussion.
also studies the ethical, legal, social, environmental and cultural implications of these
technologies, and supports the implementation and clinical translation of technological
prototypes. Particular attention should be given to the development and implementation of
adequate technical, institutional, procedural and other safeguards to ensure that they equitably
benefit society and that human rights are upheld.
74. Member States should establish clear prohibitions against the development and use of
neurotechnology in contexts that violate individual and collective human rights where the use is
not in accordance with international law, in particular international humanitarian law and human
that are rights law; all other applications .should be appropriately regulated.
72.75. Member States should conduct human rights due diligence, including regular,
comprehensive human rights impact assessments, concerning neurotechnology that they
develop, design, deploy, use, sell, operate or procure, in order to prevent and mitigate their
adverse human rights impacts. Specifically, neurotechnology should not be used for purposes
such as non-consensual interrogation in law enforcement, criminal and civil justice, development
or deployment of weapons targeted at the nervous system, social control, attempts at coercive
behavioural conformity based on personal beliefs or thoughts, political or other opinion, gender
identity or sexual orientation, or surveillance of mental states, among others. Governments
should adopt legislation that ensures neurotechnology is deployed responsibly, and based on
human rights, with robust oversight mechanisms to enforce adherence to these restrictions and
protect the right to mental privacy and freedom of thought for all individuals. These policies should Kommentiert [RC<UP40]: This clarification makes sure
be developed in consultation with diverse actors, including civil society, end-users, that we are talking of a legally enforceable right and not
just an ethical concept.
neurotechnology experts, ethicists, and human rights advocatesdefenders, to ensure broad
consensus and respect for global universal international human rights lawnorms. Kommentiert [RC<UP41]: The termin human rights
defenders is used in international contexts, cf About
73.76. Member States should ensure transparency and accountability in their support, human rights defenders | OHCHR
oversight, and regulation of neurotechnology, particularly in publicly funded initiatives such as Kommentiert [RC<UP42]: Clarifies that we are
referring to the body of international law that is
brain research and development programs. While recognizing the limitations in disclosing certain accurately described as international or “universal
sensitive information, governments should require government sponsored neurotechnology human rights law”
projects to publicly disclose the objectives, methodologies, intended uses, and societal impacts
of their neurotechnology initiatives wherever possible. This transparency is crucial for fostering
public trust and ensuring that neurotechnology advances are aligned with ethical standards, as
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human rights law .
74.77. Member States should apply a comprehensive approach to regulatory and policy
measures to protect against human rights harms related to neurotechnology developed,
marketed, operated or used by the private sector. This includes legislative and regulatory
measures and accompanying guidance, incentives, and transparency requirements. This
comprehensive approach should also require human rights due diligence, ensuring that
businesses identify, prevent, mitigate, and account for their adverse human rights impacts
through context-dependent processes, including human rights impact assessments, meaningful
public and community engagement, and transparent communications.
75.78. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, be
implemented ethically and in accordance with human rights law, and be aimed at promoting public
safety while protecting the rights and dignity of all those involved. This requires respect for
fundamental rights, such as human dignity, the right to privacybodily integrity, confidentiality of Kommentiert [RC<UP43]: A common law concept that
personal data, due process and fair trial rights, including the presumption of innocence, and the as such is not the language used in universal human
rights law. But see below covered by existing rights.
right against self-incrimination, as well as freedom from torture or
to cruel, inhuman or
Kommentiert [ES44R43]: Including ‚privacy‘ here
degrading treatment or punishment.and ill-treatment, the right to privacy, and the right to would cover both
freedom of thought. Kommentiert [RC<UP45]: Bodily integrity and
confidentiality of personal data is wholly covered by the
76. Member States should establish comprehensive incentive structures, such as tax “right to privacy” as well as the prohibition of torture.
incentives, grants, and awards, with a particular focus on encouraging the construction and
development of manufacturing, computational resources, and data analytics capabilities within
public research institutions and small and medium enterprises (SMEs). Member States should
also incentivize and support partnerships that leverage the computational resources and data
analytics capabilities of private firms to advance public research goals. These incentives should
prioritize rewarding transparency, participatory development processes, and contributions to
societal benefits, aiming to foster an environment where public institutions and companies
innovate responsibly and align with human flourishing goals. Kommentiert [RC<UP46]: Too detailed. Dilutes the the
effectiveness of implementation
77.79. Member States should establish a coordinated, cross-sectoral approach to assessing
the impacts of neurotechnology across the whole lifecycle, including human rights impact
assessments. This approach should include, but is not limited to assessments of benefits and
risks, including risk of manipulation as well as on the impact on human rights, societal impact
and on sustainable development:Iwith particular attention to vulnerable people and people living
in vulnerable situations. It should include appropriate oversight and meaningful public and
community engagement to incorporate diverse perspectives. Kommentiert [RC<UP47]: This formulation covers all.
Privacy is part of human rights assessment. Impact on
(a) Economic Impact Assessments: Conducted by relevant national bodies jobs etc would be covered under societal impact and
responsible for economic and labor policies to assess how neurotechnology sustainable development that includes the economic,
social, cultural and environmental dimension.
impacts economic growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by scientifically informed entities responsible
for public health, medical research, and consumer protections, these assessments
should rigorously evaluate the risks and benefits associated with the development,
deployment, and use of neurotechnology, including research, clinical applications,
and consumer products. The process should include thorough documentation,
ethical oversight, and continuous monitoring to ensure the safety, well-being, and
equitable treatment of all individuals involved;
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these
assessments should evaluate and mitigate risks to individuals’ mental privacy
posed by neurotechnology. This includes ensuring that appropriate safeguards
are in place to protect neural and cognitive biometric data in compliance with
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(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology. The process should ensure
that neurotechnology respects and promotes human rights, with particular
attention to vulnerable people and people living in vulnerable situations. HRIAs
should involve meaningful public and community engagement to incorporate
diverse perspectives.
78. Member States should promote equitable access to neurotechnology worldwide. To
achieve such goals, efforts should be made to support the reduction of final costs for end users,
pursue the development, adoption and continuous support of non-proprietary software solutions, Kommentiert [RC<UP48]: Too detailed what are
and explore reimbursement strategies or subsidisation commensurate with conventions in local reimbursement strategies?
jurisdictions, in sectors of crucial potential benefits.
80. Member States should adopt agile regulatory frameworks, including the use of
regulatory sandboxes—controlled environments for developing, testing, and evaluating
neurotechnology—in response to rapid advancements in neurotechnology and its convergence
with other technologies such as AI, spatial computing, and immersive technologies. These
sandboxes should be used to explore innovative applications, particularly in workplace settings,
with appropriate ethical oversight provided by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure ethical data processing, and safeguard rights by
incorporating mechanisms for regular monitoring, evaluation, and dynamic policy adjustments in
line with technological and ethical developments.
79.
IV.2. DATA POLICY
80.81. Member States should develop a robust regulatory and legal framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data. This
and existing frameworks should recognize this data to be both personal and sensitive data in
medical and non-medical contexts.
81.82. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals’ neural and cognitive biometric data. If current policies do not
adequately address these areas, Member States should adopt targeted legislation or regulatory
frameworks to secure these protections. These safeguards should for example include
affirmative informed consent, data minimization and purpose limitation, data rights (including the
right to access, correct, and delete data), and stringent data security measures, such as
advanced cybersecurity protocols to prevent unauthorized access and breaches. Such legislation
or frameworks should prohibit the practice of tying access to goods or services to the disclosure
of neural and cognitive biometric data, require explicit opt-in for any data sharing, and forbid the
use of such data for targeted advertising without the individual’s explicit, affirmative informed
consent.
82.83. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and computing
resources used for processing and storage of neural and cognitive biometric data. These policies
should emphasise data minimisation, ensuring that only the necessary amount of data is
collected and processed, and promote the proportional use of neurotechnology, aligning its
deployment with genuine needs and minimising unnecessary environmental impact. Measures
should include optimising energy efficiency, using renewable energy sources, promoting the
recycling and sustainable disposal of neurotechnology-related equipment, and ensuring the
rehabilitation of affected environments.
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83.84. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of the right tomental privacy, such as state-of-the-art encryption, secure databases with multi-
factor authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
84.85. Member States should incentivise neurotechnology manufacturers to prioritize privacy
and ethics by design, requiring the incorporation of privacy-preserving technologies as default
features in their devices.
85.86. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories should
meet stringent cybersecurity, data privacy, and ethical use standards (including data minimisation
and purpose limitations), tiered access and other privacy-enhancing approaches. Appropriate
funding mechanisms should be established for the curation and maintenance of data and data
governance processes streamlined.
86.87. Member States should prioritize efforts to reduce obstacles to cross-border data sharing
in neurotechnology research, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive biometric data, by establishing clear protocols for
data transfer that ensure secure and compliant data exchanges across borders, and standards
for interoperability of data, including governance frameworks for data sharing.
87.88. Member States should consider specific guidelines for the ethical use of neural and
cognitive biometric data in AI development and research, including consent procedures for uses
of neural and cognitive biometric data in training and application of AI models, ensuring
transparency and respecting individual and community rights.
IV.3. INTELLECTUAL PROPERTY (IP)
88.89. Member States should adopt policies to ensure that neural and cognitive biometric data,
as individual human activity derivatives, are not subject to proprietary rights. IP protection should
only apply to original data compilations (created through a process of aggregation, organization,
or selection, resulting in a new dataset) that meet strict and ethical criteria.
89.90. Member States should collaboratively establish clear, harmonised guidelines for IP
rights applicable to neurotechnology on an international scale. These guidelines should address
the patentability of AI-generated inventions and the ethical implications of IP laws, ensuring they
promote global accessibility and innovation.
90.91. Member States should ensure that all actors adopt IP management strategies that
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility.
91.92. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors.
92.93. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing.
Particularly with the convergence of digital technologies and the increasing concentration of
those innovations in industry sectors, this balance is crucial to ensure that IP protection
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mechanisms do not hinder scientific research, innovation, and the wide dissemination of
knowledge and new technologies. As a basic rule of equitable partnership, when Indigenous
Peoples are involved in neurotechnology research and development, open science processes,
IP management strategy, should be developed in collaboration with them from the beginning.
IV.4. CYBERSECURITY
93.94. Member States should collaborate internationally to establish comprehensive standards
for cybersecurity across all neurotechnology domains. These standards should encompass
hardware, software, and data security measures to protect against potential cyber threats. By
implementing uniform cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural biometric data, as well as enhance user trust
and confidence in neurotechnology devices. Additionally, these standards should evolve in
tandem with technological advancements and emerging cyber threats to maintain robust
protection against evolving risks.
94.95. Member States should employ red-teaming exercises—adversarial challenges to test
the efficacy of security systems—as a proactive measure to assess and enhance the safety,
security, and resilience of neurotechnology systems. By conducting regular red-teaming
exercises, Member States should proactively identify and address security gaps, test incident
response procedures, and strengthen the overall safety and cybersecurity posture of
neurotechnology devices.
IV.5. COMMUNICATION, PARTICIPATION, AND INFORMATION
95.96. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
96.97. Member States should collaborate with international organizations, educational
institutions, and private and non-governmental entities to develop and disseminate accessible
and engaging educational materials tailored to diverse audiences to bridge knowledge gaps,
particularly in underserved regions about the nervous system and mental health functioning, as
well as the benefits and risks of neurotechnology . These programs should aim to increase public
understanding of the technologies’ functionalitypotential and limitations, safety, efficacy, and
human rights and societal impact, in order to mitigate the misleading effects of neuromyths
empowering individuals to make informed decisions, and to enable their ethical reflection about
their use of neurotechnology .
97.98. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a
wide array of actors. The aim of these engagements should be to inform policy development,
shape ethical guidelines, increase public awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment aligns with public interests and values.
Special attention should be given to involving groups traditionally underrepresented in
technological policymaking, thereby fostering responsible innovation in the field.
98.99. Member states should collaborate in the co-creation of accurate, precise, and accessible
language and terminology for discussing neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is inclusive, non-stigmatizing, and accurately
reflects the technologies’ capabilities and limitations. Member States should establish regulatory
frameworks that require clear and ethical communication standards for
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neurotechnology. These frameworks should require evidence-based reporting of capabilities, Formatiert: Textkörper, Nach: 0,63 cm, Zeilenabstand:
risks, and limitations across all applications to avoid exaggeration of claims, including but not Mehrere 1,15 ze
limited to applications in sleep, attention, memory, and emotional regulation. Within these
frameworks should be specific guidelines for ethical marketing and protocols for responsible
communications about early-stage research and emerging technologies. In this context, better
understanding of the phenomenon of neuroenchantment that perpetuates neuromyths through Formatiert: Englisch (Vereinigte Staaten)
independent research is required. Formatiert: Englisch (Vereinigte Staaten)
Formatiert: Englisch (Vereinigtes Königreich)
99.100. Member States should develop policies that foster effective collaboration between end-
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-
compatible and meet the needs of diverse user populations.
100.101.Member States should develop age-appropriate, contextually-appropriate, culturally-
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user
and for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6. CHILDREN AND ADOLESCENTS Kommentiert [RC<UP49]: The question is whether the
termin “adolescents” was originally meant to mean
101.102.Member States should promote healthy brain development through policies that young adults from 18-21 which are considered to need
evaluate the impact of neurotechnology on children and adolescents. special protection, although under the current law the
rights of the child are only afforded to persons under 18
102.103.Member States should safeguard children and adolescents from implicit and explicit years. WHO defines 'Adolescents' as individuals in the
10-19 years age group – so “Children” as defined under
coercion to use neurotechnology. Member States should pay attention to the autonomy of
international law is already mostly covered. Young
children and adolescents through informed consent and assent that is adapted to and respectful adults are considered to be 18-21 year age group.
of age and decision-making capacity.
103.104.Member States should fund research and development grants focused on creating user-
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children, adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed
to teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
104.105.Member States should ensure research involves strict oversight and close follow-up of
all neurotechnology research involving children and adolescents. This oversight is crucial during
the developmental phases of childhood to address and mitigate any unforeseen long- term
effects. Such research must include comprehensive monitoring protocols and periodic
evaluations to ensure the ongoing safety and well-being of young participants, taking into account
their unique developmental needs and vulnerabilities. In the framework of research, involving
children and adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring
units), special attention will be given to consent and assent, particularly considering particular
aspects of research (time, iterations) to prevent any form of instrumentalization.
105.106.Member States should enact specific regulations that prohibit the use of marketing
techniques—such as neuromarketing, biometric emotional analytics, immersive advertising, and
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virtual or augmented reality advertising—that rely on sensitive neural and cognitive biometric
data collected from children and adolescents. Recognizing the heightened vulnerability of
children and adolescents in digital environments, these regulations must explicitly forbid any
practices that use such data to influence or exploit children and adolescents.
IV.7. OLDER PERSONS
106.107.Member States should promote healthy aging and support elderly individuals by funding
and implementing evidence-based programs that integrate neurotechnology into routine care.
These programs should involve the entire support ecosystem, including family, caregivers, and
medical teams, to enhance quality of life. Priority should be given to developing and implementing
tools that prevent, delay, and treat age-related health conditions, impairments, and
neurodegenerative diseases. Member States should ensure that access to these
neurotechnology programs is equitable and does not exacerbate socioeconomic inequalities.
107.108.Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
108.109.Member States should preserve, support, and promote autonomous decision-making
for older people using neurotechnology for sensorimotor and cognitive support. The consent
process should accommodate potential cognitive challenges faced by older adults, ensuring that
consent is informed, ongoing, and adaptable to changing health conditions. Policies should be in
place to ensure that assistive neurotechnology recognize changing cognitive capacities over time
and respect users’ preferences.
109.110.Member States should develop ethical guidelines to ensure that neurotechnology such
as robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8. WOMEN AND GENDER EQUALITY
110.111.Member States should adopt and enforce comprehensive policies that promote and
respect gender equality and diversity in the whole lifecycle of neurotechnology. The policies
should prioritize inclusive research for addressing women and gender specific needs and
differences, require targeted data collection and analysis, include education and training
programmes on inclusive research practices, ensure public and community engagement with
women and gender health experts and advocacy groups and, incentivise gender responsive
technology design, to meet the needs and conditions specific to women and gender minorities.
Affirmative action policies are necessary to close gender gaps in these fields, increase
representation, engagement and leadership.
111.112.Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women and gender minorities, and safeguard against
harassment and discrimination. This should include robust mechanisms for reporting and
addressing incidents of harassment and discrimination, ensuring accountability and support.
112.113.Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women’s and gender minorities’
participation in neurotechnology. This includes funding and other policies that prioritize ethical
and equitable research and innovation, but also affirmative action initiatives to support the
participation of women and gender minorities in neurotechnology through targeted education
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programs, employment opportunities, entrepreneurship support, and leadership development
within the sector. Member States should also provide support systems such as mentorship
programs, networking opportunities, and resources to help women and gender minorities
overcome barriers to participation and succeed in the neurotechnology field.
IV.9. PERSONS WITH PHYSICAL DISABILITIES Kommentiert [RC<UP50]: International law does not
distinguish among persons with disabilities.
113.114.Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support thereby
contributing to achieving equal enjoyment of human rights. They should implement regulatory
frameworks that require accessibility assessments for all new neurotechnology products to
ensure these products do not perpetuate existing disabilities or health disparities. These
frameworks should include protocols for testing with diverse groups of persons with disabilities
to ensure technology meets a wide range of needs and does not unintentionally exclude or
disadvantage any subgroup.
114.115.Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their inclusion in society, quality of life
and functional independence. These programs should include tax incentives for companies
investing in assistive neurotechnology research and development, grants for research institutions
focusing on neurotechnology for disability support, expedited regulatory reviews for technologies
offering significant advancements in mobility, communication, or daily living assistance, and
innovation prizes for breakthroughs in affordable, accessible neurotechnology solutions. Kommentiert [RC<UP51]: Seems very detailed and
prescriptive.
115.116.Member States should, whenever possible, subsidise the cost of essential
neurotechnology devices, such as neuroprosthetics, for persons with physical disabilities. They
could encourage public-private partnerships to make advanced neurotechnology affordable and
integrate neurotechnology coverage into national health insurance and other reimbursement
schemes for persons with physical disabilities. A national database of available neurotechnology
resources and support services should be developed to facilitate access and information sharing.
IV.10. PERSONS WITH MENTAL HEALTH CONDITIONS
116.117.Member States should foster research and promote awareness-raising initiatives to
address the increasing prevalence and special needs of people with mental health conditions,
including victims and survivors of trauma and violence, and the relevance of neurotechnology for
these communities.
117.118.Member States should allocate funding for long-term advocacy and efficacy studies,
post-market oversight, and tiered scrutiny with special attention to invasiveness and reversibility
of neurotechnology interventions. It is important to ensure that people with mental health
conditions are well-informed and have reasonable expectations about the process.
118.119.Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
119.120.Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
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HEALTH AND RESEARCH ETHICS
IV.11.IV.10. HEALTH
120.121.Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
121.122.Member States should build and maintain international solidarity to address global
health risks and uncertainties, and ensure that their implementation of healthcare for the nervous
system is consistent with international law, in particular international humanitarian and
rigorousinternational human rights lawobligations. This could involve creating international
forums for sharing best practices in the implementation of neurotechnology in healthcare.
122.123.Member States should establish oversight mechanisms to evaluate the physical and
mental health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results.
123.124.Member States should consider the significant cost and impact associated with
pathologies related to the nervous system, as well as the potential benefits of early diagnosis
and access to preventive and assistive neurotechnology. Public policies should prioritize the
promotion of access to these technologies and ensure health cost coverage for individuals in
need.
124.125.Member States should promote the development of reliable and durable
neurotechnology for healthcare applications. This includes encouraging the design of devices
and systems that require minimal maintenance, ensuring they remain functional and effective
under everyday conditions. Regulatory bodies or designated authorities should oversee the
enforcement of rigorous standards for quality, safety, and longevity, thereby reducing the burden
on users and enhancing the dependability and sustainability of neurotechnological solutions.
125.126.Member States should ensure the development or strengthening of existing
comprehensive neurotechnology medical device reporting systems that track and address
adverse effects. In contexts where such systems do not exist, Member States should establish
them. Where systems are already in place, they should be updated to specifically include
neurotechnology. These systems should be interoperable and contribute to a centralised, public,
and transparent international database, managed in collaboration with international
organizations, to ensure that global standards are met and accessible for public knowledge,
international oversight and research.
IV.12.IV.11. RESEARCH ETHICS
126.127.Member States should reinforce the ethical frameworks governing neurotechnology
research to ensure robust protection of human participants. Member States should adopt clear
guidelines or policies that define the qualifications to ensure that research is conducted by
professionals with appropriate knowledge about the nervous system structure and function in
addition to brain disorders and is performed in adequate research settings. Furthermore,
research protocols, public or private, in the medical as well as the non-medical domain, should
be carefully evaluated by registered ethics boards (ethics committees) and specific attention
dedicated to individuals with special situations regarding vulnerability such as diminished
capacity to consent or to make decisions. Member States should ensure that all research
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institutions have mandatory ethics training for researchers.
127.128.Member States should encourage multicentre international research that involves
various cultures and ethnic groups. Member States should promote international cooperation to
develop common reporting standards and protocols for interoperability, particularly for
implantable neurotechnology devices. This cooperation should aim to enhance the comparability
and utility of research globally, improving both the efficacy and ethical integrity of research.
128.129.Member States should ensure that the whole lifecycle of neurotechnology is considered
in the design of a clinical trial, including policies to protect patients in case of cessation of activities
of the trial sponsor or promoter. Member States should establish requirements for clinical trials
to be included in relevant nationally or internationally approved registries, and encourage
registration with community and patient registries. Also, clinical trials should report on appropriate
medical device reporting systems developed within Member States.
129.130.Technology developers should ensure that the validation of AI algorithms in
neurotechnology research include rigorous testing for biases, as well as measures to enhance
explainability and transparency, including the provenance of training datasets. Suitable
techniques should be employed to mitigate any biases present in AI models used in
neurotechnology applications.
130.131.Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual’s
subjective experience, agency and personal identity. Understanding how neurotechnology may
impact aspects of self-perception, consciousness, and identity is essential for addressing ethical
concerns and ensuring the well-being of individuals using these technologies.
131.132.Member States should ensure those engaged in research implement regular auditing
and monitoring of research practices to ensure adherence to ethical standards. This should
include evaluating the adequacy of informed consent, particularly concerning data reuse and the
potential commercialisation of neural biometric data.
132.133.Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings
to participants. These protocols should ensure that such findings are conveyed promptly,
respecting participants’ rights and autonomy. Additionally, Member States should mandate that
researchers provide the necessary support and coordination with healthcare providers to address
any health concerns that arise from these findings.
133.134.Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants’ right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13.IV.12. EDUCATIONAL SETTINGS
134.135.Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age-
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appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology’s impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
135.136.Member States should adopt policies ensuring the voluntary deployment of
neurotechnology in education, grounded in fully informed consent. These policies must include
clear, age-appropriate information about the technology’s purpose, benefits, and risks, with
adequate consideration periods. Considering the increased complexity of obtaining voluntary
consent in this context, consent and assent procedures should involve children, adolescents,
parents, guardians and all actors necessary to obtain approval required for minors. Ethical
oversight mechanisms should be established, including regular consent renewal and immediate
cessation of neurotechnology use upon withdrawal, and ensure anonymous feedback channels.
Policies must prohibit undue incentives or academic penalties for non-participation and take
measures to avoid creating or reinforcing inequalities among students. Additionally, Member
States should support student involvement in decision-making about neurotechnology integration
and fund training programs on its ethical use, empowering educators and students to critically
assess its application.
136.137.Member States should establish a unified, robust oversight mechanism for
neurotechnology use in educational settings, incorporating regular audits, public and community
feedback, culturally appropriate and according to local conventions, and strict adherence to
safety and ethical standards, including an assessment of reversibility on the nervous system.
Continuous research should be funded to assess the long-term psychological and cognitive
impacts of these technologies. Oversight should involve periodic reviews based on empirical
evidence to adjust neurotechnology usage as needed, ensuring it serves student development
and addresses risks like dependency or de-skilling. This comprehensive approach will help
maintain the safety, effectiveness, and alignment of neurotechnology with best practices for
student well-being and learning outcomes.
137.138.Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations
throughout the neurotechnology whole lifecycle. This training should include ethical design,
human rights law, and societal impact assessment, preparing the next generation of
technologists to critically evaluate the implications of their work.
IV.14.IV.13. LABOUR AND EMPLOYMENT
138.139.Member States should establish workplace policies and incentives that prioritize the
health and well-being of employees in the use of neurotechnology. These policies should ensure
that any deployment of neurotechnology is evidence-based, with a focus on applications that
have been scientifically validated to promote employee well-being, such as reducing stress or
enhancing workplace conditions (i.e., adaptive and responsive environments that adjust
workloads based on cognitive load). Deployment must be on a voluntary basis and employees
must have the option to opt out of using neurotechnology without facing any negative
consequences or discrimination. Under no circumstances should these technologies be used for
punitive measures, mental surveillance, or in ways that could compromise employee health.
139.140.Member States should require employers to clearly provide employees with
comprehensive information about how neurotechnology used in their workplace works, the
benefits it offers, transparency about what data are collected, how it is used, and who has access
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to it, and clearly disclose any potential risks of their use.
140.141.Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring
fatigue in commercial drivers or tracking attention in air traffic controllers). To respect employees’
mental privacy, employers should be prohibited from unauthorized access to neural and cognitive Formatiert: Durchgestrichen
biometric data that may be collected incidentally during routine workplace monitoring. Employers
should be prohibited from using neural and cognitive biometric data for any non-consented Formatiert: Durchgestrichen
purposes, particularly those that could negatively impact an employee’s job security or privacy.
141.142.Member States should require employers to adopt best practices for data minimisation
and secure storage of neural and cognitive biometric data, ensure that data is stored securely, Formatiert: Durchgestrichen
with access limited to authorised personnel only, is deleted once its intended purpose has been
fulfilled. Additionally, upon an employee’s departure, all related records should be fully deleted
or individual data released to the employee, ensuring that no data is retained after the termination
of employment.
142.143.Member States should ensure that when employees are issued multifunctional devices
(i.e., earbuds or headphones that also include neural sensors) that can be used at work or at
home, employers should be prohibited from collecting neural and cognitive biometric data outside Formatiert: Durchgestrichen
of workplace settings and working hours and ensure that any data collected during work is used Formatiert: Durchgestrichen, Verdichtet durch 0,75 Pt.
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
143.144.Members States should ensure that employers respect the right of employees to obtain
a copy of any neural and cognitive biometric data collected about them, along with any Formatiert: Durchgestrichen
interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise create.
144.145.Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and not
for enhancing productivity at the expense of employee health.
145.146.Member States should guard against the exploitation of employees, and they should
develop stringent regulations against using neural and cognitive biometric data for profiling in the Formatiert: Durchgestrichen
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive Formatiert: Durchgestrichen, Verdichtet durch 0,55 Pt.
biometric data to discriminate against candidates, particularly neurodiverse individuals, ensuring
Formatiert: Durchgestrichen
hiring practices are fair and inclusive.
146.147.Member States should strictly regulate the use of neurotechnology for hiring or
maintaining employment, to limit such use where such neural and cognitive biometric data are Formatiert: Durchgestrichen
directly relevant to the specific requirements of the job.
IV.15.IV.14. CONSUMER AND COMMERCIAL DOMAINS
147.148.Member States should proactively establish a regulatory framework that balances
innovation in the recreational and commercial domains with protecting individual rights and well-
being. This framework should be dynamic, allowing for timely updates as technology evolves and
new insights are gained about its impacts on society. This includes providing adequate oversight
to ensure that neurotechnology does not cause harm, are used consensually, and include robust
mechanisms to protect users from potential psychological distress or manipulation.
148.149.Member States should strengthen comprehensive consumer protection laws to include
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clear labelling on commercial neurotechnology products, detailing their effects, limitations, and
risks to prevent misleading claims and ensure transparency. This also includes prohibiting
practices of “tying” or requiring the disclosure of neural and cognitive biometric data as a condition
to access goods or services, and prohibition about third party data sharing or the uses of this data
without affirmative opt-in option.
149.150.Member States should foster an environment that ensures all claims about consumer,
non-medical technologies are supported by robust scientific evidence. They should, by
regulation, require that any products claiming to treat, prevent, or diagnose diseases or medical
conditions be validated through rigorous safety and efficacy testing, including clinical trials where
necessary, and be used under appropriate medical supervision.
150.151.Member States must enforce informed consent processes that are thorough and
transparent across all neurotechnological interventions, ensuring that participation is fully
voluntary and respects the privacy and autonomy of individuals. This principle should apply
uniformly in various domains such as sports, arts, where robust standards should safeguard
against coercive use and respect athletes’ and artists’ individual autonomy, community interests,
and IP rights.
151.152.Member States should steer the use and development of neurotechnology in the arts Kommentiert [RC<UP52]: The contradiction between
toward ensuring the enhanced learning and cultural appreciation without compromising individual points 150 and 151 is fundamental. While point 150 appears
to protect artistic freedom, point 151 immediately seeks to
autonomy or leading to cultural homogenisation.Member States should support the arts in steer art according to state interests. This approach
engaging with the use and development of neurotechnology to allow for a critical and undermines the very essence of artistic expression in a liberal
democracy.
creative reflection about the societal ramifications of neurotechnology.
By attempting to control artistic output, the proposal risks
reducing art to a mere instrument of state propaganda—
152.153.Member States should adopt policies to prevent the misuse of neurotechnology of
reminiscent of historical periods when art served only the
consumer technology, especially neurogaming and other devices that exploit the dopamine church or ruling classes. True artistic freedom requires
reward system or seek to induce problematic and unhealthy use and overconsumption. Such autonomy from institutional control.
regulations should mandate clear labeling of risks, disclosures on their effects on the nervous
system, enforce game design standards and safety, privacy and age-appropriate design
standards that prevent taking advantage of a person’s physical, mental and emotional
vulnerability to lead to compulsive use or addiction of gaming or digital recreational platforms
combined with neurotechnology, to promote healthy, balanced use, especially among children.
153.154.Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that ‘opt-out’ features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
154.155.Member States should address the profound ethical questions regarding self-
determinationfree will, consent, privacy, and the potential for manipulation raised by
neurotechnology that arise in the contexts of recommender systems, priming and nudging,
marketing during sleep and dream, neuromarketing, and closed-loop environments by adopting
comprehensive policies and regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive
biometric data in recommender systems for manipulative or deceptive purposes,
including in political context. These regulations should require that any use of such
data within these systems be based on explicit, informed opt-in consent from
users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging—
subtly influencing individuals’ decisions or behaviours, often without their explicit
awareness. This is particularly critical in sensitive areas such as political
messaging, commercial advertisement, and healthcare. These frameworks should
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require explicit, informed consent for any use of such data to influence decisions
or behaviour, the right to opt out of these systems, and transparency and clear
disclosures at the point of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that
influences or manipulates individuals during sleep, such as marketing during sleep
and dream. Regulations should strictly prohibit commercial, marketing, or political
applications that target individuals during sleep, using neurotechnology or neural
and cognitive biometric data. Additionally, robust oversight mechanisms should be
required to ensure that any research or application of such technologies prioritizes
the well-being, privacy, and autonomy of individuals, with particular attention to
the potential long-term psychological and cognitive impacts of manipulating sleep
states.
(d) Neuromarketing: safeguard against unethical aims and practices in
neuromarketing, including by requiring comprehensive disclosures to ensure that
all neuromarketing activities are conducted transparently, with participants’ explicit
informed consent. This includes ensuring that participants in neuromarketing
research or campaigns are fully aware of methods, risks, and intentions and
affirmatively opt-in to participation. The use, storage, and potential reuse of the
collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and
use of closed-loop environments—such as immersive computing devices that
adjust experiences based on detected neural and cognitive biometric data. These
policies should require clear and accessible disclosure about how neural and
cognitive biometric data are used in these environments, prohibit real-time
behavioral modification or manipulation without explicit, informed consent, and
implement safeguards specifically designed to prevent abuses such as
unauthorized surveillance, manipulative interventions, and practices that could
influence voting behavior, political opinions, or exploit psychological and emotional
vulnerabilities in real-time.
IV.16.IV.15. ENHANCEMENT Kommentiert [RC<UP53]: Chapter on enhancement
has been greatly (!) shortened compared to the first
155.156.The use of neurotechnology to improve memory, attention, or other aspects of human draft. Enhancement and augmentation are becoming
mental performance outside of the medical context introduces additional complex ethical, social, increasingly relevant because there are already some
devices on the market that promise better sleep, better
and legal challenges, which can create new kinds of disparities in the global world. When
performance, etc. This means that this topic needs
neurotechnology is used in these contexts, it raises crucial questions about equity, consent, more representation in the Recommendation. In the first
individual and community autonomy, and the nature of enhancement of the nervous system itself. draft, for example, points relating to policies, principles
of autonomy, support of research and safety testing
Member States should ensure that any policies, law and regulatory frameworks that govern the were taken up, which are completely missing here. But
research, the development and use of neurotechnology in these contexts do not exacerbate now is the time to define appropriate recommendations
We would therefore encourage the missing paragraphs
social inequalities or lead to discrimination, address the potential risks (including to reversibility, to be included again
invasiveness, and risks to self- determination) uphold human dignity, human rights and
fundamental freedoms and fully comply with international law including international humanitarian
and human rights lawand dignity.
V. IMPLEMENTATION
156.157.Member States and all other actors as identified in this Recommendation should
respect, promote and protect the ethical values, principles and standards related to this
Recommendation, and should take all feasible steps to give effect to its implementation.
157.158.Member States shall, according to their specific contexts, governing structures and
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constitutional provisions, credibly and transparently advance the ethics of neurotechnology, in
line with the UNESCO Recommendation. Member States shall monitor and evaluate policies,
programmes and mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
158.159.Member States should develop capacities in governmental institutions and support
government officials to steer ensure that the technological developmenttechnology is developed
responsibly and ethically as well as in ways that fully protect, promote and respect human Formatiert: Nicht Hervorheben
rights..
159.160.Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied in line with international human rights
law, that public health and safety are protected, and that ethical standards and human rights are
upheld throughout the whole lifecycle of neurotechnology. This includes facilitating inter-agency
collaboration, monitoring compliance with national and international standards, and ensuring that
data and insights from different regulatory domains are shared effectively to inform decision-
making and policy development. These bodies should also help coordinate public and community
engagement.
160.161.Member States should strive to extend and complement their own actions in respect of
this Recommendation, by cooperating with all relevant national and international governmental
and non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector’s interests and therefore
UNESCO needs to ensure and promote its legitimacy.
161.162. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
advisory bodies for dissemination to all levels and actors in this field.
162.163.To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shall , in cooperation with other relevant UN agencies such as the Office of the High Formatiert: Nicht Hervorheben
Commissioner for Human Rights, contribute by developing a full-fledged program with the
following elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States
in identifying their status at specific moments of their readiness trajectory along a
continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of
neurotechnology based on rigorous scientific research and grounded based onin
international human rights law, along with specific guidance for its implementation
in the whole neurotechnology lifecycle, and capacity-building tools and materials
to support Member States’ efforts to train government officials, policy-makers and
other relevant actors on the methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and
the efficiency of the policies for the ethics of neurotechnology and incentives
against defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in
a UNESCO observatory, to become a shared pool of knowledge and awareness
of good practices and innovations available to all Member States and actors, in
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neurotechnology. The research - program should take into consideration the
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converging developments of neurotechnology with other technologies such as
artificial intelligence and quantum technology, work to be conducted in
collaboration with other relevant UNESCO initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global
policy dialogue, including at Ministerial level in the context of a Global Forum on
the Eethics of Emerging Technologies. Supporting this effort, UNESCO shall
establish a network of experts, with balanced representation of all UNESCO’s
regional groups, on the neurotechnology.
163.164.Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, minorities, persons with disabilities, under-represented, vulnerable
people or people in vulnerable situations and ensuring social, cultural and gender diversity. The
monitoring and assessment of the impact of neurotechnology and related ethics policies and
practices should be carried out continuously in a systematic way proportionate to the relevant
risks. This should be based on international law, including international human rights law, as well Formatiert: Nicht Hervorheben
as other relevant internationally agreed frameworks and involve evaluations of private and public
institutions. Data collection and processing should be conducted in accordance with the right to
privacy international law, national legislation on data protection and data privacy, and the values
and principles outlined in this Recommendation.
VI. FINAL PROVISIONS
164.165.This Recommendation needs to be understood as a whole, and the foundational values
and principles are to be understood as complementary and interrelated.
165.166.Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
prejudicing Member States’ obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or
perform any act contrary to human rights, fundamental freedoms, human dignity and concern for
the environment and ecosystems.
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BAHRAIN/ BAHREÏN
Preliminary Report on the first draft of the Recommendation on the Ethics of Neurotechnology
THE PREAMBLE
A. Consider integrating the following with the existing preamble.
• Ensuring individuals understanding of risks, benefits, and implications of neurotechnology
use and that they can freely undertake, withhold, or withdraw consent.
• Point out the importance of data governance, including secure and equitable data-sharing
mechanisms that respect privacy and promote international research cooperation.
• Highlight the importance of involving the public in decision-making and promoting open
dialogue about neurotechnology's ethical, social, and legal implications.
APPLICATION AND DEFINITIONS
B. Consider integrating the following with the existing definitions.
• Incorporating a clear and brief definition encompassing invasive and non-invasive technologies and
potentially differentiating between those intended for therapeutic use, research, and enhancement.
• The ethical challenges of brain-computer interfaces, which represent a rapidly growing area of
neurotechnology with marked ethical effects
• More detail about data ownership, access rights, and potential exploitation by specifying how it can be
used and shared, as well as the individuals' rights to access and control their data.
• clarifying how neurotechnology overlaps with existing legal frameworks concerning privacy, mental
health, and disability rights.to ensure that the ethical guidelines align with and complement existing
legal protections.
AIMS AND OBJECTIVES
C. Consider integrating the following with the existing objectives.
1. To encourage the responsible development and use of neurotechnology in the context of artificial
intelligence.
2. To verify mechanisms for ongoing monitoring and assessment of the ethical implications of
neurotechnology.
(NB: This concept emphasizes the importance of creating mechanisms to track the ethical
implications of neurotechnology and amend guidelines appropriately)
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BULGARIA/BULGARIE
COUNTRY: Bulgaria
Contact person : Dimiter Prodanov
GENERAL COMMENTS
As part of the consultation process the representation of Bulgaria herby shares comments on the initial draft of UNESCO’s Recommendation on
the Ethics of Neurotechnology.
In the first place we commend UNESCO for taking up such an initiative and the work of experts who contributed to the content of the document.
This Recommendation addresses a rapidly evolving field with tremendous potential. The rapid advancement of neurotechnology, especially when
integrated with AI and big data, holds the promise of transformative applications but also bears significant risks. Such potentially transformative
developments also present complex ethical challenges that require careful, globally coordinated oversight, as well as mutually agreed
governmental policies and legal frameworks.
In this context, a global recommendation from UNESCO could play a pivotal role in encouraging Member States as well as other non-
governmental stakeholders to adopt necessary measures. This would help ensure that neurotechnological advancements align with universal
human rights principles, established ethical and legal standards in research and medicine, and remain mindful of their impact on human society
and the environment.
We hope that our comments and proposed amendments will assist in preparing the second draft for discussion at the upcoming Intergovernmental
Meeting at UNESCO.
Here follow some general comments.
AIMS, OBJECTIVES, CONTENT AND SCOPE
The primary and most crucial purpose of the recommendation should be to ensure that the development and application of neurotechnology
uphold, protect, and promote human rights, fundamental freedoms, human dignity, but also caters for the environment.
In our understanding, one of the major goals of this recommendation is to promote equitable access, and to propose clear regulatory principles
and guidelines that ensure safety for patients and other users. Regarding other areas, particularly the commercial sector and areas of
“enhancement”, we believe the primary value of the recommendation lies in promoting caution and regulation. In other words, we see a need for
the recommendation to address various issues based on the specific policy domain.
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We welcome the stance in favour of “allocation of resources for neurotechnology […] directed toward preventative, diagnostic, therapeutic,
assistive, and rehabilitative purposes that benefit the largest number of people and those who stand to gain the most, rather than consumer-driven
or commercial applications.” (§22) This position must be consistently reflected throughout the entire text, which maybe ethically ambiguous (i.e.
human enhancement). On occasion, the text expresses an almost unreasonable hope for neurotechnology to benefit humanity in general, for
instance in phrases about “human flourishing”. This borders on a transhumanist perspective. Since future scenarios within these areas (in
particular the commercialized wellness- and health industries) are hard to predict, we believe it is better for the recommendation to take a cautious
stance towards such formulations.
FEASIBILITY, IMPLEMENTATION AND RELEVANCE
The level of details should be balanced against the potential for societal, environmental, and technical changes in view of possible implementation
hurdles. The different needs, conditions and situations of the Member States must also be carefully considered.
We welcome the approach that all engaged actors in this field are responsible “[…] to ensure the embedding of ethics in all stages of the
neurotechnology lifecycle”, which is acknowledged in §19 (b) in II Aims and Objectives. However, in the forthcoming chapters, almost exclusively
Member States are addressed. To clarify and emphasize that this is a shared responsibility, the recommendation should more explicitly underline
the responsibility of each actor involved in this field.
SCOPE, DEFINITIONS AND PERSPECTIVES
The broad definition of neurotechnology (I.2 Definitions, §12-§14) has both strengths and weaknesses. A broad definition means that almost all
technologies that can predict neural states can fall under this scope. This broad inclusion might benefit from clearer boundaries or examples to
distinguish neurotechnology from other general diagnostic or inferential tools.
On the other hand, there might be good reasons for keeping a broad definition for the purpose of future relevance. However, the broader
definition, the greater scope. For clarification and avoiding misinterpretation, not at least since this is a very complex field, we believe it would be
worthwhile to explain the rationale behind excluding certain medical applications, for instance pharmacological treatment with influence on the
nervous system, with the exception for neuropharmacological infusion (§13 b.i).
In addition, we ask for improved clarifications of distinctions between neurotechnology for enhancement and for medical applications (with the
purpose of improving the lives for people with medical needs).
The importance of science-based evidence/methods/applications/integrity etc. must be better emphasized. We also ask for consistency
in the use of the terms evidence based, scientific evidence and robust scientific evidence, or clarification of their significance in relation to each
other. Qualifications of the term consent throughout the text - “free informed”, only” informed consent”,” fully informed consent”, “affirmative
consent”, “voluntary consent”, “free, informed and voluntary consent” should be harmonized.
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It is somewhat difficult to understand whether “research” is omitted consciously in some of the paragraphs when only development and
deployment of neurotechnology is mentioned. Hence, how the recommendations differentiate between different stages are sometimes unclear
(see detailed comments).
Some references to relevant international or global policies/laws are missing, for instance, the World Medical Association’s (WMA) Declaration of
Helsinki regarding ethical principles for medical research involving human participants, which regulates national laws and regulations in many
countries, including Sweden, 1 the ISO 14155:2020 Clinical Investigation of medical devices for human subjects and regulations and directives
from the European Union such as the European Union Medical Device Regulation (MDR) etc. 2
AREAS OF POLICY ACTIONS
Although the Member States are ultimately responsible for promoting and ensuring an ethical neurotechnology, the recommendation should clarify
that no actors involved in this field can be exempted from responsibility.
As previously mentioned, some of the recommendations and calls for action are very detailed, with risk of missing related issues.
Enhancement, which is an area predicted to grow tremendously and with substantial risks, should be further explored.
SUSTAINABLE DEVELOPMENT
Bulgaria welcomes that the Recommendation addresses sustainability but identifies a need for this area to be further explored, both in a broad
sense and with specific emphasis on the environmental dimension. The latter is as important since the recommendation addresses the whole
lifecycle of neurotechnology, including mining for materials and AI. Likewise, the social and economic aspects of sustainability and benefit sharing
are of great importance and should be given a prominent role. The Recommendation could refer to the Sustainable Goals as expressed in Agenda
2030, and awareness of the interdependent relationship between the three pillars of sustainability (the ecological, the social and the economic).
DISPOSITION AND STRUCTURE
We suggest moving the section Consideration for specific users, §103-§121, to its own chapter.
ORIGINAL TEXT NEW PROPOSED TEXT COMMENTS
1WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants – WMA – The World Medical Association
2ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice; Regulation - 2017/745 - EN - Medical Device
Regulation - EUR-Lex
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PREAMBLE PREAMBLE PREAMBLE
Paragraph 1 Paragraph 1 Paragraph 1
Recognizing the profound and dynamic impacts of Recognizing the profound and dynamic
neurotechnology on human kind lives and flourishing, impacts of neurotechnology on human kind
and societies, environment, and ecosystems, humankind lives and flourishing, and
societies, environments, and ecosystems,
Paragraph 2
Considering the major and growing global prevalence
of neurological and mental health conditions, along with
the profound suffering they cause for individuals and
societies worldwide,
Paragraph 3
Acknowledging the potential of neurotechnology to
offer innovative solutions and deliver better preventive
and therapeutic treatments for millions, benefitting
humanity as a whole and providing opportunities for
health improvements in all countries,
Paragraph 4
Also considering that neurotechnology raises Also considering underscoring Our advice is to use a language that
fundamental ethical issues for instance regarding self- that neurotechnology must never be used in much stronger promotes a human based
determination, privacy, personal identity, freedom of a way raises fundamental ethical issues that approach.
thought, risk of discrimination, inequality and challenges stand in conflict with the universal human
to democracy, and that justice, trust and fairness must rights, for instance regarding self- Split this paragraph in three paragraphs.
be upheld so that no country and no one should be left determination, privacy, personal identity, See suggestion below
behind, either by having fair access to neurotechnology freedom of thought, and risk of
and enjoying their benefits or in the protection against discrimination, inequality and challenges to
their risks, while recognizing the different circumstances democracy, and that justice, trust and
of different countries and respecting the desire of same fairness must be upheld so that no country
people not to take part in all technological and no one should be left behind, either by
developments, having fair access to neurotechnology and
enjoying their benefits or in the protection
against their risks, while recognizing the
different circumstances of different countries
and respecting the desire of same people
not to take part in all technological
developments,
78
Recognizing that neurotechnology raises Red text added. Even if the added
fundamental ethical issues regarding examples might be exhaustive, we
commercialization of neural data, risks believe it is important to include these
concerning security and data protection, crucial points.
long-term safety, inequality and challenges
to democracy
Underlines and that justice, trust and See §9 and §10, that also address
fairness must be upheld so that no country geographical matters. Consider collecting
and no one should be left behind, either by all paragraphs on this topic so they come
having fair access to neurotechnology and after each other.
enjoying their benefits or in the protection
against their risks, while recognizing the
different circumstances of different countries
and respecting the desire of same people
not to take part in all technological
developments,
Paragraph 5
Recalling that, by the terms of its Constitution,
UNESCO seeks to contribute to peace and security by
promoting collaboration among nations through
education, the sciences, culture, and communication
and information, in order to further universal respect for
justice, for the rule of law and for the human rights and
fundamental freedoms which are affirmed for the
peoples of the world,
Paragraph 6
Given the leading role of UNESCO, at the forefront of
the international dialogue, knowledge production and
standard setting on the ethics of science and
technology and bioethics,
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Paragraph 7
Convinced that the Recommendation presented here, This sentence is very exhaustive and
as a standard-setting instrument developed through a should preferably be split up.
global approach, based on international law, focusing on
human dignity and human rights, as well as gender
equality, social and global justice and development,
physical and mental well being and health, diversity,
interconnectedness, global solidarity, fairness, non-
discrimination, inclusiveness, and environmental and
ecosystem protection, can guide neurotechnology in a
responsible direction,
Paragraph 8
Guided by the purposes and principles of the Charter of This paragraph should be moved up,
the United Nations, maybe begin the Preamble.
Paragraph 9
Emphasizing that specific attention must be paid to
low- and middle-income countries (LMICs), including
but not limited to least developed countries (LDCs),
landlocked developing countries (LLDCs) and small
island developing States (SIDS), as they have their
capacity but have been underrepresented in the
development and access to neurotechnology,
Paragraph 10
Underscoring that global cooperation and solidarity Underscoring that global cooperation and
facilitates fair access to neurotechnology and enables solidarity is crucial to facilitates fair access to
the realization of the full potential of neurotechnology, neurotechnology and to realize enables the
while addressing the ethical challenges, mitigating realizeation of the full potential of
against potential misuse, and ensuring that national neurotechnology, while addressing the
neurotechnology strategies are guided by ethical ethical challenges, mitigating against
principles in full respect of international human rights potential misuse, and ensuring that national
law, neurotechnology strategies are guided by
ethical principles in full respect of
international human rights law,
Paragraph 11
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Noting that ethical guidelines, frameworks and open
science promote innovation, development and policies
aligned with international human rights law,
Paragraph 12
Also recalling that in November 2023, the General
Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated
the Director-General "to prepare a standard- setting
instrument on the ethics of neurotechnology in the
form of a recommendation", which is to be submitted
to the General Conference at its 43rd session in
2025,
Paragraph 13
Bearing in mind the Universal Declaration of Human
Rights (1948), the instruments of the international
human rights framework, including the Convention
Relating to the Status of Refugees (1951), the
Discrimination (Employment and Occupation)
Convention (1958), the lnternational Convention on the
Elimination of All Forms of Racial Discrimination (1965),
the lnternational Covenant on Civil and Political Rights
(1966), the lnternational Covenant on Economic, Social
and Cultural Rights (1966), the Convention on the
Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the
Child (1989), and the Convention on the Rights of
Persons with Disabilities (2006), the Convention against
Discrimination in Education (1960), the Convention on
the Protection and Promotion of the Diversity of Cultural
Expressions (2005), as well as any other relevant
international instruments, recommendations and
declarations,
Paragraph 14
Also noting the United Nations Declaration on the Right
to Development (1986); the Declaration on the
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Responsibilities of the Present Generations Towards
Future Generations (1997); the Universal Declaration
on Bioethics and Human Rights (2005); the United
Nations Declaration on the Rights of lndigenous
Peoples (2007); the Declaration of Ethical Principles in
relation to Climate Change (2017); the Recommendation
on Science and Scientific Researchers (2017); the
Recommendation on the Ethics of Artificial lntelligence
(2021); the Recommendation on Open Science (2021);
the Human Rights Council's resolution on 'The right to
privacy in the digital age" (NHRC/RES/42/15) (2019);
the Human Rights Council's resolution on "New and
emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), and the UN Guiding
Principles on Business and Human Rights (2011),
Paragraph 15
Recalling that the 2021 Recommendation on the Ethics
of Artificial lntelligence, recognizes ethical questions
related to Al-powered systems for neurotechnology and
brain-computer interfaces,
Paragraph 16
Also conscious of the existing ecosystem of national Also conscious of the existing ecosystem Consider removing the OECD. Other
policies, and other frameworks and initiatives elaborated of national policies, and other frameworks organizations might be as equally
by relevant United Nations entities, intergovernmental and initiatives elaborated by relevant United relevant to acknowledge, and then the
organizations such as OECD, including regional Nations entities, intergovernmental and recommendation will end up with a long
organizations, as well as those by the private sector, regional organizations, as well as those by list.
professional organizations, non-governmental the private sector, professional
organizations, and the scientific community, related to organizations, non-governmental
the ethics and regulation of neurotechnology, organizations, and the scientific community,
related to the ethics and regulation of
neurotechnology,
16.1
Adopts the present Recommendation on the Ethics of
neurotechnology on this XXX day of November 2025;
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16.2
Recommends that Member States, with the support of
UNESCO's Secretariat, apply the provisions of this
Recommendation by taking appropriate steps, including
whatever legislative or other measures may be
required, in conformity with the constitutional practice
and governing structures of each State, to give effect
within their jurisdictions to the principles and norms of
the Recommendation in conformity with international
law, including international human rights law;
16.3
Also recommends that Member States engage all
actors, to ensure that they play their respective roles in
the implementation of this Recommendation; and bring
the Recommendation to the attention of international,
regional and national authorities and bodies, research
and academic organizations, institutions and
organizations in public, private and civil society sectors
involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound
scientific research as well as ethical analysis and
evaluation.
I. SCOPE OF APPLICATIONS AND DEFINITIONS I. SCOPE OF APPLICATIONS AND I. SCOPE OF APPLICATIONS AND
DEFINITIONS DEFINITIONS
I.1 SCOPE We suggest that SCOPE comes after
DEFINITIONS and AIMS AND
OBJECTIVES
This section is also very extensive. Try to
condense.
See paragraph 3 in SCOPE OF
APPLCATION in the Recommendation
on the Ethics of AI (2021), which
highlights prioritized domains for the
recommendation. Something similar
83
should be done in this recommendation
for clarification.
Also see paragraph 4 in SCOPE OF
APPLCATION in the Recommendation
on the Ethics of AI (2021), which clarifies
addressed target groups (“This
Recommendation is addressed to
Member States, both as AI actors and as
authorities responsible for developing
legal and regulatory frameworks
throughout the entire AI system life cycle,
and for promoting business responsibility.
It also provides ethical guidance to all AI
actors, including the public and private
sectors, by providing a basis for an ethical
impact assessment of AI systems
throughout their life cycle.”)
This Recommendation: This recommendation applies an ethical,
Human Rights based approach to all stages
of the life cycles of neurotechnology, and, as
such:
1. Addresses ethical issues related to Acknowledges the positive impacts that The positive impacts of neurotechnology
neurotechnology, as it can have many positive and neurotechnology can have on human health, on human flourishing and the enjoyment
adverse impacts on human health, human flourishing and, at the same time, addresses the of human rights needs clarification.
and on the enjoyment of human rights. adverse impact of the technology on human
health and the enjoyment of human rights….
2. Considers neurotechnology for people of diverse 2. Considers neurotechnology for all people
backgrounds and abilities, and various fields, including of diverse backgrounds and abilities, and
health, non-medical direct-to-consumer (DTC), such as various fields, including health, non-medical
wellness devices, neurogaming), addressing various direct-to-consumer (DTC), such as wellness
settings where neurotechnology may be utilised. devices, (neurogaming), addressing various
settings where neurotechnology may be
utilised.
3. Focuses on humans only but acknowledges Where in this draft are animals
important considerations that apply to animals in considered besides in this paragraph?
research.
4. Approaches neurotechnology ethics as a systematic 4. Approaches neurotechnology ethics as a What is the meaning of normative
normative reflection based on a holistic, multicultural, systematic normative reflection based on a reflection in this context?
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multidisciplinary, pluralistic and evolving framework of holistic, multicultural, multidisciplinary,
interdependent values, principles, and actions that can pluralistic and evolving framework of
guide societies in dealing responsibly with the impacts interdependent Human Rights based values,
of neurotechnology on human beings, societies, and the principles, and actions that can guide aiming
environment and ecosystems. at guiding societies in dealing responsibly
with the impacts of neurotechnology on
human beings, societies, and the
environment and ecosystems.
a) It considers ethics as a basis for the normative
evaluation and guidance of neurotechnology,
with human rights, human dignity, well-being,
and the prevention of harm as a compass and
foundation.
b) It draws upon a full range of scholarship, It draws upon a full range of scholarship,
commentary and views from neuroscience, including commentary and views from
medicine, engineering, psychology, ethics, neuroscience, medicine, engineering,
human rights, law, sociology, anthropology and psychology, ethics, human rights, law,
other disciplines. sociology, anthropology and other
disciplines.
5. Covers the measurement, recording, and
modification of the human nervous system, the
handling, analysis, treatment, storage, use and reuse of
the data collected, along with other societal and
environmental impacts, including the emergence of new
cognitive states.
6. Recognizes that interventions involving the nervous
system are very sensitive because the highly complex
human nervous system is the coordinating centre of
behaviour and mental processes. It enables the
exercise of self-determination, the capacity to act as
moral agents, to be responsible for actions, cooperate
with others, deliberate about collective decisions and
develop personality.
7. Further recognizes that humans develop and flourish This paragraph needs clarification. It
in their interaction with other human beings and a starts with acknowledging that interaction
nurturing material and cultural environment, highlighting with other humans and the material and
85
that autonomy is not just individual but also relational, cultural environment is fundamental for
as it arises from and impacts one's interactions and our human development, and then
belonging with the community. addresses autonomy as a state that is
both individual and relational. It’s very
difficult to figure out the message and the
essence.
The established definition of autonomy,
especially in medical law, is the right of
adults with capacity to make informed
decisions about their own medical care
(and concerning non-medical applications
of neruotechnology affecting an
individual)
The autonomy principle is a main guiding
principle in medical ethics.
A respect for competent decisions by
adult patients is also a cornerstone of
medical law.
8. Addresses the ethical and human rights concerns Many of the definitions in this paragraph
that arise from the rapid developments and the are unfamiliar to the public and readers
convergence of neurotechnology with other without expert knowledge in the field of
technologies such as spatial computing, extended neurotechnology. Consider adding them
reality (XR), artificial intelligence (Al), sensors and semi- to the section of Definitions, that
conductors. Notably, other biometric data when preferably should come before Scope.
processed to infer sensory, motor, and mental states
raises similar ethical concerns. Therefore, this The paragraph needs to be re-worded.
Recommendation applies to both neurotechnology and
the use of cognitive biometric data, ensuring that ethical
principles and practices are consistently applied across
these domains.
9. Further addresses the integration of Al with
neurotechnology, which can enhance precision and
predictive capabilities, such as improving processing
86
speed, reducing cost, optimizing neurotechnology
systems. However, it also magnifies ethical threats,
including cybersecurity concerns, lack of transparency,
the potential for algorithmic bias, and risks to autonomy,
mental privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and […] Galls on Urges all concerned to act Regarding the paragraph as a whole:
seeks to raise awareness on the profound ethical responsibly with regard to neurotechnology. should it be moved to AIMS?
challenges and threats that come with the military and
security applications of neurotechnology. Galls on all
concerned to act responsibly with regard to
neurotechnology.
I.2 DEFINITIONS For pedagogical reasons, the section
about DEFINITIONS should preferably
come right after the PREAMBLE. There
might also be good reasons for adding
concepts that need to be explained for the
reader.
For the purpose of this Recommendation:
11. Nervous system. The nervous system includes the 11. Nervous system. The nervous system
central (brain, spinal cord) and peripheral (somatic, includes the central (brain, cerebellum, The terms cerebellum and brainstem
autonomic, enteric) nervous system. Scientific evidence brainstem, spinal cord) and peripheral should be added in order to be fully
demonstrates that nervous system activity is the basis (somatic, autonomic, enteric) nervous correct.
of sensory, motor, and mental states (which include system. Scientific evidence demonstrates
cognitive, affective, and conative states), and supports that nervous system activity is the basis of
consciousness, sleep and the experience of pain. The sensory, motor, and mental states (which
nervous system activity and structure provide include cognitive, affective, and conative
information inherent to all human beings and the states), and supports consciousness, sleep
community, regardless of gender, ethnicity, language, and the experience of pain. The nervous
or religion. The nervous system activity is also system activity and structure provide
instrumental in social and cultural interactions. information inherent to all human beings and
the community, regardless of gender,
ethnicity, language, or religion. The nervous
system activity is also instrumental in social
and cultural interactions.
12. Neurotechnology. Neurotechnology refers to Neurotechnology refers to devices, systems, or indirectly measure should be added to
devices, systems, and procedures encompassing both and procedures encompassing both cover so called non-touch and remote
hardware and software-that directly access, monitor, hardware and software- that directly or methods that may influence the nervous
analyze, predict or modulate the nervous system to indirectly measure, access, monitor, system.
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understand, influence, restore, or anticipate its structure, analyze, predict or modulate the nervous
activity, function, or intentions (speech, motor). system to understand, influence, restore, or The text in the parenthesis (speech,
Neurotechnology combines elements of neuroscience, anticipate its structure, activity, function, or motor) is unclear, suggested additions
engineering, and computing, among others intentions (speech, motor, auditory-, visual- contributes to clarification.
or tactile sensations). Neurotechnology
combines elements of neuroscience, It is unclear what doesn’t qualify as
engineering, and computing, among others neurotechnology in this definition. Since it
includes technologies that can predict
neural states, almost anything could fall
under this scope – even tools like
questionnaires. This broad inclusion
might benefit from clearer boundaries or
examples to distinguish neurotechnology
from other general diagnostic or
inferential tools. Are police tasers
considered as neurotechnology?
13. Neurotechnology spans medical and non-medical
applications and includes tools that measure, infer, and
influence nervous system activity, whether through
direct interaction with the nervous system or by
interfacing it with devices and systems. It includes but is
not limited to:
a) Technical tools that measure and analyse b) Technical tools that measure and Consider adding cell therapy.
physical (i.e., acoustic, electrical, optical, analyse physical (i.e., acoustic, And cells that can be conditionally altered
magnetic and/or mechanical), chemical and electrical, optical, magnetic and/or by opto or chemogenetics. The cells
biological signals associated with the structure mechanical), chemical and function can be altered and therefore also
of and functional signals from the nervous biological signals associated with change the human feeling and behaviour.
system. These may be used to identify, record, the structure of and functional
and/or monitor properties of nervous system signals from the nervous system
activity, understand how the nervous system (including cell therapy). These may
works, diagnose pathological conditions, or be used to identify, record, and/or
central external devices (brain machine monitor properties of nervous
interfaces (BMI), often referred to as brain system activity, understand how the
computer interfaces (BCI)). Of note, both open- nervous system works, diagnose
loop (i.e., fixed-parameter brain stimulation) pathological conditions, or central
and closed loop systems (i.e., state dependent external devices (brain machine
stimulation) introduce complex ethical issues. interfaces (BMI), often referred to as
brain computer interfaces (BCI). Of
note, both open-loop (i.e., fixed-
88
parameter brain stimulation) and
closed loop systems (i.e., state
dependent stimulation) introduce
complex ethical issues.
a) (i). Examples include but are not limited to (i). Examples of measurement methods
Electroencephalography (EEG), include but are not limited to Please clarify that this section refers to
Magnetoencephalography (MEG), Magnetic Electroencephalography (EEG), examples: “of measurement methods“
resonance imaging (MRI), Functional Magnetic Magnetoencephalography (MEG), Magnetic fMRI is one type of MRI method/protocol.
resonance imaging (fMRI), Positron emission resonance imaging (MRI), Functional Several other exists e.g. diffusion
tomography (PET), Functional Near-infrared Magnetic resonance imaging (fMRI), weighted imaging. It is also suggested to
spectroscopy (fNIRS), lmplanted Diffusion weighted imaging, and other MRI add: and other MRI methods
microelectrodes, Optogenetics, Optical methods, Positron emission tomography
imaging, Diffusion weighted imaging, Calcium (PET), Computed Tomography (CT), Computed Tomography (CT) is a
imaging, Voltage dye sensors, or Microdialysis. Neuronavigation systems, Functional Near- common imaging method and has been
infrared spectroscopy (fNIRS), lmplanted added.
microelectrodes, Optogenetics, Optical
imaging and monitoring, Calcium imaging, Neuronavigation systems are used
Voltage dye sensors, or Microdialysis. together with brain images to calculate
anatomical position e.g. during brain
surgery and has therefore been added.
Since optical monitoring is common, and
monitoring was added.
Even if the scope is very broad, maybe an
explanation of what is excluded, might be
to consider.
b) Technical tools that interact with the nervous Technical tools that interact with the nervous DBS and other simulation methods
system to change its activity, for example, to system to change its activity, for example, to doesn’t remove or treat the disorder.
restore sensory input, such as hearing (i.e., restore sensory input, such as hearing (i.e., More examples of common use have
cochlear implants) or Deep Brain Stimulation cochlear implants) or Deep Brain Stimulation been added.
(DBS) to treat tremors and other pathological (DBS) to treat reduce symptoms of tremor,
conditions. They are meant to either modulate movement disorders and other pathological Vagus nerve stimulation can also be
the functions of the nervous system and/or send symptoms. They are meant to either added as an example of method.
89
signals directly to the nervous system by modulate the functions of the nervous
applying acoustic, electrical, magnetic or optical system and/or send signals directly to the The last parts has been deleted since
stimulation and/or inhibition of the peripheral or nervous system by applying acoustic, modulate includes inhibition.
central nervous system. electrical, magnetic or optical stimulation
and/or inhibition of the peripheral or central
nervous system.
(b). (i). Examples of this neurotechnology are implanted Examples of this neurotechnology are Optogenetic is one method and optical
microelectrodes, BMI, DBS, Optogenetic optical implanted microelectrodes, BMI, DBS, stimulation without genetic modification is
stimulation, Transcranial electrical stimulation (tES), Optogenetic or optical stimulation, Ablation another method, and these should be
Transcranial Magnetic Stimulation (TMS) or (by ultrasound or other mechanical waves, separated.
Neuropharmacological infusion. radiofrequency heating or cryo),
Transcranial electrical stimulation (tES), Ablative methods are not mentioned, they
Transcranial Magnetic Stimulation (TMS) or destruct nervous tissue in a controlled
Neuropharmacological infusion. way.
14. Of note, several sensor technologies collect data Of note, several sensor technologies collect It is perhaps important to emphasize that
indirectly informing about neural activity. Even if they data indirectly informing about neural detailed monitoring of human behaviour
are not neurotechnology per se, they raise similar activity. Even if they are not neurotechnology (eye-tracking, tracking of gestures and
ethical and human rights issues as neurotechnology per se, they already raise similar ethical and facial expressions, voice/speech
when used to infer mental states. They include but are human rights issues as neurotechnology characteristics, language use etc.) is
not limited to eye-tracking, Video Oculography, Typing when used to infer mental states. They currently a much more effective method
dynamics, Voice recognition and analysis, Gait include but are not limited to eye-tracking, to reveal hidden internal states,
analysis, Skin conductance, Heart rate variability, Sleep Video Oculography, Typing dynamics, Voice intentions, responses to external stimuli
movement monitoring, Blood pressure measurement, or recognition and analysis, Gait analysis, Skin relating to inner goals, preferences etc.
facial- emotion recognition systems. conductance, Heart rate variability, Sleep than any existing neurotechnological
movement monitoring, Blood pressure technique.
measurement, or facial- emotion recognition
systems. Thus, a regulation of such applications
could become a blueprint for future
neurotechnological applications (relates
to §16 below)
15. Neural data. Neural data are qualitative and The implications of direct correlates in this
quantitative data about the structure, activity and context needs to be either clarified, or left
function of the nervous system. They encompass data out.
relating to a nervous system's activity, including both
direct measurements of neuronal structure, activity
and/or function (i.e., neuronal firing or averaged
bioelectric signals from EEG) and indirect functional
90
indicators (i.e., blood flow in fMRI and fNIRS). At the
neurobiological level, neural data are the most direct
correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with It could be mentioned here or at other
data collected by non-neural biometric technologies can suitable place in the document that non-
be processed to infer mental states, which this neural parameters can be GPS positions,
Recommendation refers to as "cognitive biometric eye-tracking data, gait parameters,
data". posture etc.
It is not clear when “neural data” is also
considered to be “cognitive biometric
data”. The overlap between the two
notions seems confusing. Therefore, we
propose one definition, as follows:
15. Neural data. Neural data are
qualitative and quantitative data about the
structure, activity and function of the
nervous system. They encompass data
relating to a nervous system's activity,
including both direct measurements of
neuronal structure, activity and/or function
(i.e., neuronal firing or averaged
bioelectric signals from EEG) and indirect
functional indicators (i.e., blood flow in
fMRI and fNIRS). At the neurobiological
level, neural data are the most direct
correlates of mental states.(This sentence
is describing and shall be left out of the
notion and placed in the text of the
Recommendations). Neural data shall be
considered also data derived from any
biosensor technology, like non-neural
biometric technologies, referred to as
“cognitive biometric data”.
17. Whole lifecycle. Neurotechnology should be
considered from the early stages of mining for materials,
prototyping, research, design and development to
deployment and use, including maintenance, operation;
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trade, financing, monitoring and evaluation, validation,
end-of-use, disassembly, termination, disposal and
recycling. The whole lifecycle of neurotechnology
includes its convergence with other technologies and the
diversity of actors who are involved in every stage.
II. AIMS AND OBJECTIVES
18. This Recommendation has been created with the Consider leaving out. Feels redundant.
aim of guiding the development and use of
neurotechnology in ways that are ethical, safe and
effective for the good of humanity, individuals,
communities, societies, the environment and
ecosystems, and to prevent harm in the present and the
future based on international law, in particular the
Charter of the United Nations and international human
rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect
of human rights and fundamental freedoms,
human dignity and equality, including gender
equality, and to respect cultural diversity during
the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, All actors addressed here, besides
individuals, groups, communities, institutions, Member States, i.e. individuals, groups,
private sector companies and every other communities, institutions, private sector
relevant actor to ensure the embedding of companies and every other relevant
ethics in all stages of the neurotechnology actor, should consequently be addressed
lifecycle; in the recommendation, when
appropriate.
(c) to ensure that neurotechnology in its whole to ensure that neurotechnology in its whole The term evidence-based has a specific
lifecycle is evidence-based, reliable and lifecycle is evidence-based science based, meaning in medical usage, i.e. does not
reproducible; reliable and reproducible; mean “based on evidence” but rather
based on evidence collected and
interpreted in a specific manner that
includes striving for randomized clinical
trials as the gold standard.
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Science-based is more accurate in this
context.
Also se §100 and §136.
(d) to provide a universal framework that not only
articulates values and principles, but also
translates into concrete policy
recommendations and effective implementation
to guide Member States in their engagement
with neurotechnology in its whole lifecycle,
consistent with their obligations under
international human rights law and other
international standards;
(e) to foster multi-stakeholder, multidisciplinary and to foster a multi-stakeholder,
pluralistic dialogue and consensus building multidisciplinary and pluralistic dialogue and
about ethical issues relating to consensus building about ethical issues
neurotechnology; relating to neurotechnology;
(f) to promote justice and equitable access to What is the message here? Is this
developments and knowledge in the field of referring to neurotechnology for all kind of
neurotechnology and the sharing of benefits; purposes, including enhancement? This
paragraph needs to be adjusted in order
to not give that impression.
(g) to ensure accountability and solidarity among
all actors to prevent misuse of neurotechnology
and to uphold human rights and ethical
standards.
III. VALUES AND PRINCIPLES Suggestion: Consider begin this chapter
with common statements that are
applicable to all areas/dimensions in
order to avoid repetitions and
duplications.
Some of the paragraphs also overlaps
with IV AREAS OF POLICY ACTION or
could fit there as well.
93
III.1 VALUES The difference between VALUES and
ETHICAL PRINCIPLAS AND HUMAN
RIGHTS is unclear and must be refined.
III.1.1 Respect, protection and promotion of human Human rights return in III.2. Ethical
rights, fundamental freedoms and human dignity Principles and Human Rights.
20. The inviolable and inherent dignity of every human
being is the foundation of universal human rights and
fundamental freedoms. Respect, protection, and
promotion of human dignity, as established by
international human rights law, are essential in the
whole lifecycle of neurotechnology. Dignity
encompasses the recognition of the intrinsic and equal
worth of each person. Neurotechnology must never be
used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any
individual, including people living in vulnerable
situations.
III.1.2 Promoting human health and well-being
21. Prioritizing the development and application of Proritizing research, development, and Maybe move highlighted text to
neurotechnology that promotes comprehensive application of neurotechnology that DEFINITIONS?
human health and well-being, viewing health as a promotes comprehensive human
holistic state of physical, mental, and social well- health and well-being, viewing health as
being. a holistic state of physical, mental, and
social well-being.
22. The responsible allocation of resources for The responsible allocation of resources for This is very important. Neurotechnology
neurotechnology should be directed toward neurotechnology should be directed towards for the benefit of those who gain most
preventative, diagnostic, therapeutic, assistive, and preventative, diagnostic, therapeutic, from the technology must be in the centre
rehabilitative purposes that benefit the largest number of assistive, and rehabilitative purposes that of this recommendation.
people and those who stand to gain the most, rather benefit the largest number of people and
than consumer-driven or commercial applications. those who stand to gain the most, rather Compare §25 where neurotechnology in a
than consumer-driven or commercial general sense is promoted as something
applications. that unconditionally benefits humanity.
III.1.3 Ensuring and respecting diversity and
fairness
23. Respect for diversity and fairness, must be upheld in 23. Respect for diversity and fairness, must
the whole lifecycle of neurotechnology. Special be upheld in the whole lifecycle of
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consideration should be given to neurodiversity, minority neurotechnology. Special consideration
groups, lndigenous Peoples, and underrepresented should be given to neurodiversity, minority
voices. groups, lndigenous Peoples, and
underrepresented voices.groups of peoples.
24. Given that widely recognized neurotechnological Given that widely recognized Add a definition of “technological
innovation largely occurs in the urban well resourced neurotechnological innovation largely occurs colonisation” to DEFINITIONS.
sector, specific attention to underserved and in the urban well resourced sector, specific
marginalised people is crucial to prevent bias, ongoing attention to underserved and marginalised
disparities in healthcare, stigma, neglect, and people is crucial to prevent bias, ongoing
disrespect. Technological assimilation, or using disparities in healthcare, stigma, neglect,
technology as a tool of colonisation (a term the and disrespect. Technological assimilation,
Recommendation refers to as "technological or using technology as a tool of colonisation
colonialism"), can threaten cultural diversity and (a term the Recommendation refers to as
heritage, therefore must be protected against. "technological colonialism"), can threaten
cultural diversity and heritage, therefore
must be protected against.
25. Equitable access to neurotechnology should be The requirement of equitable access to
prioritized globally, ensuring that its benefits are neurotechnology needs to be specified.
accessible to all, regardless of socioeconomic status or Equitable access to medical treatment is
geographical location. Special attention must be given certainly to be desired, but not all
to low- and middle-income countries, resource- potential uses of neurotechnology may be
constrained settings, and marginalised communities, desirable.
including the specific needs of different groups, ages,
segments, cultural systems, languages, communities,
and marginalised and vulnerable populations, people
with disabilities, neurological disorders, and mental
health conditions.
26. lndividuals and groups should be allowed to make 26. lndividuals and groups of peoples should What is the purpose of this paragraph?
lifestyle choices, express beliefs and opinions, share be allowed to make lifestyle choices, As it is worded now, it gives the
personal experiences, and participate in co-designing express beliefs and opinions, share personal impression that UNESCO promotes non-
technologies, provided that these choices are made in experiences, and participate in co-designing scientifically based experiments as long
ways that respect the rights of others. technologies, provided that these choices as those involved respect the rights of
are made in ways that respect the rights of others.
others.
III.1.4 Consideration for cross-cultural perspectives This section (§27-§28) can be removed.
on human knowledge and its sharing The essence can be communicated in
other paragraphs/sections.
27. Respectful knowledge sharing on the human Important to clarify that respectful
nervous system and its functions across communities knowledge sharing must follow the
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and cultures fosters trust and strengthens global principles of open science in accordance
cohesion in the pursuit of health and quality of life. with UNESCOs recommendation on
Open Science (2021).
28. It is essential that any research and How does this translate to practice?
development involving diverse groups and Permission of a whole group/community
communities is done with their permission and seems broad.
guidance, and conducted with their full prior and
informed consent and partnership in ways that
serve their interests and respect their traditional
knowledge and epistemic contributions.
III.1.5 Commitment to peace, fairness and justice in
society
29. The use of neurotechnology should be used to The text refers to the need for “consent”
promote, not undermine freedom of thought especially where established medical ethics would
in situations where refusal to use the technology could require something more, namely
lead to competitive disadvantage. Such interferences “informed consent”.
include but are not limited to the use of force, threats,
undisclosed access, manipulation, or any scenario See §28 where informed consent it used.
where consent is compromised, including as a result of
power imbalances.
30. The use of neurotechnology should be particularly
scrutinized to avoid uses that segregate, objectify or
subordinate individuals or communities, reduce social
cohesion by exacerbating pre existing inequalities or
generating novel inequalities that divide and antagonize
individuals against each other, and thereby threaten the
coexistence between humans, other living beings and
the natural environment.
III.1.6 Global Solidarity and International
Cooperation
31. The Recommendation should guide all actors in the Is research exempted here?
development, deployment and use of neurotechnology It would be good to clarify.
to act in solidarity and call for accountability in instances
where neurotechnology may be misused in ways that
threaten human rights.
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32. lnternational cooperation is essential to addressing lnternational cooperation is essential to Yellow marked sentence needs
cross-border issues related to neurotechnology. addressing cross-border issues related to clarification. How and why must particular
Particular attention must be given to differing neurotechnology. Particular attention must attention be given to differing
perspectives on acceptable use to prevent abuse and be given to differing perspectives on perspectives on acceptable use in order
uphold global ethical standards. acceptable use to prevent abuse and uphold to prevent abuse and uphold global
global ethical standards. ethical standards? What kind of different
perspectives are referred to?
III.1.7 Sustainability
33. Considering that sustainability requires that 33. Neurotechnology must Considering that
neurotechnology be developed and used with a deep sustainability requires that neurotechnology
respect for environmental stewardship, prioritizing the be developed and used with a deep respect
minimisation of ecological harm throughout the lifecycle for environmental stewardship,
of the materials used, including, for mining extraction, ensuring/safeguarding that prioritizing the
data processing and storage, recycling and disposal minimisation of ecological harm is
practices. minimized/avoided throughout the lifecycle of
the materials used, including, for That includes
mining extraction, data processing and
storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, This paragraph must be reworded into an
especially for non-medical purposes, might lead to aspiration or position.
disproportionate consumption of resources and energy
and waste production.
35. Respect for lndigenous rights, in accordance with 35. Respect for lndigenous rights, in
the United Nations Declaration on the Rights of accordance with the United Nations
lndigenous Peoples (UNDRIP), requires that Declaration on the Rights of lndigenous
neurotechnology, through its whole lifecycle, be guided Peoples (UNDRIP), requires that
by a profound respect for lndigenous rights, ensuring neurotechnology, through its whole lifecycle,
that their lands (including during mining), knowledge, be is guided by a profound respect for
communal rights, and privacy are honoured in all lndigenous rights, ensuring that their lands
activities, including those related to resource extraction. (including during mining), knowledge,
communal rights, and privacy are honoured
in all activities, including those related to
resource extraction.
III.1.8 lntegrity and Responsibility
36. lntegrity requires that all actors in the whole lifecycle Is this VALUE or POLICY?
of neurotechnology field act with ethical steadfastness. It
includes adhering to ethical guidelines and ensuring
97
that all actions align with both professional standards
and societal values.
37. lntegrity includes a commitment to taking
responsibility for one's actions and being accountable
for their outcomes. This involves not only acknowledging
successes but also owning up to mistakes and taking
corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous Consider moving to DEFINITIONS
pursuit of truth through evidence-based, objective and
transparent research practices. It ensures that all
scientific endeavours are conducted with honesty,
accuracy, and respect for the scientific method of
disciplines relevant for neurotechnology.
III.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred
approach through fundamental ethical principles
including but not limited to self-determination, agency,
freedom of thought, privacy, cognitive liberty, personal
and collective identity, trustworthiness, respect,
reciprocity, and justice. Furthermore, it incorporates the
respect, promotion and protection of human rights.
III.2.1 Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and
well-being, and empower individuals to make §40- §42 The text about enhancement
informed decisions about their nervous system and (medical interventions that provide
mental health while fostering a better functionality beyond normal human
understanding of themselves. functionality) is unclear. The phrase in
40§ that neurotechnology should
“empower individuals to make informed
decisions about their nervous system and
mental health” gives the impression of
allowing for enhancements. The text in
42§ mentions that enhancement may
involve medical risks but does not
exclude such risk-taking, whereas 41§
says that neurotechnology should not
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cause harms. From the viewpoint of
established medical ethics, the principle
of non-maleficence excludes the
performance of enhancing interventions
with significant medical risks. It is
surprising that this standpoint is not
clearly supported in the document.
41. Neurotechnology should contribute to human See comments above.
flourishing without causing harm or subordination,
whether physically, economically, socially, politically,
culturally, or mentally. The "do no harm" principle must
guide the whole lifecycle of neurotechnology, ensuring
that the quality of life is protected and promoted.
42. Embracing neurotechnology for enhancement may This paragraph must be reworded and
lead to the risk of not only unexpected damage to the much clearer distance itself from
nervous system, but also to amplified inequalities within enhancement and its risks. The
society. paragraph also, at least partly, overlaps
with the IV.16 Enhancement.
43. Any restrictions to human rights must meet all This paragraph is redundant and should
applicable requirements under human rights law, be left out.
including the principles of legality, legitimate aim,
necessity and proportionality.
44. The principles of proportionality, balance and Is this VALUE or POLICY?
legitimacy should govern the use of neurotechnology
and the data it enables, to ensure their use is: (a)
appropriate and proportional to the objective and
expected benefits that are aimed to be achieved; (b) do
not infringe upon the foundational values of this
document; (c) appropriate to the context and target user
group; (d) based on safety principles and rigorous
scientific evidence.
III.2.2 Self-determination and the Freedom of
Thought
45. Throughout the whole lifecycle of neurotechnology,
the protection and promotion of the rights of freedom of
thought, and self-determination must be secured.
46. lndividuals have the right to make free, informed, This description appears to be closer to
and voluntary decisions about their engagement with the medical ethical concept of autonomy.
99
neurotechnology throughout the whole lifecycle, in
accordance with international human rights law and ‘Self-determination’ is for most people in
other international standards, including the right to medicine and psychology probably more
refuse or withdraw from its use, at any time, ensuring related to explaining the driving forces
their autonomy and respect for their decision-making behand motivation (SDT theory)
capacity is upheld and where surrogate consent is
used, the best interests of the affected individual are See comment §7 above.
considered. lndividuals who are enrolled in research
should be informed of potential side effects and given The part about the right of individuals who
the opportunity to disclose if they have any take part in a clinical trial does not
contraindications for the procedures used. lnformed mention their right to retain a medically
consent procedures should be affirmative, dynamic, and useful treatment that they received in a
require opt-in, comprehensive and transparent trial, if they so wish. In several trials with
providing detailed information about the purposes, risks, implanted neurotechnological devices,
benefits, alternatives, and possible outcomes of the participants who could not themselves
technology in all its application domains, ensuring that pay for continued treatment were forced
consent is voluntary and that individuals fully to have a well-functioning device
understand the implications for their privacy, autonomy, surgically removed at the end of the trial. 3
and well-being. The rights of trial patients to continued
treatment should be supported in the
document.
47. Neurotechnology should never be used to exert
undue influence or manipulation, whether through
force, coercion, or other means that compromise self-
determination and freedom of thought. This protection
covers both the internal processing of thoughts and
their externa! expression, ensuring freedom from any
interference.
III.2.3 Protection of Neural and Cognitive Biometric
Data for Mental Privacy
48. Neurotechnology and cognitive biometric Very long sentence and difficult to grasp.
technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct This is correct, but mainly for cognitive
and indirect data about the nervous system that is biometric technologies (see comment §14
uniquely sensitive because they can be processed and above).
analysed to provide deep insights in the processes that
3 Sven Ove Hansson, “The ethics of explantation”, BMC Medical Ethics, 22:121, 2021. Link: https://rdcu.be/cxqdJ
100
underpin our mental states and behaviour, including
self-awareness and introspection. As it becomes
increasingly difficult to anonymize data, there remains
persistent risks of misuse of this data by revealing
neurobiological correlates of diseases, disorders, or
general mental states without the authorization of the
person from whom data are collected.
49. Mental privacy is fundamental for the protection of 49. Mental privacy is fundamental for the Crossed out sentence is important, but
human dignity, personal identity, and agency. The protection of human dignity, personal could be moved to an introductory part of
collection, processing, modification, and sharing of identity, and agency. In order to protect VALUES AND PRINCIPLES, if such a
neural data must be conducted with free and informed mental privacy, the collection, processing, section is added. Mental privacy is
consent, in ways that respect the ethical and human modification, and sharing of neural data fundamental for the protection of human
rights principles outlined in this Recommendation. must be conducted with free and informed dignity, personal identity, and agency.
consent, in ways that safeguards and
respect the ethical and human rights Provide more concrete examples of
principles outlined in this Recommendation. potential violations of mental privacy,
such as unauthorized access to neural
data, discriminatory use of brain-based
information, and manipulation of mental
states
50. There should be clear safeguards against the
misuse or unauthorised access of neural and cognitive
biometric data, including affirmative consent, data
minimization and purpose specification, data rights
(such as rights to access, correct and delete), and data
security, particularly in contexts where such data might
be aggregated with other sources.
III.2.4 Non-Discrimination and Inclusivity
51. All actors involved in the whole lifecycle of
neurotechnology, particularly in its interface with other
technologies like Al, must commit to upholding ethical
principles that prevent discrimination, stigmatisation,
targeting, or exploitation of any individuals or groups,
particularly those in vulnerable situations.
52. There is a shared responsibility to ensure that
these technologies do not perpetuate or amplify
existing inequalities or create new forms of
discrimination based on neurological or mental
101
characteristics, or other grounds protected under
human rights law.
53. Non-inclusive technological development and Shouldn’t this statement be followed by a
standardisation may drive a trend toward recommendation?
homogenisation and the dominance of neurotypicality
and capacities that may threaten cultural and collective
identity.
54. Garnering the trust and acceptance of communities This sentence is vague.
in the whole lifecycle of neurotechnology requires
transparent engagement with the public, seeking their
input and validation to align these technologies with
societal values and the common good.
55. Discrimination on any grounds, including intellectual 55. Discrimination on any grounds, including Yellow marked sentence is difficult to
differences or those related to atypicality, should be intellectual differences or those related to understand. Is it neurotechnological
condemned. Neurotechnology should not be used to atypicality, should be condemned. solutions or evaluations of
inform, justify, or reify such discrimination. Care should Neurotechnology should must not be used to neurotechnological solutions that should
be taken to evaluate neurotechnology solutions inform, justify, or reify such discrimination. be carefully conducted? If the latter,
promoted through governments for essential services Care should be taken to evaluate explain why.
such as education. neurotechnology solutions promoted through
governments for essential services such as §67 and §136-138: Here the use of
education. neurotechnology in education is
discussed without any mention of the
specific neurotechnologies that could be
used for education. In §138 it is proposed
that “neurotechnology in educational
settings” could include technologies that
need “an assessment of reversibility on
the nervous system” and could give rise
to “dependency or de-skilling”. Nothing is
said about which these technologies are.
56. Neurotechnology should not be used to perpetuate 56. Neurotechnology should not be used to This should apply to everyone.
stereotypes, stigma, or discrimination against older perpetuate stereotypes, stigma, or
persons. discrimination against older any persons or
groups of people.
III.2.5 Accountability
57. Maintaining trust and integrity throughout the whole 57. Maintaining trust and integrity throughout Very important to underline that design,
lifecycle of neurotechnology requires all actors to the whole lifecycle of neurotechnology adjustments etc. must be scientifically
102
adhere to the highest ethical standards, remain open to requires all actors to adhere to the highest based. “Evidence” is too vague in this
feedback, be committed to adjusting practices in ethical standards, remain open to feedback, context, since it is quite often used
response to new evidence or ethical concerns, and be be committed to adjusting practices in carelessly to give the appearance of a
held accountable for their actions. response to new scientific evidence or ethical scientific approach.
concerns, and be held accountable for their
actions.
58. Accountability is grounded in responsibility, clear Remove or re-word? This is a general
and transparent communication, and a duty to description of accountability.
anticipate and address potential harms-whether short-
term, long-term or arising from unintended use and
impact.
59. A commitment to accountability requires global, How should accountability be addressed
governmental, societal and collective action to ensure within different stages of development?
those harmed by neurotechnology have access to I.e. research, development, deployment?
justice, and that those responsible for wrongdoing are A differentiation is missing.
required to take meaningful steps to identify, prevent,
mitigate and account for how they address and redress
their adverse human rights impacts, including through
corrective actions and reparations.
III.2.6 Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection The message here is also applicable on
of human rights and fundamental freedoms, all actors other areas, such as for instance
throughout the whole lifecycle of neurotechnology must Accountability, Non-Discrimination
ensure that their activities are transparent, grounded in and Inclusivity, Integrity and
scientific evidence, and aligned with international Responsibility.
principles of responsible conduct and scientific integrity.
This includes preventing the replication or amplification
of biases, ensuring that neurotechnology is traceable Who defines the conditions for
and explainable, its capacities and limitations are accountability?
accurately portrayed, the conditions for accountability
are clearly defined, adhering to ethical guidelines in
research and development, including the registration of
trials, fair participant selection, and approval by
independent ethics committees.
III.2.7 Epsitemic Justice, Inclusive Engagement and
Public Empowerment
103
61. Ensuring fair and equitable distribution and creation 61. Ensuring fair and equitable distribution Delete diverse ways of knowing since
of knowledge about neurotechnology, including and creation of knowledge about knowledge should be science-based.
recognizing diverse ways of knowing, and that all neurotechnology, including recognizing
individuals and communities can participate in its diverse ways of knowing, and that all
creation, sharing, and applications. individuals and communities can participate
in its creation, sharing, and applications.
62. Promoting open and accessible education, along Here it is very important to underline that
with public and community engagement, to ensure knowledge must be scientifically based
diverse populations can gain and exchange knowledge and with public good interest in mind.
about nervous system functioning, mental health, and
medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement 63. Effective public and community Again, “respect different ways of knowing
throughout the whole lifecycle of neurotechnology engagement throughout the whole lifecycle and understanding” is promoted. What’s
requires respect for diversity, including linguistic, social, of neurotechnology requires respect for the purpose and implications in this
cultural, heritage, and identity, to respect different ways diversity, including linguistic, social, cultural, context? Does it also include non-science
of knowing and understanding. This respect for diversity heritage, and identity, to respect different based ways of knowing and
ensures that the knowledge and perspectives of diverse ways of knowing and understanding. This understanding?
communities are valued and included in decision respect for diversity ensures that the
making processes, and respects self-determination. knowledge and perspectives of diverse Respect for diversity is generally
communities are valued and included in important but cannot be promoted when it
decision making processes, and respects comes to knowledge in neurotechnology,
self-determination. that must be science based.
64. Grounding education in human rights ensures that This claim is quite far-fetched; education
the knowledge shared and produced respects the in human rights do not necessarily
rights of all individuals, preventing epistemic injustice ensures that knowledge sharing and
where certain groups may be marginalized or excluded production respects the rights of all
from knowledge production and dissemination. individuals etc.
65. All communities should have a voice in decisions that This is vague. Does this refer to all kinds
affect them, particularly when it comes to the of neurotechnology and all kinds of
development and use of neurotechnology. communities, including those that wants
to develop and use neurotechnology for
enhancement and/or for commercial
purpose?
III.2.8 Best Interest of the Child and Protection of Consider merging this part to IV.6, where
future generations CHILDREN AND ADOLESCNETS also is
addressed.
104
66. The nervous system is rapidly evolving during
childhood and critically changing during adolescence,
which makes it crucial to preserve the privacy, self-
determination and the right of children and adolescents
to participate in decisions that affect them. Technology
should be rigorously assessed to ensure it serves the
best interests, well-being and healthy development of
children, as they grow into autonomous individuals and
safeguard the rights of future generations by ensuring
that today's decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the From an ethical perspective, while The text felt incomplete. Brain research
potential benefits of neurotechnology for early recognizing the potential benefits of suggests that a healthy lifestyle should
diagnosis, instruction, education, and continuous neurotechnology for early diagnosis, also prioritize sleep and access to nature.
learning, it is equally important to make a commitment instruction, education, and continuous
to the holistic development of the child. This includes learning, it is equally important to make a
nurturing their social lite, fostering meaningful commitment to the holistic development of
relationships, and promoting a healthy lifestyle the child. This includes nurturing their social
encompassing nutrition and physical activity. lite, fostering meaningful relationships, and
promoting a healthy lifestyle encompassing
nutrition, sleep, and physical activity and
access to nature.
III.2.9 Global and social justice, enjoying the
benefits of scientific progress and its application
68. Access to and benefits arising from research and 68. Access to and benefits arising from Important to underline that research and
development in neurotechnology must be shared science based research and development in development must be science based.
equitably among all contributors to that research and neurotechnology must be shared equitably This paragraph could also go under IV
development, with a particular focus on ensuring global among all contributors to ensure that research AREAS OF POLICY ACTION.
distribution that promotes fairness and reduces and development, with a particular focus on
disparities. ensuring global distribution that promotes
fairness and reduces disparities.
69. Neurotechnology developments should be This paragraph is based on the
leveraged to reduce global health inequities. These assumption that neurotechnology can
technologies should serve as catalysts for improving the contribute to reducing global health
quality of lite, particularly in resource-limited settings. inequalities. For this to be credible, it
would have to be shown that access to
neurotechnology is a priority for
healthcare in low- and middle income
countries. The claim that
105
neurotechnologies can “serve as
catalysts” would need an explanation of
how this could happen.
70. Research, development, and trials in Are there any risks of using
neurotechnology must adhere to the highest ethical disproportionately in this context, i.e. is
standards, ensuring the non-exploitative participation of this a word open for interpretations that
all individuals involved. This includes safeguarding the can counteract the objectives of this
rights and well-being of participants, and patients and recommendation in general and of this
their caregivers, as well as ensuring the ethical paragraph in particular?
collection and use of data. Special attention should be
given to ensure that those contributing to research and participants, and patients and their
development have their fair share of the benefits and do caregivers - Are they also considered as
not bear disproportionately the risks. contributors ?
71. Efforts, including international cooperation, should
be made to overcome, and never take advantage of,
the lack of necessary technological or medical
infrastructure, education and skills, as well as ethical-
legal frameworks, particularly in LMICs, LDCs, LLDCs
and SIDS, affecting communities.
72. The development and impact assessment of novel What are the implications of this
neurotechnology should consider the implementation of paragraph? The paragraph is vague.
human-centred paradigms in which end-users are not
merely passive recipients of the technologies but active End-users should be clarified, maybe in
co-shapers on an equal footing. DEFINITIONS.
IV. AREAS OF POLICY ACTIONS In order to avoid repetition and to
condense the text, this chapter could
preferably begins with paragraphs that
address issues that are applicable to and
relevant for all areas, ex. cross country
collaboration, multi stakeholder
perspective etc.
Throughout this chapter, it is the Member
States that are held responsible. In some
cases, this is correct. In other cases,
other actors should be addressed (for
106
instance employers in section IV.14
Labour and Employment).
Finally, try to avoid repeating values and
ethical principles etc. that already have
been addressed. This chapter should
instead focus on how these values and
principles should be applied into policies
and actions.
IV.1 GOVERNMENT INVESTMENT, USE AND
REGULATION
73. Member States, private actors and international Member States, private actors and Until today, medical applications are by
institutions should actively support the research, international institutions should actively far the most important use of these
development, and deployment of neurotechnology for support the science based research, technologies. The deployment of
the public good. lnvestments should prioritize development, and deployment of neurotechnology for the public good
applications that foster human flourishing, and the use neurotechnology for the public good. therefore needs to have a strong medical
of which respects, promotes and protects individual and lnvestments should prioritize applications focus, including access to these new
collective human rights. This commitment should that foster human health and well-being treatment approaches for everyone in
include funding for interdisciplinary research that not flourishing, and the use of which respects, society – based on the individual’s
only advances neurotechnological innovation but also promotes and protects individual and medical needs.
studies the ethical, legal, social, environmental and collective human rights. This commitment
cultural implications of these technologies, and supports should include funding for interdisciplinary The requirement that member states
the implementation and clinical translation of research that not only advances should support the development of
technological prototypes. Particular attention should be neurotechnological innovation but also neurotechnology that fosters “human
given to the development and implementation of studies the ethical, legal, social, flourishing” is too vague to be meaningful.
adequate technical, institutional, procedural and other environmental and cultural implications of
safeguards to ensure that they equitably benefit society these technologies, and supports the
and that human rights are upheld. implementation and clinical translation of
technological prototypes. Particular attention
should be given to the development and
implementation of adequate technical,
institutional, procedural and other safeguards
to ensure that they equitably benefit society
and that human rights are upheld.
74. Member States should establish clear prohibitions Member States should establish clear The paragraph is very long. Maybe split
against the use of neurotechnology in contexts that prohibitions against the use of into three paragraphs as suggested.
violate individual and collective human rights. Member neurotechnology in contexts that violate
States should conduct human rights due diligence, individual and collective human rights.
107
including regular, comprehensive human rights impact Member States should conduct human rights
assessments, concerning neurotechnology that they due diligence, including regular,
develop, design, deploy, use, sell, operate or procure, comprehensive human rights impact
in order to prevent and mitigate their adverse human assessments, concerning neurotechnology They in this context is a bit confusing.
rights impacts. Specifically, neurotechnology should not that they develop, design, deploy, use, sell, Does They refer to the Member States
be used for purposes such as non-consensual operate or procure, in order to prevent and (i.e. governments/the state) or to actors
interrogation in law enforcement, criminal and civil mitigate their adverse human rights impacts. operating within a state? Preferably,
justice, development or deployment of weapons actors operating within a state should be
targeted at the nervous system, social control, attempts --- included.
at coercive behavioural conformity based on personal Specifically, neurotechnology should not be
beliefs or thoughts, political or other opinion, gender used for purposes such as non-consensual That part of the sentence should be
identity or sexual orientation, or surveillance of mental interrogation in law enforcement, criminal clarified. What does that mean “contexts
states, among others. Governments should adopt and civil justice, development or deployment that violate individual and collective
legislation that ensures neurotechnology is deployed of weapons targeted at the nervous system, human rights” ?
responsibly, and based on human rights, with robust social control, attempts at coercive
oversight mechanisms to enforce adherence to these behavioural conformity based on personal
restrictions and protect mental privacy and freedom of beliefs or thoughts, political or other opinion,
thought for all individuals. These policies should be gender identity or sexual orientation, or
developed in consultation with diverse actors, including surveillance of mental states, among others.
civil society, end-users, neurotechnology experts,
ethicists, and human rights advocates, to ensure broad ---
consensus and respect for global human rights norms. Governments should adopt legislation that
ensures neurotechnology is deployed
responsibly, and based on human rights,
with robust oversight mechanisms to enforce
adherence to these restrictions and protect
mental privacy and freedom of thought for all
individuals. These policies should be
developed in consultation with diverse
actors, including civil society, end-users,
neurotechnology experts, ethicists, and
human rights advocates, to ensure broad
consensus and respect for global human
rights norms.
75. Member States should ensure transparency and This paragraph is problematic.
accountability in their support, oversight, and regulation Distinctions regarding transparency and
of neurotechnology, particularly in publicly funded accountability should not be made based
initiatives such as brain research and development on funding (public or private). Such a
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programs. While recognizing the limitations in disclosing distinction might stand in conflict with the
certain sensitive information, governments should Recommendation on Open Science and
require government sponsored neurotechnology general scientific standard procedures
projects to publicly disclose the objectives, and give advantages to private funded
methodologies, intended uses, and societal impacts of research.
their neurotechnology initiatives wherever possible. This
transparency is crucial for fostering public trust and The phrase “[…] recognizing the
ensuring that neurotechnology advances are aligned limitations in disclosing certain sensitive
with ethical standards and human rights. information […]” is problematic from an
Open Science perspective, since it gives
companies mandate to prevent
researchers from publishing material/data
that may be sensitive to the company.
Sensitive information and limitations
needs to be clarified.
76. Member States should apply a comprehensive Consider modifying this paragraph so it
approach to regulatory and policy measures to protect applies to all actors – private as well as
against human rights harms related to neurotechnology public. A lot of research and medical care
developed, marketed, operated or used by the private is taken place in public institutions
sector. This includes legislative and regulatory (hospitals and universities). Otherwise,
measures and accompanying guidance, incentives, and clearly underline that this specific
transparency requirements. This comprehensive paragraph is addressed to the private
approach should also require human rights due sector.
diligence, ensuring that businesses identify, prevent,
mitigate, and account for their adverse human rights
impacts through context-dependent processes,
including human rights impact assessments, meaningful
public and community engagement, and transparent
communications.
77. Member States should ensure that any use of 77. Member States should ensure that any This is the first time that robust scientific
neurotechnology in the justice system, including its use of neurotechnology in the justice evidence is used. Shouldn’t this apply to
consideration by the judiciary should be grounded in system, including its consideration by the all areas, and especially to the medical
robust scientific evidence, be implemented ethically in judiciary, should be grounded in scientific field? Are there any deliberate reasons
accordance with human rights, and be aimed at evidence, be implemented ethically in for making a distinction “robust scientific
promoting public safety while protecting the rights and accordance with human rights, and be evidence” and “scientific evidence”?
dignity of all those involved. This requires respect for aimed at promoting public safety while
fundamental rights, such as human dignity, bodily protecting the rights and dignity of all those The paragraph is also very long, it would
integrity, confidentiality of personal data, due process involved. This requires respect for benefit from being shortened.
and fair trial rights, including the presumption of fundamental rights, such as human dignity,
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innocence, and the right against self-incrimination, as bodily integrity, confidentiality of personal In addition, informed consent should be
well as freedom from torture and ill-treatment, the right data, due process, and fair trial rights, included.
to privacy, and the right to freedom of thought. including the presumption of innocence, and
the right against self-incrimination, as well as
freedom from torture and ill-treatment, the
right to privacy, and the right to freedom of
thought.
78. Member States should establish comprehensive This paragraph demands that all Member
incentive structures, such as tax incentives, grants, and States should have “incentive structures,
awards, with a particular focus on encouraging the such as tax incentives, grants, and
construction and development of manufacturing, awards” that support “computational
computational resources, and data analytics capabilities resources” and certain other capabilities.
within public research institutions and small and medium This may not be an appropriate demand
enterprises (SMEs). Member States should also on all member states, since their
incentivize and support partnerships that leverage the industrial and fiscal policies may have to
computational resources and data analytics capabilities take other issues into account, such as
of private firms to advance public research goals. These resource limitations.
incentives should prioritize rewarding transparency,
participatory development processes, and contributions
to societal benefits, aiming to foster an environment
where public institutions and companies innovate
responsibly and align with human flourishing goals.
79. Member States should establish a coordinated, The sustainability/the environmental
cross-sectoral approach to assessing the impacts of aspects of neurotechnology should be
neurotechnology across the whole lifecycle. This highlighted in a separate paragraph.
approach should include, but is not limited to:
a) Economic lmpact Assessments: Conducted by
relevant national bodies responsible for
economic and labor policies to assess how
neurotechnology impacts economic growth,
jobs, social justice, and environmental
sustainability;
b) Benefit-Risk Assessments: Managed by entities
responsible for public health, medical research,
and consumer protections, these assessments
should rigorously evaluate the risks and
benefits associated with the development,
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deployment, and use of neurotechnology,
including research, clinical applications, and
consumer products. The process should
include thorough documentation, ethical
oversight, and continuous monitoring to ensure
the safety, well-being, and equitable treatment
of all individuals involved;
c) Privacy lmpact Assessments (PIAs): under the
oversight of relevant national authorities or
agencies responsible for data protection and
privacy, these assessments should evaluate
and mitigate risks to individuals' mental privacy
posed by neurotechnology. This includes
ensuring that appropriate safeguards are in
place to protect neural and cognitive biometric
data in compliance with national and
international privacy standards, and the data
policy practices discussed herein;
d) Human Rights lmpact Assessments (HRIAs):
with oversight from relevant national human
rights institutions or international bodies,
identify, prevent, and address potential human
rights impacts of neurotechnology. The process
should ensure that neurotechnology respects
and promotes human rights, with particular
attention to vulnerable people and people living
in vulnerable situations. HRIAs should involve
meaningful public and community engagement
to incorporate diverse perspectives.
80. Member States should promote equitable access to This paragraph requires that member
neurotechnology worldwide. To achieve such goals, states should “support the reduction of
efforts should be made to support the reduction of final final costs for end users” of
costs for end users, pursue the development, adoption neurotechnology. This requirement has
and continuous support of non-proprietary software no restriction to specific types of
solutions, and explore reimbursement strategies or neurotechnology. It is reasonable to
demand such government support for
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subsidisation commensurate with conventions in local medical uses, but not beyond that and
jurisdictions, in sectors of crucial potential benefits. especially not for enhancement or
entertainment. It’s a huge difference
between neurotechnology for medical
purpose that can save lives or facilitate
the lives of severely ill individuals,
compared to treatments on healthy
persons based on their desire to boost
their health.
In addition, the definition of end-users
should be explained earlier in the text,
maybe in Definitions.
81. Member States should adopt agile regulatory It is questionable whether Member States
frameworks, including the use of regulatory sandboxes- could and should be held responsible for
controlled environments for developing, testing, and using sandbox environments to develop
evaluating neurotechnology-in response to rapid all types of neurotechnology. Member
advancements in neurotechnology and its convergence States can/should be urged to introduce
with other technologies such as Al, spatial computing, laws and other incentives that ensure
and immersive technologies. These sandboxes should ethical, safe, and sustainable
be used to explore innovative applications, particularly neurotechnology, but this does not
in workplace settings, with appropriate ethical oversight necessarily mean that it is the Member
provided by regulatory bodies or national authorities. States themselves who should be
These frameworks should facilitate innovation, ensure responsible for implementing the
ethical data processing, and safeguard rights by sandboxes. In the case of the private
incorporating mechanisms for regular monitoring, sector, including the entertainment and
evaluation, and dynamic policy adjustments in line with wellness industries, that responsibility
technological and ethical developments. should lie with the companies.
IV.2 DATA POLICY
82. Member States should develop a robust regulatory It is important to emphasize that the
and legal framework to govern the collection, sharing of data in a scientific context is
processing, sharing, and all other uses of neural and extremely important for medical science.
cognitive biometric data. This and existing frameworks Thus, regulations need to balance the
should recognize this data to be both personal and potential gains for humanity against the
sensitive data in medical and non-medical contexts. right to personal integrity.
This relates to §85 and §87 below
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Moreover, diversification should be
considered with regard to the source of
data. For example, when it comes from a
minor, the regulatory framework should
provide for stricter rules on the collection,
processing, use and storage of the data.
83. Member States should ensure that their existing The concern is clear but the paragraph is
privacy policies comprehensively cover stringent very long, detailed and difficult to grasp.
safeguards for individuals' neural and cognitive
biometric data. lf current policies do not adequately
address these areas, Member States should adopt
targeted legislation or regulatory frameworks to secure
these protections. These safeguards should for example
include affirmative informed consent, data minimization
and purpose !imitation, data rights (including the right to
access, correct, and delete data), and stringent data
security measures, such as advanced cybersecurity
protocols to prevent unauthorized access and
breaches. Such legislation or frameworks should
prohibit the practice of tying access to goods or
services to the disclosure of neural and cognitive
biometric data, require explicit opt-in for any data
sharing, and forbid the use of such data for targeted
advertising without the individual's explicit, affirmative
informed consent.
84. Member States should develop and implement 84. Member States should develop and Environmental sustainability must be
specific policies to reduce the ecological footprint of implement specific policies to reduce which better pronounced.
neurotechnology, particularly in relation to large-scale ensure that the ecological footprints of
data centers and computing resources used for neurotechnology are sustainable, particularly
processing and storage of neural and cognitive in relation to large-scale data centers and
biometric data. These policies should emphasise data computing resources used for processing
minimisation, ensuring that only the necessary amount and storage of neural and cognitive biometric
of data is collected and processed, and promote the data. These policies should emphasise data
proportional use of neurotechnology, aligning its minimisation, ensuring that only the
deployment with genuine needs and minimising necessary amount of data is collected and
unnecessary environmental impact. Measures should processed, and promote the proportional use
include optimising energy efficiency, using renewable of neurotechnology, aligning its deployment
energy sources, promoting the recycling and with genuine needs and minimising
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sustainable disposal of neurotechnology-related unnecessary environmental impact.
equipment, and ensuring the rehabilitation of affected Measures These policies should include
environments. optimising energy efficiency, using
renewable energy sources, promoting the
recycling and sustainable disposal of
neurotechnology-related equipment, and
ensuring the rehabilitation of affected
environments.
85. Member States should support and incentivise the What is the definition of cutting-edge
development and implementation of technological anonymization techniques in this context?
innovations and design standards for neurotechnology Needs to be clarified.
that prioritize the protection of mental privacy, such as
state-of-the-art encryption, secure databases with multi-
factor authentication, cutting-edge anonymization
techniques, and edge-processing and storage
(processing and storing data closer to where it is being
generated), leading to greater action-led results in real
time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology
manufacturers to prioritize privacy and ethics by design,
requiring the incorporation of privacy-preserving
technologies as default features in their devices.
87. Member States should encourage ethical data Between which parties should the data be
sharing by establishing secure, data repositories for shared? Who should have access to the
neural and cognitive biometric data used in research. data? Needs to be clarified.
These repositories should meet stringent cybersecurity,
data privacy, and ethical use standards (including data
minimisation and purpose limitations), tiered access
and other privacy-enhancing approaches. Appropriate
funding mechanisms should be established for the
curation and maintenance of data and data governance
processes streamlined.
88. Member States should prioritize efforts to reduce
obstacles to cross-border data sharing in
neurotechnology research, working towards greater
alignment of data protection standards, particularly
concerning neural and cognitive biometric data, by
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establishing clear protocols for data transfer that ensure
secure and compliant data exchanges across borders,
and standards for interoperability of data, including
governance frameworks for data sharing.
89. Member States should consider specific guidelines should consider is rather weak.
for the ethical use of neural and cognitive biometric data
in Al development and research, including consent
procedures for uses of neural and cognitive biometric
data in training and application of Al models, ensuring
transparency and respecting individual and community
rights.
IV.3 INTELLECTUAL PROPERTY (IP) This section is too detailed.
90. Member States should adopt policies to ensure that Can neural and cognitive biometric data
neural and cognitive biometric data, as individual human should remain property of the individuals
activity derivatives, are not subject to proprietary rights. who’s, data has been collected.
IP protection should only apply to original data
compilations (created through a process of aggregation,
organization, or selection, resulting in a new dataset)
that meet strict and ethical criteria.
91. Member States should collaboratively establish
clear, harmonised guidelines for IP rights applicable to
neurotechnology on an international scale. These
guidelines should address the patentability of Al-
generated inventions and the ethical implications of IP
laws, ensuring they promote global accessibility and
innovation.
92. Member States should ensure that all actors adopt Difficult to understand the essence and
IP management strategies that encourage innovation implication of marked text. Does it stand
and avoid overly restrictive patent use, fostering an in conflict with norms/laws regarding
open innovation ecosystem. This approach should patent protection and copyright?
continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the
neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while
ensuring ethical use and broad accessibility.
93. Member States should foster an environment of co- It is not clear who benefits from this
creation in neurotechnology, by facilitating policies and recommendation. To what extent does
incentives for co-ownership and preferential licensing this fall within the scope?
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agreements to ensure equitable compensation and
recognition for all contributors.
94.Member States should adopt policies with respect to
open science that balance the protection of IP with the
promotion of immediate publication of results and data
sharing. Particularly with the convergence of digital
technologies and the increasing concentration of those
innovations in industry sectors, this balance is crucial to
ensure that IP protection mechanisms do not hinder
scientific research, innovation, and the wide
dissemination of knowledge and new technologies. As a
basic rule of equitable partnership, when lndigenous
Peoples are involved in neurotechnology research and
development, open science processes, IP management
strategy, should be developed in collaboration with
them from the beginning.
IV.4 CYBERSECURITY
95. Member States should collaborate internationally to
establish comprehensive standards for cybersecurity
across all neurotechnology domains. These standards
should encompass hardware, software, and data
security measures to protect against potential cyber
threats. By implementing uniform cybersecurity
standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data,
as well as enhance user trust and confidence in
neurotechnology devices. Additionally, these standards
should evolve in tandem with technological
advancements and emerging cyber threats to maintain
robust protection against evolving risks.
96. Member States should employ red-teaming
exercises-adversarial challenges to test the efficacy of
security systems-as a proactive measure to assess and
enhance the safety, security, and resilience of
neurotechnology systems. By conducting regular red-
teaming exercises, Member States should proactively
identify and address security gaps, test incident
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response procedures, and strengthen the overall safety
and cybersecurity posture of neurotechnology devices.
IV.5 COMMUNICATION, PARTICIPATION, AND This section can be condensed. Seems
INFORMATION like many paragraphs address the
same/similar topics, for instance §97 and
§99, and §98 and §101.
In addition, factors regarding open and
accessible education, public and
community engagement are already
addressed in III.2.7 Epistemic Justice,
Inclusive Engagement and Public
Empowerment (§61-§65).
In the UNESCO Recommendation on the
Ethics of AI (2021), public participation,
awareness and understanding of AI
technologies etc., is addressed under
Awareness and literacy (§44-45), while
Communication and Information is
addressed as Policy Area 9 (§112-115).
Consider making a similar distinction.
97. Member States should promote communication and
develop engagement policies for neurotechnology that
foster informed, inclusive, and respectful dialogue
between researchers, developers, diverse users, and
the broader public to respect individual and community
rights, promote public trust, and harness the collective
intelligence and diversity of communities.
98. Member States should collaborate with international
organizations, educational institutions, and private and
non-governmental entities to develop and disseminate
accessible and engaging educational materials tailored
to diverse audiences to bridge knowledge gaps,
particularly in underserved regions about the nervous
system and mental health functioning, as well as the
benefits and risks of neurotechnology. These programs
should aim to increase public understanding of the
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technologies' functionality, safety, efficacy, and societal
impact, empowering individuals to make informed
decisions and to enable their ethical reflection about
their use of neurotechnology.
99. Member States should implement public and
community engagement processes that facilitate
genuine mutual learning and collaboration throughout
the whole lifecycle of neurotechnology. These
processes should include regular and inclusive
consultations with a wide array of actors. The aim of
these engagements should be to inform policy
development, shape ethical guidelines, increase public
awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment
aligns with public interests and values. Special attention
should be given to involving groups traditionally
underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co- The term “evidence-based” has a specific
creation of accurate, precise, and accessible language meaning in medical usage, i.e. does not
and terminology for discussing neurotechnology that mean “based on evidence” but rather
involves actors from diverse backgrounds to ensure that based on evidence collected and
the language used is inclusive, non-stigmatizing, and interpreted in a specific manner that
accurately reflects the technologies' capabilities and includes striving for randomized clinical
limitations. Member States should establish regulatory trials as the gold standard.
frameworks that require clear and ethical
communication standards for neurotechnology. These Science-based is more accurate in this
frameworks should require evidence-based reporting of context.
capabilities, risks, and limitations across all applications
to avoid exaggeration of claims, including but not limited Also see §19c and §136
to applications in sleep, attention, memory, and
emotional regulation. Within these frameworks
should be specific guidelines for ethical marketing and
protocols for responsible communications about early-
stage research and emerging technologies.
101. Member States should develop policies that foster This paragraph can be condensed. It
effective collaboration between end users, researchers seems like the same message is
and innovators throughout the whole lifecycle of repeated, but with different wordings.
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neurotechnology product development, with special
focus given to the places where the neurotechnology is
being developed. These policies should mandate the
creation of diverse advisory panels, including
representatives from various user groups and
respecting neurodiversity. Member States should also
establish platforms for ongoing dialogue and feedback
between users, researchers and developers. Advisory
panels should be involved in the process of developing
and testing new neurotechnology products to optimize
device efficacy, usability, longevity, and sustainability.
This collaborative approach aims to ensure that
innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, Member States should develop age- Medical technologies or technologies in
contextually-appropriate, culturally appropriate, and appropriate, contextually-appropriate, general? Can Member State be held
linguistically-appropriate education about culturally appropriate, and linguistically- responsible for educating and supporting
neurotechnology. This should include training modules appropriate science based education about healthy individuals to use
to aid in the supportive use of these technologies at neurotechnology that is age-, contextually, neurotechnological tools for boosting their
home, both for the user and for caregivers and family culturally and linguistically appropriate. This health, ability etc?
members. should include training modules to aid in the
supportive use of these technologies at Add that education must be scientifically
home, both for the user and for caregivers based and arranged by established
and family members. actors, preferably acknowledged science-
or medical institutions/centres or
universities.
CONSIDERATION FOR SPECIFIC USERS We suggest that this section begins with
recommendations that are applicable to
all, and then address issues that are
unique for selected users.
Also consider moving this section to a
separate chapter.
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain Member States should promote ensure should promote is too vague. Also see
development through policies that evaluate the impact healthy brain development through policies comment on §106.
of neurotechnology on children and adolescents. that evaluate the impact of neurotechnology
on children and adolescents.
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104. Member States should safeguard children and Member States should must safeguard should pay attention is too vague.
adolescents from implicit and explicit coercion to use children and adolescents from implicit and
neurotechnology. Member States should pay attention to explicit coercion to use neurotechnology.
the autonomy of children and adolescents through Member States should pay attention to the
informed consent and assent that is adapted to and autonomy of children and adolescents
respectful of age and decision-making capacity. through informed consent and assent that is
adapted to and respectful of age and
decision-making capacity.
105. Member States should fund research and We welcome strong support to children
development grants focused on creating user friendly and adolescents with disabilities (incl.
assistive neurotechnology tailored for children and their families and caregivers) regarding
adolescents with disabilities. These projects should user-friendly assistive neurotechnology.
involve children, adolescents, parents and caregivers in
the design process to ensure the technologies meet However, we are not sure that this
their specific needs. Educational programs should be recommendation should pinpoint methods
developed to teach children and adolescents and their and efforts such as educational programs.
caregivers how to effectively use and maintain these If remained, educational programs should
technologies, with support available in multiple be defined.
languages and accessible without discriminating
against those who either cannot or choose not to
engage with the proposed technology.
106. Member States should ensure research involves This paragraph about research on
strict oversight and close follow-up of all children omits the most basic requirement
neurotechnology research involving children and that established medical research ethics
adolescents. This oversight is crucial during the has on research on children (and all
developmental phases of childhood to address and individuals who are unable to give their
mitigate any unforeseen long- term effects. Such informed consent), namely that research
research must include comprehensive monitoring that can be performed on adult subjects
protocols and periodic evaluations to ensure the should not be performed on children. On
ongoing safety and well-being of young participants, the other hand, there is a need for more
taking into account their unique developmental needs clinical research on children. Important
and vulnerabilities. In the framework of research, that the recommendation shows
involving children and adolescents in medically awareness of this dilemma/tension
vulnerable situations (i.e., children in epilepsy
monitoring units), special attention will be given to
consent and assent, particularly considering particular
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aspects of research (time, iterations) to prevent any
form of instrumentalization.
107. Member States should enact specific regulations Member States should enact specific We suggest expanding this paragraph
that prohibit the use of marketing techniques-such as regulations that prohibit the use of marketing with this extra text to incorporate
neuromarketing, biometric emotional analytics, techniques-such as neuromarketing, additional neuroscientific and ethical
immersive advertising, and virtual or augmented reality biometric emotional analytics, immersive considerations. This expansion would
advertising-that rely on sensitive neural and cognitive advertising, and virtual or augmented reality provide a more comprehensive
biometric data collected from children and adolescents. advertising-that rely on sensitive neural and understanding of the risks associated with
Recognizing the heightened vulnerability of children and cognitive biometric data collected from these marketing techniques and
adolescents in digital environments, these regulations children and adolescents. strengthen the rationale for their
must explicitly forbid any practices that use such data to prohibition when targeting children and
influence or exploit children and adolescents. ------ adolescents.
Recognizing the heightened vulnerability of
children and adolescents in digital Maybe split into two paragraphs as
environments, and with regards to children's suggested.
and adolescents' developing brains,
especially in areas related to decision-
making, these regulations must explicitly
forbid any practices that use such data to
influence or exploit children and
adolescents.
---
To effectively implement and support this
prohibition, it is strongly recommended to
foster collaboration among neuroscientists,
psychologists, ethicists, and policymakers to
ensure the prohibition is comprehensive and
effectively enforced across all relevant digital
platforms and technologies.
IV.7 OLDER PERSONS
108. Member States should promote healthy aging and Member States should promote healthy Important point. But may be hard to
support elderly individuals by funding and implementing aging and support elderly individuals by implement in states without a publicly
evidence-based programs that integrate funding and implementing science based funded/weak health system
neurotechnology into routine care. These programs evidence-based programs that integrate
should involve the entire support ecosystem, including neurotechnology into routine care. These
family, caregivers, and medical teams, to enhance programs should involve the entire support The term equitable in this context requires
quality of life. Priority should be given to developing and ecosystem, including family, caregivers, and further clarification. It is unclear whether it
121
implementing tools that prevent, delay, and treat age- medical teams, to enhance quality of life. solely addresses socioeconomic equity or
related health conditions, impairments, and Priority should be given to developing and encompasses a broader scope of
neurodegenerative diseases. Member States should implementing tools that prevent, delay, and equality, including geographical, cultural,
ensure that access to these neurotechnology programs treat age-related health conditions, and other relevant factors. A more precise
is equitable and does not exacerbate socioeconomic impairments, and neurodegenerative definition would enhance the
inequalities. diseases. Member States should ensure that understanding and implementation of this
access to these neurotechnology programs recommendation.
is equitable and does not exacerbate
socioeconomic inequalities. It should be clarified that Member States’
Member States should strive to provide responsibility to “promote healthy aging
uniform access to these neurotechnology and support elderly individuals by funding
programs across all regions within their and implementing evidence-based
territories, including rural and remote areas, programs that integrate neurotechnology
to ensure equal availability and prevent into routine care” must be restricted
geographical disparities in care quality and to/focused on programs that are the best
outcomes. means to achieve the goals of geriatric
and nursing care. It cannot be Member
States’ responsibility to promote healthy
aging, delay or prevent age-related health
conditions to “stay fit and young”.
109. Member States should establish guidelines for The section seems incomplete. Consider
neurotechnology design sensitive to the needs of older adding hardware design and functionality
adults, carefully considering human-computer interface in order to include the physical/material
factors for usability (such as fonts, buttons, and colour) aspects.
and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and The information given, has to be adapted
promote autonomous decision-making for older people to the culture, language and education of
using neurotechnology for sensorimotor and cognitive the patient
support. The consent process should accommodate
potential cognitive challenges faced by older adults,
ensuring that consent is informed, ongoing, and
adaptable to changing health conditions. Policies should
be in place to ensure that assistive neurotechnology
recognize changing cognitive capacities over time and
respect users' preferences.
111. Member States should develop ethical guidelines
to ensure that neurotechnology such as robotic
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caregivers enhance rather than replace human
interaction, particularly in the care of individuals with
neurodegeneration. These guidelines should
emphasize the augmentation of human care, not its
replacement.
IV.8 WOMEN AND GENDER
112. Member States should adopt and enforce 112. Member States should adopt and In Bulgaria and many other countries
comprehensive policies that promote and respect enforce comprehensive policies that promote “gender” is not a legally normative
gender equality and diversity in the whole lifecycle of and respect gender equality and diversity in concept, normative is the biological sex.
neurotechnology. The policies should prioritize inclusive the whole lifecycle of neurotechnology. The “Affirmative action” has specific
research for addressing women and gender specific policies should prioritize inclusive research connotations in US policy.
needs and differences, require targeted data collection for addressing women and their needs ,
and analysis, include education and training require targeted data collection and analysis,
programmes an inclusive research practices, ensure include education and training programmes
public and community engagement with women and and inclusive research practices that ensure
gender health experts and advocacy groups and, gender equality. Targeted policies are
incentivise gender responsive technology design, to necessary to close gender gaps in these
meet the needs and conditions specific to women and fields, increase representation, engagement
gender minorities. Affirmative action policies are and leadership.
necessary to close gender gaps in these fields,
increase representation, engagement and leadership.
113. Member States should establish clear guidelines Member States should establish clear See comment above.
and legal frameworks to ensure that workplaces and guidelines and legal frameworks to ensure
research environment, throughout the whole lifecycle of that workplaces and research environment,
neurotechnology, are inclusive and supportive, throughout the whole lifecycle of
particularly for women and gender minorities, and neurotechnology, are inclusive and
safeguard against harassment and discrimination. This supportive, particularly for women and
should include robust mechanisms for reporting and safeguard against harassment and
addressing incidents of harassment and discrimination, discrimination. This should include robust
ensuring accountability and support. mechanisms for reporting and addressing
incidents of harassment and discrimination,
ensuring accountability and support.
114. Member States should adopt a range of measures
that prioritize ethical and equitable research and
innovation and support programs that foster women's
and gender minorities' participation in neurotechnology.
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This includes funding and other policies that prioritize
ethical and equitable research and innovation, but also
affirmative action initiatives to support the participation of
women and gender minorities in neurotechnology
through targeted education programs, employment
opportunities, entrepreneurship support, and leadership
development within the sector. Member States should
also provide support systems such as mentorship
programs, networking opportunities, and resources to
help women and gender minorities overcome barriers to
participation and succeed in the neurotechnology field.
IV.9 PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness
the potential of neurotechnology by removing barriers
experienced by persons with physical disabilities and
providing support thereby contributing to achieving
equal enjoyment of human rights. They should
implement regulatory frameworks that require
accessibility assessments for all new neurotechnology
products to ensure these products do not perpetuate
existing disabilities or health disparities. These
frameworks should include protocols for testing with
diverse groups of persons with disabilities to ensure
technology meets a wide range of needs and does not
unintentionally exclude or disadvantage any subgroup.
116. Member States should create incentive programs Member States should create incentive Important to clarify that not only assistive
to promote the development of neurotechnology for programs to promote the development of neurotechnology should be covered.
people with disabilities to promote their quality of life neurotechnology for people with disabilities
and functional independence. These programs should to promote their quality of life and functional
include tax incentives for companies investing in independence. These programs should
assistive neurotechnology research and development, include tax incentives for companies
grants for research institutions focusing on investing in assistive and/or rehabilitative
neurotechnology for disability support, expedited neurotechnology research and development,
regulatory reviews for technologies offering significant grants for research institutions focusing on
advancements in mobility, communication, or daily neurotechnology for disability support and
living assistance, and innovation prizes for rehabilitation, expedited regulatory reviews
for technologies offering significant
124
breakthroughs in affordable, accessible advancements in mobility, communication,
neurotechnology solutions. or daily living assistance, and innovation
prizes for breakthroughs in affordable,
accessible neurotechnology solutions.
117. Member States should, whenever possible, Member States should, whenever possible, The added text in red ensures that
subsidise the cost of essential neurotechnology devices, subsidise the cost of essential language accessibility is presented as an
such as neuroprosthetics, for persons with physical neurotechnology devices, such as integral part of making neurotechnology
disabilities. They could encourage public-private neuroprosthetics, for persons with physical resources truly accessible to all potential
partnerships to make advanced neurotechnology disabilities. They could encourage public- users, regardless of their linguistic
affordable and integrate neurotechnology coverage into private partnerships to make advanced background.
national health insurance and other reimbursement neurotechnology affordable and integrate
schemes for persons with physical disabilities. A national neurotechnology coverage into national Yellow-marked section is too detailed and
database of available neurotechnology resources and health insurance and other reimbursement could be left out.
support services should be developed to facilitate schemes for persons with physical
access and information sharing. disabilities. A national database of available
neurotechnology resources and support
services should be developed to facilitate
access and information sharing. To ensure
accessibility and understanding for all users,
this database and related information should
be available in multiple languages, allowing
individuals to access critical information in
their preferred language.
IV.10 PERSONS WITH MENTAL HEALTH
CONDITIONS
118. Member States should foster research and promote 118. Member States should foster research Is communities the correct word here? Is
awareness-raising initiatives to address the increasing and promote awareness-raising initiatives to groups of peoples be more correct or
prevalence and special needs of people with mental address the increasing prevalence and individuals suffering from these health
health conditions, including victims and survivors of special needs of people with mental health conditions or something similar more
trauma and violence, and the relevance of conditions, including victims and survivors of appropriate?
neurotechnology for these communities. trauma and violence, and the relevance of
neurotechnology for these communities.
119. Member States should allocate funding for long- Member States should allocate funding for What is the essence of long-term
term advocacy and efficacy studies, post market long-term advocacy and efficacy studies, advocacy in this context? “Defense” or
oversight, and tiered scrutiny with special attention to post market oversight, and tiered scrutiny “opinion/policy impact”?
invasiveness and reversibility of neurotechnology with special attention to invasiveness and
interventions. It is important to ensure that people with reversibility of neurotechnology
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mental health conditions are well-informed and have interventions. It is important to ensure that This paragraph is very difficult to
reasonable expectations about the process. people People with mental health conditions understand and needs to be reworded.
are must be well-informed and have
reasonable expectations about the process.
120. Member States should prioritize funding for State based funding in this context must
neurotechnology that is designed to improve quality of be science based and should (as far as
life and daily functioning of individuals with mental possible) be safeguarded from pro-profit
health conditions. This includes technologies that assist interests.
in managing symptoms, improving cognitive functions,
and providing emotional support at home, in the
workplace, in their communities, and in society.
Research and development should be guided by
feedback and engagement with persons with mental
health conditions and their advocates.
121. Member States should establish policies that
improve access to timely advances in neurotechnology
for those with mental health conditions to ensure that
cost is not a barrier to accessing potentially life-altering
treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
122. Member States should support the development of 122. Member States should support the
health applications that prioritize the unmet needs in the development of health applications that
provision of neurological and mental health. This should prioritize the unmet medical needs in the
include establishing research funding programs provision of neurological and mental health.
specifically targeted at addressing identified gaps in This should include establishing research
nervous system care. funding programs specifically targeted at
addressing identified gaps in nervous
system care.
123. Member States should build and maintain 123. Member States should build and Consider leaving out the last sentence,
international solidarity to address global health risks maintain international solidarity to address since it might be redundant.
and uncertainties, and ensure that their implementation global health risks and uncertainties, and
of healthcare for the nervous system is consistent with ensure that their implementation of
international law and rigorous human rights obligations. healthcare for the nervous system is
This could involve creating international forums for consistent with international law, medical
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sharing best practices in the implementation of and scientific standards, and rigorous
neurotechnology in healthcare. human rights obligations. This could involve
creating international forums for sharing best
practices in the implementation of
neurotechnology in healthcare.
124. Member States should establish oversight
mechanisms to evaluate the physical and mental health
impacts of long-term use of neurotechnological devices,
with special attention to invasiveness and reversibility of
neurotechnology interventions. This includes
implementing regulatory measures requiring long-term
follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval
based on these studies results.
125. Member States should consider the significant costMember States should consider the Important to add rehabilitative
and impact associated with pathologies related to the significant cost and impact associated with neurotechnology.
nervous system, as well as the potential benefits of pathologies related to the nervous system,
early diagnosis and access to preventive and assistive as well as the potential benefits of early The implication and meaning of “[…]
neurotechnology. Public policies should prioritize the diagnosis and access to preventive, and consider the significant cost and impact
promotion of access to these technologies and ensure assistive and rehabilitative neurotechnology. […]” is unclear.
health cost coverage for individuals in need. Public policies should prioritize the promotion
of access to these technologies and ensure
health cost coverage for individuals in need.
126. Member States should promote the development 126. Member States should promote the
of reliable and durable neurotechnology for healthcare development of reliable, safe and durable
applications. This includes encouraging the design of neurotechnology for healthcare applications.
devices and systems that require minimal maintenance, This includes encouraging the design of
ensuring they remain functional and effective under devices and systems that require minimal
everyday conditions. Regulatory bodies or designated maintenance, ensuring they remain safe,
authorities should oversee the enforcement of rigorous functional and effective under everyday
standards for quality, safety, and longevity, thereby conditions. Regulatory bodies or designated
reducing the burden on users and enhancing the authorities should oversee the enforcement
dependability and sustainability of neurotechnological of rigorous standards for quality, safety, and
solutions. longevity, thereby reducing the burden on
users and enhancing the dependability and
sustainability of neurotechnological
solutions.
127
127. Member States should ensure the development or
strengthening of existing comprehensive
neurotechnology medical device reporting systems that
track and address adverse effects. In contexts where
such systems do not exist, Member States should
establish them. Where systems are already in place,
they should be updated to specifically include
neurotechnology. These systems should be
interoperable and contribute to a centralised, public,
and transparent international database, managed in
collaboration with international organizations, to ensure
that global standards are met and accessible for public
knowledge, international oversight and research.
IV.12 RESEARCH ETHICS
128. Member States should reinforce the ethical […] Furthermore, research protocols, public The requirements of “[…] specific
frameworks governing neurotechnology research to or private, in the medical as well as the non- attention dedicated to individuals with
ensure robust protection of human participants. medical domain, should be carefully special situations regarding vulnerability
Member States should adopt clear guidelines or policies evaluated by registered ethics boards (ethics such as diminished capacity to consent or
that define the qualifications to ensure that research is committees) and specific attention dedicated to make decisions […]” is vague in
conducted by professionals with appropriate knowledge to individuals with special situations comparison to established medical ethics,
about the nervous system structure and function in regarding vulnerability such as diminished which require that research is not
addition to brain disorders and is performed in adequate capacity to consent or to make decisions. performed on people with diminished
research settings. Furthermore, research protocols, […] capacity to consent/dissent if it can be
public or private, in the medical as well as the non- performed on people with full capacity to
medical domain, should be carefully evaluated by do so.
registered ethics boards (ethics committees) and
specific attention dedicated to individuals with special Consequently, the text must be reworded
situations regarding vulnerability such as diminished to stay in line with established medical
capacity to consent or to make decisions. Member and research ethical standards.
States should ensure that all research institutions have
mandatory ethics training for researchers.
129. Member States should encourage multicentre
international research that involves various cultures and
ethnic groups. Member States should promote
international cooperation to develop common reporting
standards and protocols for interoperability, particularly
128
for implantable neurotechnology devices. This
cooperation should aim to enhance the comparability
and utility of research globally, improving both the
efficacy and ethical integrity of research.
130. Member States should ensure that the whole As in §46, the document fails to support
lifecycle of neurotechnology is considered in the design the rights of trial patients to continued
of a clinical trial, including policies to protect patients in treatment after the end of the trial.
case of cessation of activities of the trial sponsor or
promoter. Member States should establish
requirements for clinical trials to be included in relevant
nationally or internationally approved registries and
encourage registration with community and patient
registries. Also, clinical trials should report on
appropriate medical device reporting systems
developed within Member States.
131. Technology developers should ensure that the Maybe it would it be more feasible to
validation of Al algorithms in neurotechnology research address AI in a separate section/chapter?
include rigorous testing for biases, as well as measures This paragraph is applicable for other
to enhance explainability and transparency, including the areas besides health.
provenance of training datasets. Suitable techniques
should be employed to mitigate any biases present in Al
models used in neurotechnology applications.
132. Member States should ensure that research efforts This paragraph presumes that issues
not only focus on biomedical risks associated with concerning the patient’s “[…] subjective
neurotechnology but also investigate potential effects on experience, agency and personal identity”
an individual's subjective experience, agency and are not part of “biomedical” assessments.
personal identity. Understanding how neurotechnology These issues are essential parts of any
may impact aspects of self-perception, consciousness, competent clinical assessment of a
and identity is essential for addressing ethical concerns patient’s health and well-being.
and ensuring the well-being of individuals using these
technologies.
133. Member States should ensure those engaged in
research implement regular auditing and monitoring of
research practices to ensure adherence to ethical
standards. This should include evaluating the adequacy
129
of informed consent, particularly concerning data reuse
and the potential commercialisation of neural data.
134. Member States should require researchers in
neurotechnology to establish clear and transparent
protocols for communicating clinically significant and
actionable incidental findings to participants. These
protocols should ensure that such findings are conveyed
promptly, respecting participants' rights and autonomy.
Additionally, Member States should mandate that
researchers provide the necessary support and
coordination with healthcare providers to address any
health concerns that arise from these findings.
135. Member States should ensure that individuals
involved in neurotechnology research or receiving
neurotechnological interventions are adequately
informed about the potential for incidental findings,
particularly those with significant health implications.
The informed consent process should clearly outline
what these findings might entail, the participants' right to
choose whether they wish to be informed about such
findings, and guarantee that their decisions in this
regard will be respected throughout the study or
treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF
HEALTH
IV.13 EDUCATIONAL SETTINGS Are the recommendations applicable to all
educational settings or would references
to specific educational settings improve
the feasibility?
136. Member States should approach with caution the
integration of neurotechnology in education, ensuring
that its use is evidence-based and aligned with the
education goals and complements traditional learning
methods. Emphasis should be placed on promoting the
holistic development of students, focusing not just on
academic performance but also on mental health, well-
130
being, and overall interests. To ensure inclusivity,
Member States should develop age appropriate
guidelines for neurotechnology use across different
educational stages and learning styles. Regular
assessments of neurotechnology's impact on student
development, including mental health, should be
conducted, with ethical review processes established to
oversee deployment. The primary focus should be on
fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic
performance.
137. Member States should adopt policies ensuring the Member States should adopt policies Long paragraph, should be split up.
voluntary deployment of neurotechnology in education, ensuring that the voluntary deployment of
grounded in fully informed consent. These policies must neurotechnology in education are grounded
include clear, age appropriate information about the in fully informed consent. These policies
technology's purpose, benefits, and risks, with adequate must include clear, age appropriate
consideration periods. Considering the increased information about the technology's purpose,
complexity of obtaining voluntary consent in this context, benefits, and risks, with adequate
consent and assent procedures should involve children, consideration periods. Considering the
adolescents, parents, guardians and all actors increased complexity of obtaining voluntary
necessary to obtain approval required for minors. consent in this context, consent and assent
Ethical oversight mechanisms should be established, procedures should involve children,
including regular consent renewal and immediate adolescents, parents, guardians and all
cessation of neurotechnology use upon withdrawal, actors necessary to obtain approval required
and ensure anonymous feedback channels. Policies for minors.
must prohibit undue incentives or academic penalties ---
for non-participation and take measures to avoid Ethical oversight mechanisms should be
creating or reinforcing inequalities among students. established, including regular consent
Additionally, Member States should support student renewal and immediate cessation of
involvement in decision-making about neurotechnology neurotechnology use upon withdrawal, and
integration and fund training programs on its ethical use, ensure anonymous feedback channels.
empowering educators and students to critically assess Policies must prohibit undue incentives or
its application. academic penalties for non-participation and
take measures to avoid creating or
reinforcing inequalities among students.
---
131
Additionally, Member States should support
student involvement in decision-making
about neurotechnology integration and fund
training programs on its ethical use,
empowering educators and students to
critically assess its application.
138. Member States should establish a unified, robust Member States should establish a unified, Long paragraph, should be split up.
oversight mechanism for neurotechnology use in robust oversight mechanism for
educational settings, incorporating regular audits, public neurotechnology use in educational settings Consider giving examples of these
and community feedback, culturally appropriate and at all levels of education, incorporating technologies. Also see §55.
according to local conventions, and strict adherence to regular audits, public and community
safety and ethical standards, including an assessment feedback, culturally appropriate and
of reversibility on the nervous system. Continuous according to local conventions, and strict
research should be funded to assess the long-term adherence to safety and ethical standards,
psychological and cognitive impacts of these including an assessment of reversibility on
technologies. Oversight should involve periodic reviews the nervous system.
based on empirical evidence to adjust neurotechnology
usage as needed, ensuring it serves student ----
development and addresses risks like dependency or Continuous research should be funded to
de-skilling. This comprehensive approach will help assess the short- and long-term
maintain the safety, effectiveness, and alignment of psychological and cognitive impacts of these
neurotechnology with best practices for student well- technologies. Oversight should involve
being and learning outcomes. periodic reviews based on empirical
evidence to adjust neurotechnology usage
as needed, ensuring it serves student
development and addresses risks like
dependency or de-skilling. This
comprehensive approach will help maintain
the safety, effectiveness, and alignment of
neurotechnology with best practices for
student well-being and learning outcomes.
139. Member States should invest in educational and Questionable to make the state
professional development programs to equip innovators responsible for this type of capacity
and business leaders with the skills to integrate ethical development for the business sector.
considerations throughout the neurotechnology whole If this paragraph will remain, also
lifecycle. This training should include ethical design, consider moving it. Capacity building in
human rights law, and societal impact assessment, the private sector could also be under
preparing the next generation of technologists to IV.14 LABOUR AND EMPLOYMENT.
critically evaluate the implications of their work.
132
IV.14 LABOUR AND EMPLOYMENT The responsibilities of the employers
should be emphasized.
This section is very long, should benefit
from being shortened.
140. Member States should establish workplace 140. Member States should establish
policies and incentives that prioritize the health and policies and laws regarding the use of
well-being of employees in the use of neurotechnology. neurotechnology in the workplace to
These policies should ensure that any deployment of safeguard the privacy and safety of the
neurotechnology is evidence-based, with a focus on employees. workplace policies and
applications that have been scientifically validated to incentives that prioritize the health and well-
promote employee well-being, such as reducing stress being of employees in the use of
or enhancing workplace conditions (i.e., adaptive and neurotechnology. These policies should
responsive environments that adjust workloads based ensure that any deployment of
on cognitive load). Deployment must be on a voluntary neurotechnology is evidence-based, with a
basis and employees must have the option to opt out of focus on applications that have been
using neurotechnology without facing any negative scientifically validated to promote employee
consequences or discrimination. Under no well-being, such as reducing stress or
circumstances should these technologies be used for enhancing workplace conditions (i.e.,
punitive measures, mental surveillance, or in ways that adaptive and responsive environments that
could compromise employee health. adjust workloads based on cognitive load).
----
Deployment must be on a voluntary basis Consider splitting the paragraph here.
and employees must have the option to opt
out of using neurotechnology without facing
any negative consequences or
discrimination. Under no circumstances
should these technologies be used for
punitive measures, mental surveillance, or
in ways that could compromise employee
health.
141. Member States should require employers to clearly
provide employees with comprehensive information
about how neurotechnology used in their workplace
works, the benefits it offers, transparency about what
data are collected, how it is used, and who has access
to it, and clearly disclose any potential risks of their use.
133
142. Member States should require employers who use
neurotechnology in the workplace to adopt transparent
policies that disclose the purpose of the use, limit the
scope of its use to legitimate purposes in the interest of
the employee and third parties (i.e., safety, monitoring
fatigue in commercial drivers or tracking attention in air
traffic controllers). To respect employees' mental
privacy, employers should be prohibited from
unauthorized access to neural and cognitive biometric
data that may be collected incidentally during routine
workplace monitoring. Employers should be prohibited
from using neural and cognitive biometric data for any
non-consented purposes, particularly those that could
negatively impact an employee's job security or privacy.
143. Member States should require employers to adopt
best practices for data minimisation and secure storage
of neural and cognitive biometric data, ensure that data
is stored securely, with access limited to authorised
personnel only, is deleted once its intended purpose has
been fulfilled. Additionally, upon an employee's
departure, all related records should be fully deleted or
individual data released to the employee, ensuring that
no data is retained after the termination of employment.
144. Member States should ensure that when Re-write this paragraph in order to make
employees are issued multifunctional devices (i.e., this recommendation applicable also for
earbuds or headphones that also include neural other types of devices, unless it is
sensors) that can be used at work or at home, relevant to highlight these devices
employers should be prohibited from collecting neural specifically.
and cognitive biometric data outside of workplace
settings and working hours and ensure that any data Moreover, Member States should ensure
collected during work is used exclusively for agreed- that during work, only minimal and
upon purposes. Employers should implement necessary data is collected for the
technological safeguards to automatically disable data exclusive use for agreed-upon purposes.
collection during non-work hours.
134
145. Members States should ensure that employers
respect the right of employees to obtain a copy of any
neural and cognitive biometric data collected about
them, along with any interpretations drawn from it in an
accessible and comprehensible manner. To use these
tools without consent constitutes a breach of trust,
undermining the value they would otherwise create.
146. Member States should require, through stringent
regulations, that any use of neurotechnology in the
workplace require explicit employee consent, and be
used only for purposes that demonstrably enhance
workplace safety, employee well-being and dignity, and
not for enhancing productivity at the expense of
employee health.
147. Member States should guard against the
exploitation of employees, and they should develop
stringent regulations against using neural and cognitive
biometric data for profiling in the workplace, including in
hiring. These regulations should prohibit the use of
neural and cognitive biometric data to discriminate
against candidates, particularly neurodiverse
individuals, ensuring hiring practices are fair and
inclusive.
148. Member States should strictly regulate the use of
neurotechnology for hiring or maintaining employment,
to limit such use where such neural and cognitive
biometric data are directly relevant to the specific
requirements of the job.
IV. 15 CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a We are afraid that this is too vague to
regulatory framework that balances innovation in the ensure that the recreational and
recreational and commercial domains with protecting commercial industries respect individual
individual rights and well-being. This framework should rights etc. since their whole business idea
be dynamic, allowing for timely updates as technology
135
evolves and new insights are gained about its impacts is to profit on people’s desire to boost
on society. This includes providing adequate oversight their health and well-being.
to ensure that neurotechnology does not cause harm,
are used consensually, and include robust mechanisms
to protect users from potential psychological distress or
manipulation.
150. Member States should strengthen comprehensive
consumer protection laws to include clear labelling on
commercial neurotechnology products, detailing their
effects, limitations, and risks to prevent misleading
claims and ensure transparency. This also includes
prohibiting practices of "tying" or requiring the
disclosure of neural and cognitive biometric data as a
condition to access goods or services, and prohibition
about third party data sharing or the uses of this data
without affirmative opt-in option.
151. Member States should foster an environment that
ensures all claims about consumer, non medical
technologies are supported by robust scientific
evidence. They should, by regulation, require that any
products claiming to treat, prevent, or diagnose
diseases or medical conditions be validated through
rigorous safety and efficacy testing, including clinical
trials where necessary, and be used under appropriate
medical supervision.
152. Member States must enforce informed consent Member States must enforce informed Are there good reasons for addressing
processes that are thorough and transparent across all consent processes that are thorough and sports and arts specifically?
neurotechnological interventions, ensuring that transparent across all neurotechnological
participation is fully voluntary and respects the privacy interventions, ensuring that participation is
and autonomy of individuals. This principle should apply fully voluntary and respects the privacy and
uniformly in various domains such as sports, arts, where autonomy of individuals. This principle
robust standards should safeguard against coercive use should apply uniformly in various all domains
and respect athletes' and artists' individual autonomy, such as sports, arts, where robust standards
community interests, and IP rights. should safeguard against coercive use and
respect athletes' and artists' individual
136
autonomy, community interests, and IP
rights.
153. Member States should steer the use and The message here is unclear. Does
development of neurotechnology in the arts toward neurotechnology have the potential to
ensuring the enhanced learning and cultural enhance cultural appreciation? Member
appreciation without compromising individual autonomy States should definitely not intervene on
or leading to cultural homogenisation. people’s cultural experiences.
154. Member States should adopt policies to prevent the adopt policies too vague? And what are
misuse of neurotechnology of consumer technology, the Tech companies’ responsibilities?
especially neurogaming and other devices that exploit
the dopamine reward system or seek to induce
problematic and unhealthy use and overconsumption.
Such regulations should mandate clear labeling of risks,
disclosures on their effects on the nervous system,
enforce game design standards and safety, privacy and
age-appropriate design standards that prevent taking
advantage of a person's physical, mental and emotional
vulnerability to lead to compulsive use or addiction of
gaming or digital recreational platforms combined with
neurotechnology, to promote healthy, balanced use,
especially among children.
155. Member States should ensure that devices Should management and ownership over
capable of multiple functions, such as XR glasses or data generated through the use of these
smart earbuds with neural sensors, include hardware- devices be mentioned? Or is this taken
based controls that allow users to selectively disable care of in the section of Data Policy? If
neurotechnology features while maintaining basic yes, maybe a good idea to refer to that
functionality. Regulations should ensure that 'opt-out' section?
features are accessible and straightforward, promoting
healthy, balanced use especially among children and
vulnerable populations.
156. Member States should address the profound
ethical questions regarding self-determination, consent, Subliminal messaging should also be
privacy, and the potential for manipulation raised by included. Is this the same term?
neurotechnology that arise in the contexts of
recommender systems, priming and nudging, marketing
during sleep and dream, neuromarketing, and closed-
137
loop environments by adopting comprehensive policies
and regulations that:
(a) Recommender systems: explicitly
prohibit the use of neural and
cognitive biometric data in
recommender systems for
manipulative or deceptive
purposes, including in political
context. These regulations should
require that any use of such data
within these systems be based on
explicit, informed opt-in consent
from users.
(b) Nudging: govern the use of neural
and cognitive biometric data for
nudging-subtly influencing
individuals' decisions or
behaviours, often without their
explicit awareness. This is
particularly critical in sensitive
areas such as political messaging,
commercial advertisement, and
healthcare. These frameworks
should require explicit, informed
consent for any use of such data to
influence decisions or behaviour,
the right to opt out of these
systems, and transparency and
clear disclosures at the point of
data collection, with strict
limitations on using data for
purposes beyond those explicitly
disclosed.
138
(c) Marketing during sleep and dream:
prohibit the use of neurotechnology
that influences or manipulates
individuals during sleep, such as
marketing during sleep and dream.
Regulations should strictly prohibit
commercial, marketing, or political
applications that target individuals
during sleep, using
neurotechnology or neural and
cognitive biometric data.
Additionally, robust oversight
mechanisms should be required to
ensure that any research or
application of such technologies
prioritizes the well-being, privacy,
and autonomy of individuals, with
particular attention to the potential
long-term psychological and
cognitive impacts of manipulating
sleep states.
(d) Neuromarketing: safeguard against
unethical aims and practices in
neuromarketing, including by
requiring comprehensive
disclosures to ensure that all
neuromarketing activities are
conducted transparently, with
participants' explicit informed
consent. This includes ensuring
that participants in neuromarketing
research or campaigns are fully
aware of methods, risks, and
intentions and affirmatively opt-in
to participation. The use, storage,
and potential reuse of the collected
139
data should be strictly regulated.
(e) Closed Loop Environments: provide
clear regulatory guidelines on the
design and use of closed-loop
environments-such as immersive
computing devices that adjust
experiences based on detected
neural and cognitive biometric data.
These policies should require clear
and accessible disclosure about
how neural and cognitive biometric
data are used in these
environments, prohibit real-time
behavioral modification or
manipulation without explicit,
informed consent, and implement
safeguards specifically designed to
prevent abuses such as
unauthorized surveillance,
manipulative interventions, and
practices that could influence voting
behavior, political opinions, or
exploit psychological and emotional
vulnerabilities in real-time.
IV.16 ENHANCEMENT This section should be given more
attention.
The implications of neurotechnological
enhancement, especially when
innovations extend beyond therapeutic
applications within healthcare and move
into areas of human enhancement,
require particular attention. As new
neurotechnological innovation emerge,
there is a growing potential for their
application in enhancing human cognition
140
and abilities outside traditional medical
contexts, raising important ethical and
social considerations. In reviewing the
draft of this Recommendation, we note
that while the document addresses
various ethical aspects of
neurotechnology, there is limited
exploration of enhancement applications
of new neurotechnological innovations.
Considering the profound implications of
such applications, we would encourage a
more comprehensive analysis of this topic
within the recommendations. It is crucial
that the risks and responsibilities
associated with human enhancement
technologies are further considered in
order to ensure that ethical principles and
appropriate legislation are robustly
applied in this emerging area.
157. The use of neurotechnology to improve memory, The use of neurotechnology to improve The phrase outside of the medical context
attention, or other aspects of human mental performance memory, attention, or other aspects of human is difficult to interpret, particularly since
outside of the medical context introduces complex mental performance outside of the medical enhancement of the nervous system itself
ethical, social, and legal challenges, which can create context introduces complex ethical, social, is included. The principle of non-
new kinds of disparities in the global world. When and legal challenges […] When maleficence in medical ethics should be
neurotechnology is used in these contexts, it raises neurotechnology is used in these contexts, it an important part of the ethics of
crucial questions about equity, consent, individual and raises crucial questions about equity, neurotechnology and other applied
community autonomy, and the nature of enhancement of consent, individual and community neuroscience.
the nervous system itself. Member States should ensure autonomy, and the nature of enhancement of
that any policies, law and regulatory frameworks that the nervous system itself.[…]
govern the use of neurotechnology in these contexts do
not exacerbate social inequalities or lead to
discrimination, address the potential risks (including to
reversibility, invasiveness, and risks to self-
determination) and fully comply with human rights and
dignity.
V. IMPLEMENTATION
141
158. Member States and all other actors as identified in
this Recommendation should respect, promote and
protect the ethical values, principles and standards
related to this Recommendation, and should take all
feasible steps to give effect to its implementation.
159. Member States shall, according to their specific
contexts, governing structures and constitutional
provisions, credibly and transparently advance the
ethics of neurotechnology, in line with the UNESCO
Recommendation. Member States shall monitor and
evaluate policies, programmes and mechanisms related
to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and
qualitative approaches.
160. Member States should develop capacities in
governmental institutions and support government
officials to steer the technological development
ethically.
161. Member States should establish or designate
national organizations responsible for overseeing and
coordinating the regulation, vigilance, and oversight of
neurotechnology across relevant government agencies.
These coordinating bodies should be tasked with
ensuring that legal and regulatory frameworks are
consistently applied, that public health and safety are
protected, and that ethical standards and human rights
are upheld throughout the whole lifecycle of
neurotechnology. This includes facilitating inter-agency
collaboration, monitoring compliance with national and
international standards, and ensuring that data and
insights from different regulatory domains are shared
effectively to inform decision-making and policy
development. These bodies should also help coordinate
public and community engagement.
142
162. Member States should strive to extend and
complement their own actions in respect of this
Recommendation, by cooperating with all relevant
national and international governmental and non-
governmental organizations, as well as transnational
corporations and scientific organizations, whose
activities fall within the scope and objectives of this
Recommendation. Civil society will be an important
actor to advocate for the public sector's interests and
therefore UNESCO needs to ensure and promote its
legitimacy.
163. UNESCO should publicize and disseminate this
Recommendation widely through all available means,
and share it with Member States, National Commissions
for UNESCO, relevant international and regional
partners, human rights institutions as well as with
UNESCO ethics advisory bodies for dissemination to
all levels and actors in this field.
164. To support Member States implementing this Compare VII. Promotion of
Recommendation by developing concrete programs the present Recommendation, §137-
and policies and developing institutional capacities in 139 in the Recommendation on the Ethics
the ethics of neurotechnology, UNESCO shall of Artificial lntelligence (2021). For this
contribute by developing a full-fledged program with the Recommendation to be relevant for many
following elements: years to come, it might be a good idea to
outline guidelines rather than a list of
concrete initiatives.
(a) UNESCO Readiness Assessment Methodology
(RAM) to assist Member States in identifying their
status at specific moments of their readiness trajectory
along a continuum of dimensions;
(b) UNESCO methodology for Ethical lmpact
Assessment (EIA) of neurotechnology based on
rigorous scientific research and grounded in
international human rights law, along with specific
guidance for its implementation in the whole
neurotechnology lifecycle, and capacity-building tools
143
and materials to support Member States' efforts to train
government officials, policy-makers and other relevant
actors on the methodology;
( c) UNESCO methodology to evaluate ex ante and ex
post the effectiveness and the efficiency of the policies
for the ethics of neurotechnology and incentives against
defined objectives;
(d) UNESCO research program that will focus an the
ethics of neurotechnology, grounded on an appraisal
that is informed by the current state of technological
developments, to assess the current and future impact
of neurotechnology an societies and the environment.
This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of
knowledge and awareness of good practices and
innovations available to all Member States and actors,
in the form of research reports, data, and statistics
regarding policies for ethics of neurotechnology. The
research program should take into consideration the
converging developments of neurotechnology with other
technologies such as artificial intelligence and quantum
technology, work to be conducted in collaboration with
other relevant UNESCO initiatives.
( e) UNESCO collaborative platform fostering
meaningful exchanges and facilitating collaboration
among Member States and among all actors to promote
a global policy dialogue, including at Ministerial level in
the context of a Global Forum an the ethics of Emerging
Technologies. Supporting this effort, UNESCO shall
establish a network of experts, with balanced
representation of all UNESCO's regional groups, on the
neurotechnology.
165. Processes for monitoring and evaluation should
ensure broad participation of all actors, including, but
not limited to, under-represented, vulnerable people or
144
people in vulnerable situations and ensuring social,
cultural and gender diversity. The monitoring and
assessment of the impact of neurotechnology and
related ethics policies and practices should be carried
out continuously in a systematic way proportionate to
the relevant risks. This should be based on
internationally agreed frameworks and involve
evaluations of private and public institutions. Data
collection and processing should be conducted in
accordance with international law, national legislation
on data protection and data privacy, and the values and
principles outlined in this Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a
whole, and the foundational values and principles are to
be understood as complementary and interrelated.
167. Nothing in this Recommendation may be
interpreted as replacing, altering or otherwise
prejudicing Member States' obligations or rights under
international law, or as approval for any State, other
political, economic or social actor, group or person to
engage in any activity or perform any act contrary to
human rights, fundamental freedoms, human dignity
and concern for the environment and ecosystems.
145
BURKINA FASO
BURKINA FASO
AMENDEMENT DU RAPPORT PRÉLIMINAIRE
SUR L’AVANT-PROJET DE RECOMMANDATION
SUR L’ÉTHIQUE DES NEUROTECHNOLOGIES
DE L’UNESCO
28 Décembre 2024
146
Objet : Amendement du rapport
préliminaire sur l’avant-projet de
recommandation sur l’éthique des
neurotechnologies de l’UNESCO
Madame la Directrice Générale,
Le Gouvernement du Burkina Faso, se félicite de la bonne collaboration
traditionnelle qui existe entre l'Organisation des Nations Unies pour l'éducation,
la science et la culture (UNESCO) et notre pays. Il voudrait donc adresser tous ses
compliments à la Directrice Générale de l’UNESCO pour son leadership, sa
clairvoyance et sa détermination à bâtir un monde épris de paix et de justice ; un
monde où chaque individu est traité avec dignité et respect, un monde en progrès
ayant à cœur le bien intégral de l’Homme et de tout Homme dans son
développement.
Madame la Directrice Générale, après avoir organisé en 2021 la rencontre
internationale traitant la problématique de l’Intelligence Artificielle (IA) qui sans
doute bouleversera, dans les années à venir, nos sciences, nos vies et nos cultures,
vous vous attelez maintenant à baliser, au niveau international, les chemins des
recherches fondamentales et cliniques sur les neurotechnologies.
Les neurotechnologies sont comme des couteaux à double tranchant. Elles peuvent
faire du bien à l’Homme tout comme elles peuvent le porter à la dérive. En effet,
« les neurotechnologies soulèvent des questions éthiques fondamentales », non
seulement en ce qui concerne la transformation de l’être humain dans son identité
ontologique mais aussi son autodétermination, sa vie privée, son identité
personnelle, sa liberté de pensée, avec des risques de discriminations, d’inégalité,
de fracture et des dérives épigénétiques avec « l’Homme augmenté » en quotient
intellectuel (QI).
Nous félicitons également le Groupe d’experts ad hoc (GEAH) qui a été établi par
vous, Madame la Directrice Générale de l’UNESCO, pour élaborer cet avant-projet
de Recommandation sur l’éthique des neurotechnologies. Le GEAH a
effectivement réalisé un dossier bien documenté, bien structuré et bien équilibré du
point de vu éthique et bioéthique.
147
Madame la Directrice Générale, dans votre lettre Réf. CL/4483 du 23 Septembre
2024, vous nous demandiez d’amender cette Recommandation sur l’éthique des
neurotechnologies qui a été élaborée par le GEAH.
Nous vous envoyons les contributions du Burkina Faso.
1 - Les points IV.8 et IV.9 du document cible la notion de « femme et minorités
de genre » (alinéas 112, 113 et 114). Nous nous demandons pourquoi le GEAH a-
t-il mis dans le même lot en associant dans le texte « femme et minorités de
genre » ? Nous n'avons pas d'arguments pour refuser les soi-disant minorités de
genre, qui s'imposent à nous.
En acceptant ce document tel quel, nous acceptons de fait ses prescriptions et c'est
là notre réserve.
2 – Principe de précaution.
Selon la définition du GEAH, « les neurotechnologies font référence aux appareils,
systèmes et procédures – englobant à la fois le matériel et les logiciels – qui
permettent d’accéder directement au système nerveux, de le surveiller, de
l’analyser, d’en prévoir l’activité ou de le moduler, afin de comprendre, influencer,
restaurer ou anticiper sa structure, son activité, sa fonction ou ses intentions (parole,
motricité). Les neurotechnologies combinent des éléments des neurosciences, de
l’ingénierie et de l’informatique, entre autres ». Cependant, les connaissances
scientifiques des neurotechnologistes ne sont pas encore suffisantes pour évaluer
les risques de manière certaine ; par conséquent, nous suggérons d’inclure dans
l’avant-projet de Recommandation sur l’éthique des neurotechnologies, le principe
éthique de précaution.
3 - Régulation moléculaire de la synaptogenèse
De nombreux chercheurs dans leurs études scientifiques ont démontré que des
modifications épigénétiques telles que la méthylation de l'ADN et la modification
des histones jouent un rôle crucial dans la régulation de l'expression des gènes
impliqués dans la synaptogenèse (Jobe and Zhao, 2017; Kameda et al., 2021;
Zocher et al., 2021; Xie et al., 2023). Les recherches sur les régulations
moléculaires épigénétiques de la synaptogenèse, le déchiffrage du « code
synaptique » et sur la connectomique ne peuvent-ils pas conduire à une
augmentation significative du quotient intellectuel (QI) d’un groupe humain par
rapport au reste de l’humanité ? Cette recherche ne pourra-t-elle pas alors pousser
Homo sapiens dans l’« aryanisme » ? Par conséquent, ne serait-il pas pertinent
d’introduire l’éthique de la recherche sur les régulations moléculaires
épigénétiques de la synaptogenèse, le déchiffrage du « code synaptique » et sur la
148
connectomique dans le document de l’avant-projet de Recommandation sur
l’éthique des neurotechnologies.
4 – Application de la neurotechnologie à toutes les structures y compris les forces
armées et de sécurité
Les recherches scientifiques et les technologies des structures des forces armées et
de sécurités sont souvent très poussées dans ces domaines plus que dans le monde
civil. Il faudrait dans le texte souligner fortement et clairement que l’éthique
s’applique également à ces structures.
5 – Proposition d’un Comité consultatif international d’experts sur la
gouvernance et la surveillance de l’éthique de la neurotechnologie et de
l’Intelligence artificielle (IA)
A l’instar de l'Agence internationale de l'énergie atomique (AIEA), n’est-il pas
judicieux d’avoir des experts qui n’ont aucun conflit d’intérêts pour s’occuper de
la gouvernance et de la surveillance de l’éthique de la neurotechnologie et de
l’Intelligence artificielle (IA) ?
Madame la Directrice Générale, le Burkina Faso soutient, avec ses amendements,
l'avant-projet de recommandation de l’UNESCO qui règlemente et
balise l’ensemble du cycle de vie des neurotechnologies, « depuis les premières
étapes de l’extraction des matériaux, du prototypage, de la recherche, de la
conception et du développement jusqu’au déploiement et à l’utilisation, y compris
la maintenance, l’exploitation, la commercialisation, le financement, le suivi et
l’évaluation, la validation, la fin de l’utilisation, le désassemblage, l’arrêt,
l’élimination et le recyclage ; la convergence des neurotechnologies avec d’autres
technologies, comme l’intelligence artificielle ».
JOBE, E. M. & ZHAO, X. 2017. DNA Methylation and Adult Neurogenesis. Brain Plast, 3, 5-26.
KAMEDA, T., NAKASHIMA, H., TAKIZAWA, T., MIURA, F., ITO, T., NAKASHIMA, K. & IMAMURA, T. 2021.
Neuronal activation modulates enhancer activity of genes for excitatory synaptogenesis through
de novo DNA methylation. J Reprod Dev, 67, 369-379.
XIE, J., XIE, L., WEI, H., LI, X. J. & LIN, L. 2023. Dynamic Regulation of DNA Methylation and Brain
Functions. Biology (Basel), 12.
ZOCHER, S., OVERALL, R. W., BERDUGO-VEGA, G., RUND, N., KARASINSKY, A., ADUSUMILLI, V. S.,
STEINHAUER, C., SCHEIBENSTOCK, S., HÄNDLER, K., SCHULTZE, J. L., CALEGARI, F. &
KEMPERMANN, G. 2021. De novo DNA methylation controls neuronal maturation during adult
hippocampal neurogenesis. Embo j, 40, e107100.
149
CANADA
AVANT-PROJET DE RECOMMANDATION SUR L’ÉTHIQUE DES Commenté [GdQ1]: De façon générale, l’avant-projet
NEUROTECHNOLOGIES de texte pourrait être davantage concis, avec une
portée large, à vocation universelle. Certaines
PRÉAMBULE dispositions pourraient être écourtées. On note des
répétitions, différents styles de rédaction. Un style
neutre et uniformisé serait à prioriser. Le style très
Consciente des répercussions profondes et dynamiques des neurotechnologies sur académique et la longueur du texte nous font craindre
l’esprit, la vie et l’épanouissement de l’être humain, ainsi que sur les sociétés, des difficultés pour sa mise en œuvre.
l’environnement et les écosystèmes,
Considérant la prévalence mondiale importante et croissante des troubles
neurologiques et de santé mentale, ainsi que les profondes souffrances qu’ils causent
aux individus et aux sociétés dans le monde entier,
Notant que les neurotechnologies peuvent apporter des solutions innovantes et de
meilleurs traitements préventifs et thérapeutiques à des millions de personnes, au
bénéfice de l’humanité dans son ensemble et avec des possibilités d’amélioration de la
santé dans tous les pays,
Considérant également que les neurotechnologies soulèvent des questions éthiques
fondamentales, notamment en ce qui concerne l’autodétermination, la vie privée,
l’identité personnelle, la liberté de pensée, le risque de discrimination, l’inégalité et les
défis posés à la démocratie, et qu’il faut maintenir la justice, la confiance et l’équité pour
qu’aucun pays ni aucune personne ne soient laissés de côté, qu’il s’agisse de jouir d’un
accès équitable aux neurotechnologies et de profiter de leurs avantages ou de se
prémunir contre les risques qu’elles comportent, tout en reconnaissant les différences de
situation qui prévalent entre les pays et en respectant le souhait de certaines personnes
de ne pas prendre part à toutes les innovations technologiques,
Rappelant que l’UNESCO se propose, aux termes de son Acte constitutif, de contribuer
à la paix et à la sécurité et de resserrer, par l’éducation, les sciences, la culture et la
communication et l’information, la collaboration entre nations, afin d’assurer le respect
universel de la justice, de la loi, des droits de l’homme et des libertés fondamentales
reconnus à tous les peuples,
Sachant que l’UNESCO joue un rôle moteur, à l’avant-garde du dialogue international,
de la production de connaissances et de l’action normative en matière d’éthique des
sciences et des technologies et de bioéthique,
Convaincue que la Recommandation présentée ici, en tant qu’instrument normatif,
développée selon une approche globale, fondée sur le droit international et centrée sur
la dignité humaine et les droits de l’homme, ainsi que sur l’égalité des genres, la justice
sociale et mondiale et le développement, le bien-être et la santé physiques et mentaux,
la diversité, l’interdépendance, la solidarité mondiale, l’équité, la non-discrimination,
l’inclusion et la protection de l’environnement et des écosystèmes, peut donner une
orientation responsable aux neurotechnologies,
Guidée par les objectifs et les principes de la Charte des Nations Unies,
Soulignant qu’il est nécessaire de prêter une attention particulière aux pays à revenu
intermédiaire de la tranche inférieure (PRITI), y compris, sans s’y limiter, aux pays les
moins avancés (PMA), aux pays en développement sans littoral (PDSL) et aux petits
150
États insulaires en développement (PEID), car ils disposent de capacités mais sont
sous-représentés dans le développement des neurotechnologies et l’accès à ces
dernières,
Soulignant également que la coopération et la solidarité mondiales facilitent un accès
équitable aux neurotechnologies et permettent d’en tirer pleinement parti, tout en
relevant les défis éthiques, en réduisant les risques d’utilisation abusive et en veillant à
ce que les stratégies nationales en matière de neurotechnologies soient guidées par des
principes éthiques dans le plein respect du droit international des droits de l’homme,
Notant que des lignes directrices et des cadres éthiques ainsi qu’une science ouverte
favorisent l’innovation, le développement et les politiques conformes au droit
international des droits de l’homme,
Rappelant également que la Conférence générale de l’UNESCO, à sa 42e session en
novembre 2023, a adopté la résolution 42 C/29, par laquelle elle a chargé la Directrice
générale « d’élaborer un instrument normatif sur l’éthique des neurotechnologies, sous
la forme d’une recommandation », qui doit lui être présenté à sa 43e session en 2025,
Ayant à l’esprit la Déclaration universelle des droits de l’homme (1948), les instruments
internationaux relatifs aux droits de l’homme, dont la Convention relative au statut des
réfugiés (1951), la Convention concernant la discrimination (emploi et profession)
(1958), la Convention internationale sur l’élimination de toutes les formes de
discrimination raciale (1965), le Pacte international relatif aux droits civils et politiques
(1966), le Pacte international relatif aux droits économiques, sociaux et culturels (1966),
la Convention sur l’élimination de toutes les formes de discrimination à l’égard des
femmes (1979), la Convention relative aux droits de l’enfant (1989), la Convention
relative aux droits des personnes handicapées (2006), la Convention concernant la lutte
contre la discrimination dans le domaine de l’enseignement (1960), et la Convention sur
la protection et la promotion de la diversité des expressions culturelles (2005), ainsi que
tous autres instruments, recommandations et déclarations internationaux pertinents,
Prenant acte de la Déclaration des Nations Unies sur le droit au développement (1986)
; de la Déclaration sur les responsabilités des générations présentes envers les
générations futures (1997) ; de la Déclaration universelle sur la bioéthique et les droits
de l’homme (2005) ; de la Déclaration des Nations Unies sur les droits des peuples
autochtones (2007) ; de la Déclaration de principes éthiques en rapport avec le
changement climatique (2017) ; de la Recommandation concernant la science et les
chercheurs scientifiques (2017) ; de la Recommandation sur l’éthique de l’intelligence
artificielle (2021) ; de la Recommandation sur une science ouverte (2021) ; de la
résolution du Conseil des droits de l’homme sur « Le droit à la vie privée à l’ère du
numérique » (A/HRC/RES/42/15) (2019) ; de la résolution du Conseil des droits de
l’homme « Nouvelles technologies numériques et droits de l’homme »
(A/HRC/RES/41/11) (2019) ; et des Principes directeurs des Nations Unies relatifs aux
entreprises et aux droits de l’homme (2011),
Rappelant en outre que la Recommandation sur l’éthique de l’intelligence artificielle
(2021) reconnaît les questions éthiques posées par les systèmes alimentés par l’IA pour
les neurotechnologies et les interfaces cerveau-ordinateur,
151
Consciente également qu’il existe des écosystèmes de politiques à l’échelle nationale
ainsi que d’autres cadres et initiatives élaborés par les entités des Nations Unies
concernées, par des organisations intergouvernementales telles que l’OCDE, y compris
des organisations régionales, ainsi que celles du secteur privé, des organisations
professionnelles, des organisations non gouvernementales et de la communauté
scientifique, relatifs à l’éthique et à la réglementation des neurotechnologies,
1. Adopte, en ce XXX jour de novembre 2025, la présente
Recommandation sur l’éthique des neurotechnologies ;
2. Recommande aux États membres d’appliquer, avec l’appui du
Secrétariat de l’UNESCO, les dispositions de la présente
Recommandation en prenant des mesures appropriées, notamment
législatives, conformes aux pratiques constitutionnelles et aux structures
de gouvernance de chaque État, en vue de donner effet, dans leurs
juridictions, aux principes et normes énoncés dans la Recommandation
conformément au droit international, y compris le droit international des
droits de l’homme ;
3. Recommande également aux États membres d’impliquer tous les
acteurs afin de veiller à ce qu’ils jouent leurs rôles respectifs dans la mise
en œuvre de la Recommandation, et de porter la présente
Recommandation à la connaissance des autorités et organismes
internationaux, régionaux et nationaux, instituts de recherche et
organismes universitaires, et institutions et organisations des secteurs
public, privé et de la société civile engagés dans les neurotechnologies,
afin que le développement et l’utilisation des neurotechnologies soient
guidés par des recherches scientifiques de qualité ainsi que par une
analyse et une évaluation éthiques.
I. CHAMP D’APPLICATION ET DÉFINITIONS
I.1 CHAMP D’APPLICATION
La présente Recommandation :
1. Traite des questions éthiques liées aux neurotechnologies, qui peuvent avoir de
nombreux effets positifs et négatifs sur la santé et l’épanouissement de l’être humain,
ainsi que sur l’exercice des droits de l’homme.
2. Prend en considération les neurotechnologies pour des personnes de milieux et
niveaux d’aptitude divers, et dans différents domaines, notamment la santé et les
applications non médicales directement destinées au consommateur (telles que les
dispositifs de bien-être ou les jeux vidéo pilotés par ondes cérébrales) et aborde
différents contextes dans lesquels les neurotechnologies peuvent être utilisées.
3. Porte uniquement sur l’être humain, mais prend acte de considérations
importantes qui s’appliquent aux animaux dans le domaine de la recherche.
152
4. Aborde l’éthique des neurotechnologies en tant que réflexion normative
systématique, basée sur un cadre global, multiculturel, pluridisciplinaire, pluraliste et
évolutif de valeurs, de principes et d’actions interdépendants de nature à orienter les
sociétés pour qu’elles apportent des réponses responsables aux conséquences des
impacts des neurotechnologies sur les êtres humains, les sociétés, l’environnement et
les écosystèmes.
(a) Elle considère l’éthique comme une base pour l’évaluation et l’orientation
normatives des neurotechnologies, ayant pour repères et comme fondement les Commenté [GdQ2]: Il est suggéré d’ajouter dans les
droits de l’homme, la dignité humaine, le bien-être et la prévention des repères et les fondements:
1)Justice et équité
dommages. 2) Reconnaissance de la diversité
3)Le dialogue et la délibération
(b) Elle s’appuie sur un large éventail d’études, de commentaires et de points de
vue issus des neurosciences, de la médecine, de l’ingénierie, de la psychologie,
de l’éthique, des droits de l’homme, du droit, de la sociologie, de l’anthropologie
et d’autres disciplines.
5. Couvre la mesure, l’enregistrement et la modification du système nerveux
humain, la gestion, l’analyse, le traitement, le stockage, l’utilisation et la réutilisation des
données collectées, ainsi que d’autres impacts sociétaux et environnementaux, y
compris l’émergence de nouveaux états cognitifs.
6. Reconnaît que les interventions impliquant le système nerveux sont très
sensibles car le système nerveux humain, très complexe, est le centre de coordination Commenté [GdQ3]: Et par conséquent : reconnaît que
du comportement et des processus mentaux. Le système nerveux permet l’exercice de les données neurales personnelles sont des données
personnelles sensibles qui doivent bénéficier d’une
l’autodétermination, ainsi que la capacité d’agir en tant qu’agent moral, d’être protection spéciale, au même titre que les données
responsable de ses actes, de coopérer avec les autres, de délibérer sur des décisions biométriques et les données génétiques. (comme le
collectives et de développer la personnalité. reconnaît le rapport sur les aspects éthiques des
neurotechnologies du CIB de l’UNESCO (2021, p. 51).
7. Reconnaît en outre que les êtres humains se développent et s’épanouissent
dans leur interaction avec d’autres êtres humains et dans un environnement matériel et
culturel stimulant, soulignant que l’autonomie n’est pas seulement individuelle, mais
aussi relationnelle, car elle découle des interactions et de l’appartenance d’une
personne à une communauté et a des incidences sur celles-ci. Commenté [GdQ4]: Ceci pourrait être déplacé dans le
préambule. Cela ne correspond pas au champ
8. Aborde les préoccupations en matière d’éthique et de droits de l’homme qui d’application.
découlent de l’évolution rapide et de la convergence des neurotechnologies avec
d’autres technologies telles que l’informatique spatiale, la réalité étendue (XR),
l’intelligence artificielle (IA), et les capteurs et semiconducteurs. Notamment, d’autres
données biométriques, lorsqu’elles sont traitées pour déduire un état sensoriel, moteur
ou mental, soulèvent des préoccupations éthiques du même ordre. Par conséquent, la
présente Recommandation s’applique à la fois aux neurotechnologies et à l’utilisation
des données biométriques cognitives, en veillant à ce que des principes et pratiques
éthiques soient appliqués de manière cohérente dans l’ensembles de ces domaines.
9. Aborde également l’intégration de l’IA dans les neurotechnologies, qui peut
améliorer la précision et les capacités de prévision, notamment en accélérant la vitesse
de traitement, en réduisant les coûts ou en optimisant les systèmes
neurotechnologiques. Cependant, elle amplifie également les menaces d’ordre éthique,
notamment les problèmes de cybersécurité, le manque de transparence, le potentiel de
153
biais algorithmique et les risques pour l’autonomie, la vie privée mentale, AJOUT :
l’identité personnelle et la manipulation. Commenté [GdQ5]: Le terme ‘manipulation’ revient
très souvent dans le document. Il conviendrait de bien
10. Vise à promouvoir un usage pacifique des neurotechnologies et à sensibiliser le définir (une forme d’influence insidieuse qui vise à
aux immenses défis et menaces d’ordre éthique qu’impliquent les applications militaires modifier les comportements et les croyances des
individus en exploitant certaines de leurs failles
et de sécurité des neurotechnologies, en appelant tous les acteurs concernés à agir de cognitives ou des asymétries d’information et de
façon responsable en ce qui concerne les neurotechnologies. pouvoir). Voir par exemple ce papier de Cass Sunstein :
I.2 DÉFINITIONS https://papers.ssrn.com/sol3/papers.cfm?abstract_id=25
65892
11. Le système nerveux. Le système nerveux comprend le système nerveux central
Commenté [GdQ6]: Ceci semble plus convenir à la
(cerveau, moelle épinière) et périphérique (somatique, autonome, entérique). Des section Objectifs.
données scientifiques démontrent que l’activité du système nerveux est à la base des
Commenté [GdQ7]: Les définitions pourraient être plus
états sensoriels, moteurs et mentaux (ce qui englobe les états cognitifs, affectifs et concises.
conatifs) et contribue à la conscience, au sommeil et à l’expérience de la douleur.
L’activité et la structure du système nerveux fournissent des informations inhérentes à
tous les êtres humains et à la communauté, indépendamment du genre, de
l’appartenance ethnique, de la langue ou de la religion. L’activité du système nerveux
joue également un rôle dans les interactions sociales et culturelles.
12. Les neurotechnologies. Les neurotechnologies font référence aux appareils,
systèmes et procédures – englobant à la fois le matériel et les logiciels – qui permettent
d’accéder directement au système nerveux, de le surveiller, de l’analyser, d’en prévoir
l’activité ou de le moduler, afin de comprendre, influencer, restaurer ou anticiper sa
structure, son activité, sa fonction ou ses intentions (parole, motricité). Les
neurotechnologies combinent des éléments des neurosciences, de l’ingénierie et de
l’informatique, entre autres.
13. Les neurotechnologies recouvrent des applications médicales et non médicales
et comprennent des outils qui mesurent, déduisent et influencent l’activité du système
nerveux, que ce soit par une interaction directe avec ce dernier ou par une interface
avec des appareils et des systèmes. Cela comprend, sans toutefois s’y limiter :
(a) les outils techniques qui mesurent et analysent les signaux physiques
(acoustiques, électriques, optiques, magnétiques et/ou mécaniques),
chimiques et biologiques associés à la structure et aux signaux fonctionnels
du système nerveux. Ils peuvent être utilisés pour identifier, enregistrer et/ou
surveiller les propriétés de l’activité du système nerveux, en comprendre le
fonctionnement, diagnostiquer des pathologies ou contrôler des dispositifs
externes (les interfaces cerveau-machine (ICM), souvent appelées interfaces
cerveau-ordinateur). Il convient de noter que tant les systèmes en boucle
ouverte (par exemple, la stimulation cérébrale à paramètres fixes) que les
systèmes en boucle fermée (par exemple, la stimulation dépendante de
l’état) soulèvent des questions éthiques complexes ;
(i) les exemples incluent, sans toutefois s’y limiter,
l’électroencéphalographie (EEG), la magnétoencéphalographie
(MEG), l’imagerie par résonance magnétique (IRM), l’imagerie par
résonance magnétique fonctionnelle (IRMf), la tomographie par
émission de positons (TEP), la spectroscopie proche infrarouge
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fonctionnelle (fNIRS), les microélectrodes implantées,
l’optogénétique, l’imagerie optique, l’imagerie en tenseur de
diffusion, l’imagerie calcique, les capteurs de couleurs ou la
microdialyse ;
(b) les outils techniques qui interagissent avec le système nerveux pour en
modifier l’activité, par exemple pour rétablir l’influx sensoriel, comme les
implants cochléaires pour restaurer l’audition ou la stimulation cérébrale
profonde pour traiter les tremblements et d’autres affections pathologiques.
Ils sont destinés à moduler les fonctions du système nerveux et/ou à
envoyer des signaux directement au système nerveux en appliquant une
stimulation et/ou une inhibition acoustique, électrique, magnétique ou
optique au système nerveux périphérique ou central ;
(i) les microélectrodes implantées, les interfaces cerveau-machine
(ICM), la stimulation cérébrale profonde, la stimulation
optogénétique, la stimulation transcrânienne électrique (TES), la
stimulation magnétique transcrânienne (TMS) ou la perfusion
neuropharmacologique sont autant d’exemples de ces
neurotechnologies.
14. Il convient de noter que plusieurs technologies de détection recueillent des
données qui renseignent indirectement sur l’activité neurale. Même s’il ne s’agit pas de
neurotechnologies à proprement parler, ces technologies soulèvent des questions en
matière d’éthique et de droits de l’homme similaires aux questions que soulèvent les
neurotechnologies lorsqu’elles sont utilisées pour déduire des états mentaux. Elles
comprennent, sans s’y limiter, l’oculométrie, la vidéooculographie, la dynamique de
frappe au clavier, la reconnaissance vocale et l’analyse de la voix, l’analyse de la
démarche, la conductance cutanée, la variabilité de la fréquence cardiaque, la
surveillance des mouvements du sommeil, la mesure de la tension artérielle ou les
systèmes de reconnaissance des expressions émotionnelles du visage.
15. Données neurales. Les données neurales sont des données qualitatives et Commenté [GdQ8]: Devrait-on d’emblée distinguer les
quantitatives concernant la structure, l’activité et la fonction du système nerveux. Elles données neurales personnelles des données
personnelles ordinaires, les premières étant
englobent les données relatives à l’activité d’un système nerveux, y compris des particulièrement sensibles et devant être protégées par
mesures directes de la structure, de l’activité et/ou de la fonction neurales (par exemple, des mesures spéciales, plus contraignantes (comme on
les décharges s ou la moyenne des signaux bioélectriques de l’EEG) et des indicateurs le fait dans Aspects éthiques des neurotechnologies,
UNESCO 2021, p. 51)?
fonctionnels indirects (par exemple, le flux sanguin dans l’IRMf et la fNIRS). Au niveau
neurobiologique, les données neurales sont les corrélats les plus directs d’un état
mental.
16. Données biométriques cognitives. Les données neurales, ainsi que d’autres
données recueillies par le biais de technologies biométriques non neurales peuvent être
traitées pour déduire des états mentaux, ce que la présente Recommandation qualifie
de « données biométriques cognitives ».
17. Ensemble du cycle de vie. Les neurotechnologies doivent être considérées
dans l’ensemble de leur cycle de vie, allant des premiers stades de l’extraction de
matériaux, du prototypage, de la recherche, de la conception et du développement au
déploiement et à l’utilisation, et incluant la maintenance, l’exploitation, la
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commercialisation, le financement, le suivi et l’évaluation, la validation, la fin de
l’utilisation, le démontage, la mise hors service, l’élimination et le recyclage. L’ensemble
du cycle de vie des neurotechnologies comprend leur convergence avec d’autres
technologies et la diversité des acteurs qui interviennent à chaque étape.
II. BUTS ET OBJECTIFS
18. La présente Recommandation a été élaborée dans le but de guider le
développement et l’utilisation des neurotechnologies de manière éthique, sûre et
efficace pour le bien de l’humanité, des individus, des communautés, des sociétés, de
l’environnement et des écosystèmes, ainsi que de prévenir les préjudices dans le
présent et l’avenir en se fondant sur le droit international, en particulier la Charte des
Nations Unies et le droit international des droits de l’homme.
19. Les objectifs de la présente Recommandation sont les suivants :
(a) assurer la protection, la promotion et le respect des droits de l’homme et
des libertés fondamentales, de la dignité humaine et de l’équité, y compris
l’égalité des genres, et respecter la diversité culturelle tout au long du
cycle de vie des neurotechnologies ;
(b) guider les actions des États membres, des individus, des groupes, des
communautés, des institutions, des entreprises du secteur privé et de tout
autre acteur concerné afin de garantir la prise en compte de l’éthique à
tous les stades du cycle de vie des neurotechnologies ;
(c) faire en sorte que les neurotechnologies soient, tout au long de leur cycle
de vie, fondées sur des données factuelles, fiables et reproductibles ;
(d) offrir un cadre universel, permettant non seulement de définir des valeurs
et des principes, mais qui se concrétise également sous la forme de
recommandations stratégiques et d’une mise en œuvre efficace pour
guider les États membres dans leur action en matière de
neurotechnologies dans l’ensemble du cycle de vie de ces dernières,
conformément aux obligations qui leur incombent au regard du droit
international des droits de l’homme et à d’autres normes internationales ;
(e) favoriser un dialogue multipartite, pluridisciplinaire et pluraliste ainsi que
la recherche du consensus au sujet des questions éthiques en lien avec
les neurotechnologies ;
(f) promouvoir la justice et un accès équitable aux progrès et aux
connaissances dans le domaine des neurotechnologies, ainsi que le
partage des bienfaits qui en découlent ;
(g) garantir l’obligation de rendre des comptes et la solidarité parmi tous les
acteurs afin de prévenir l’utilisation abusive des neurotechnologies et de
faire respecter les droits de l’homme et les normes éthiques.
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III. VALEURS ET PRINCIPES
III.1 VALEURS
III.1.1 Respect, protection et promotion des droits de l’homme, des libertés
fondamentales et de la dignité humaine
20. La dignité inviolable et intrinsèque de chaque être humain est le fondement des
droits de l’homme universels et des libertés fondamentales. Le respect, la protection et
la promotion de la dignité humaine établis par le droit international, notamment le droit
international relatif aux droits de l’homme, tiennent une place essentielle dans
l’ensemble du cycle de vie des neurotechnologies. La dignité humaine se rapporte à la
reconnaissance de la valeur intrinsèque et égale de chaque être humain. Les
neurotechnologies ne doivent en aucun cas être utilisées de manière à réduire à l’état
d’objet, à exploiter les vulnérabilités des individus, ni à porter atteinte à la dignité et aux
droits d’une personne, notamment les personnes en situation de vulnérabilité.
III.1.2 Promouvoir la santé et le bien-être humains
21. Il convient de privilégier le développement et l’application des neurotechnologies
qui favorisent la santé et le bien-être humains dans leur intégralité, la santé étant
considérée comme un état global de bien-être physique, mental et social.
22. L’affectation responsable des ressources devrait être orientée à des fins
préventives, diagnostiques, thérapeutiques, d’assistance ou de réparation, qui
bénéficient au plus grand nombre et à ceux qui en ont le plus besoin, plutôt qu’à des
applications commerciales ou destinées au consommateur.
III.1.3 Assurer et respecter la diversité et l’équité
23. Il convient de faire prévaloir le respect de la diversité et de l’équité tout au long
du cycle de vie des neurotechnologies. Une attention particulière devrait être accordée à
la neurodiversité, aux groupes minoritaires, aux peuples autochtones et aux voix sous- Commenté [GdQ9]: Il pourrait être utile de définir la
représentées. neurodiversité et le neurotype tout en soulignant les
enjeux liés à la stigmatisation potentielle de certaines
24. Étant donné que l’innovation largement reconnue en matière de communautés neurodivergentes (personnes
malentendantes ou malvoyantes, ou sur le spectre de
neurotechnologies se produit en grande partie dans les zones urbaines bien dotées en l’autisme, par exemple).
ressources, il est essentiel d’accorder une attention particulière aux personnes mal
desservies et marginalisées afin de prévenir les préjugés, les disparités persistantes en
matière de soins de santé, la stigmatisation, la négligence et le manque de respect.
L’assimilation technologique, ou l’utilisation de la technologie comme outil de
colonisation (notion désignée dans la Recommandation par le terme « colonialisme Commenté [GdQ10]: Il pourrait être utile de préciser
technologique »), peut menacer la diversité et le patrimoine culturels et il convient donc les mécanismes par lesquels cette forme de
colonialisme opère. Par exemple, est-ce que les
de s’en prémunir. pressions sociales pour rester compétitifs face à
certains pans de la population qui auraient recours aux
25. L’accès équitable aux neurotechnologies devrait être une priorité au niveau neurotechnologies pour des fins d’amélioration
mondial, en veillant à ce que leurs bienfaits soient accessibles à tous, indépendamment pourraient constituer une telle forme de colonialisme?
de la situation socioéconomique ou géographique. Une attention particulière doit être
accordée aux pays à revenu faible ou intermédiaire, aux environnements aux
ressources limitées et aux communautés marginalisées, notamment aux besoins
spécifiques des différents groupes, tranches d’âge, segments, systèmes culturels,
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langues, communautés et populations marginalisées et vulnérables, ainsi que des
personnes présentant un handicap, des troubles neurologiques ou des troubles
mentaux.
26. Les individus et les groupes devraient être autorisés à choisir leur mode de vie,
à exprimer leurs croyances et leurs opinions, à partager leurs expériences personnelles
et à participer à la conception conjointe des technologies, sous réserve que ces choix
soient faits dans le respect des droits d’autrui.
III.1.4 Prise en compte des perspectives interculturelles sur les connaissances
humaines et leur partage
27. Un partage des connaissances respectueux concernant le système nerveux
humain et ses fonctions entre les différentes communautés et cultures favorise la
confiance et renforce la cohésion mondiale dans la quête de la santé et de la qualité de
vie.
28. Il est essentiel que toute activité de recherche et de développement concernant
divers groupes et communautés soit menée avec leur autorisation et selon leurs
orientations, ainsi qu’avec leur consentement préalable, donné librement et en
connaissance de cause, et leur pleine collaboration de manière à servir leurs intérêts et
à respecter leur savoir traditionnel et leurs contributions épistémiques.
III.1.5 Engagement en faveur de la paix, de l’équité et de la justice dans la société
29. L’utilisation des neurotechnologies devrait permettre de promouvoir la liberté de
pensée, et non de lui porter atteinte, en particulier dans les situations où le refus de
recourir à la technologie peut entraîner un désavantage concurrentiel. Ces ingérences
englobent, sans s’y limiter, l’usage de la force, les menaces, l’accès non déclaré, la
manipulation ou tout scénario dans lequel le consentement n’est pas respecté, y
compris du fait de rapports de force défavorables.
30. L’utilisation des neurotechnologies devrait faire l’objet d’un examen
particulièrement attentif afin d’éviter les usages qui entraînent la ségrégation,
l’objectification ou la subordination d’individus ou de communautés, qui réduisent la
cohésion sociale en exacerbant les inégalités préexistantes ou en en générant de
nouvelles, qui divisent les individus et les dressent les uns contre les autres, et qui
compromettent par là-même la coexistence entre les êtres humains, les autres êtres
vivants et le milieu naturel. Commenté [GdQ11]: Les usages problématiques qui
font l’objet de ces deux paragraphes semblent liés à
III.1.6 Solidarité mondiale et coopération internationale des cas où les neurotechnologies servent des finalités
d’amélioration ou à des cas d’exclusion discriminatoire
31. La Recommandation devrait aider tous les acteurs du développement, du dans les usages thérapeutiques. Il serait utile de
déploiement et de l’utilisation des neurotechnologies à faire preuve de solidarité et à préciser davantage quels types d’utilisations peuvent
avoir les conséquences sociales mentionnées.
demander des comptes dans les cas où les neurotechnologies pourraient être utilisées à
mauvais escient et menacer les droits de l’homme.
32. La coopération internationale est essentielle pour répondre aux enjeux
transfrontaliers liés aux neurotechnologies. Une attention particulière doit être accordée
aux différences de points de vue quant à l’utilisation acceptable afin de prévenir les abus
et de respecter les normes éthiques mondiales.
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III.1.7 Durabilité
33. Le principe de durabilité exige que les neurotechnologies soient développées et
utilisées dans un profond respect de la bonne gestion de l’environnement, en s’attachant
avant tout à réduire au minimum les préjudices écologiques tout au long du cycle de vie
des matériaux utilisés, notamment pour l’extraction de minerais, le traitement et le
stockage des données, le recyclage et les pratiques d’élimination.
34. Le développement non réglementé des neurotechnologies, notamment à des fins
non médicales, pourrait entraîner une consommation disproportionnée de ressources et
d’énergie, ainsi que la production de déchets.
35. Le respect des droits des peuples autochtones, conformément à la Déclaration
des Nations Unies sur les droits des peuples autochtones, exige que les
neurotechnologies, tout au long de leur cycle de vie, soient guidées par un profond
respect des droits des peuples autochtones, en veillant à ce que leurs terres (y compris Commenté [GdQ12]: Cette disposition pourrait être
pendant l’exploitation minière), leurs savoirs, leurs droits communautaires et la clarifiée, car il y a des éléments répétitifs (le respect des
droits des peuples autochtones à deux reprises).
protection de leur vie privée soient respectés dans le cadre de toutes les activités,
notamment celles qui relèvent de l’extraction des ressources.
III.1.8 Intégrité et responsabilité
36. L’intégrité exige de chaque acteur de l’ensemble du cycle de vie des
neurotechnologies qu’il agisse avec une constance éthique. Il s’agit notamment
d’adhérer à des principes directeurs éthiques et de veiller à ce que toutes les actions
soient conformes aux normes professionnelles et aux valeurs de la société.
Commenté [GdQ13]: Le gouvernement du Québec
37. L’intégrité suppose que l’on s’engage à assumer la responsabilité de ses actes et suggère que la Recommandation s’appuie d’abord sur
à rendre compte de leurs résultats. Il ne s’agit pas seulement de reconnaître les succès le cadre des droits de la personne et non sur les
principes éthiques fondamentaux. Les droits de la
mais aussi de prendre acte des erreurs et de prendre des mesures correctives si personne sont prépondérants sur les principes éthiques
nécessaire. fondamentaux et le cadre de la Recommandation visant
les neurotechnologies doit refléter cette prépondérance.
38. L’intégrité scientifique désigne l’engagement en faveur d’une quête rigoureuse de
la vérité selon des pratiques de recherche fondées sur les données factuelles, objectives Telle que formulée, la section III.2 laisse sous-entendre
que les droits de la personne sont secondaires au
et transparentes. Elle garantit que l’ensemble des activités scientifiques soient menées présent cadre. La phrase suivante l’illustre bien: « Elle
avec honnêteté, exactitude et dans le respect de la méthode scientifique des disciplines intègre en outre le respect, la promotion et la protection
relevant des neurotechnologies. des droits de l’homme.» (par. 39).
III.2 DROITS DE L’HOMME ET PRINCIPES ÉTHIQUES ET DROITS DE L’HOMME Lorsque des droits sont en jeu, ils doivent primer sur les
principes éthiques. On reconnait toutefois que les
39. La présente Recommandation adopte une approche centrée sur l’être humain principes éthiques fondamentaux peuvent jouer un
certain rôle dans l’interprétation des droits de la
reposant sur AJOUT : le respect, la promotion et la protection des droits de l’homme et personne. Ils ne peuvent toutefois pas primer sur les
ldes principes éthiques fondamentaux tels que l’autodétermination, la capacité d’action, droits établis et reconnus.
la liberté de pensée, le droit à la vie privée, la liberté cognitive, l’identité personnelle et
Au Québec, la Charte des droits et libertés de la
collective, la confiance, le respect, la réciprocité et la justice, entre autres. personne reconnait les droits sur lesquels s’appuient les
SUPPRIMER : Elle intègre en outre le respect, la promotion et la protection des droits de principes éthiques nommés dans la Recommandation,
l’homme. tels que le droit à l’intégrité, la liberté de conscience,
liberté d’opinion et d’expression, le droit au respect de
III.2.1 Principes de bénéficience, de proportionnalité et d’innocuité sa vie privée, les droits judiciaires et le droit à
l’information. En droit international, ces droits sont
également consacrés dans les différents traités et
40. Les neurotechnologies devraient promouvoir la santé et le bien-être, et donner aux instruments dont il est fait mention dans le préambule
individus les moyens de prendre des décisions éclairées concernant leur système de la présente Recommandation.
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nerveux et leur santé mentale, tout en favorisant une meilleure compréhension d’eux-
mêmes.
41. Les neurotechnologies devraient contribuer à l’épanouissement de l’être humain
sans lui faire subir de préjudice ou d’assujettissement physique, économique, social,
politique, culturel ou mental. Le principe d’innocuité (« ne pas nuire ») doit guider
l’ensemble du cycle de vie des neurotechnologies, assurant ainsi la protection et la
promotion de la qualité de vie.
42. L’adoption des neurotechnologies à des fins d’amélioration peut entraîner non
seulement des dommages inattendus du système nerveux, mais aussi un accroissement
des inégalités au sein de la société.
43. Toute restriction des droits de l’homme doit satisfaire à toutes les exigences
applicables en vertu du droit relatif aux droits de l’homme, notamment les principes de
légalité, d’objectif légitime, de nécessité et de proportionnalité.
44. Les principes de proportionnalité, d’équilibre et de légitimité devraient régir
l’utilisation des neurotechnologies et des données qu’elles permettent d’obtenir, afin de
veiller à ce que leur utilisation : (a) soit appropriée et proportionnelle à l’objectif et aux
bienfaits escomptés ; (b) ne porte pas atteinte aux valeurs fondamentales énoncées
dans le présent document ; (c) soit adaptée au contexte et au groupe d’utilisateurs cible
; (d) repose sur des principes de sécurité et des éléments de preuve scientifiques
rigoureux.
III.2.2 Autodétermination et liberté de pensée Commenté [GdQ14]: Cette section gagnerait à intégrer
une discussion de certains principes liés de près à
45. Tout au long de l’ensemble du cycle de vie des neurotechnologies, la protection l’autodétermination et à la liberté de pensée figurant
et la promotion des droits à la liberté de pensée et à l’autodétermination des personnes souvent sur les listes de soi-disant nouveaux
neurodroits qu’il faudrait incorporer aux outils existants
doivent être assurées. de droits humains, à savoir :
1)Un droit à la continuité psychologique protégeant
46. Les individus ont le droit de prendre des décisions libres, éclairées et volontaires contre des altérations par un tiers de l’activité
quant à leur participation à l’ensemble du cycle de vie des neurotechnologies, cérébrale qui résulteraient chez la personne les
conformément au droit international des droits de l’homme et à d’autres normes subissant en une transformation radicale de la
personnalité remettant en question sa capacité à
internationales, notamment le droit de refuser ou d’interrompre le recours aux faire l’expérience d’elle-même en tant qu’entité qui
neurotechnologies à tout moment, en veillant au respect de leur autonomie et de leur perdure à travers le temps;
capacité à prendre des décisions et, en cas de délégation du consentement, à ce que 2) un droit à l’intégrité mentale protégeant contre les
formes d’interférences externes empêchant une
l’intérêt supérieur de la personne concernée soit pris en compte. Les personnes qui personne de contrôler le fil de ses propres pensées;
participent à des recherches devraient être informées des effets secondaires potentiels 3) un droit à la liberté cognitive protégeant la capacité
et avoir la possibilité de signaler toute contre-indication aux procédures employées. Les des personnes à prendre des décisions éclairées
relatives à l’usage des neurotechnologies (que ce soit
procédures d’obtention du consentement éclairé devraient être explicites, dynamiques et pour des fins de thérapie ou d’amélioration).
exiger l’adhésion, tout en étant exhaustives et transparentes, en fournissant des
informations détaillées sur les fins, les risques, les bénéfices, les solutions de
remplacement et les effets possibles de la technologie dans tous ses domaines
d’application, et faire en sorte que les intéressés comprennent parfaitement les
incidences sur leur vie privée, leur autonomie et leur bien-être.
47. Les neurotechnologies ne devraient jamais être utilisées pour exercer une
influence ou une manipulation indue, que ce soit par la force, la coercition ou d’autres
moyens qui compromettent l’autodétermination et la liberté de pensée. Cette protection
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s’applique aussi bien à la réflexion intérieure qu’à son expression extérieure,
garantissant ainsi la liberté contre toute interférence.
III.2.3 Protection des données biométriques neurales et cognitives pour la vie
privée mentale
48. Les neurotechnologies et les technologies biométriques cognitives soulèvent des
questions relatives au droit à la vie privée en raison de leur capacité croissante à
collecter directement et indirectement des données sur le système nerveux, lesquelles
ont un caractère particulièrement sensible car elles peuvent être traitées et analysées
pour apporter un éclairage approfondi sur les processus qui sous-tendent nos états
mentaux et notre comportement, y compris la conscience de soi et l’introspection. Alors
qu’il devient de plus en plus difficile d’anonymiser les données, il subsiste des risques
persistants d’utilisation abusive de ces données, notamment par la révélation de
corrélats neurobiologiques de maladies, de troubles ou d’états mentaux généraux sans
l’autorisation de la personne auprès de laquelle les données ont été recueillies.
49. La protection de la vie privée mentale est fondamentale pour la protection de la
dignité humaine, de l’identité personnelle et de la capacité d’action. La collecte, le
traitement, la modification et le partage de données neurales doivent s’effectuer avec un
consentement libre et éclairé, dans le respect des principes relatifs à l’éthique et aux
droits de l’homme énoncés dans la présente Recommandation. Commenté [GdQ15]: Le rapport du CIB Aspects
éthiques des neurotechnologies de 2021 soulignait les
50. Il devrait exister des garanties claires contre l’utilisation abusive des données multiples difficultés à obtenir un consentement
biométriques neurales et cognitives ou l’accès non autorisé à celles-ci, notamment le véritablement libre et éclairé pour la collecte de
données neurales. Il proposait, en conséquence, de
consentement exprès, la minimisation des données et la spécification des finalités, les protéger ces données par des mécanismes plus serrés,
droits sur les données (tels que les droits d’accès, de rectification et d’effacement) et la comme le refus par défaut, tel qu’on le fait dans certains
sécurité des données, en particulier dans les contextes où ces données peuvent être endroits pour les organes et tissus (p. 52). Cette
approche plus restrictive avait pour avantage de
agrégées avec d’autres sources. pleinement reconnaître le caractère particulièrement
sensible des données neuronales. L’idée d’une
III.2.4 Non-discrimination et inclusion protection plus forte pour ces données semble
beaucoup moins présente dans ce projet de texte.
51. Tous les acteurs intervenant dans l’ensemble du cycle de vie des
neurotechnologies, en particulier dans leur interface avec d’autres technologies comme
l’intelligence artificielle (IA), doivent s’engager à défendre des principes éthiques qui
empêchent la discrimination, la stigmatisation, la prise pour cible ou l’exploitation de tout
individu ou groupe, en particulier ceux qui se trouvent dans des situations de
vulnérabilité.
52. Il existe une responsabilité partagée de veiller à ce que ces technologies ne
perpétuent ni n’amplifient les inégalités existantes, ou ne créent pas de nouvelles formes
de discrimination fondées sur des caractéristiques neurologiques ou mentales, ou sur
d’autres motifs protégés par le droit relatif aux droits de l’homme.
53. Un développement technologique et un travail de normalisation non inclusifs
peuvent entraîner une tendance à l’homogénéisation ainsi que la prédominance de la
neurotypie et des capacités qui pourraient menacer l’identité culturelle et collective.
54. Pour gagner la confiance et susciter l’adhésion des communautés dans
l’ensemble du cycle de vie des neurotechnologies, il faut nouer un dialogue transparent
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avec le public, en sollicitant son avis et sa validation afin que ces technologies soient en
adéquation avec les valeurs sociétales et le bien commun.
55. La discrimination, quel qu’en soit le motif, y compris les différences intellectuelles
ou liées à l’atypisme, doit être condamnée. Les neurotechnologies ne devraient pas
servir à étayer, justifier ou réifier de telles discriminations. Il convient d’évaluer avec soin
les solutions neurotechnologiques promues par les pouvoirs publics pour des services
essentiels tels que l’éducation. Commenté [GdQ16]: Le document gagnerait en
cohésion à mentionner plus directement la valeur du
56. Les neurotechnologies ne devraient pas être utilisées pour perpétuer les respect de la neurodiversité dans ce passage.
stéréotypes, la stigmatisation ou la discrimination à l’égard des personnes âgées.
III.2.5 Responsabilité
57. Le maintien de la confiance et de l’intégrité tout au long de l’ensemble du cycle
de vie des neurotechnologies exige que tous les acteurs adhèrent aux normes éthiques
les plus élevées, restent ouverts au retour d’informations, s’engagent à ajuster leurs
pratiques face à des preuves ou à des préoccupations éthiques nouvelles, et soient
tenus responsables de leurs actions.
58. L’obligation redditionnelle repose sur la responsabilité, une communication claire
et transparente, et le devoir d’anticiper et de prendre en compte les dommages
potentiels, qu’ils soient à court terme, à long terme ou qu’ils résultent d’une utilisation ou
d’une conséquence imprévue.
59. L’engagement en matière d’obligation redditionnelle exige une action mondiale,
gouvernementale, sociétale et collective pour faire en sorte que les personnes
auxquelles les neurotechnologies ont porté préjudice aient accès à la justice et que les
auteurs d’actes répréhensibles soient tenus de prendre des mesures concrètes pour
identifier, prévenir et atténuer les effets négatifs de leurs actions sur les droits de
l’homme, ainsi que pour rendre compte de la manière dont ils y répondent et y
remédient, y compris par des mesures correctives et des réparations.
III.2.6 Confiance et transparence
60. Afin de garantir le respect, la promotion et la protection des droits de l’homme et
des libertés fondamentales, tous les acteurs de l’ensemble du cycle de vie des
neurotechnologies doivent veiller à ce que leurs activités soient transparentes, fondées
sur des preuves scientifiques et en adéquation avec les principes internationaux de
conduite responsable et d’intégrité scientifique. Il s’agit notamment d’empêcher la
reproduction ou l’amplification des préjugés, ainsi que de faire en sorte que les
neurotechnologies soient traçables et explicables, que leur potentiel et leurs limites
soient présentés avec exactitude, que les conditions en matière d’obligation
redditionnelle soient clairement définies et que les principes éthiques en matière de
recherche et de développement soient respectés, notamment en ce qui concerne
l’enregistrement des essais, la sélection équitable des participants et l’approbation par
des comités d’éthique indépendants.
III.2.7 Justice épistémique, participation inclusive et autonomisation du public
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61. Il convient d’assurer la création et la diffusion justes et équitables de savoirs sur
les neurotechnologies, notamment en reconnaissant divers modes de connaissance, et
de faire en sorte que tous les individus et toutes les communautés puissent participer à
leur création, à leur partage et à leurs applications.
62. Il convient de promouvoir une éducation ouverte et accessible, ainsi que la
participation du public et de la communauté, afin que diverses populations puissent
acquérir et échanger des connaissances sur le fonctionnement du système nerveux, la
santé mentale, les applications médicales et non médicales des neurotechnologies et
les outils correspondants.
63. Une participation efficace du public et de la communauté tout au long de
l’ensemble du cycle de vie des neurotechnologies exige le respect de la diversité,
notamment linguistique, sociale, culturelle, patrimoniale et identitaire, afin de respecter
les différents modes de connaissance et de compréhension. Ce respect de la diversité Commenté [GdQ17]: Proposition d’ajout: la diversité
permet de faire en sorte que les savoirs et les points de vue de diverses communautés neurologique
soient valorisés et pris en compte dans les processus décisionnels, dans le respect de
l’autodétermination.
64. Une éducation ancrée dans les droits de l’homme permet de veiller à ce que les
savoirs créés et partagés respectent les droits de tous les individus, évitant ainsi une
injustice épistémique qui ferait que certains groupes seraient marginalisés ou exclus de
la production et de la diffusion de connaissances.
65. Toutes les communautés devraient pouvoir faire entendre leur voix pour les
décisions qui les concernent, en particulier lorsqu’il s’agit du développement et de
l’utilisation des neurotechnologies.
III.2.8 Intérêt supérieur de l’enfant et protection des générations futures
66. Le système nerveux évolue rapidement au cours de l’enfance, puis de manière
décisive lors de l’adolescence. Il est donc essentiel de préserver la vie privée,
l’autodétermination et le droit des enfants et des adolescents à prendre part aux
décisions qui les concernent. Les technologies doivent faire l’objet d’une évaluation
rigoureuse pour s’assurer qu’elles servent l’intérêt supérieur, le bien-être et le
développement sain des enfants, à mesure qu’ils deviennent des individus autonomes,
et qu’elles protègent les droits des générations futures en veillant à ce que les décisions
prises aujourd’hui favorisent leur bien-être à l’avenir.
67. D’un point de vue éthique, même s’il faut reconnaître que les neurotechnologies
présentent des avantages potentiels pour le diagnostic précoce, l’instruction, l’éducation
et l’apprentissage continu, il est tout aussi important d’être attaché au développement
global de l’enfant. Il s’agit notamment de stimuler leur vie sociale, d’encourager les
relations enrichissantes et de promouvoir un mode de vie sain englobant la nutrition et
l’activité physique.
III.2.9 Justice mondiale et sociale, et jouissance des bienfaits du progrès
scientifique et de ses applications
68. L’accès à la recherche et au développement dans le domaine des
neurotechnologies et les bienfaits qui en découlent doivent être équitablement partagés
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entre tous ceux qui y contribuent, en veillant tout particulièrement à assurer une
répartition mondiale qui favorise l’équité et réduise les disparités.
69. Les progrès des neurotechnologies devraient être mis à profit pour réduire les
inégalités en matière de santé dans le monde. Ces technologies devraient jouer un rôle
moteur pour l’amélioration de la qualité de vie, en particulier dans les contextes où les
ressources sont limitées.
70. La recherche, le développement et les essais dans le domaine des
neurotechnologies doivent respecter les normes éthiques les plus élevées et garantir la
participation sans exploitation de toutes les personnes concernées. Il s’agit notamment
de protéger les droits et le bien-être des participants, des patients et des personnes qui
en ont la charge, ainsi que de veiller à la collecte et à l’utilisation éthiques des données.
Il convient de veiller tout particulièrement à ce que ceux qui contribuent à la recherche et
au développement bénéficient d’une part équitable des bienfaits et n’aient pas à en
supporter les risques de façon disproportionnée.
71. Il conviendrait également de s’efforcer, notamment par la coopération
internationale, de pallier l’absence des infrastructures, formations et compétences
technologiques ou médicales ainsi que des cadres juridiques nécessaires dont souffrent
certaines communautés, en particulier dans les PRITI, les PMA, les PDSL et les PEID,
mais jamais d’en profiter.
72. Le développement de nouvelles neurotechnologies et l’évaluation de leur impact
devraient prendre en considération la mise en œuvre de paradigmes centrés sur
l’humain, dans lesquels les utilisateurs finaux ne sont pas simplement les destinataires
passifs de ces technologies, mais contribuent activement à les façonner, sur un pied
d’égalité.
IV. DOMAINES D’ACTION STRATÉGIQUE
IV.1 INVESTISSEMENT, UTILISATION ET RÉGLEMENTATION PUBLICS
73. Les États membres, les acteurs privés et les institutions internationales devraient
soutenir activement la recherche sur les neurotechnologies, ainsi que leur
développement et leur déploiement dans l’intérêt du public. Les investissements
devraient porter en priorité sur les applications qui favorisent l’épanouissement humain
et dont l’utilisation respecte, favorise et protège les droits de l’homme individuels et
collectifs. Cet engagement devrait inclure le financement de travaux de recherche
interdisciplinaire visant non seulement à faire progresser l’innovation
neurotechnologique, mais également à étudier les implications éthiques, juridiques,
sociales, environnementales et culturelles de ces technologies et à soutenir la mise en
œuvre et l’application clinique de prototypes technologiques. Une attention particulière
devrait être accordée à l’élaboration et à la mise en œuvre de garanties adéquates sur
les plans technique, institutionnel, procédural et autres, afin de s’assurer que la société
en bénéficie de manière équitable et que les droits de l’homme sont respectés.
74. Les États membres devraient établir des interdictions claires contre l’utilisation
des neurotechnologies dans les contextes où les droits de l’homme individuels et
collectifs sont bafoués. Les États membres devraient faire preuve de diligence
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raisonnable en matière de droits humains, notamment en procédant régulièrement à des
études approfondies de l’impact sur les droits humains des neurotechnologies qu’ils
développent, conçoivent, mettent en place, utilisent, vendent, exploitent ou achètent,
afin de prévenir et d’atténuer leurs incidences négatives sur les droits humains. Plus
précisément, les neurotechnologies ne devraient pas être utilisées à des fins telles que
les interrogatoires non consensuels par les forces de l’ordre et dans le cadre de la
justice pénale ou civile, la mise au point ou le déploiement d’armes attaquant le système Commenté [GdQ18]: Il serait éclairant de faire un
nerveux, le contrôle social, les tentatives de modification forcée des comportements en paragraphe entier, voire une sous-section entière, sur
les risques liés à l’utilisation des neurotechnologies
fonction des croyances ou des opinions personnelles, des opinions politiques ou autres, comme moyen de preuve lors des procès, civils et
de l’identité de genre ou de l’orientation sexuelle, ou la surveillance des états mentaux, criminels. Les usages de ces technologies vont au-delà
entre autres. Les gouvernements devraient adopter des législations garantissant que les d’interrogatoires forcés ou de collecte de données
neurales pour connaître l’état mental d’un témoin ou
neurotechnologies sont déployées de manière responsable et fondée sur les droits de
d’une partie mise en accusation (pour savoir si elle
l’homme, et assorties de mécanismes de surveillance solides pour faire respecter ces ment ou dit la vérité). Des preuves basées sur des
restrictions et protéger la vie privée mentale et la liberté de pensée de tous les individus. expertises en neurosciences peuvent aussi consister à
Ces politiques devraient être élaborées en consultation avec divers acteurs, notamment prédire le comportement futur des accusés (pour
évaluer les chances de récidives), pour questionner la
la société civile, les utilisateurs finaux, les experts en neurotechnologie, les mens rea (un accusé était-il libre et en pleine
déontologues et les défenseurs des droits de l’homme, afin de garantir un large possession de ses moyens lorsqu’il a commis l’action
consensus ainsi que le respect des normes internationales en matière de droits de faisant l’objet d’une poursuite?), pour dresser le profil
de certains accusés ou introduire des éléments liés aux
l’homme. caractéristiques de groupes de personnes (impulsivité
et instabilité émotionnelle chez les adolescents, par
75. Les États membres devraient garantir la transparence et l’obligation exemple), etc.
redditionnelle dans le soutien qu’ils apportent, le contrôle qu’ils exercent et la
réglementation qu’ils établissent en matière de neurotechnologies, notamment en ce qui
concerne les initiatives bénéficiant de fonds publics telles que les programmes de
recherche-développement sur le cerveau. Tout en restreignant la divulgation de
certaines informations sensibles, les gouvernements devraient imposer aux projets de
neurotechnologie subventionnés par l’État de rendre publics les objectifs, les méthodes,
les finalités et les incidences sur la société de leurs initiatives en matière de
neurotechnologies, lorsque cela est possible. Une telle transparence est essentielle pour
renforcer la confiance du public et garantir que les progrès des neurotechnologies soient
conformes aux normes éthiques et aux droits de l’homme.
76. Les États membres devraient adopter une approche globale concernant les
mesures réglementaires et stratégiques visant à protéger des atteintes aux droits de
l’homme liées aux neurotechnologies élaborées, commercialisées, exploitées ou
utilisées par le secteur privé. Il s’agit notamment des mesures législatives et Commenté [GdQ19]: Plus précisément, cela implique-
réglementaires ainsi que des orientations, des incitations et des exigences de t-il d’élaborer des protocoles de certification et des
normes iso pour les produits commerciaux découlant
transparence dont elles sont assorties. Cette approche globale devrait également exiger des neurotechnologies?
de faire preuve de diligence raisonnable en matière de droits de l’homme, pour faire en
sorte que les entreprises identifient, préviennent et atténuent les effets néfastes de leurs
activités sur les droits de l’homme et qu’elles en rendent compte, dans le cadre de
processus adaptés au contexte, notamment des études d’impact sur les droits de
l’homme, une participation significative du public et de la communauté, et des
communications transparentes.
77. Les États membres devraient veiller à ce que toute utilisation des
neurotechnologies dans le système judiciaire, notamment leur examen par le pouvoir
judiciaire, repose sur des preuves scientifiques solides, soit mise en œuvre dans le
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respect de l’éthique et des droits de l’homme, et vise à promouvoir la sécurité publique
tout en protégeant les droits et la dignité de toutes les personnes concernées. Cela
exige le respect des droits fondamentaux, tels que la dignité humaine, l’intégrité
corporelle, la confidentialité des données personnelles, le droit à un procès équitable et
à une procédure régulière, notamment la présomption d’innocence, le droit de ne pas
contribuer à sa propre incrimination, ainsi que le droit de ne pas être soumis à la torture
ou à de mauvais traitements, le droit au respect de la vie privée et le droit à la liberté de
pensée.
78. Les États membres devraient mettre en place un cadre complet de mesures
d’incitation, telles que des incitations fiscales, des subventions et des prix, en s’attachant
particulièrement à encourager la constitution et le développement des capacités en
matière de fabrication, de ressources informatiques et d’analyse des données au sein
des établissements de recherche et des petites et moyennes entreprises (PME). Les
États membres devraient également encourager et soutenir les partenariats qui mettent
à profit les ressources informatiques et les capacités d’analyse de données des
entreprises privées pour faire avancer les objectifs de la recherche publique. Ces
mesures d’incitation devraient viser en priorité à récompenser la transparence, les
processus de développement participatifs et les contributions aux avantages sociétaux,
afin de favoriser un environnement dans lequel les institutions publiques et les
entreprises innovent de manière responsable et en adéquation avec les objectifs
d’épanouissement humain.
79. Les États membres devraient établir une approche coordonnée et intersectorielle
pour évaluer les effets des neurotechnologies tout au long de leur cycle de vie. Cette
approche devrait comporter, sans s’y limiter :
(a) des études d’impact économique : menées par les instances nationales
compétentes chargées des politiques relatives à l’économie et à l’emploi
afin de mesurer l’impact des neurotechnologies sur la croissance
économique, les emplois, la justice sociale et la durabilité
environnementale ;
(b) des évaluations du rapport bénéfices-risques : gérées par les entités
responsables de la santé publique, de la recherche médicale et de la
protection du consommateur, ces évaluations devraient permettre de
mesurer rigoureusement les bénéfices et les risques associés au
développement, au déploiement et à l’utilisation des neurotechnologies,
notamment en ce qui concerne la recherche, les applications cliniques et
les produits de consommation. Ce processus devrait être solidement
étayé et prévoir une surveillance éthique et un suivi constant pour garantir
la sécurité, le bien-être et le traitement équitable de toutes les personnes
concernées ;
(c) des études d’impact sur la vie privée : sous la supervision des autorités
nationales compétentes ou des organismes chargés de la protection des
données et de la vie privée, ces études devraient évaluer et atténuer les
risques que les neurotechnologies font peser sur la vie privée mentale
des individus. Il s’agit notamment de veiller à la mise en place de
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garanties appropriées pour protéger les données biométriques neurales
et cognitives conformément aux normes nationales et internationales en
matière de vie privée, ainsi qu’aux pratiques en matière de politique des
données mentionnées dans le présent document ;
(d) des études d’impact sur les droits de l’homme : sous la supervision des
institutions nationales et des organisations internationales de défense des
droits de l’homme, ces études visent à recenser les effets potentiels des
neurotechnologies sur les droits de l’homme, à les prévenir et à y
remédier. Le processus devrait garantir que les neurotechnologies
respectent et défendent les droits de l’homme, en prêtant une attention
particulière aux personnes vulnérables et aux personnes en situation de
vulnérabilité. Les études d’impact sur les droits de l’homme devraient
prévoir la participation significative du public et de la communauté afin de
prendre en compte différents points de vue.
80. Les États membres devraient promouvoir un accès équitable aux
neurotechnologies dans le monde entier. Pour y parvenir, des efforts devraient être
déployés pour soutenir la réduction du coût total pour l’utilisateur final, poursuivre le
développement et l’adoption de solutions logicielles non propriétaires tout en leur
apportant un soutien constant, et étudier les stratégies de remboursement et les
possibilités de subventions à la hauteur de ce que prévoient les conventions dans les
juridictions locales, dans les secteurs où les avantages potentiels sont cruciaux.
81. Les États membres devraient adopter des cadres réglementaires agiles,
prévoyant notamment l’utilisation de « bacs à sable » réglementaires – des
environnements contrôlés permettant de développer, de mettre à l’essai et d’évaluer les
neurotechnologies – pour faire face aux progrès rapides des neurotechnologies et à leur
convergence avec d’autres technologies telles que l’IA, l’informatique spatiale et les
technologies immersives. Ces bacs à sable devraient être utilisés afin d’explorer des
applications novatrices, en particulier dans le cadre du lieu de travail, sous la
surveillance éthique appropriée des organismes réglementaires ou des autorités
nationales. Ces cadres devraient faciliter l’innovation, garantir un traitement éthique des
données et protéger les droits en prévoyant des mécanismes qui permettent de
procéder régulièrement au suivi, à l’évaluation et à des ajustements stratégiques
dynamiques en fonction des évolutions technologiques et éthiques.
IV.2 POLITIQUES EN MATIÈRE DE DONNÉES
82. Les États membres devraient élaborer un cadre juridique et réglementaire solide
pour régir la collecte, le traitement, le partage et toute autre utilisation des données
biométriques neurales et cognitives. Un tel cadre et ceux déjà en place devraient
considérer que ces données revêtent un caractère à la fois personnel et sensible dans
les contextes médicaux et non médicaux. Commenté [GdQ20]: Et un tel cadre devrait considérer
qu’en vertu de ce caractère sensible, les données
83. Les États membres devraient veiller à ce que leurs politiques en vigueur en neurales devraient bénéficier de protections
matière de protection de la vie privée prévoient systématiquement des garanties strictes particulièrement rigoureuses.
concernant les données biométriques neurales et cognitives des individus. Si les
politiques en vigueur ne répondent pas de manière adéquate à ces préoccupations, les
États membres devraient adopter une législation ou des cadres réglementaires ciblés
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pour garantir de telles protections. Les garanties en question devraient par exemple
comprendre le consentement éclairé exprès, la minimisation des données et la limitation
des finalités, les droits en matière de données (y compris le droit de consulter, de
corriger et de supprimer des données), et des mesures strictes de sécurité en matière
de données, comme des protocoles avancés de cybersécurité permettant de prévenir
les accès non autorisés et les violations de données. Cette législation ou ces cadres
devraient interdire la pratique consistant à conditionner l’accès à des biens ou services à
la divulgation de données biométriques neurales ou cognitives, exiger un consentement
explicite pour tout partage de données et interdire l’utilisation de ces données à des fins
de publicité ciblée sans le consentement explicite, exprès et éclairé de l’intéressé.
84. Les États membres devraient élaborer et mettre en œuvre des politiques visant à Commenté [GdQ21]: Des politiques de sobriété
réduire l’empreinte écologique des neurotechnologies, notamment en ce qui concerne énergétique
les centres de données et les ressources informatiques de grande envergure utilisées
pour traiter et stocker les données biométriques neurales et cognitives. Ces politiques
devraient mettre l’accent sur la minimisation des données, en veillant à ce que seule la
quantité nécessaire de données soit collectée et traitée, et encourager une utilisation
proportionnelle des neurotechnologies, en les déployant selon les besoins réels et en
réduisant le plus possible l’impact environnemental inutile. Les mesures devraient
notamment porter sur l’optimisation de l’efficacité énergétique, le recours aux sources
d’énergie renouvelables, la promotion du recyclage et l’élimination durable de
l’équipement relatif aux neurotechnologies, et la réhabilitation des environnements
dégradés.
85. Les États membres devraient soutenir et encourager le développement et la mise
en œuvre des innovations technologiques et des normes de conception relatives aux
neurotechnologies qui placent la protection de la vie privée mentale parmi les priorités,
telles que le cryptage de pointe, les bases de données sécurisées par une
authentification multifactorielle, les techniques les plus avancées en matière
d’anonymisation et le traitement et la conservation en périphérie (traitement et
conservation des données au plus près du lieu où elles ont été produites), conduisant à
des résultats plus concrets concernant le stockage en temps réel des données
biométriques neurales et cognitives.
86. Les États membres devraient inciter les fabricants de neurotechnologies à
accorder une attention prioritaire au respect de la vie privée et à l’éthique dès la
conception, en exigeant que des technologies de protection de la vie privée soient
intégrées par défaut dans leurs dispositifs.
87. Les États membres devraient encourager le partage éthique des données en
mettant en place des entrepôts de données sécurisés pour les données biométriques
neurales et cognitives utilisées dans la recherche. Ces entrepôts devraient satisfaire à
des normes strictes en matière de cybersécurité, de confidentialité des données et
d’utilisation éthique (dont la minimisation des données et la limitation des finalités), et
prévoir un accès différencié et d’autres approches du renforcement de la protection de la
vie privée. Des mécanismes de financement appropriés devraient être mis en place pour
la sélection et la gestion des données tandis que les processus de gouvernance de
données devraient être simplifiés.
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88. Les États membres devraient consacrer en priorité leurs efforts à atténuer les
obstacles au partage des données entre pays dans la recherche en neurotechnologie,
grâce à une plus grande harmonisation des normes de protection des données, en
particulier en matière de données biométriques neurales et cognitives, en établissant
des protocoles clairs de transfert de données pour garantir des échanges de données
sûrs et conformes entre pays, ainsi que des normes d’interopérabilité des données, y
compris des cadres de gouvernance concernant le partage de données.
89. Les États membres devraient envisager d’adopter des lignes directrices
spécifiques pour l’utilisation éthique des données biométriques neurales et cognitives
dans le développement et la recherche en matière d’IA, notamment des procédures de
consentement concernant l’utilisation des données biométriques neurales et cognitives
en vue d’entraîner et d’appliquer les modèles d’IA, en garantissant la transparence et en
respectant les droits individuels et collectifs.
IV.3 PROPRIÉTÉ INTELLECTUELLE
90. Les États membres devraient adopter des politiques garantissant que les
données biométriques neurales et cognitives, en tant que dérivés de l’activité humaine
individuelle, ne sont pas soumises à des droits de propriété. La protection de la propriété
intellectuelle ne devrait s’appliquer qu’aux compilations de données originales (créées
par un processus d’agrégation, d’organisation ou de sélection, aboutissant à un nouvel
ensemble de données) qui répondent à des critères stricts en matière d’éthique.
91. Les États membres devraient élaborer conjointement des lignes directrices
claires et harmonisées en ce qui concerne les droits de propriété intellectuelle
applicables aux neurotechnologies SUPPRIMER : à l’échelle internationale. Ces lignes
directrices devraient porter sur la brevetabilité des inventions générées par l’intelligence Commenté [GdQ22]: Cependant, afin de pallier aux
artificielle ainsi que sur les implications éthiques des lois en matière de propriété craintes d’une marchandisation ou commercialisation
du vivant en cette matière, le maintien de l’exclusion du
intellectuelle, en veillant à ce que celles-ci favorisent l’accessibilité et l’innovation au principe de non-brevetabilité du corps humain devrait
niveau mondial. constituer une garantie essentielle face à un possible
élargissement du champ de la brevetabilité des
92. Les États membres devraient veiller à ce que l’ensemble des acteurs adoptent inventions contraire à la dignité de la personne, à l’ordre
des stratégies de gestion de la propriété intellectuelle qui encouragent l’innovation et public et à la morale. Il s’agira donc pour les États de
s’interroger sur les voies de protection offertes par les
évitent une utilisation trop restrictive des brevets, favorisant ainsi un écosystème droits de la propriété intellectuelle pour assurer ce
d’innovation ouvert. Cette approche devrait s’adapter en permanence à l’évolution du compromis.
paysage des neurotechnologies. L’impact des politiques en matière de propriété
intellectuelle sur le secteur des neurotechnologies devrait faire l’objet d’un suivi continu
afin de s’assurer que ces politiques stimulent l’innovation tout en garantissant une
utilisation éthique et une large accessibilité.
93. Les États membres devraient favoriser un environnement de co-création dans le
domaine des neurotechnologies, en proposant des politiques et des incitations qui
facilitent la copropriété et les accords de licence préférentiels afin de garantir une
rémunération et une reconnaissance équitables pour tous les contributeurs.
94. Les États membres devraient adopter des politiques de science ouverte
permettant de concilier la protection de la propriété intellectuelle et l’incitation à la
publication immédiate des résultats et au partage des données. Il est essentiel de
trouver cet équilibre, compte tenu en particulier de la convergence des technologies
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numériques et de la concentration croissante de ces innovations dans les secteurs
industriels, afin de garantir que les mécanismes de protection de la propriété
intellectuelle n’entravent pas la recherche scientifique, l’innovation et la large diffusion
des connaissances et des nouvelles technologies. Suivant le principe de base d’un
partenariat équitable, les processus de science ouverte et la stratégie de gestion de la
propriété intellectuelle devraient être élaborés dès le départ en collaboration avec les
peuples autochtones associés aux activités de recherche et de développement en
neurotechnologie.
IV.4 CYBERSÉCURITÉ
95. Les États membres devraient collaborer à l’échelle internationale pour établir des
normes de cybersécurité détaillées pour tous les domaines neurotechnologiques. Ces
normes devraient englober des mesures de sécurité du matériel, des logiciels et des
données afin de se prémunir contre les cybermenaces potentielles. En mettant en
oeuvre des normes de cybersécurité uniformes, les États membres devraient garantir
l’intégrité, la confidentialité, la sécurité et la disponibilité des données neurales, et
renforcer la confiance des utilisateurs dans les dispositifs neurotechnologiques. En
outre, ces normes devraient évoluer en même temps que les progrès technologiques et
les nouvelles cybermenaces afin de maintenir une protection solide contre des risques
en constante évolution.
96. Les États membres devraient recourir à des exercices de « red-teaming »
(méthode dite de l’équipe rouge : des défis posés par une équipe adverse chargée de
mettre à l’épreuve l’efficacité des systèmes de sécurité) comme mesure proactive pour
évaluer et renforcer la sûreté, la sécurité et la résilience des systèmes
neurotechnologiques. En organisant régulièrement des exercices de « red-teaming »,
les États membres devraient identifier et combler de manière proactive les lacunes en
matière de sécurité, mettre à l’essai les procédures de réponse aux incidents et
renforcer la posture globale de sûreté et de cybersécurité des dispositifs
neurotechnologiques.
IV.5 COMMUNICATION, PARTICIPATION ET INFORMATION
97. Les États membres devraient promouvoir la communication et élaborer des
politiques de mobilisation en faveur des neurotechnologies qui encouragent un dialogue
éclairé, inclusif et respectueux entre les chercheurs, les développeurs, différents
utilisateurs et le grand public pour respecter les droits individuels et collectifs,
promouvoir la confiance du public et tirer parti de l’intelligence collective et de la
diversité des communautés.
98. Les États membres devraient collaborer avec des organisations internationales,
des établissements d’enseignement et des organismes privés et non gouvernementaux,
afin d’élaborer et de diffuser des matériels pédagogiques accessibles, attrayants et
adaptés à divers publics, afin de combler les lacunes en matière de connaissances, en
particulier dans les régions défavorisées, en ce qui concerne le fonctionnement du
système nerveux et de la santé mentale, ainsi que les bénéfices et les risques des
neurotechnologies. Ces programmes devraient viser à mieux faire comprendre au public
les fonctionnalités, la sécurité, l’efficacité et l’impact sociétal des technologies, afin de
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permettre aux individus de prendre des décisions éclairées et de mener une réflexion
éthique quant à leur utilisation.
99. Les États membres devraient mettre en place des processus de participation du
public et de la communauté qui facilitent un véritable apprentissage mutuel ainsi que la
collaboration tout au long du cycle de vie des neurotechnologies. Ces processus
devraient prévoir des consultations régulières et inclusives auprès d’un large éventail
d’acteurs. Leurs contributions devraient avoir pour objectif d’éclairer l’élaboration des
politiques, d’orienter les principes directeurs éthiques, d’accroître la sensibilisation et la
compréhension du public, d’harmoniser les priorités en matière d’investissement et de
faire en sorte que le déploiement des neurotechnologies coïncide avec les intérêts et les
valeurs du public. Il conviendrait de veiller tout particulièrement à associer les groupes
traditionnellement sous-représentés dans la formulation des politiques technologiques,
en encourageant ainsi l’innovation responsable dans le domaine.
100. Les États membres devraient élaborer conjointement un langage et une
terminologie exacts, précis et accessibles pour parler des neurotechnologies, en faisant
participer des acteurs de divers horizons, afin de garantir que le langage utilisé est
inclusif et non stigmatisant et qu’il reflète fidèlement les capacités et les limites des
technologies. Les États membres devraient mettre en place des cadres réglementaires
qui imposent des normes de communication claires et éthiques en matière de
neurotechnologies. Ces cadres devraient exiger que la présentation des possibilités, des Commenté [GdQ23]: Exiger un étiquetage des produits
risques et des limites soit fondée sur des données factuelles pour l’ensemble des qui contiennent des mises en garde claires relatives aux
possibilités, aux risques.
applications, afin d’éviter l’exagération des assertions, notamment pour ce qui est des
applications dans le domaine du sommeil, de l’attention, de la mémoire et de la
régulation émotionnelle. Ces cadres devraient comporter des lignes directrices
spécifiques pour une commercialisation éthique ainsi que des protocoles garantissant
une communication responsable concernant les recherches à un stade précoce et les
nouvelles technologies.
101. Les États membres devraient élaborer des politiques encourageant une
collaboration efficace entre les utilisateurs finaux, les chercheurs et les innovateurs tout
au long du cycle de vie du développement des produits de neurotechnologie, en
accordant une attention particulière aux lieux dans lesquels les neurotechnologies sont
développées. Ces politiques devraient imposer la création de groupes consultatifs
divers, composés de représentants de groupes d’utilisateurs variés et respectant la
neurodiversité. Les États membres devraient également mettre en place des plates-
formes permettant d’assurer un dialogue et un retour d’informations continus. Les
groupes consultatifs devraient être associés au processus d’élaboration et de mise à
l’essai des nouveaux produits technologiques afin d’optimiser l’efficacité, la facilité
d’utilisation, la longévité et la durabilité des dispositifs. Cette approche collaborative vise
à garantir que les innovations neurotechnologiques sont compatibles avec le contexte et
répondent aux besoins des différentes populations d’utilisateurs.
102. Les États membres devraient mettre en place un enseignement relatif aux
neurotechnologies qui soit adapté à l’âge, au contexte, à la culture et à la langue. Cet
enseignement pourrait comprendre des modules de formation afin de faciliter l’utilisation
de ces technologies à domicile, à l’intention des utilisateurs, ainsi que des personnes qui
en ont la charge et des membres de leur famille.
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PRISE EN COMPTE DES UTILISATEURS SPÉCIFIQUES
IV.6 ENFANTS ET ADOLESCENTS
103. Les États membres devraient favoriser un développement cérébral sain au
moyen de politiques évaluant les effets des neurotechnologies sur les enfants et les
adolescents.
104. Les États membres devraient protéger les enfants et les adolescents contre toute
action visant implicitement ou explicitement à les contraindre à recourir à des
neurotechnologies. Les États membres devraient être attentifs à l’autonomie des enfants
et des adolescents en veillant à l’obtention de leur consentement éclairé et de leur
assentiment d’une manière qui soit adaptée à leur âge et à leurs capacités de prise de
décisions, et respectueuse à cet égard.
105. Les États membres devraient financer des subventions pour la recherche-
développement portant sur la création de neurotechnologies d’assistance faciles à
utiliser et adaptées aux enfants et adolescents en situation de handicap. Ces projets
devraient associer les enfants, les adolescents, les personnes qui en ont la
responsabilité et les parents au processus de conception pour faire en sorte que ces
technologies répondent à leurs besoins spécifiques. Des programmes éducatifs
devraient être mis au point pour apprendre aux enfants, aux adolescents et à ceux qui
en ont la responsabilité à utiliser et à entretenir efficacement ces technologies, en
proposant une aide dans différentes langues et dans des formats accessibles, sans
discrimination à l’égard de ceux qui ne peuvent pas recourir à la technologie proposée
ou qui choisissent de ne pas le faire.
106. Les États membres devraient veiller à ce que l’ensemble des recherches en
neurotechnologie faisant participer des enfants et des adolescents fassent l’objet d’une
surveillance stricte et d’un suivi étroit. Il est primordial qu’une telle surveillance soit
assurée au cours des phases de développement de l’enfant afin de faire face à tout effet
à long terme imprévu et de l’atténuer. Ces recherches doivent être assorties de
protocoles de suivi complet et d’évaluations périodiques afin de garantir la sécurité et le
bien-être constants des jeunes participants, en tenant compte du caractère particulier de
leurs besoins en matière de développement et de leurs vulnérabilités. Dans le cadre des
recherches faisant participer des enfants et des adolescents en situation de vulnérabilité
sur le plan médical (par exemple, les enfants placés dans des unités de surveillance de
l’épilepsie), une attention particulière sera accordée au consentement et à l’assentiment,
compte tenu notamment de certains aspects de la recherche (temps, répétitions) afin de
prévenir toute forme d’instrumentalisation.
107. Les États membres devraient adopter des réglementations spécifiques pour
interdire l’utilisation de techniques de marketing – comme le neuromarketing, l’analyse
biométrique des émotions, la publicité immersive et la publicité en réalité virtuelle ou
augmentée – qui reposent sur des données biométriques neurales et cognitives à
caractère sensible collectées auprès d’enfants et d’adolescents. Compte tenu de la plus
grande vulnérabilité des enfants et des adolescents dans les environnements
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numériques, ces réglementations doivent expressément interdire toute pratique utilisant
ces données pour influencer ou exploiter les enfants et les adolescents. Commenté [GdQ24]: Et interdire toute pratique visant
à créer des dépendances chez les enfants et les
IV.7 PERSONNES ÂGÉES adolescents (particulièrement pertinent pour le
neurogaming).
108. Les États membres devraient favoriser un vieillissement en bonne santé et
soutenir les personnes âgées en finançant et en mettant en œuvre des programmes
fondés sur des données factuelles qui intègrent les neurotechnologies dans les soins
courants. Ces programmes devraient impliquer l’ensemble de l’écosystème de soutien,
notamment la famille, les aidants et les équipes médicales, afin d’améliorer la qualité de
vie. La priorité devrait être donnée à l’élaboration et à la mise en œuvre d’outils
permettant de prévenir, de retarder et de traiter les problèmes de santé, les déficiences
et les maladies neurodégénératives liés à l’âge. Les États membres devraient garantir
que l’accès à ces programmes de neurotechnologie soient équitables et ne creusent pas
les inégalités socioéconomiques.
109. Les États membres devraient définir des lignes directrices relatives à la
conception des neurotechnologies qui tiennent compte des besoins des personnes
âgées, en considérant avec attention les facteurs de convivialité de l’interface homme-
machine (polices de caractères, boutons, couleurs, etc.) ainsi que les données
d’expérience permettant d’améliorer les repères visuels et auditifs.
110. Les États membres devraient protéger, appuyer et favoriser la prise de décisions
autonome chez les personnes âgées qui se servent des neurotechnologies pour
disposer d’un soutien sensorimoteur et cognitif. Le processus d’obtention du
consentement devrait s’adapter aux éventuelles difficultés cognitives rencontrées par les
personnes âgées, en s’assurant que leur consentement est éclairé, toujours actuel et
adaptable selon l’évolution de leur état de santé. Des politiques devraient être mises en
place pour veiller à ce que les neurotechnologies d’assistance tiennent compte de
l’évolution des capacités cognitives dans le temps et respectent les préférences de
l’utilisateur.
111. Les États membres devraient élaborer des principes éthiques pour veiller à ce
que les neurotechnologies telles que les robots de soin améliorent les interactions
humaines sans s’y substituer, notamment dans les soins aux personnes atteintes de
neurodégénérescence. Ces principes devraient mettre l’accent sur l’augmentation des
soins humains, et non sur leur remplacement.
IV.8 FEMMES ET GENRE
112. Les États membres devraient adopter et appliquer des politiques globales pour
promouvoir et respecter l’égalité des genres et la diversité dans l’ensemble du cycle de
vie des neurotechnologies. Ces politiques devraient donner la priorité aux recherches
inclusives en vue de répondre aux besoins spécifiques et aux différences des femmes et
en fonction des genres, exiger la collecte et l’analyse ciblées des données, inclure des
programmes d’éducation et de formation sur les pratiques de recherche inclusive,
assurer la coopération du public et de la communauté avec les groupes de défense et
les spécialistes de la santé des femmes et des minorités de genre, et encourager la
conception de technologies tenant compte des questions de genre, afin de répondre aux
besoins et à la condition propres aux femmes et aux minorités de genre. Des politiques
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d’action positive sont nécessaires pour combler les écarts entre les genres dans ces
domaines, et accroître la représentation, la mobilisation et le leadership.
113. Les États membres devraient établir des orientations et des cadres juridiques
clairs pour veiller à ce que les lieux de travail et le monde de la recherche, tout au long
du cycle de vie des neurotechnologies, soient inclusifs et porteurs, particulièrement pour
les femmes et les minorités de genre, et qu’ils protègent des actes de harcèlement et
des discriminations. Des mécanismes fiables devraient notamment être prévus pour
signaler et traiter les faits de harcèlement et les discriminations, en garantissant que les
auteurs répondent de leurs actes et qu’un soutien soit apporté.
114. Les États membres devraient adopter une série de mesures donnant la priorité à
la recherche et à l’innovation éthiques et équitables et soutenant les programmes qui
encouragent la participation des femmes et des minorités de genre aux
neurotechnologies. Cela peut passer par des politiques de financement et autres
privilégiant la recherche et l’innovation éthiques et équitables, mais aussi par des
initiatives d’action positive soutenant la participation des femmes et des minorités de
genre dans les neurotechnologies par le biais de programmes éducatifs ciblés, de
possibilités d’emploi, d’un soutien à l’entreprenariat et du développement de leur
leadership au sein du secteur. Les États membres devraient également proposer des
systèmes de soutien tels que des programmes de mentorat, des possibilités de mise en
réseau et des ressources permettant d’aider les femmes et les minorités de genre à
surmonter les obstacles à la participation et à réussir dans le domaine des
neurotechnologies.
IV.9 PERSONNES EN SITUATION DE HANDICAP PHYSIQUE
115. Les États membres devraient adopter des politiques qui tirent parti du potentiel
des neurotechnologies en supprimant les obstacles rencontrés par les personnes en
situation de handicap physique et en leur apportant un soutien, contribuant ainsi à ce
qu’elles exercent leurs droits humains dans des conditions d’égalité. Ils devraient
appliquer des cadres réglementaires qui imposent la réalisation d’évaluation de
l’accessibilité de tous les nouveaux produits neurotechnologiques, afin de veiller à ce
que ces produits ne perpétuent pas les handicaps ou les disparités en matière de santé
qui existent déjà. Ces cadres devraient prévoir des protocoles d’essai auprès de
groupes variés de personnes en situation de handicap afin que les technologies
répondent à un large éventail de besoins, et qu’elles n’excluent pas ou ne
désavantagent pas involontairement tel ou tel sous-groupe.
116. Les États membres devraient créer des programmes d’incitation pour promouvoir
le développement de neurotechnologies destinées aux personnes en situation de
handicap afin de favoriser leur qualité de vie et leur indépendance fonctionnelle. Ces
programmes devraient inclure des mesures d’incitation fiscale pour les entreprises
investissant dans la recherche-développement concernant les neurotechnologies
d’assistance, des subventions destinées aux institutions de recherche s’intéressant aux
neurotechnologies d’aide aux personnes porteuses d’un handicap, des autorisations
réglementaires accélérées pour les technologies représentant de grandes avancées en
matière de mobilité, de communication ou d’assistance dans la vie quotidienne et des
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prix d’innovation distinguant des progrès décisifs en faveur de solutions
neurotechnologiques abordables et accessibles.
117. Les États membres devraient, autant que possible, financer les coûts liés aux
dispositifs neurotechnologiques indispensables, tels que les neuroprothèses, pour les
personnes en situation de handicap physique. Ils pourraient encourager les partenariats
public-privé afin de rendre les neurotechnologies accessibles et faire en sorte que les
neurotechnologies soient couvertes pour les personnes en situation de handicap
physique dans les régimes nationaux d’assurance maladie et autres systèmes de
remboursement. Une base de données nationale des ressources et des services de
soutien disponibles en matière de neurotechnologies devrait être mise en place pour
faciliter l’accès et le partage des informations. Commenté [GdQ25]: Une question à considérer : les
neuroprothèses devraient-elles être considérées
IV.10 PERSONNES SOUFFRANT DE TROUBLES MENTAUX comme des biens, protégés par les droits de propriété
(en cas de dommages causés par une tierce partie), ou
118. Les États membres devraient encourager la recherche et promouvoir des plutôt comme des parties de leur corps, protégées par
initiatives de sensibilisation pour faire face à la proportion croissante et aux besoins le droit à l’intégrité physique ?
spéciaux des personnes souffrant de troubles mentaux, notamment les victimes et les
survivants de traumatismes et de violences, et examiner l’importance des
neurotechnologies pour ces populations.
119. Les États membres devraient allouer des fonds aux efforts de plaidoyer à long
terme et aux études d’efficacité, au contrôle après mise sur le marché et à la
surveillance à plusieurs niveaux, en portant une attention particulière au caractère
invasif et à la réversibilité des interventions neurotechnologiques. Il est important de
veiller à ce que les personnes souffrant de troubles mentaux soient bien informées et
que leurs attentes à l’égard du processus soient raisonnables.
120. Les États membres devraient financer en priorité les neurotechnologies conçues
pour améliorer la qualité de vie et le fonctionnement quotidien des individus souffrant de
troubles mentaux. Il s’agit notamment des technologies qui aident à gérer les
symptômes, à améliorer les fonctions cognitives et à apporter un soutien émotionnel à
domicile, au travail, au sein de la communauté et dans la société. La recherche-
développement devrait être guidée par des retours d’information et en coopérant avec
des personnes atteintes de troubles mentaux et ceux qui défendent leurs intérêts.
121. Les États membres devraient mettre en place des politiques visant à améliorer
l’accès des personnes souffrant de troubles mentaux aux avancées récentes en matière
de neurotechnologies, afin que leur coût ne représente pas un obstacle pour avoir accès
à des traitements et à des aides susceptibles de transformer l’existence.
ÉTHIQUE DE LA SANTÉ ET DE LA RECHERCHE
IV.11 SANTÉ
122. Les États membres devraient encourager le développement d’applications de
soins de santé qui répondent en priorité aux besoins non satisfaits en termes d’offre de
services de santé neurologique et mentale. Il s’agit notamment de mettre en place des
programmes de financement de la recherche visant spécifiquement à combler les
lacunes identifiées dans les soins du système nerveux.
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123. Les États membres devraient renforcer et entretenir la solidarité internationale en
vue de répondre aux risques et incertitudes mondiaux en matière de santé, et veiller à
ce que la mise en œuvre de leurs soins de santé du système nerveux soit conforme au
droit international et aux obligations strictes qui leur incombent en matière de droits de
l’homme. Il pourrait s’agir de créer des forums internationaux pour l’échange des
meilleures pratiques dans la mise en œuvre des neurotechnologies dans les soins de
santé.
124. Les États membres devraient établir des mécanismes de contrôle afin d’évaluer
les effets de l’utilisation à long terme des dispositifs neurotechnologiques sur la santé
physique et mentale, en prêtant une attention particulière au degré d’intrusion et de
réversibilité des interventions neurotechnologiques. Il s’agit notamment de mettre en
œuvre des mesures réglementaires exigeant des études de suivi à long terme pour les
dispositifs neurotechnologiques approuvés et d’établir des critères clairs pour le maintien
de l’approbation sur la base des résultats de ces études.
125. Les États membres devraient prendre en considération l’importance du coût et
de l’impact que représentent les pathologies liées au système nerveux, ainsi que les
avantages potentiels du diagnostic précoce et de l’accès aux neurotechnologies de
prévention et d’assistance. Les politiques publiques devraient promouvoir en priorité
l’accès à ces technologies et assurer la prise en charge des frais de santé des
personnes qui en ont besoin.
126. Les États membres devraient promouvoir le développement de
neurotechnologies fiables et durables pour les applications de soins de santé. Il s’agit
notamment d’encourager la conception de dispositifs et de systèmes qui nécessitent un
minimum d’entretien, en veillant à ce qu’ils restent fonctionnels et efficaces dans les
conditions de la vie quotidienne. Les organismes de réglementation ou les autorités
désignées devraient superviser l’application de normes de qualité, de sécurité et de
longévité rigoureuses, afin de réduire la charge pesant sur les utilisateurs et d’améliorer
la fiabilité et la durabilité des solutions neurotechnologiques.
127. Les États membres devraient élaborer des systèmes de communication
d’informations exhaustives sur les dispositifs médicaux neurotechnologiques qui
permettent de suivre les effets indésirables et d’y remédier, ou renforcer ceux qui
existent déjà. Dans les contextes où de tels systèmes n’existent pas, les États membres
devraient les mettre en place. Lorsque des systèmes sont déjà en place, ils devraient
être actualisés pour inclure spécifiquement les neurotechnologies. Ces systèmes
devraient être interopérables et contribuer à l’établissement d’une base de données
internationale centralisée, publique et transparente, gérée en collaboration avec des
organisations internationales afin de garantir le respect des normes mondiales, et
accessible aux fins de l’information du public, du contrôle international et de la
recherche.
IV.12 ÉTHIQUE DE LA RECHERCHE Commenté [GdQ26]: Et des participants non-humains,
en s’assurant de veiller au remplacement, lorsque
128. Les États membres devraient renforcer les cadres éthiques régissant les possible, des modèles animaux par des alternatives, en
recherches en neurotechnologie afin de garantir une protection solide des participants réduisant le nombre d’animaux participant à ces études
et en améliorant le bien-être des animaux participant
humains. Les États membres devraient adopter des politiques ou des principes (minimisation de la douleur et bonification de
directeurs clairs pour définir les qualifications afin de s’assurer que les travaux de l’environnement de vie des modèles animaux).
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recherche sont conduits par des professionnels disposant des connaissances adéquates
sur la structure et le fonctionnement du système nerveux, ainsi que sur les troubles du
cerveau, et menés dans des environnements de recherche appropriés. En outre, les
protocoles de recherche, publics ou privés, dans le domaine médical ou non, devraient
être soigneusement évalués par des conseils d’éthique agréés (comités d’éthique) et
une attention particulière devrait être portée aux personnes se trouvant dans des
situations particulières de vulnérabilité, telles qu’une diminution de la faculté à donner
son consentement ou à prendre des décisions. Les États membres devraient veiller à ce
que tous les établissements de recherche proposent aux chercheurs une formation
obligatoire en matière d’éthique.
129. Les États membres devraient encourager une recherche internationale
multicentrique, associant différentes cultures et différents groupes ethniques. Les États
membres devraient promouvoir la coopération internationale en vue d’élaborer des
normes et des protocoles d’interopérabilité communs pour la communication des
informations, notamment en ce qui concerne les dispositifs neurotechnologiques
implantables. Une telle coopération devrait viser à améliorer la comparabilité et l’utilité
des travaux de recherche à l’échelle mondiale, en améliorant à la fois leur efficacité et
leur intégrité éthique.
130. Les États membres devraient veiller à ce que l’ensemble du cycle de vie des
neurotechnologies soit pris en compte lors de la conception d’un essai clinique, y
compris les politiques de protection des patients en cas de cessation des activités du
commanditaire ou du promoteur de l’essai. Les États membres devraient imposer
l’obligation pour les essais cliniques d’être inscrits sur les registres adéquats approuvés
au niveau national ou international, et encourager l’inscription sur des registres
communautaires et des registres de patients. Par ailleurs, les essais cliniques devraient
faire état des systèmes appropriés de communication d’informations sur les dispositifs
médicaux élaborés au sein des États membres.
131. Les développeurs de technologies devraient garantir que la validation des
algorithmes d’IA dans la recherche en neurotechnologie repose sur des tests rigoureux
pour déceler les biais, ainsi que sur des mesures visant à améliorer l’explicabilité et la
transparence, notamment la provenance des ensembles de données d’entraînement.
Des techniques adaptées devraient être employées pour atténuer tout biais présent
dans les modèles d’IA utilisés dans les applications neurotechnologiques.
132. Les États membres devraient veiller à ce que les efforts de recherche ne se
limitent pas aux risques biomédicaux associés aux neurotechnologies, mais examinent
également les effets potentiels sur l’expérience subjective, la capacité d’action et
l’identité personnelle de l’individu. Il est essentiel de comprendre la façon dont les
neurotechnologies peuvent influencer certains aspects de la perception de soi, de la
conscience et de l’identité pour répondre aux préoccupations éthiques et garantir le
bien-être des individus qui utilisent ces technologies.
133. Les États membres devraient veiller à ce que les personnes participant à des
travaux de recherche procèdent régulièrement à des audits et au suivi des pratiques de
recherche afin de garantir le respect des normes éthiques. Il convient notamment
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d’évaluer la conformité du consentement éclairé, en particulier en ce qui concerne la
réutilisation des données et l’éventuelle commercialisation des données neurales.
134. Les États membres devraient exiger des chercheurs en neurotechnologie qu’ils
établissent des protocoles clairs et transparents pour communiquer aux participants les
découvertes fortuites importantes sur le plan clinique, et qui appellent une action. Ces
protocoles devraient garantir la transmission rapide de ces résultats, dans le respect des
droits et de l’autonomie des participants. En outre, les États membres devraient exiger
que les chercheurs apportent le soutien nécessaire aux prestataires de soins de santé et
qu’ils assurent la coordination avec ces derniers pour remédier à tout problème de santé
découlant de ces découvertes.
135. Les États membres devraient veiller à ce que les personnes participant à des
travaux de recherche en neurotechnologie ou subissant des interventions
neurotechnologiques soient dûment informées des risques de découvertes fortuites, en
particulier celles qui entraînent des répercussions importantes sur la santé. Le
processus de consentement éclairé devrait indiquer clairement ce que ces découvertes
pourraient impliquer, donner aux participants le droit de choisir s’ils souhaitent être
informés ou non de ces découvertes, et garantir que leurs décisions à cet égard seront
respectées tout au long de l’étude ou du traitement.
DOMAINES D’APPLICATION SPÉCIFIQUES EN DEHORS DE LA SANTÉ
IV.13 ENVIRONNEMENTS ÉDUCATIFS
136. Les États membres devraient aborder avec prudence la question de l’intégration
des neurotechnologies dans l’éducation, en veillant à ce que leur utilisation soit fondée
sur des données probantes, qu’elle corresponde aux objectifs éducatifs et qu’elle
complète les méthodes d’apprentissage traditionnelles. Il importe en particulier de
promouvoir le développement holistique des élèves, en mettant l’accent non seulement
sur leurs résultats scolaires, mais aussi sur leur santé mentale, leur bien-être et leur
intérêt général. AJOUT : Il importe également de former adéquatement les éducateurs
pour qu’ils soient en mesure de déployer correctement les neurotechnologies dans les
environnements éducatifs. Pour garantir l’inclusivité, les États membres devraient
élaborer des lignes directrices adaptées à l’âge pour l’utilisation des neurotechnologies à
différents stades de l’éducation et dans différents styles d’apprentissage. Des
évaluations régulières de l’impact des neurotechnologies sur le développement des
élèves, notamment leur santé mentale, devraient être réalisées, et des processus
d’examen éthique devraient être mis en place pour superviser le déploiement de ces
technologies. Il convient de s’attacher avant tout à favoriser la réflexion critique, la
créativité et l’intelligence émotionnelle, plutôt que de s’employer uniquement à améliorer
les résultats scolaires AJOUT : ou à orienter les jeunes strictement en fonction des
besoins ponctuels du marché du travail.
137. Les États membres devraient adopter des politiques garantissant le déploiement
volontaire des neurotechnologies dans l’éducation, sur la base d’un consentement plein
et éclairé. Ces politiques doivent inclure des informations claires et adaptées à l’âge sur
les objectifs, les avantages et les risques de ces technologies, ainsi que des délais de
réflexion adéquats. Étant donné qu’il est de plus en plus difficile d’obtenir un
consentement volontaire dans ce contexte, les procédures de consentement et
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d’assentiment devraient associer les enfants, les adolescents, les parents, les tuteurs et
tous les acteurs nécessaires pour obtenir l’approbation exigée pour les mineurs. Il
convient de mettre en place des mécanismes de contrôle éthique, y compris le
renouvellement régulier du consentement et l’arrêt immédiat de l’utilisation des
neurotechnologies en cas de rétractation, ainsi que des canaux de retour d’information
anonymes. Les politiques doivent interdire les mesures incitatives injustifiées ou les
sanctions scolaires en cas de non-participation, et prévoir des mesures pour éviter de
créer ou de renforcer des inégalités entre les élèves. En outre, les États membres
devraient encourager la participation des élèves AJOUT : et des éducateurs à la prise de
décisions concernant l’intégration des neurotechnologies et financer des programmes de
formation sur leur utilisation éthique AJOUT : et sur les risques associés à ces
technologies, en donnant aux éducateurs et aux élèves les moyens d’évaluer leur
application de manière critique.
138. Les États membres devraient mettre en place un mécanisme de surveillance
unifié et solide pour l’utilisation des neurotechnologies dans les environnements
éducatifs, qui devrait inclure des audits réguliers ainsi que des retours d’information du
public et des communautés, être adapté à la culture et conforme aux conventions
locales, et garantir un respect strict des normes de sécurité et d’éthique, notamment par
une évaluation de la réversibilité des effets sur le système nerveux. Des efforts continus
de recherche devraient être financés pour évaluer les effets psychologiques et cognitifs
à long terme de ces technologies. Le contrôle devrait comporter des examens
périodiques fondés sur des données empiriques afin d’adapter l’utilisation des
neurotechnologies en fonction des besoins, en veillant à ce qu’elle serve le
développement de l’élève et à ce qu’elle tienne compte des risques tels que la
dépendance ou l’appauvrissement des compétences. Cette approche globale
contribuera à maintenir la sécurité et l’efficacité des neurotechnologies ainsi que leur
alignement sur les meilleures pratiques en faveur du bien-être et des résultats
d’apprentissage des élèves.
139. Les États membres devraient investir dans des programmes d’éducation et de
développement professionnel visant à doter les innovateurs et les chefs d’entreprise des
compétences nécessaires pour intégrer les considérations éthiques tout au long de
l’ensemble du cycle de vie des neurotechnologies AJOUT : , même dès la phase de
conception. Ces formations devraient porter notamment sur la conception éthique, le
droit relatif aux droits de l’homme et l’évaluation de l’impact sociétal, afin de préparer la
prochaine génération de technologues à évaluer de manière critique les incidences de
leurs travaux.
IV.14 TRAVAIL ET EMPLOI
140. Les États membres devraient mettre en place des politiques et des mesures
incitatives sur le lieu de travail qui donnent la priorité à la santé et au bien-être des
employés dans l’utilisation des neurotechnologies. Ces politiques devraient garantir que
tout déploiement de neurotechnologies repose sur des données probantes, en mettant
l’accent sur les applications qui ont été scientifiquement validées pour promouvoir le
bien-être des employés, comme la réduction du stress ou l’amélioration des conditions
de travail (c’est-à-dire des environnements adaptatifs et réactifs qui ajustent la charge
de travail en fonction de la charge cognitive). Le déploiement doit se faire sur une base
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volontaire et les employés doivent avoir la possibilité de refuser d’utiliser les
neurotechnologies sans subir de conséquences négatives ou de discrimination. Ces
technologies ne doivent en aucun cas être utilisées à des fins punitives ou de
surveillance mentale, ou d’une manière qui pourrait compromettre la santé des
employés.
141. Les États membres devraient exiger des employeurs qu’ils fournissent aux
employés des informations claires et complètes sur le fonctionnement des
neurotechnologies utilisées sur leur lieu de travail, sur les avantages qu’elles offrent, sur
la transparence quant au type de données collectées, sur la manière dont elles sont
utilisées et sur les personnes qui y ont accès, et qu’ils annoncent clairement tous les
risques pouvant découler de leur utilisation.
142. Les États membres devraient exiger des employeurs qui utilisent les
neurotechnologies sur le lieu de travail qu’ils adoptent des politiques transparentes
précisant l’objectif de leur utilisation et limitant leur champ d’application à des fins
légitimes, dans l’intérêt des employés et des tiers (c’est-à-dire, la sécurité, la
surveillance de la fatigue chez les conducteurs commerciaux ou le suivi de l’attention
chez les contrôleurs aériens). Afin de respecter la vie privée mentale des employés, les
employeurs devraient se voir interdire l’accès sans autorisation aux données
biométriques neurales et cognitives pouvant être recueillies fortuitement dans le cadre
de la surveillance de routine sur le lieu de travail. Il devrait être interdit aux employeurs
d’utiliser les données biométriques neurales et cognitives à des fins non consenties, en
particulier celles qui pourraient nuire à la sécurité de l’emploi ou à la vie privée d’un
employé.
143. Les États membres devraient exiger des employeurs qu’ils adoptent les
meilleures pratiques en matière de minimisation des données et de conservation
sécurisée des données biométriques neurales et cognitives, en veillant à ce que les
données soient conservées en toute sécurité, que leur accès soit limité uniquement au
personnel autorisé et qu’elles soient supprimées aussitôt atteint l’objectif pour lequel
elles ont été recueillies. En outre, lors du départ d’un employé, tous les dossiers
connexes doivent être entièrement supprimés ou les données personnelles doivent être
communiquées à l’employé, de sorte qu’aucune donnée ne soit conservée après la
cessation de service.
144. Les États membres devraient veiller à ce que, lorsque les employés reçoivent
des dispositifs multifonctionnels (c’est-à-dire, des oreillettes ou des casques d’écoute
comprenant également des capteurs neuronaux) qui peuvent être utilisés au travail ou à
domicile, il soit interdit aux employeurs de recueillir des données biométriques neurales
et cognitives en dehors du cadre et des heures de travail, et garantir que toute donnée
recueillie pendant le travail est utilisée exclusivement aux fins convenues. Les
employeurs devraient mettre en place des mesures de protection technologiques pour
désactiver automatiquement la collecte de données en dehors des heures de travail.
145. Les États membres devraient veiller à ce que les employeurs respectent le droit
des employés d’obtenir une copie de toutes les données biométriques neurales et
cognitives recueillies à leur sujet, ainsi que de toutes les interprétations qui en sont
tirées, d’une manière accessible et compréhensible. L’utilisation de ces outils sans
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consentement constitue un abus de confiance, qui remet en question la valeur qu’ils Commenté [GdQ27]: Plutôt une violation du droit au
pourraient autrement créer. respect de la vie privée.
146. Les États membres devraient exiger, par le biais de réglementations strictes, que
toute utilisation des neurotechnologies sur le lieu de travail nécessite le consentement
explicite des employés, et que celles-ci ne soient utilisées qu’à des fins qui améliorent
manifestement la sécurité sur le lieu de travail, ainsi que le bien-être et la dignité des
employés, et non pour accroître la productivité au détriment de la santé de ces derniers.
147. Les États membres devraient se prémunir contre l’exploitation des employés et
élaborer des réglementations strictes contre l’utilisation des données biométriques
neurales et cognitives à des fins de profilage sur le lieu de travail, notamment lors du
recrutement. Ces réglementations devraient interdire l’utilisation des données
biométriques neurales et cognitives pour discriminer les candidats, en particulier les
personnes neurodivergentes, afin de garantir des pratiques de recrutement équitables et
inclusives.
148. Les États membres devraient réglementer strictement l’utilisation des
neurotechnologies à des fins de recrutement ou de maintien de l’emploi, afin de limiter
cette utilisation aux cas où les données biométriques neurales et cognitives ont un
rapport direct avec les exigences spécifiques de l’emploi.
IV.15 DOMAINES DE LA CONSOMMATION ET DU COMMERCE
149. Les États membres devraient mettre en place de façon proactive un cadre
réglementaire qui assure un équilibre entre l’innovation dans les domaines récréatif et
commercial et la protection des droits et du bien-être des individus. Ce cadre devrait être
dynamique et devrait pouvoir être actualisé de manière opportune, à mesure que les
technologies évoluent et que de nouvelles connaissances sont acquises quant à leur
impact sur la société. Il s’agit notamment d’assurer une surveillance adéquate pour
garantir que les neurotechnologies ne causent pas de dommages, qu’elles sont utilisées
de manière consensuelle et qu’elles comportent des mécanismes solides pour protéger
les utilisateurs contre tout risque de détresse psychologique ou de manipulation.
150. Les États membres devraient renforcer les législations en matière de protection
globale des consommateurs afin d’inclure un étiquetage clair sur les produits
neurotechnologiques commerciaux, détaillant leurs effets, leurs limites et leurs risques
afin d’éviter les allégations trompeuses et de garantir la transparence. Il s’agit également
d’interdire les pratiques de « vente liée » ou celles exigeant la divulgation de données
biométriques neurales et cognitives comme condition d’accès à des biens ou à des
services, ainsi que le partage de données avec des tiers ou l’utilisation de ces données
sans que les individus aient la possibilité de formuler leur consentement exprès.
151. Les États membres devraient créer un environnement qui garantisse que toutes
les allégations concernant les technologies grand public, non médicales, soient étayées
par des preuves scientifiques solides. Ils devraient, par voie réglementaire, exiger que
tout produit prétendant traiter, prévenir ou diagnostiquer des maladies ou des problèmes
médicaux soit validé par des tests rigoureux de sécurité et d’efficacité, y compris des
essais cliniques, le cas échéant, et qu’il soit utilisé sous contrôle médical approprié.
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152. Les États membres doivent mettre en œuvre des procédures de consentement
éclairé approfondies et transparentes pour toutes les interventions neurotechnologiques,
en veillant à ce que la participation soit pleinement volontaire et respecte la vie privée et
l’autonomie des individus. Ce principe devrait s’appliquer uniformément dans divers
domaines tels que le sport ou les arts, où des normes solides devraient protéger les
individus contre une utilisation coercitive et respecter l’autonomie individuelle des
athlètes et des artistes, les intérêts de la communauté et les droits de propriété
intellectuelle.
153. Les États membres devraient orienter l’utilisation et le développement des
neurotechnologies dans le domaine des arts afin d’améliorer l’apprentissage et
l’appréciation culturelle AJOUT : , de favoriser la connaissance et la reconnaissance de
sa propre culture ainsi que de stimuler l’intérêt de participer à la vie culturelle de sa
communauté, sans compromettre l’autonomie individuelle ou entraîner une
homogénéisation culturelle.
154. Les États membres devraient adopter des politiques visant à prévenir l’utilisation
abusive des neurotechnologies dans les technologies grand public, en particulier les
jeux vidéo pilotés par ondes cérébrales (neurogaming) et autres dispositifs qui exploitent
le circuit de la récompense de la dopamine ou qui cherchent à susciter une utilisation
problématique et malsaine ainsi qu’une surconsommation. Ces réglementations
devraient imposer de fournir une indication claire des risques associés à ces produits
ainsi que des informations concernant leurs effets sur le système nerveux, et faire
appliquer des normes de conception des jeux et des normes de sécurité, de respect de
la vie privée et de conception adaptée à l’âge, visant à empêcher que l’on profite de la
vulnérabilité physique, mentale et émotionnelle d’une personne pour la conduire à une
utilisation compulsive ou à une dépendance à l’égard des jeux ou des plates-formes
récréatives numériques combinées aux neurotechnologies, afin de promouvoir une
utilisation saine et équilibrée, en particulier chez les enfants.
155. Les États membres devraient veiller à ce que les dispositifs comportant des
fonctions multiples, tels que les lunettes XR ou les écouteurs intelligents dotés de
capteurs neuronaux, soient équipés de commandes matérielles permettant aux
utilisateurs de désactiver sélectivement les fonctions neurotechnologiques tout en
conservant les fonctionnalités de base. Les réglementations devraient garantir que les
options de désactivation sont accessibles et pratiques, afin de promouvoir une utilisation
saine et équilibrée, en particulier chez les enfants et les populations vulnérables.
156. Les États membres devraient se pencher sur les questions éthiques profondes
relatives à l’autodétermination, au consentement, à la vie privée et au risque de
manipulation soulevées par les neurotechnologies dans le contexte des systèmes de
recommandation, de l’amorçage et de l’incitation, du marketing du sommeil et du rêve,
du neuromarketing et des environnements en boucle fermée, en adoptant des politiques
et des réglementations globales qui :
(a) systèmes de recommandation : interdisent explicitement l’utilisation des
données biométriques neurales et cognitives dans les systèmes de Commenté [GdQ28]: L’intention pourrait être précisée.
recommandation à des fins de manipulation ou de tromperie, notamment S’agit-il d’interdire l’usage de données neurales pour
dans un contexte politique. Ces réglementations devraient exiger que faire du profilage et du microciblage dans les
communications politiques?
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toute utilisation de ces données dans ces systèmes soit fondée sur le
consentement explicite et éclairé des utilisateurs ;
(b) incitation : régissent l’utilisation des données biométriques neurales et
cognitives à des fins d’incitation – c’est-à-dire pour influencer subtilement
les décisions ou les comportements des individus, souvent sans qu’ils en
aient effectivement conscience. Ces réglementations sont
particulièrement importantes dans des domaines sensibles tels que les
messages politiques, la publicité commerciale et les soins de santé. Ces
cadres devraient exiger un consentement explicite et éclairé pour toute
utilisation de ces données visant à influencer les décisions ou les
comportements, le droit de se retirer de ces systèmes, ainsi que la
transparence et la fourniture d’informations claires au moment de la
collecte des données, et imposer des limites strictes s’agissant de
l’utilisation des données à des fins autres que celles explicitement
mentionnées ;
(c) marketing du sommeil et du rêve : interdisent l’utilisation des
neurotechnologies qui influencent ou manipulent les individus pendant
leur sommeil, comme le marketing du sommeil et du rêve. Les
réglementations devraient interdire strictement les applications
commerciales, de marketing ou politiques qui ciblent les individus pendant
leur sommeil, en utilisant les neurotechnologies ou les données
biométriques neurales et cognitives. En outre, des mécanismes de
contrôle solides devraient être exigés pour garantir que toute recherche
portant sur ces technologies ou toute application de celles-ci donne la
priorité au bien-être, à la vie privée et à l’autonomie des individus, en
accordant une attention particulière aux effets psychologiques et cognitifs
potentiels à long terme de la manipulation des états de sommeil ;
(d) neuromarketing : visent à se prémunir contre les objectifs et les pratiques
contraires à l’éthique dans le domaine du neuromarketing, notamment en
imposant la fourniture d’informations exhaustives pour garantir que toutes
les activités de neuromarketing sont menées de manière transparente,
avec le consentement éclairé explicite des participants. Il s’agit
notamment de s’assurer que les participants aux campagnes de
neuromarketing ou aux travaux de recherche dans ce domaine sont
pleinement conscients des méthodes, des risques et des intentions et
qu’ils consentent expressément à participer. L’utilisation, la conservation
et la réutilisation potentielle des données recueillies devraient être
strictement réglementées ;
(e) environnements en boucle fermée : fournissent des directives
réglementaires claires sur la conception et l’utilisation des
environnements en boucle fermée – tels que les systèmes informatiques
immersifs qui ajustent les expériences en fonction des données
biométriques neurales et cognitives détectées. Ces politiques devraient
imposer la fourniture d’informations claires et accessibles sur la manière
dont les données biométriques neurales et cognitives sont utilisées dans
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ces environnements, interdire la modification ou la manipulation des
comportements en temps réel sans consentement explicite et éclairé, et
mettre en oeuvre des garanties spécifiquement conçues pour prévenir les
abus tels que la surveillance non autorisée, les interventions
manipulatrices et les pratiques susceptibles d’influencer le comportement
électoral ou les opinions politiques, ou d’exploiter les vulnérabilités
psychologiques et émotionnelles en temps réel.
IV.16 AMÉLIORATION
157. L’utilisation des neurotechnologies pour améliorer la mémoire, l’attention ou
d’autres aspects des performances mentales humaines en dehors du contexte médical
pose des défis éthiques, sociaux et juridiques complexes, qui sont susceptibles de créer
de nouveaux types de disparités dans le monde. Lorsque les neurotechnologies sont
utilisées dans ces contextes, elles soulèvent des questions cruciales concernant l’équité,
le consentement, l’autonomie individuelle et communautaire, ainsi que la nature même
de l’amélioration du système nerveux. Les États membres devraient veiller à ce que les
politiques, les lois et les cadres réglementaires qui régissent l’utilisation des
neurotechnologies dans ces contextes n’exacerbent pas les inégalités sociales ou
n’entraînent pas de discrimination, qu’ils tiennent compte des risques potentiels
(notamment la réversibilité des effets, le degré d’intrusion et les risques pour
l’autodétermination) et qu’ils respectent pleinement les droits de l’homme et la dignité
humaine.
V. MISE EN OEUVRE
158. Les États membres et tous les autres acteurs identifiés dans la présente
Recommandation devraient respecter, promouvoir et protéger les valeurs, principes et
normes éthiques qui y sont énoncés, et prendre toutes les mesures en leur pouvoir pour
garantir sa mise en œuvre.
159. Les États membres – en fonction des contextes, des structures de gouvernance
et des dispositions constitutionnelles qui sont les leurs – devront faire progresser de
manière crédible et transparente l’éthique des neurotechnologies, conformément à la
Recommandation de l’UNESCO. Les États membres devront assurer le suivi et
l’évaluation des politiques, programmes et mécanismes relatifs aux neurotechnologies et
à leur éthique. Le suivi des progrès pourrait s’appuyer sur une combinaison d’approches
quantitatives et qualitatives.
160. Les États membres devraient développer les capacités des institutions
gouvernementales et aider les responsables gouvernementaux à orienter le
développement technologique de manière éthique.
161. Les États membres devraient créer ou désigner des organismes nationaux
chargés de superviser et de coordonner la réglementation, le contrôle et la surveillance
des neurotechnologies au sein des organismes gouvernementaux concernés. Ces
organes de coordination devraient être chargés de veiller à ce que les cadres juridiques
et réglementaires soient appliqués de manière cohérente, à ce que la santé et la
sécurité publiques soient protégées et à ce que les normes éthiques et les droits de
l’homme soient respectés dans l’ensemble du cycle de vie des neurotechnologies. Il
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s’agit notamment de faciliter la collaboration interinstitutions, de veiller au respect des
normes nationales et internationales, et de s’assurer que les données et les
connaissances issues des différents domaines réglementaires sont partagées
efficacement afin d’éclairer la prise de décisions et l’élaboration des politiques. Ces
organismes devraient également contribuer à coordonner la participation du public et de
la communauté.
162. Les États membres devraient s’efforcer d’élargir et de compléter leur propre
action en ce qui concerne la présente Recommandation en coopérant avec toutes les
organisations nationales et internationales, gouvernementales et non gouvernementales
concernées, ainsi qu’avec les sociétés transnationales et les organisations scientifiques
dont les activités sont en rapport avec le champ d’application et les objectifs de la
présente Recommandation. La société civile jouera un rôle important pour défendre les
intérêts du secteur public. L’UNESCO doit par conséquent asseoir et mettre en avant sa
légitimité.
163. L’UNESCO devrait faire largement connaître et circuler la présente
Recommandation par tous les moyens disponibles, et la communiquer aux États
membres, aux commissions nationales pour l’UNESCO, aux partenaires internationaux
et régionaux concernés, aux institutions de défense des droits de l’homme ainsi qu’aux
organes consultatifs de l’UNESCO en matière d’éthique, afin qu’ils la diffusent à tous les
niveaux et auprès de tous les acteurs dans ce domaine.
164. Pour aider les États membres à mettre en oeuvre la Recommandation en
élaborant des programmes et des politiques concrets et en développant les capacités
institutionnelles dans le domaine de l’éthique des neurotechnologies, l’UNESCO
contribuera à l’élaboration d’un programme à part entière comportant les éléments
suivants :
(a) une méthodologie d’évaluation de l’état de préparation (RAM) pour aider
les États membres à déterminer leur état d’avancement, à divers égards,
à des moments précis de leur parcours de préparation ;
(b) une méthodologie UNESCO d’évaluation de l’impact éthique (EIE) des
neurotechnologies reposant sur des travaux scientifiques rigoureux, et
basée sur le droit international des droits de l’homme, accompagnée de
lignes directrices spécifiques concernant sa mise en œuvre dans
l’ensemble du cycle de vie des neurotechnologies, ainsi que d’outils et de
matériels de renforcement des capacités destinés à soutenir les initiatives
des États membres visant à former des responsables gouvernementaux,
les responsables politiques et autres acteurs concernés à la
méthodologie;
(c) une méthodologie UNESCO pour évaluer en amont et en aval l’efficacité
et l’efficience des politiques et des mesures d’incitation relatives à
l’éthique des neurotechnologies par rapport aux objectifs fixés ;
(d) un programme de recherche de l’UNESCO qui mettra l’accent sur
l’éthique des neurotechnologies, reposant sur une évaluation fondée sur
l’état actuel des développements technologiques, afin d’évaluer l’impact
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185
actuel et futur des neurotechnologies sur les sociétés et l’environnement.
Ces analyses fondées sur des éléments factuels seront rassemblées
dans un observatoire de l’UNESCO, qui constituera un réservoir commun
de connaissances et d’informations sur les bonnes pratiques et les
innovations à la disposition de tous les États membres et acteurs, sous la
forme de rapports de recherche, de données et de statistiques concernant
les politiques en matière d’éthique des neurotechnologies. Le programme
de recherche devrait prendre en considération les développements
convergents des neurotechnologies avec d’autres technologies telles que
l’intelligence artificielle et la technologie quantique, les travaux devant être
menés en collaboration avec d’autres initiatives pertinentes de
l’UNESCO;
(e) une plate-forme de collaboration de l’UNESCO visant à favoriser
l’établissement d’échanges fructueux et à faciliter la collaboration entre
les États membres ainsi qu’entre tous les acteurs concernés afin de
promouvoir un dialogue politique mondial, y compris au niveau ministériel,
dans le cadre d’un Forum mondial sur l’éthique des technologies
émergentes. Pour soutenir cette initiative, l’UNESCO mettra en place un
réseau d’experts sur les neurotechnologies, au sein duquel tous les
groupes régionaux de l’UNESCO seront représentés de manière
équilibrée.
165. Les processus de suivi et d’évaluation devraient assurer une large participation
de tous les acteurs, notamment, mais pas exclusivement, des personnes sous-
représentées, vulnérables ou en situation de vulnérabilité, et garantir une diversité sur
les plans social, culturel et du genre. Le suivi et l’évaluation de l’impact des
neurotechnologies et des politiques et pratiques connexes relatives à l’éthique devraient
être assurés en permanence et de façon systématique, proportionnellement aux risques
correspondants. Ce processus devrait s’appuyer sur des cadres convenus au niveau
international et s’accompagner d’évaluations des établissements privés et publics. La
collecte et le traitement des données devraient être menés conformément au droit
international, à la législation nationale sur la protection et la confidentialité des données,
ainsi qu’aux valeurs et principes énoncés dans la présente Recommandation.
VI. DISPOSITIONS FINALES
166. La présente Recommandation doit s’entendre comme un tout, et les valeurs et
principes fondamentaux comme étant complémentaires et interdépendants.
167. Aucune disposition de la présente Recommandation ne peut être interprétée
comme remplaçant, modifiant ou portant atteinte de toute autre manière aux obligations
ou aux droits des États membres en vertu du droit international, ni comme autorisant un
État, tout autre acteur de la vie politique, économique ou sociale, un groupe ou un
individu à se livrer à une activité ou à accomplir un acte contraire aux droits de l’homme,
aux libertés fondamentales, à la dignité humaine et au souci de l’environnement et des
écosystèmes.
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CHINA/CHINE
Suggested Revisions to the First Draft of the Recommendation on the Ethics of
Neurotechnology
(China)
Paragraph Original text Suggested revisions Rationale
PREAMBLE,
the 7th Convinced…, and environmental and
Convinced…, and environmental and
paragraph: ecosystem protection
ecosystem protection ...
(Page 1) sustainability......
Underscoring that global cooperation
Underscoring that global cooperation and solidarity…, and ensuring that The word “international” is added
PREAMBLE,
and solidarity…, and ensuring that national and international before the word “national” to
the 10th
national neurotechnology strategies neurotechnology strategies are emphasize that both international
paragraph:
are guided by ethical principles in full guided by ethical principles in full and domestic strategies need to be
(Page 1)
respect of international human rights respect of international human rights guided by corresponding ethical
law... law...... principles.
187
PREAMBLE, Noting that ethical guidelines, Noting that ethical guidelines,
the 11th frameworks and open science frameworks and open science
The word “responsible” is added
paragraph: promote innovation, development and promote responsible innovation,
to define innovation.
(Page 1) policies aligned with international development and policies aligned
human rights law... with international human rights law,
Also conscious of the existing
Also conscious of the existing
ecosystem of national policies…, as
PREAMBLE, ecosystem of national policies…, as
well as those by the private sector,
the 16th well as those by the private sector,
professional organizations,
paragraph: professional organizations,
non-governmental organizations, and
(Page 2) non-governmental organizations, the
the scientific community, related to
general public, and the scientific
the ethics and regulation of
community, related to the ethics and
neurotechnology,
regulation of neurotechnology,
188
3. Also recommends that Member 3. Also recommends that Member
PREAMBLE,
States engage all actors…, so that the States engage all actors…, so that the
the 16th
development and use of development and use of To further strengthen the
paragraph:
neurotechnology are guided by sound neurotechnology are guided by sound assessment requirements.
(Page 2)
scientific research and ethical scientific research and ethical
analysis and evaluation... analysis and evaluation
deliberation...
1. Addresses ethical issues related to
1. Addresses ethical issues related to
neurotechnology, as it can have Neurotechnology may have
neurotechnology, as it can have many
many positive and adverse impacts impacts on not only human
1 positive and adverse impacts on
on human health, daily living, health, but also on people’s daily
human health, human flourishing and
human flourishing and on the life on a larger scale.
on the enjoyment of human rights.
enjoyment of human rights.
The first Part of this Draft （ I ）
provides some definitions. Similar
Reverse the order of the “scope” (I.1) to the second paragraph of the
and “definitions” (I.2) Part. “Recommendation on the Ethics
I.1 SCOPE
I.1 Specifically, move paragraphs 11 to of Artificial Intelligence”, which
I.2 DEFINITIONS
17, which contain definitions, to a states that there is no single
position before the “scope” Part. definition for artificial
intelligence and that definitions
need to evolve with technological
189
advancements, definitions related
to neural technology also require
ongoing updates. Furthermore,
definitions such as
“neurotechnology” and “nervous
system” in paragraphs 11 to 17
appear before the “scope”
part(I.1). Therefore, it is
recommended to place these
definitions before the “scope” part
to facilitate a better understanding
of the scope.
The key terms “neural data” and
“Cognitive Biometric Data” in the
whole document are still vague and
confusing. Given the context of this
document, we believe Cognitive
Neural Data and Cognitive Biometric
4 Biometric Data would be more
Data
accurate and particularly specific.
Thus, some editorial work is needed
to ensure coherence when
mentioning “data” in the whole
document.
190
Promotes the peaceful use of Promotes the peaceful responsible
neurotechnology and seeks to raise use of neurotechnology and seeks to
awareness on the profound ethical raise awareness on the profound “Responsible use” has more
10
challenges and threats that come with ethical challenges and threats that ethical connotations.
the military and security applications come with the military and security
of neurotechnology. applications of neurotechnology.
According to “Towards a
Governance Framework for Brain
Data,” human brain data are
defined as quantitative data
regarding human brain structure,
activity, and function. This
definition aligns closely with the
Neural data (often referred to as concept of neural data.
Neural data are qualitative and
brain data) are qualitative and “Brain Data in Context: Are New
quantitative data about the structure,
15 quantitative data about the structure, Rights the Way to Mental and
activity and function of the nervous
activity and function of the nervous Brain Privacy?” points out in the
system.
system. context of discussing the privacy
issues arising from
neurotechnologies, the terms
“brain data” and “neural data” are
often used interchangeably.
Although there may be slight
differences in their scopes, the
ethical implications of both are
191
similar.
Change the order of the three
19. The objectives of this 19. The objectives of this words to ensure internal
Recommendation are: Recommendation are: consistency in the document. For
19 (a) to ensure the protection, (a) to ensure the respect, protection instance, Ⅲ.1.1 (page 6);
promotion and respect of human and promotion of human rights and paragraph 39 (page 8), paragraph
rights and fundamental freedoms, fundamental freedoms, 60 (page 10)
192
20. …, or undermine the dignity or
The same amendment proposal
20. …, or undermine the dignity or rights of any individual, including
also works for paragraph 51 (page
20 rights of any individual, including people living in vulnerable situation
9), paragraph 79(d)(page 13),
people living in vulnerable situation with vulnerabilities.
paragraph 165 (page 25).
1. Referencing paragraph 11 of the Part 3 of this Draft (III) is
“Recommendation on the Ethics of dedicated to values and
Artificial Intelligence ” , it is principles. This Part is
suggested to add a paragraph comprehensive, presenting eight
An implementation plan is included before paragraph 20: “ While all values, nine ethical principles,
in the draft Recommendation.It the values and principles outlined and human rights. Values, ethical
proposes a UNESCO full-fledged below are desirable per se, in any principles, and human rights all
program on the ethics of practical contexts, there may be serve as the foundational values
20 neurotechnology,based on the tensions between these values and of this Recommendation.
successful program established for principles. In any given situation, a However, the current text presents
the implementation of the UNESCO's contextual assessment will be some inconsistencies: On one
Recommendation on the Ethics of necessary to manage potential hand, while Part 3(III) is titled
Artificial Intelligence(2021)...... tensions, taking into account the “ Values and Principles ” , the
principle of proportionality and in subsections are further divided
compliance with human rights and into“Values” （III.1）and“Ethical
fundamental freedoms.” Principles and Human Rights ”
2. It is suggested to consolidate （ III.2 ） , which does not align
193
“ values, ethical principles, and with the main title. In other
human rights”into a single category, words, the current draft equates
such as “general principles”. “ ethical principles and human
rights” with “principles”. Such
an equivalence is not logically
comprehensive. On the other
hand, the concepts of “values”,
“ ethical principles ” , and
“ human rights” are similar or
interrelated. In some cases, there
may be conflicts between values
and principles, while in others,
they may overlap.
24. Given that widely recognized
24. Given that widely recognized neurotechnological innovation
neurotechnological innovation largely largely occurs in the urban
occurs in the urban well-resourced well-resourced sector, specific
sector, specific attention to attention to underserved and Disparities exist not only in health
24
underserved and marginalised people marginalised people is crucial to care, but also in other areas.
is crucial to prevent bias, ongoing prevent bias, ongoing disparities in
disparities in healthcare, stigma, and beyond healthcare, stigma,
neglect, and disrespect. neglect, and disrespect.
194
26. Individuals and groups should be
26. Individuals and groups should be allowed…., and engage in the whole
allowed…., and participate in lifecycle of participate in
26 co-designing technologies, provided co-designing technologies, provided
that these choices are made in ways that these choices are made in ways
that respect the rights of others that respect the rights of others
36. Integrity requires that all actors in 36. Integrity requires that all actors in
the whole lifecycle of the whole lifecycle of
neurotechnology field act with ethical neurotechnology field act with
In view of the diversity of societal
steadfastness. It includes adhering to ethical steadfastness. It includes
values, it is proposed to add
36 ethical guidelines and ensuring that adhering to ethical guidelines and
"shared" before "societal values"
all actions align with both ensuring that all actions align with
to qualify.
professional standards and societal both professional standards and
values. shared societal values.
38. Scientific integrity is…, 38. Scientific integrity is…,
conducted with honesty, accuracy, conducted with honesty, accuracy,
It is suggested to add “sound”
and respect for the scientific method and respect for the sound scientific
38 before “scientific method” to
of disciplines relevant for method of disciplines relevant for
ensure accuracy.
neurotechnology neurotechnology
195
Change the order of the three
39.This Recommendation......it words to ensure internal
39.This Recommendation......it
incorporates the respect, protection consistency in the document. For
incorporates the respect, promotion
39 and promotion and protection of instance, paragraph 19 (page 5);
and protection of human rights.
human rights. Ⅲ.1.1 (page 6); paragraph 60
(page 10).
the current title of section 2 of
Part 3 (III.2) is “ Ethical
principles and human rights ” .
However, “human rights” is a
III.2 ETHICAL PRINCIPLES AND concept that encompasses a
III.2 ETHICAL PRINCIPLES AND
III.2 HUMAN RIGHTS GENERAL variety of specific rights and
HUMAN RIGHTS
PRINCIPLES freedoms. Using this term as the
title of the section is overly
narrow and does not accurately
reflect the full range of topics
covered.
III.2 ETHICAL PRINCIPLE AND
HUMAN RIGHTS
An ethical principle could be added
III.2 ETHICAL PRINCIPLE AND to this section: Beneficial to repair
III.2 HUMAN RIGHTS vulnerability.
This principle is intended to
emphasise the need for the
development and use of
neurotechnologies to be more
10
196
sensitive to the well-being and
interests of socially vulnerable
groups, as in the case of the
‘SPECIFIC USERS’ mentioned
later in the Recommendation, and
in view of this, it is necessary to
add a focus on special populations
to the general principle.
47. Neurotechnology…, This
47. Neurotechnology…, This
protection. covers both the internal
protection. covers both the internal It is suggested to add
processing of thoughts and their
47 processing of thoughts and their “inappropriate” to define
external expression, ensuring
external expression, ensuring “interference”.
freedom from any inappropriate
freedom from any interference.
interference.
11
197
Biometric data are not the only
means of accessing cognitive
processes; therefore, the
particularly in contexts where such protection of neural and cognitive
particularly in contexts where such
data might be aggregated with other biometric data need to be
50 data might be aggregated with other
sources, for non-biometric data considered alongside other
sources.
may also infer cognitive processes. non-biometric cognitive and
sensitive data to ensure the
comprehensive safeguarding of
mental privacy.
The same amendment proposal
51.All actors......particularly those
51.All actors......particularly those also works for paragraph 20 (page
with vulnerabilities in
51 in vulnerable situations. 6), paragraph 79(d)(page 13),
vulnerable situations.
paragraph 165 (page 25).
12
198
54. Garnering the trust and 54. Garnering the trust and
acceptance of communities in the acceptance of communities in the
whole lifecycle of neurotechnology whole lifecycle of neurotechnology
It is suggested to add
requires transparent engagement with requires transparent and meaningful
“meaningful” to strengthen the
54 the public, seeking their input and engagement with the public, seeking
ethical requirements for public
validation to align these technologies their input and validation to align
participation.
with societal values and the common these technologies with societal
good. values and the common good.
56. Neurotechnology should not be
used to perpetuate stereotypes,
56. Neurotechnology should not be
stigma, or discrimination against
used to perpetuate stereotypes,
56 older persons particular
stigma, or discrimination against
individuals, groups or
older persons.
communities.
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199
59.A commitment to accountability
59.A commitment to accountability requires global, governmental,
requires global, governmental, societal and collective action of The original text “requires global,
societal and collective action to different actors at the global level governmental, societal, and
59
ensure those harmed by to ensure those harmed by collective action” is inconsistent
neurotechnology have access to neurotechnology have access to in its internal logic.
justice justice
60. To guarantee.....all actors
throughout the whole lifecycle of
60. To guarantee.....all actors
neurotechnology must ensure that
throughout the whole lifecycle of
their activities are
neurotechnology must ensure that
transparent,grounded in scientific
their activities are
evidence, with respect of cultural
60 transparent,grounded in scientific
differences, in compliance with
evidence,and aligned with
national ethical requirements and
international principles of
aligned with international principles
responsible conduct and
of responsible conduct and
scientific integrity......
scientific integrity.....
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200
60. To guarantee the respect, 1. Change the order of the three
protection and promotion and words to ensure internal
60. To guarantee the
protection of human consistency in the document. For
respect,promotion and protection
rights...This includes preventing the instance, paragraph 19 (page 5);
of human rights... This includes
replication or amplification of biases, Ⅲ.1.1 (page 6); paragraph
preventing the replication or
60 ensuring that neurotechnology is 39(page 8).
amplification of biases, ensuring that
traceable and explainable, especially 2. As AI increasingly intervenes
neurotechnology is traceable and
since these issues already exist in in the analysis of neural data,
explainable, its capacities and
artificial intelligence, its capacities trustworthiness and transparency
limitations are accurately portrayed,
and limitations are accurately becomes more difficult to
portrayed, maintain.
61.Ensuring fair and equitable
distribution and creation of
61. It could be emphasized in this
knowledge about neurotechnology,
section that research data should be
including recognizing diverse ways
61 made open for informed public
of knowing, and that all individuals
participation and to promote trust.
and communities can participate in its
creation, sharing, and applications.
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201
68. Access to and benefits arising
68. Access to and benefits arising
from research and development in
from research and development in
neurotechnology must be shared For the sake of distributive
neurotechnology must be shared
equitably among all contributors, as justice,considering the social
equitably among all contributors, to
well as other actors impacted, to value of R&D for public good, in
68 that research and development, with a
that research and development, with addition to “all contributors”, it is
particular focus on ensuring global
a particular focus on ensuring global recommended to add “other actors
distribution that promotes fairness
distribution that promotes fairness impacted”.
and reduces disparities.
and reduces disparities.
70. Research, development, and trials
70. Research, development, and trials
in implications of neurotechnology
in neurotechnology must adhere to
must adhere to the highest ethical
the highest ethical standards, Research and trials have overlap
70 standards, ensuring the
ensuring the non-exploitative meanings.
non-exploitative participation of all
participation of all individuals
individuals involved.
involved.
16
202
Add a new paragraph before the
Part IV discusses“areas of policy
current paragraph 73: UNESCO
recognizes that Member States will action” (IV). These areas are the
be at different stages of readiness implementation of the
to implement this aforementioned principles.
Recommendation, in terms of Considering the diverse
IV IV. AREAS OF POLICY ACTIONS scientific, technological, economic, circumstances and stages of
educational, legal, regulatory, development among UNESCO
infrastructural, societal, cultural member states, referencing
and other dimensions. It is noted paragraph 49, it is recommended
that “ readiness ” here is a to acknowledge these differences
in policy implementation.
dynamic status.
Part IV “Areas of Policy Action”
specifically addresses
considerations for certain groups,
including children and
In Part IV, “Areas of Policy Action” adolescents, the elderly, women
instead of distinguishing between and gender, persons with
different groups in the title, it is disabilities, and those with mental
IV IV. AREAS OF POLICY ACTIONS suggested to use a more general health conditions. There is a
heading such as “Vulnerabilities of strong connection between the
Specific Groups and ethics of neural technologies and
Communities”. the protection of specific groups,
as these groups may face more
pronounced challenges related to
neural technologies. However, the
current classification in the Draft
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203
may lead to overlaps or gaps in
coverage. It is suggested to refer
to the relevant methods outlined
in the Declaration of Helsinki
(2024 edition).
In the context of the rapid
development of neurotechnology,
the media and public opinion play
a crucial role in shaping public
The entry “MEDIA AND PUBLIC
perceptions, guiding societal
OPTION” could be added to the
IV IV. AREAS OF POLICY ACTIONS attitudes and promoting ethical
AREAS OF POLICY ACTIONS.
dialogue. In view of this, it is
proposed to place ethical
emphasis on the social and moral
responsibility of the media.
77. Member States should ensure It is recommended that this
that any use of neurotechnology in paragraph be deleted, as its
the justice system, including its content conflicts with article 74,
consideration by the judiciary should “Neurotechnology should not be
It is recommended that this
77 be grounded in robust scientific used for purposes such as
paragraph be deleted.
evidence, be implemented ethically in non-consensual interrogation in
accordance with human rights,and be law enforcement, criminal and
aimed at promoting public safety civil justice”, and tends to create
while protecting the rights and ambiguity of purpose. It is
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204
dignity of all those involved.This recommended that any current use
requires respect for fundamental of neurotechnology for
rights, such as human dignity, bodily interrogation purposes in the
integrity, confidentiality of personal justice system be strictly limited,
data, due process and fair trial rights, as neurotechnology, as it has
including the presumption of developed, does not provide
innocence, and the right against conclusive evidence of
self-incrimination, as well as freedom personality, human nature and
from torture and illtreatment, the individual capacity, and therefore
right to privacy, and the right to data measured by
freedom of thought. neurotechnology should not be
used as judicial evidence, as its
relevance cannot be
demonstrated.
Privacy is a big concern, while
“Confidentiality” was only
mentioned twice in paragraphs 77
and 95. Given the sensitivity of
77，95 Confidentiality
neural data and Cognitive Biometric
Data, we propose more consideration
regarding “privacy protection and
data confidentiality.”
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205
79.(b) Benefit-Risk
79.(b) Benefit-Risk Assessments......The process should
Assessments.......The process should include thorough documentation,
include thorough documentation, ethical oversight, and continuous
ethical oversight, and continuous monitoring to ensure the safety, with vulnerabilities
monitoring to ensure the safety, well-being, and equitable treatment
well-being, and equitable treatment access of all individuals involved; The same amendment proposal
79 of all individuals involved; also works for paragraph 20 (page
(d) Human Rights Impact 6), paragraph 51 (page 9),
(d) Human Rights Impact Assessments (HRIAs)......with paragraph 165 (page 25).
Assessments (HRIAs)......with particular attention to vulnerable
particular attention to vulnerable people and people with
people and people living in vulnerabilities living in vulnerable
vulnerable situations. situations.
IV.2 82. .Member States should
The following could be added to the
develop a robust regulatory
entry: Member States should
and legal framework to
proactively work with industry
govern the
groups and associations to
collection,processing,sharing,andall
encourage them to develop
other uses of neural and cognitive
IV.2 industry-wide ethical codes of
biometricdata.This and existing
conduct and technical standards to
frameworks should recognize this
promote the fair rationalisation of
data to be both personal and sensitive
neurological and cognitive
data in medical and non-medical
biometric data.
contexts.
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206
IV.5 COMMUNICATION, IV.5 COMMUNICATION,
PARTICIPATION, AND PARTICIPATION engagement, It is more accurate to use
IV.5
INFORMATION AND INFORMATION “engagement” here.
IV.6 CHILDREN AND
ADOLESCENTS
The following could be added to this
IV.6 CHILDREN AND
section: Member States should
IV.6 ADOLESCENTS
ensure that schools and education
systems provide consistently good
support for special education.
105. Member States should......These 105. Member States should......These
projects should involve children, projects should involve children,
adolescents, parents and caregivers in adolescents, parents and caregivers in
105 the design process to ensure the the design and whole processes to
technologies meet their specific ensure the technologies meet their
needs. specific needs.
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107.Member States......Recognizing 107. Member States…...Recognizing
the heightened vulnerability of the heightened vulnerability of
It is suggested to add "negative"
children and adolescents in digital children and adolescents in digital
to qualify “influence” (potential
environments, these regulations must environments, these regulations must
107 positive influence is welcomed,
explicitly forbid any practices that explicitly forbid any practices that
but potential negative influence
use such data to influence or exploit use such data to influence or exploit
needs to be addressed).
children and adolescents. children and adolescents negatively.
IV.10 PERSONSS WITH MENTAL
HEALTH CONSITIONS
An article could be added to this
section: when neurotechnology is
applied to the study and treatment
IV.10 PERSONSS WITH MENTAL
of mental disorders, the study
IV.10 HEALTH CONSITIONS
design, intent and results need to
be treated with caution to avoid
deepening societal discrimination
against people with mental
disorders.
129.Member States should encourage The following could be added to this
multicentre international research that entry: Member States should
involves various cultures and ethnic promote equality, diversity and
129 groups. Member States should inclusion by leveraging funding
promote international cooperation to and removing barriers to
develop common reporting encourage members of
standards and protocols for marginalised groups to join the
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interoperability, particularly for neurotechnical profession. This is
implantable neurotechnology essential to maintain cognitive
devices.This cooperation should aim justice in knowledge production.
to enhance the comparability and
utility of research globally,
improving both the efficacy and
ethical integrity of research.
154. Member States should adopt 154. Member States should adopt
policies to prevent the misuse of policies to prevent the misuse or
154 neurotechnology of consumer abuse of neurotechnology of
technology consumer technology
165. Processes for monitoring and
165. Processes for monitoring and
evaluation should ensure broad
evaluation should ensure broad
participation and engagement of all
participation of all actors,
165 actors,including......or people with
including......or people in
vulnerabilities in vulnerable
vulnerable situations......
situations......
It is suggested to add a new
It is recommended to add a clause
paragraph before the current
on “updates” in Part 6 “Final
paragraph 166 in Part 6, “ Final
VI VI. FINAL PROVISIONS Provisions ” (VI), to reflect the
Provisions”as follows: To ensure the
ongoing nature of the
viability and effectiveness of this
Recommendation.
(draft) Recommendation, updates
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and modifications to this (Draft)
Recommendation shall be
communicated to and consulted
with all Member States, and the
update date shall be reflected in
the preamble.
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COLOMBIA/COLOMBIE
RECOMMENDATIONS AND SUGGESTIONS
FIRST DRAFT OF THE RECOMMENDATION ON THE ETHICS OF
NEUROTECHNOLOGY
MINISTRY OF SCIENCE, TECHNOLOGY AND INNOVATION OF COLOMBIA
General Considerations
1. The development and use of neurotechnology, which has the potential to influence
cognitive and neurological processes, must be regulated through ethical, political,
and technical frameworks that prioritize strengthening public health systems,
ensuring health sovereignty, and reducing social inequities. Addressing the
structural conditions shaping access to these technologies is imperative,
considering that global inequalities in scientific capacities and market-driven logic
limit their positive impact on public health.
2. Regulatory frameworks should promote the democratization of knowledge and
technology production by strengthening alliances between countries with greater
disparities and fostering technological self-determination among states. This
includes the ability to define priorities in the research, development, and distribution
of neurotechnology in line with the health needs of their populations. Integrating
epistemic justice is central to this process, acknowledging the diversity of
knowledge related to health, the mind, and the brain. Incorporating ancestral and
local knowledge avoids exclusionary dynamics and ensures these technologies
address social demands rather than solely meeting technical efficiency criteria.
3. It is essential to ensure that neurotechnology is a common good that is accessible
through strengthened public health systems. This requires designing mechanisms
to reduce economic, social, and geographic barriers while prohibiting their use for
profit-driven purposes that perpetuate existing inequalities. Furthermore, the
commodification of neural and biometric data must be prevented by managing such
data under data sovereignty, privacy, and informed consent principles. Ethical and
social oversight should be carried out by monitoring bodies with interdisciplinary
and community representation to assess risks, prevent misuse, and guarantee
respect for human rights.
4. Regulation should align with principles of solidarity and social, environmental, and
economic justice, ensuring fair and equitable access to the benefits of
neurotechnology and a just distribution of associated risks. Safeguards must be
implemented to prevent harmful uses, such as mass surveillance, cognitive
manipulation, and social exclusion while ensuring that regulatory frameworks
respect cultural diversity and different understandings of health. Mechanisms for
technology transfer and public financing must be established to enable regions with
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fewer resources to actively participate in neurotechnology research and
development.
5. Likewise, the democratization of knowledge must ensure transparency and the free
circulation of data and results, promoting open science and preventing their
concentration in corporations or specific groups. This transparency allows for public
scrutiny and informed decision-making. Additionally, implementing educational and
awareness programs for the general population and decision-makers is essential to
foster informed and reflective use that is aligned with ethical principles and oriented
toward collective well-being.
6. The regulation of these technologies must be dynamic, adapting to scientific
advances and the emerging needs of populations. This requires continuously
assessing the ethical, social, and political impacts of neurotechnology and
establishing mechanisms for public auditing and citizen participation. Only through
an ethical, political, and technical framework that prioritizes collective health,
self-determination, and equity can neurotechnology become a tool for advancing
social justice and global well-being.
7. Prioritize the right to health and life as a central ethical framework. Ensure that
neurotechnology is regulated and designed from a perspective that prioritizes
human well-being over economic and corporate interests. This implies that their
development and access should not be left solely to the market but should be
safeguarded by public policies that view health equity as an essential objective.
8. Incorporate epistemic justice. Acknowledge and value local, ancestral, and popular
knowledge about mental health and brain functioning, integrating them into the
design, evaluation, and use of neurotechnology. This will prevent these
technologies from reproducing colonizing dynamics and displacing knowledge that
has historically been marginalized.
9. Democratization of knowledge and active participation. Create deliberative and
participatory spaces where community actors, social organizations, and
marginalized collectives can voice their opinions and make decisions about the
relevance, design, and regulation of neurotechnology, ensuring that these
decisions are not solely in the hands of technical experts or corporate entities.
10. Redirect investment priorities in neurotechnology toward public health issues.
Focus investment on public health challenges such as neurodegenerative
diseases, community mental health, and neurological rehabilitation, addressing
these needs from a collective rather than individualistic approach.
11. Prevent the use of neurotechnology to increase labor productivity or perpetuate
capitalist exploitation and prioritize their use in improving people's living and health
conditions. This will influence regulations regarding the use of these technologies in
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educational and workplace contexts to prevent the creation of control or evaluation
mechanisms that perpetuate social inequalities.
Propositions
I. SCOPE OF APPLICATION AND DEFINITIONS
I.1. SCOPE
5. Covers the measurement, recording, and modification of the human nervous system,
the handling, analysis, treatment, storage, use, and reuse of the data collected, ensuring
privacy, informed consent, and sovereignty over the data, while preventing its
improper manipulation. Furthermore, a comprehensive analysis is required, along
with others of the social, economic, and environmental impacts, including the potential
emergence of new cognitive states, which must be evaluated under the principles of
self-determination and social equity;
Justification: This wording introduces an ethical and social approach that emphasizes
the need to protect individuals' rights over their neural data, aligning with principles of
social justice and equity. It acknowledges the risks associated with data management in
contexts where power dynamics may exploit these resources for purposes unrelated to
collective well-being. Furthermore, it frames new cognitive states as a phenomenon that
should be critically observed, avoiding the normalization of changes that could threaten
individual and collective identity or autonomy.
7. Further recognizes that humans develop and flourish in their interaction with other
human beings and a nurturing material and cultural environment, highlighting that
autonomy is not just individual but also relational, as it arises from and impacts one´s
interactions and belonging with the community. In turn, this autonomy influences social
dynamics, highlighting the interdependence and importance of socioeconomic and
cultural contexts for the full exercise of freedom and well-being;
Justification: This expression incorporates socioeconomic contexts as essential
processes for development and autonomy and justifies the need for a comprehensive
vision that recognizes interdependence in the development of the full exercise of
freedom and well-being.
II. AIMS AND OBJECTIVES
19. h. Establish an ethical, political, and technical framework that enables the
development, implementation, and regulation of neurotechnology under a health
sovereignty approach, ensuring that their access, use, and benefits are aimed at
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strengthening public health systems, reducing social inequities, and protecting
collective rights while avoiding their commercialization and guaranteeing the
technological self-determination of states based on the health needs of their
populations.
Justification: Ensuring that the development and use of neurotechnology address public
health needs, promoting equity and the protection of collective rights from a health
sovereignty approach, guarantees that technologies do not become instruments of
commercialization, but rather are used to strengthen public health systems and reduce
social inequalities. Additionally, it is essential to ensure that states maintain control over
technological decisions, respecting their autonomy based on the health needs of their
populations.
III. VALUES AND PRINCIPLES
III.1. VALUES
III.1.4. Consideration for cross-cultural perspectives and human knowledge and its
sharing
XX. The knowledge generated through scientific research and developments should
be transferred in a fair and accessible manner to communities, promoting the social
appropriation of knowledge. This implies that scientific and technological advances
should not only be utilized by academic or corporate elites but should be distributed
equitably, strengthening local capacity to apply and adapt this knowledge for the
benefit of collective health and well-being, while always respecting the cultural and
social particularities of each community.
Justification: We believe that the benefits of scientific knowledge must be guaranteed to
reach all communities equitably, promoting social justice in access to information and
technology. Transferring scientific advances fairly strengthens local capacities, allowing
communities to adapt this knowledge to their specific contexts, thereby improving their
collective health and well-being. Furthermore, by respecting cultural and social
particularities, a respectful and sustainable application of the generated knowledge is
ensured.
III.1.5. Commitment to peace, fairness, and justice in society
XX. Advances in neurotechnology should be directed towards contributing to the
processes of recovery and mental health care, addressing the damage caused by
global conflicts and wars, as well as the environmental crisis. These technologies
must be used to mitigate the psychological suffering of victims of violence,
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promoting emotional recovery and collective well-being. Furthermore, they must be
implemented within the context of social justice, ensuring that communities affected
by these traumas have equitable access to the benefits of neurotechnology,
fostering the reconstruction of social cohesion and respect for human rights.
Justification: We believe that directing these technologies towards the repair of damage
caused by conflict and environmental crises will contribute to alleviating the
psychological suffering of victims, promoting emotional recovery and collective
well-being. Furthermore, ensuring equitable access to these tools in the context of social
justice will help rebuild social cohesion and protect human rights.
III.1.7. Sustainability
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on
the Rights of Indigenous Peoples (UNDRIP), requires that neurotechnology, through its
whole lifecycle, be guided by a profound respect for Indigenous rights, ensuring that their
lands (including during mining), knowledge, communal rights, and privacy are honored in
all activities, including those related to resource extraction.
35. The implementation of neurotechnology must guarantee the self-determination
of indigenous peoples, by the United Nations Declaration on the Rights of
Indigenous Peoples, ensuring that these processes do not violate their rights to
domains, resources, knowledge, and community ways of life. Indigenous
communities must participate in an active and binding manner in all stages of the
life cycle of these technologies, from resource extraction to their implementation, by
respecting their free, prior, and informed consent and protecting their privacy. This
approach must avoid any practice that reproduces dynamics of dispossession,
colonization, or misappropriation of ancestral knowledge.
Justification: Positions Indigenous peoples as actors with the agency, not just recipients
of protection measures. By referring to "self-determination" and "free, prior and informed
consent", it incorporates principles that transcend simple respect, guaranteeing active
participation in decision-making. It also emphasizes the need to prevent colonizing
practices, recognizing the historical tensions that these communities face about the
processes of resource extraction and the appropriate knowledge.
III.2. ETHICAL PRINCIPLES AND HUMAN RIGHTS
III.2.2. Self-determination and Freedom of Thought
XX. In the context of indigenous peoples, the principle of self-determination must be
fully respected, ensuring that their cultural, social, political, and territorial rights are
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not compromised using neurotechnology. Indigenous peoples must have the
autonomy to decide whether to participate in any application of neurotechnology
while respecting their values, worldviews, and traditional practices. The
self-determination of these people also entails the right to define their models of
development and well-being, ensuring that technologies do not interfere with their
ancestral knowledge systems or undermine their cultural sovereignty. Furthermore,
informed consent processes should be adapted and accessible in their languages
and contexts, considering their community-based decision-making practices and
their right to self-determination in all matters related to neurotechnology.
Justification: It must be recognized and guaranteed that the cultural, social, and
territorial rights of indigenous peoples are protected. This ensures that they can make
autonomous decisions about their participation in using these technologies, respecting
their values and worldviews. Furthermore, it promotes the integration of their ancestral
knowledge systems and strengthens their cultural sovereignty, ensuring an inclusive and
ethical approach to the development and application of neurotechnology.
I.I.I.2.7. Epistemic Justice, Inclusive Engagement and Public Empowerment
62. Promoting open and accessible education, along with public and community
engagement, to ensure diverse populations can gain and exchange knowledge about
nervous system functioning, mental health, and medical and non-medical applications and
tools of neurotechnology. Likewise, fosters the transfer and social appropriation of
knowledge by various communities regarding mental health, the nervous system,
and developments in neurotechnology.
Justification: Social appropriation and knowledge transfer were incorporated because we
recognize the importance of these processes in promoting the democratization of
knowledge.
65. All communities should must participate have a voice in decisions that affect them,
particularly when it comes to the development and use of neurotechnology. Therefore,
they must be provided with the tools and instruments necessary to enable this.
Justification: The recognition of communities' voices and participation must be a
reciprocal process, not solely dependent on the communities themselves but also the
researchers. Researchers must facilitate the mechanisms, spaces, and tools necessary
to ensure that these voices and demands have a platform.
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I.I.I.2.9. Global and social justice, enjoying the benefits of scientific progress and its
applications
XX. The development and management of neurotechnology must aim to promote the
health sovereignty of countries, particularly those at a disadvantage in accessing
and ensuring fair and timely availability of essential resources to safeguard health
and life.
Justification: Ensure that the development and management of neurotechnology benefit
not only those with greater resources but also take into account the needs of
disadvantaged countries. Health sovereignty is a key principle that guarantees each
nation has control over its health policies, enabling it to access and distribute essential
resources equitably to safeguard the health and life of its citizens.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.17. POLITICAL AND ELECTORAL
xxx. Member States must develop strict policies that prohibit the use of
neurotechnology in political campaigns for manipulative purposes. The collection of
neural and cognitive biometric data must be conducted only with the explicit and
informed consent of voters. Technologies that subtly influence individual decisions,
such as "nudging," must be regulated to ensure that citizens are fully aware of the
methods used and can exercise their right to decide whether or not to participate.
This oversight is crucial to protect voter autonomy and prevent undue manipulation
during electoral processes.
xxx. To prevent abuses in the electoral realm, Member States must establish strict
regulations that ensure the mental privacy of voters, especially regarding the use of
neurotechnology. The collection of brain and cognitive data cannot be used to
interfere with citizens' political decisions without their informed and explicit
consent. Campaigns must be free from practices such as neuromarketing and sleep
manipulation, ensuring that any technology applied in this context is transparent
and does not affect the freedom of thought and decision-making of the voter.
xxx. Recommendation systems that use neurotechnology must be regulated to
prevent their use for manipulation or deceit, especially in the political realm.
Member States must require that all neurotechnology applications in this field be
carried out under a framework of explicit and informed consent. Political campaigns
employing these systems must ensure that citizens understand how their data is
used and can exercise their right to decide whether or not to participate. This will
help maintain the integrity of democratic processes.
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xxx. Member States must conduct regular audits and impact assessments of these
technologies in electoral processes, with special attention to their potential
influence on voters' decision-making. Technologies that may induce biases or alter
political opinions must be carefully evaluated to avoid unintended consequences
and, protect the well-being and autonomy of citizens in elections.
xxx. Member States must establish clear policies to prevent the use of technologies
that may alter individuals' political behavior without their knowledge. Furthermore,
measures must be implemented to prevent the exploitation of voters' emotional and
psychological vulnerabilities, ensuring that the electoral process is based on
informed decisions free from external manipulation.
Elaboró: Jennifer Cardona Malaver, contratista - Dirección Ciencia
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CÔTE D'IVOIRE
REPUBLIQUE DECÔTE D’IVOIRE
Union-Discipline -Travail
……………………… -----------------
LE DIRECTEUR DE CABINET
.……………………..
N°_________ /MESRS/CAB/DAJC/AJ Abidjan, le 30 décembre 2024
A
Madame la Sous- Directrice générale
Pour les sciences sociales et humaines.
UNESCO
Objet : Formulation des avis, observations, commentaires et suggestions relative à
l’avant-projet de Recommandation sur l’éthique des neurotechnologies.
Madame la Sous-Directrice générale,
Par courrier N°00-673/DPU-CI/SG/GGNK/FBT, en date du 11 octobre 2024, vous avez sollicité
des avis, des observations, commentaires et suggestions relatives à l’avant –projet de
Recommandation sur l’éthique des neurotechnologies.
Tout en accusant bonne réception, j’ai l’honneur de vous informer, que les services compétents
de mon Ministère, ont examiné le document avec une attention particulière.
Aussi, voudrais- je porter à votre attention que cet avant –projet de Recommandation sur
l’éthique des neurotechnologies, n’appelle aucune observation de notre part.
Je vous prie d’agréer, Madame la Sous-Directrice générale, l’expression de ma considération
distinguée.
Prof. Arsène T. KOBEA
219
DENMARK/ DANEMARK
Comment received from Dr Naimah Hussain, Danish Agency for Higher Education and Science,
Ministry of Higher Education and Science of Denmark:
220
FINLAND/FINLANDE
SHS/BIO/AHEG-Neuro/2024/2
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
Comments by Finland; 19th December 2024
I General Comments
The UNESCO recommendation, once completed, will be a welcome addition to the ethical quality
control instruments, also complementing the global UNESCO 2021 Recommendation on the Ethics
of Artificial Intelligence.
The draft recommendation appropriately emphasizes the importance of protecting human rights,
outlines key ethical principles and considerations (which are quite extensively explained), and gives
a comprehensive picture of different perspectives and stakeholders and of specific ethical problems
or challenges. Special attention is paid to vulnerable individuals and groups, which is important. At
the same time, the right of individuals to autonomy, freedom of thought and cognitive liberty could
be emphasized even further.
However, the recommendation needs to be considerably more concise and clearer, with the content
of the recommendation strictly aligned to the title. This requires a clear definition of
neurotechnology, as it defines the recommendation's core content. The need for other definitions
should be carefully considered, and if needed, they should be formulated as adjuncts to the main
definition of neurotechnology.
Several sections should be shortened for clarity: For example, the Scope (I.1.) of the
recommendation should be refined and shortened to avoid excessive breadth and ensure clarity.
The Scope should also be compared with the Aims and Objectives (II) to identify repetition or
overlapping elements. Likewise, there is certain repetition between the Values (III.1.) and the
Ethical principles and human rights (III.2.).
One way to clarify the recommendation could be to separately address the ethical risks and
considerations that affect individuals and those that impact societies, the environment and/or
ecosystems. In this sense, the sections/paragraphs on data and its processing should also be
gathered into one chapter.
The ethical issues should be clearly separated from the consequences they may cause. For
example, a key ethical concern of neurotechnology arises from the potential to influence thoughts
in previously unknown ways. Therefore, it is important to highlight the importance of ensuring
autonomy and freedom of thought, regardless of the specific technology used, and across all areas
of society and human life. Outlining an extensive list of possible consequences of a specific ethical
issue complicates the recommendation and makes it unnecessarily extensive.
The consistency of terminology needs to be verified throughout the document to avoid any
inconsistencies. Also, the terminology and structure of the document should be consistent with that
of UNESCO´s Recommendation on the Ethics of Artificial intelligence. Ethical principles should be
conceptually distinguished from universally accepted human rights. For example, while human
dignity is a fundamental and important ethical principle, and central to the concept of human rights,
it is not a human right as such. Human rights must remain a central focus in the recommendation.
It is also important to avoid overlap with other existing instruments or ongoing work at the
international level, such as UNESCO's Recommendation on the Ethics of Artificial Intelligence
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(2021) and OECD Recommendation of the Council on Responsible Innovation in Neurotechnology
(2019). The UNESCO recommendation should focus on gaps specific to ethics of neurotechnology
that are not covered by existing global frameworks.
Finally, the recommendation should include mechanisms for regular safety audits and transparent
reporting to track adverse effects and ensure reversibility of harmful interventions as
neurotechnology is advancing rapidly.
II Specific comments
PREAMBLE
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health
conditions, along with the profound suffering they cause for individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better
preventive and therapeutic treatments for millions, benefitting humanity as a whole and providing
opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
self-determination, privacy, personal identity, freedom of thought, risk of discrimination, inequality
and challenges to democracy, and that justice, trust and fairness must be upheld so that no country
and no one should be left behind, either by having fair access to neurotechnology and enjoying
their benefits or in the protection against their risks, while recognizing the different circumstances
of different countries and respecting the desire of some people not to take part in all technological
developments,
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security
by promoting collaboration among nations through education, the sciences, culture, and
communication and information, in order to further universal respect for justice, for the rule of law
and for the human rights and fundamental freedoms which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human
rights, as well as gender equality, social and global justice and development, physical and mental
well-being and health, diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide neurotechnology in a
responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development and
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policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General “to prepare a standard-
setting instrument on the ethics of neurotechnology in the form of a recommendation”, which is to
be submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration
on the Responsibilities of the Present Generations Towards Future Generations (1997); the
Universal Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on
the Rights of Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate
Change (2017); the Recommendation on Science and Scientific Researchers (2017); the
Recommendation on the Ethics of Artificial Intelligence (2021); the Recommendation on Open
Science (2021); the Human Rights Council’s resolution on “The right to privacy in the digital age”
(A/HRC/RES/42/15) (2019); the Human Rights Council’s resolution on “New and emerging digital
technologies and human rights” (A/HRC/RES/41/11) (2019), and the UN Guiding Principles on
Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to AI-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX day
of November 2025;
2. Recommends that Member States, with the support of UNESCO’s Secretariat, apply the
provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other measures may be required, in conformity with the constitutional practice
and governing structures of each State, to give effect within their jurisdictions to the
principles and norms of the Recommendation in conformity with international law,
including international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development and
use of neurotechnology are guided by both sound scientific research as well as ethical
analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
NOTE: Careful consideration should be given to which definitions are essential to include in the
document (in addition to that of neurotechnology). For example, lists of different technologies can
quickly become outdated as new technologies emerge.
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I.1. SCOPE
This Recommendation:
1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing and on the enjoyment of human rights.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (DTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to
animals in research.
4. Approaches neurotechnology ethics as a systematic normative reflection based on a
holistic, multicultural, multidisciplinary, pluralistic and evolving framework of interdependent
values, principles, and actions that can guide societies in dealing responsibly with the impacts of
neurotechnology on human beings, societies, and the environment and ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the
prevention of harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from
neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology and other disciplines.
5. Covers the measurement, recording, and modification of the human nervous system,
the handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because
the highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to
be responsible for actions, cooperate with others, deliberate about collective decisions and
develop personality.
7. Further recognizes that humans develop and flourish in their interaction with other
human beings and a nurturing material and cultural environment, highlighting that autonomy is
not just individual but also relational, as it arises from and impacts one’s interactions and
belonging with the community.
8. Addresses the ethical and human rights concerns that arise from the rapid
developments and the convergence of neurotechnology with other technologies such as spatial
computing, extended reality (XR), artificial intelligence (AI), sensors and semi-conductors.
Notably, other biometric data when processed to infer sensory, motor, and mental states raises
similar ethical concerns. Therefore, this Recommendation applies to both neurotechnology and
the use of cognitive biometric data, ensuring that ethical principles and practices are consistently
applied across these domains.
9. Further addresses the integration of AI with neurotechnology, which can enhance
precision and predictive capabilities, such as improving processing speed, reducing cost,
optimizing neurotechnology systems. However, it also magnifies ethical threats, including
cybersecurity concerns, lack of transparency, the potential for algorithmic bias, and risks to
autonomy, mental privacy and of manipulation.
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10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications of
neurotechnology. Calls on all concerned to act responsibly with regard to neurotechnology.
NOTE: The phrase “dual use” should be mentioned here as a key word for the ethical
considerations.
I.2. DEFINITIONS
11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include
cognitive, affective, and conative states), and supports consciousness, sleep and the experience
of pain. The nervous system activity and structure provide information inherent to all human
beings and the community, regardless of gender, ethnicity, language, or religion. The nervous
system activity is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures—
encompassing both hardware and software—that directly access, monitor, analyze, predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity,
function, or intentions (speech, motor). Neurotechnology combines elements of neuroscience,
engineering, and computing, among others.
13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction with the
nervous system or by interfacing it with devices and systems. It includes but is not limited to:
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical,
optical, magnetic and/or mechanical), chemical and biological signals associated
with the structure of and functional signals from the nervous system. These may
be used to identify, record, and/or monitor properties of nervous system activity,
understand how the nervous system works, diagnose pathological conditions, or
control external devices (brain machine interfaces (BMI), often referred to as brain
computer interfaces (BCI)). Of note, both open-loop (i.e., fixed-parameter brain
stimulation) and closed-loop systems (i.e., state dependent stimulation) introduce
complex ethical issues.
(i). Examples include but are not limited to Electroencephalography
(EEG), Magnetoencephalography (MEG), Magnetic resonance
imaging (MRI), Functional Magnetic resonance imaging (fMRI),
Positron emission tomography (PET), Functional Near-infrared
spectroscopy (fNIRS), Implanted microelectrodes, Optogenetics,
Optical imaging, Diffusion weighted imaging, Calcium imaging,
Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for
example, to restore sensory input, such as hearing (i.e., cochlear implants) or
Deep Brain Stimulation (DBS) to treat tremors and other pathological conditions.
They are meant to either modulate the functions of the nervous system and/or
send signals directly to the nervous system by applying acoustic, electrical,
magnetic or optical stimulation and/or inhibition of the peripheral or central
nervous system.
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(i). Examples of this neurotechnology are implanted microelectrodes,
BMI, DBS, Optogenetic optical stimulation, Transcranial electrical
stimulation (tES), Transcranial Magnetic Stimulation (TMS) or
Neuropharmacological infusion.
NOTE: If the para 13 with long lists are kept in the text, we propose adding High-Intensity
Focused Ultrasound (HIFU) to the list of methods used clinically to create local lesions in the
brain.
14. Of note, several sensor technologies collect data indirectly informing about neural
activity. Even if they are not neurotechnology per se, they raise similar ethical and human rights
issues as neurotechnology when used to infer mental states. They include but are not limited to
eye-tracking, Video Oculography, Typing dynamics, Voice recognition and analysis, Gait
analysis, Skin conductance, Heart rate variability, Sleep movement monitoring, Blood pressure
measurement, or facial- emotion recognition systems.
NOTE: If the para 14 with its list is kept in the text, we propose adding motion tracking in the list.
Motion tracking is already widely used in consumer devices.
15. Neural data. Neural data are qualitative and quantitative data about the structure,
activity and function of the nervous system. They encompass data relating to a nervous system’s
activity, including both direct measurements of neuronal structure, activity and/or function (i.e.,
neuronal firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e.,
blood flow in fMRI and fNIRS). At the neurobiological level, neural data are the most direct
correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non-neural
biometric technologies can be processed to infer mental states, which this Recommendation
refers to as “cognitive biometric data”.
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining
for materials, prototyping, research, design and development to deployment and use, including
maintenance, operation, trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology
includes its convergence with other technologies and the diversity of actors who are involved in
every stage.
II. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the development and
use of neurotechnology in ways that are ethical, safe and effective for the good of humanity,
individuals, communities, societies, the environment and ecosystems, and to prevent harm in the
present and the future based on international law, in particular the Charter of the United Nations
and international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity and equality, including gender equality, and to respect
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cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities,
institutions, private sector companies and every other relevant actor to ensure the
embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable
and reproducible;
(d) to provide a universal framework that not only articulates values and principles,
but also translates into concrete policy recommendations and effective
implementation to guide Member States in their engagement with
neurotechnology in its whole lifecycle, consistent with their obligations under
international human rights law and other international standards;
(e) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and
consensus building about ethical issues relating to neurotechnology;
(f) to promote justice and equitable access to developments and knowledge in the
field of neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.
NOTE: Point g is very important, as it clearly addresses the potential for misuse.
It is unrealistic to assume that neurotechnology will only be used for good
purposes. Moreover, even when used for beneficial aims, it may still lead to
unwanted or harmful consequences.
III. VALUES AND PRINCIPLES
III.1. VALUES
III.1.1. Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
20. The inviolable and inherent dignity of every human being is the foundation of universal
human rights and fundamental freedoms. Respect, protection, and promotion of human dignity,
as established by international human rights law, are essential in the whole lifecycle of
neurotechnology. Dignity encompasses the recognition of the intrinsic and equal worth of each
person. Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including people living in
vulnerable situations.
III.1.2. Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical,
mental, and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the
largest number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
NOTE: The words “…rather than consumer-driven or commercial applications” should be
removed if the allocation of resources is thought here to refer to a state level actor, rather than
the private sector.
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III.1.3. Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of
neurotechnology. Special consideration should be given to neurodiversity, minority groups,
Indigenous Peoples, and underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban
well-resourced sector, specific attention to underserved and marginalised people is crucial to
prevent bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological
assimilation, or using technology as a tool of colonisation (a term the Recommendation refers to
as “technological colonialism”), can threaten cultural diversity and heritage, therefore must be
protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its
benefits are accessible to all, regardless of socioeconomic status or geographical location.
Special attention must be given to low- and middle-income countries, resource-constrained
settings, and marginalised communities, including the specific needs of different groups, ages,
segments, cultural systems, languages, communities, and marginalised and vulnerable
populations, people with disabilities, neurological disorders, and mental health conditions.
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided
that these choices are made in ways that respect the rights of others.
NOTE: Does lifestyle choices fall within the scope of neurotechnology? Suggestion is to delete
this para.
III.1.4. Consideration for cross-cultural perspectives on human knowledge and its sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
28. It is essential that any research and development involving diverse groups and
communities is done with their permission and guidance, and conducted with their full prior and
informed consent and partnership in ways that serve their interests and respect their traditional
knowledge and epistemic contributions.
III.1.5. Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of
thought especially in situations where refusal to use the technology could lead to competitive
disadvantage. Such interferences include but are not limited to the use of force, threats,
undisclosed access, manipulation, or any scenario where consent is compromised, including as
a result of power imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that
segregate, objectify or subordinate individuals or communities, reduce social cohesion by
exacerbating pre-existing inequalities or generating novel inequalities that divide and antagonize
individuals against each other, and thereby threaten the coexistence between humans, other
living beings and the natural environment.
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III.1.6. Global Solidarity and International Cooperation
31. The Recommendation should guide all actors in the development, deployment and use
of neurotechnology to act in solidarity and call for accountability in instances where
neurotechnology may be misused in ways that threaten human rights.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use
to prevent abuse and uphold global ethical standards.
III.1.7. Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used
with a deep respect for environmental stewardship, prioritizing the minimisation of ecological
harm throughout the lifecycle of the materials used, including, for mining extraction, data
processing and storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
NOTE: This point has no normative aspect in it. It should be left out or rephrased in a way that it
has normativity.
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP), requires that neurotechnology, through its whole
lifecycle, be guided by a profound respect for Indigenous rights, ensuring that their lands
(including during mining), knowledge, communal rights, and privacy are honoured in all activities,
including those related to resource extraction.
III.1.8. Integrity and Responsibility
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with
ethical steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align
with both professional standards and societal values.
37. Integrity includes a commitment to taking responsibility for one’s actions and being
accountable for their outcomes. This involves not only acknowledging successes but also owning
up to mistakes and taking corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-
based, objective and transparent research practices. It ensures that all scientific endeavours are
conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant
for neurotechnology.
III.2. ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred approach through fundamental
ethical principles including but not limited to self-determination, agency, freedom of thought,
privacy, cognitive liberty, personal and collective identity, trustworthiness, respect, reciprocity,
and justice. Furthermore, it incorporates the respect, promotion and protection of human rights.
III.2.1. Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and well-being, and empower individuals to
make informed decisions about their nervous system and mental health while fostering a better
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understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally. The
“do no harm” principle must guide the whole lifecycle of neurotechnology, ensuring that the
quality of life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only
unexpected damage to the nervous system, but also to amplified inequalities within society.
NOTE: This point has no normative aspect in it. It should be rephrased in a way that it has
normativity.
43. Any restrictions to human rights must meet all applicable requirements under human
rights law, including the principles of legality, legitimate aim, necessity and proportionality.
44. The principles of proportionality, balance and legitimacy should govern the use of
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon
the foundational values of this document; (c) appropriate to the context and target user group;
(d) based on safety principles and rigorous scientific evidence.
III.2.2. Self-determination and Freedom of Thought
45. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the
rights of freedom of thought, and self-determination must be secured.
46. Individuals have the right to make free, informed, and voluntary decisions about their
engagement with neurotechnology throughout the whole lifecycle, in accordance with
international human rights law and other international standards, including the right to refuse or
withdraw from its use, at any time, ensuring their autonomy and respect for their decision-making
capacity is upheld and where surrogate consent is used, the best interests of the affected
individual are considered. Individuals who are enrolled in research should be informed of
potential side effects and given the opportunity to disclose if they have any contraindications for
the procedures used. Informed consent procedures should be affirmative, dynamic, and require
opt-in, comprehensive and transparent providing detailed information about the purposes, risks,
benefits, alternatives, and possible outcomes of the technology in all its application domains,
ensuring that consent is voluntary and that individuals fully understand the implications for their
privacy, autonomy, and well-being.
NOTE: This aim encompasses multiple challenges: no-one knows the full effects of
neuromodulation treatments because we do not have a proper model of the system. The
researchers have identified a need to develop a so called “virtual brain twins”, a special case of
a “digital twin” in order to better understand and direct individualized treatments.
47. Neurotechnology should never be used to exert undue influence or manipulation,
whether through force, coercion, or other means that compromise self-determination and
freedom of thought. This protection covers both the internal processing of thoughts and their
external expression, ensuring freedom from any interference.
III.2.3. Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the
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right to privacy due to their increasing ability to collect direct and indirect data about the nervous
system that is uniquely sensitive because they can be processed and analysed to provide deep
insights into the processes that underpin our mental states and behaviour, including self-
awareness and introspection. As it becomes increasingly difficult to anonymize data, there
remains persistent risks of misuse of this data by revealing neurobiological correlates of
diseases, disorders, or general mental states without the authorization of the person from whom
data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural data must be conducted
with free and informed consent, in ways that respect the ethical and human rights principles
outlined in this Recommendation.
50. There should be clear safeguards against the misuse or unauthorised access of neural
and cognitive biometric data, including affirmative consent, data minimization and purpose
specification, data rights (such as rights to access, correct and delete), and data security,
particularly in contexts where such data might be aggregated with other sources.
III.2.4. Non-Discrimination and Inclusivity
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface
with other technologies like AI, must commit to upholding ethical principles that prevent
discrimination, stigmatisation, targeting, or exploitation of any individuals or groups, particularly
those in vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or
mental characteristics, or other grounds protected under human rights law.
53. Non-inclusive technological development and standardisation may drive a trend toward
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural
and collective identity.
54. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their input and
validation to align these technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or
discrimination against older persons.
NOTE: In addition to age, discrimination may also target other demographic characteristics, such
as gender, ethnicity, etc. Therefore, the recommendation should emphasize preventing social
inequalities for all individuals: “…against any person”.
III.2.5. Accountability
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology
requires all actors to adhere to the highest ethical standards, remain open to feedback, be
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committed to adjusting practices in response to new evidence or ethical concerns, and be held
accountable for their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and
a duty to anticipate and address potential harms—whether short-term, long-term or arising from
unintended use and impact.
59. A commitment to accountability requires global, governmental, societal and collective
action to ensure those harmed by neurotechnology have access to justice, and that those
responsible for wrongdoing are required to take meaningful steps to identify, prevent, mitigate
and account for how they address and redress their adverse human rights impacts, including
through corrective actions and reparations.
III.2.6. Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection of human rights and fundamental
freedoms, all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international
principles of responsible conduct and scientific integrity. This includes preventing the replication
or amplification of biases, ensuring that neurotechnology is traceable and explainable, its
capacities and limitations are accurately portrayed, the conditions for accountability are clearly
defined, adhering to ethical guidelines in research and development, including the registration of
trials, fair participant selection, and approval by independent ethics committees.
III.2.7. Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about
neurotechnology, including recognizing diverse ways of knowing, and that all individuals and
communities can participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community
engagement, to ensure diverse populations can gain and exchange knowledge about nervous
system functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and
identity, to respect different ways of knowing and understanding. This respect for diversity
ensures that the knowledge and perspectives of diverse communities are valued and included in
decision-making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may be
marginalized or excluded from knowledge production and dissemination.
65. All communities should have a voice in decisions that affect them, particularly when it
comes to the development and use of neurotechnology.
III.2.8. Best Interests of the Child and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right of
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children and adolescents to participate in decisions that affect them. Technology should be
rigorously assessed to ensure it serves the best interests, well-being and healthy development
of children, as they grow into autonomous individuals and safeguard the rights of future
generations by ensuring that today’s decisions promote their future wellbeing.
NOTE: The best interests of the child should be assessed in a systematic, multidisciplinary
manner, taking into account the child’s view. The child impact assessment (CIA) can be used as
a tool to support the assessment process.
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology
for early diagnosis, instruction, education, and continuous learning, it is equally important to make
a commitment to the holistic development of the child. This includes nurturing their social life,
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and
physical activity.
NOTE: To promote this, it is important to engage in multi-professional cooperation between, for
example, professionals in health care and education.
III.2.9. Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must
be shared equitably among all contributors to that research and development, with a particular
focus on ensuring global distribution that promotes fairness and reduces disparities.
69. Neurotechnology developments should be leveraged to reduce global health inequities.
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings.
70. Research, development, and trials in neurotechnology must adhere to the highest
ethical standards, ensuring the non-exploitative participation of all individuals involved. This
includes safeguarding the rights and well-being of participants, and patients and their caregivers,
as well as ensuring the ethical collection and use of data. Special attention should be given to
ensure that those contributing to research and development have their fair share of the benefits
and do not bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never
take advantage of, the lack of necessary technological or medical infrastructure, education and
skills, as well as ethical-legal frameworks, particularly in LMICs, LDCs, LLDCs and SIDS,
affecting communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive
recipients of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1. GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
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promotes and protects individual and collective human rights. This commitment should include
funding for interdisciplinary research that not only advances neurotechnological innovation but
also studies the ethical, legal, social, environmental and cultural implications of these
technologies, and supports the implementation and clinical translation of technological
prototypes. Particular attention should be given to the development and implementation of
adequate technical, institutional, procedural and other safeguards to ensure that they equitably
benefit society and that human rights are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology
in contexts that violate individual and collective human rights. Member States should conduct
human rights due diligence, including regular, comprehensive human rights impact assessments,
concerning neurotechnology that they develop, design, deploy, use, sell, operate or procure, in
order to prevent and mitigate their adverse human rights impacts. Specifically, neurotechnology
should not be used for purposes such as non-consensual interrogation in law enforcement,
criminal and civil justice, development or deployment of weapons targeted at the nervous system,
social control, attempts at coercive behavioural conformity based on personal beliefs or thoughts,
political or other opinion, gender identity or sexual orientation, or surveillance of mental states,
among others. Governments should adopt legislation that ensures neurotechnology is deployed
responsibly, and based on human rights, with robust oversight mechanisms to enforce
adherence to these restrictions and protect mental privacy and freedom of thought for all
individuals. These policies should be developed in consultation with diverse actors, including civil
society, end-users, neurotechnology experts, ethicists, and human rights advocates, to ensure
broad consensus and respect for global human rights norms.
75. Member States should ensure transparency and accountability in their support,
oversight, and regulation of neurotechnology, particularly in publicly funded initiatives such as
brain research and development programs. While recognizing the limitations in disclosing certain
sensitive information, governments should require government sponsored neurotechnology
projects to publicly disclose the objectives, methodologies, intended uses, and societal impacts
of their neurotechnology initiatives wherever possible. This transparency is crucial for fostering
public trust and ensuring that neurotechnology advances are aligned with ethical standards and
human rights.
76. Member States should apply a comprehensive approach to regulatory and policy
measures to protect against human rights harms related to neurotechnology developed,
marketed, operated or used by the private sector. This includes legislative and regulatory
measures and accompanying guidance, incentives, and transparency requirements. This
comprehensive approach should also require human rights due diligence, ensuring that
businesses identify, prevent, mitigate, and account for their adverse human rights impacts
through context-dependent processes, including human rights impact assessments, meaningful
public and community engagement, and transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, be
implemented ethically in accordance with human rights, and be aimed at promoting public safety
while protecting the rights and dignity of all those involved. This requires respect for fundamental
rights, such as human dignity, bodily integrity, confidentiality of personal data, due process and
fair trial rights, including the presumption of innocence, and the right against self-incrimination,
as well as freedom from torture and ill-treatment, the right to privacy, and the right to freedom of
thought.
78. Member States should establish comprehensive incentive structures, such as tax
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incentives, grants, and awards, with a particular focus on encouraging the construction and
development of manufacturing, computational resources, and data analytics capabilities within
public research institutions and small and medium enterprises (SMEs). Member States should
also incentivize and support partnerships that leverage the computational resources and data
analytics capabilities of private firms to advance public research goals. These incentives should
prioritize rewarding transparency, participatory development processes, and contributions to
societal benefits, aiming to foster an environment where public institutions and companies
innovate responsibly and align with human flourishing goals.
NOTE: This statement about prioritization is quite general and the connection to neurotechnology
remains unclear. Suggestion is to delete the para.
79. Member States should establish a coordinated, cross-sectoral approach to assessing
the impacts of neurotechnology across the whole lifecycle. This approach should include, but is
not limited to:
(a) Economic Impact Assessments: Conducted by relevant national bodies
responsible for economic and labor policies to assess how neurotechnology
impacts economic growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by entities responsible for public health,
medical research, and consumer protections, these assessments should
rigorously evaluate the risks and benefits associated with the development,
deployment, and use of neurotechnology, including research, clinical applications,
and consumer products. The process should include thorough documentation,
ethical oversight, and continuous monitoring to ensure the safety, well-being, and
equitable treatment of all individuals involved;
NOTE: In this para “research, clinical applications, consumer products” are taken
well into account. The same division has not always been identified in other
sections where it could be relevant.
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these
assessments should evaluate and mitigate risks to individuals’ mental privacy
posed by neurotechnology. This includes ensuring that appropriate safeguards
are in place to protect neural and cognitive biometric data in compliance with
national and international privacy standards, and the data policy practices
discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology. The process should ensure
that neurotechnology respects and promotes human rights, with particular
attention to vulnerable people and people living in vulnerable situations. HRIAs
should involve meaningful public and community engagement to incorporate
diverse perspectives.
80. Member States should promote equitable access to neurotechnology worldwide. To
achieve such goals, efforts should be made to support the reduction of final costs for end users,
pursue the development, adoption and continuous support of non-proprietary software solutions,
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and explore reimbursement strategies or subsidisation commensurate with conventions in local
jurisdictions, in sectors of crucial potential benefits.
81. Member States should adopt agile regulatory frameworks, including the use of
regulatory sandboxes—controlled environments for developing, testing, and evaluating
neurotechnology—in response to rapid advancements in neurotechnology and its convergence
with other technologies such as AI, spatial computing, and immersive technologies. These
sandboxes should be used to explore innovative applications, particularly in workplace settings,
with appropriate ethical oversight provided by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure ethical data processing, and safeguard rights by
incorporating mechanisms for regular monitoring, evaluation, and dynamic policy adjustments in
line with technological and ethical developments.
IV.2. DATA POLICY
82. Member States should develop a robust regulatory and framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data. This
and existing frameworks should recognize this data to be both personal and sensitive data in
medical and non-medical contexts.
83. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals’ neural and cognitive biometric data. If current policies do not
adequately address these areas, Member States should adopt targeted legislation or regulatory
frameworks to secure these protections. These safeguards should for example include
affirmative informed consent, data minimization and purpose limitation, data rights (including the
right to access, correct, and delete data), and stringent data security measures, such as
advanced cybersecurity protocols to prevent unauthorized access and breaches. Such
legislation or frameworks should prohibit the practice of tying access to goods or services to the
disclosure of neural and cognitive biometric data, require explicit opt-in for any data sharing, and
forbid the use of such data for targeted advertising without the individual’s explicit, affirmative
informed consent.
84. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and computing
resources used for processing and storage of neural and cognitive biometric data. These policies
should emphasise data minimisation, ensuring that only the necessary amount of data is
collected and processed, and promote the proportional use of neurotechnology, aligning its
deployment with genuine needs and minimising unnecessary environmental impact. Measures
should include optimising energy efficiency, using renewable energy sources, promoting the
recycling and sustainable disposal of neurotechnology-related equipment, and ensuring the
rehabilitation of affected environments.
85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, such as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy
and ethics by design, requiring the incorporation of privacy-preserving technologies as default
features in their devices.
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87. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories should
meet stringent cybersecurity, data privacy, and ethical use standards (including data
minimisation and purpose limitations), tiered access and other privacy-enhancing approaches.
Appropriate funding mechanisms should be established for the curation and maintenance of data
and data governance processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing
in neurotechnology research, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive biometric data, by establishing clear protocols for
data transfer that ensure secure and compliant data exchanges across borders, and standards
for interoperability of data, including governance frameworks for data sharing.
89. Member States should consider specific guidelines for the ethical use of neural and
cognitive biometric data in AI development and research, including consent procedures for uses
of neural and cognitive biometric data in training and application of AI models, ensuring
transparency and respecting individual and community rights.
IV.3. INTELLECTUAL PROPERTY (IP)
90. Member States should adopt policies to ensure that neural and cognitive biometric data,
as individual human activity derivatives, are not subject to proprietary rights. IP protection should
only apply to original data compilations (created through a process of aggregation, organization,
or selection, resulting in a new dataset) that meet strict and ethical criteria.
NOTE: This is important. Any extensions of IP protection should always be based on thorough
evaluation. Especially copyright has a very long (automatically generated) term of protection to
the author when conditions for protection are met.
91. Member States should collaboratively establish clear, harmonised guidelines for IP
rights applicable to neurotechnology on an international scale. These guidelines should address
the patentability of AI-generated inventions and the ethical implications of IP laws, ensuring they
promote global accessibility and innovation.
92. Member States should ensure that all actors adopt IP management strategies that
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility.
93. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors.
94. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing.
Particularly with the convergence of digital technologies and the increasing concentration of
those innovations in industry sectors, this balance is crucial to ensure that IP protection
mechanisms do not hinder scientific research, innovation, and the wide dissemination of
knowledge and new technologies. As a basic rule of equitable partnership, when Indigenous
Peoples are involved in neurotechnology research and development, open science processes,
IP management strategy, should be developed in collaboration with them from the beginning.
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NOTE: This point should mention data privacy. Furthermore, the concern here is only for
Indigenous Peoples. Other marginalized groups and local communities should be mentioned as
well.
IV.4. CYBERSECURITY
95. Member States should collaborate internationally to establish comprehensive standards
for cybersecurity across all neurotechnology domains. These standards should encompass
hardware, software, and data security measures to protect against potential cyber threats. By
implementing uniform cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data, as well as enhance user trust and
confidence in neurotechnology devices. Additionally, these standards should evolve in tandem
with technological advancements and emerging cyber threats to maintain robust protection
against evolving risks.
96. Member States should employ red-teaming exercises—adversarial challenges to test
the efficacy of security systems—as a proactive measure to assess and enhance the safety,
security, and resilience of neurotechnology systems. By conducting regular red-teaming
exercises, Member States should proactively identify and address security gaps, test incident
response procedures, and strengthen the overall safety and cybersecurity posture of
neurotechnology devices.
IV.5. COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
98. Member States should collaborate with international organizations, educational
institutions, and private and non-governmental entities to develop and disseminate accessible
and engaging educational materials tailored to diverse audiences to bridge knowledge gaps,
particularly in underserved regions about the nervous system and mental health functioning, as
well as the benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies’ functionality, safety, efficacy, and societal impact,
empowering individuals to make informed decisions and to enable their ethical reflection about
their use of neurotechnology.
NOTE: This is an important paragraph.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a
wide array of actors. The aim of these engagements should be to inform policy development,
shape ethical guidelines, increase public awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment aligns with public interests and values.
Special attention should be given to involving groups traditionally underrepresented in
technological policymaking, thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation of accurate, precise, and
accessible language and terminology for discussing neurotechnology that involves actors from
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diverse backgrounds to ensure that the language used is inclusive, non-stigmatizing, and
accurately reflects the technologies’ capabilities and limitations. Member States should establish
regulatory frameworks that require clear and ethical communication standards for
neurotechnology. These frameworks should require evidence-based reporting of capabilities,
risks, and limitations across all applications to avoid exaggeration of claims, including but not
limited to applications in sleep, attention, memory, and emotional regulation. Within these
frameworks should be specific guidelines for ethical marketing and protocols for responsible
communications about early-stage research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end-
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-
compatible and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally-
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user
and for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6. CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that
evaluate the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit and explicit
coercion to use neurotechnology. Member States should pay attention to the autonomy of
children and adolescents through informed consent and assent that is adapted to and respectful
of age and decision-making capacity.
105. Member States should fund research and development grants focused on creating user-
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children, adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed
to teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
NOTE: When developing and providing neurotechnology to people with a disability or long-term
disease, their personal wishes and views on what constitutes a good life should be respected. It
should be noted that the needs and wishes of disabled and non-disabled individuals may differ
and yet both are equally valid and valuable.
106. Member States should ensure research involves strict oversight and close follow-up of
all neurotechnology research involving children and adolescents. This oversight is crucial during
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the developmental phases of childhood to address and mitigate any unforeseen long- term
effects. Such research must include comprehensive monitoring protocols and periodic
evaluations to ensure the ongoing safety and well-being of young participants, taking into account
their unique developmental needs and vulnerabilities. In the framework of research, involving
children and adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring
units), special attention will be given to consent and assent, particularly considering particular
aspects of research (time, iterations) to prevent any form of instrumentalization.
NOTE: Children's acceptance of research should be based on age-appropriate information and
the opportunity to express their opinions in a way that suits them, such as through alternative
communication methods.
107. Member States should enact specific regulations that prohibit the use of marketing
techniques—such as neuromarketing, biometric emotional analytics, immersive advertising, and
virtual or augmented reality advertising—that rely on sensitive neural and cognitive biometric
data collected from children and adolescents. Recognizing the heightened vulnerability of
children and adolescents in digital environments, these regulations must explicitly forbid any
practices that use such data to influence or exploit children and adolescents.
NOTE: Through education, children and young people must be given the skills to identify and
protect also themselves from this kind of marketing.
IV.7. OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by funding
and implementing evidence-based programs that integrate neurotechnology into routine care.
These programs should involve the entire support ecosystem, including family, caregivers, and
medical teams, to enhance quality of life. Priority should be given to developing and implementing
tools that prevent, delay, and treat age-related health conditions, impairments, and
neurodegenerative diseases. Member States should ensure that access to these
neurotechnology programs is equitable and does not exacerbate socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making
for older people using neurotechnology for sensorimotor and cognitive support. The consent
process should accommodate potential cognitive challenges faced by older adults, ensuring that
consent is informed, ongoing, and adaptable to changing health conditions. Policies should be
in place to ensure that assistive neurotechnology recognize changing cognitive capacities over
time and respect users’ preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such
as robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8. WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive policies that promote and
respect gender equality and diversity in the whole lifecycle of neurotechnology. The policies
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should prioritize inclusive research for addressing women and gender specific needs and
differences, require targeted data collection and analysis, include education and training
programmes on inclusive research practices, ensure public and community engagement with
women and gender health experts and advocacy groups and, incentivise gender responsive
technology design, to meet the needs and conditions specific to women and gender minorities.
Affirmative action policies are necessary to close gender gaps in these fields, increase
representation, engagement and leadership.
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women and gender minorities, and safeguard against
harassment and discrimination. This should include robust mechanisms for reporting and
addressing incidents of harassment and discrimination, ensuring accountability and support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women’s and gender minorities’
participation in neurotechnology. This includes funding and other policies that prioritize ethical
and equitable research and innovation, but also affirmative action initiatives to support the
participation of women and gender minorities in neurotechnology through targeted education
programs, employment opportunities, entrepreneurship support, and leadership development
within the sector. Member States should also provide support systems such as mentorship
programs, networking opportunities, and resources to help women and gender minorities
overcome barriers to participation and succeed in the neurotechnology field.
IV.9. PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support
thereby contributing to achieving equal enjoyment of human rights. They should implement
regulatory frameworks that require accessibility assessments for all new neurotechnology
products to ensure these products do not perpetuate existing disabilities or health disparities.
These frameworks should include protocols for testing with diverse groups of persons with
disabilities to ensure technology meets a wide range of needs and does not unintentionally
exclude or disadvantage any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their quality of life and functional
independence. These programs should include tax incentives for companies investing in
assistive neurotechnology research and development, grants for research institutions focusing
on neurotechnology for disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living assistance, and innovation
prizes for breakthroughs in affordable, accessible neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential
neurotechnology devices, such as neuroprosthetics, for persons with physical disabilities. They
could encourage public-private partnerships to make advanced neurotechnology affordable and
integrate neurotechnology coverage into national health insurance and other reimbursement
schemes for persons with physical disabilities. A national database of available neurotechnology
resources and support services should be developed to facilitate access and information sharing.
IV.10. PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to
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address the increasing prevalence and special needs of people with mental health conditions,
including victims and survivors of trauma and violence, and the relevance of neurotechnology for
these communities.
119. Member States should allocate funding for long-term advocacy and efficacy studies,
post-market oversight, and tiered scrutiny with special attention to invasiveness and reversibility
of neurotechnology interventions. It is important to ensure that people with mental health
conditions are well-informed and have reasonable expectations about the process.
120. Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11. HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
NOTE: Why should the recommendation guide the priority of applications and their intended use?
The suggestion is to delete the paragraph.
123. Member States should build and maintain international solidarity to address global
health risks and uncertainties, and ensure that their implementation of healthcare for the nervous
system is consistent with international law and rigorous human rights obligations. This could
involve creating international forums for sharing best practices in the implementation of
neurotechnology in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and
mental health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results.
125. Member States should consider the significant cost and impact associated with
pathologies related to the nervous system, as well as the potential benefits of early diagnosis
and access to preventive and assistive neurotechnology. Public policies should prioritize the
promotion of access to these technologies and ensure health cost coverage for individuals in
need.
126. Member States should promote the development of reliable and durable
neurotechnology for healthcare applications. This includes encouraging the design of devices
and systems that require minimal maintenance, ensuring they remain functional and effective
under everyday conditions. Regulatory bodies or designated authorities should oversee the
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enforcement of rigorous standards for quality, safety, and longevity, thereby reducing the burden
on users and enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States should ensure the development or strengthening of existing
comprehensive neurotechnology medical device reporting systems that track and address
adverse effects. In contexts where such systems do not exist, Member States should establish
them. Where systems are already in place, they should be updated to specifically include
neurotechnology. These systems should be interoperable and contribute to a centralised, public,
and transparent international database, managed in collaboration with international
organizations, to ensure that global standards are met and accessible for public knowledge,
international oversight and research.
IV.12. RESEARCH ETHICS
128. Member States should reinforce the ethical frameworks governing neurotechnology
research to ensure robust protection of human participants. Member States should adopt clear
guidelines or policies that define the qualifications to ensure that research is conducted by
professionals with appropriate knowledge about the nervous system structure and function in
addition to brain disorders and is performed in adequate research settings. Furthermore,
research protocols, public or private, in the medical as well as the non-medical domain, should
be carefully evaluated by registered ethics boards (ethics committees) and specific attention
dedicated to individuals with special situations regarding vulnerability such as diminished
capacity to consent or to make decisions. Member States should ensure that all research
institutions have mandatory ethics training for researchers.
129. Member States should encourage multicentre international research that involves
various cultures and ethnic groups. Member States should promote international cooperation to
develop common reporting standards and protocols for interoperability, particularly for
implantable neurotechnology devices. This cooperation should aim to enhance the comparability
and utility of research globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered
in the design of a clinical trial, including policies to protect patients in case of cessation of
activities of the trial sponsor or promoter. Member States should establish requirements for
clinical trials to be included in relevant nationally or internationally approved registries, and
encourage registration with community and patient registries. Also, clinical trials should report on
appropriate medical device reporting systems developed within Member States.
131. Technology developers should ensure that the validation of AI algorithms in
neurotechnology research include rigorous testing for biases, as well as measures to enhance
explainability and transparency, including the provenance of training datasets. Suitable
techniques should be employed to mitigate any biases present in AI models used in
neurotechnology applications.
132. Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual’s
subjective experience, agency and personal identity. Understanding how neurotechnology may
impact aspects of self-perception, consciousness, and identity is essential for addressing ethical
concerns and ensuring the well-being of individuals using these technologies.
133. Member States should ensure those engaged in research implement regular auditing
and monitoring of research practices to ensure adherence to ethical standards. This should
include evaluating the adequacy of informed consent, particularly concerning data reuse and the
potential commercialisation of neural data.
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134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings
to participants. These protocols should ensure that such findings are conveyed promptly,
respecting participants’ rights and autonomy. Additionally, Member States should mandate that
researchers provide the necessary support and coordination with healthcare providers to address
any health concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants’ right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13. EDUCATIONAL SETTINGS
NOTE: When using neurotechnology in education, it is very important to implement a thorough
ex-ante assessment for each new application. Education targets vulnerable groups of people
(adolescents and children), and the potential adverse effects can be significant on their growth
and development. Before introducing neurotechnology into the education system, it must be
ensured that the benefits are significant.
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age-
appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology’s impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
NOTE: The use of neurotechnology and artificial intelligence in education must be controlled and
monitored by the national educational agencies. The impact of these technologies should be
assessed comprehensively, considering both learning outcomes and well-being factors. It is
essential to develop and utilize monitoring metrics that cover both these dimensions. Cooperation
between education and health authorities is essential. When introducing new teaching
technologies, careful ex-ante assessments, such as child impact assessments (CIA) and social
impact assessments (SIA), must be implemented to evaluate the potential effects.
137. Member States should adopt policies ensuring the voluntary deployment of
neurotechnology in education, grounded in fully informed consent. These policies must include
clear, age-appropriate information about the technology’s purpose, benefits, and risks, with
adequate consideration periods. Considering the increased complexity of obtaining voluntary
consent in this context, consent and assent procedures should involve children, adolescents,
parents, guardians and all actors necessary to obtain approval required for minors. Ethical
oversight mechanisms should be established, including regular consent renewal and immediate
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cessation of neurotechnology use upon withdrawal, and ensure anonymous feedback channels.
Policies must prohibit undue incentives or academic penalties for non-participation and take
measures to avoid creating or reinforcing inequalities among students. Additionally, Member
States should support student involvement in decision-making about neurotechnology integration
and fund training programs on its ethical use, empowering educators and students to critically
assess its application.
NOTE: To ensure informed consent, special attention must be paid to informing students
according to their age and level of development, using alternative methods of communication.
Everyone must have access to information regardless of previous understanding of the matter.
138. Member States should establish a unified, robust oversight mechanism for
neurotechnology use in educational settings, incorporating regular audits, public and community
feedback, culturally appropriate and according to local conventions, and strict adherence to
safety and ethical standards, including an assessment of reversibility on the nervous system.
Continuous research should be funded to assess the long-term psychological and cognitive
impacts of these technologies. Oversight should involve periodic reviews based on empirical
evidence to adjust neurotechnology usage as needed, ensuring it serves student development
and addresses risks like dependency or de-skilling. This comprehensive approach will help
maintain the safety, effectiveness, and alignment of neurotechnology with best practices for
student well-being and learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations
throughout the neurotechnology whole lifecycle. This training should include ethical design,
human rights law, and societal impact assessment, preparing the next generation of
technologists to critically evaluate the implications of their work.
IV.14. LABOUR AND EMPLOYMENT
140. Member States should establish workplace policies and incentives that prioritize the
health and well-being of employees in the use of neurotechnology. These policies should ensure
that any deployment of neurotechnology is evidence-based, with a focus on applications that
have been scientifically validated to promote employee well-being, such as reducing stress or
enhancing workplace conditions (i.e., adaptive and responsive environments that adjust
workloads based on cognitive load). Deployment must be on a voluntary basis and employees
must have the option to opt out of using neurotechnology without facing any negative
consequences or discrimination. Under no circumstances should these technologies be used for
punitive measures, mental surveillance, or in ways that could compromise employee health.
141. Member States should require employers to clearly provide employees with
comprehensive information about how neurotechnology used in their workplace works, the
benefits it offers, transparency about what data are collected, how it is used, and who has access
to it, and clearly disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring
fatigue in commercial drivers or tracking attention in air traffic controllers). To respect employees’
mental privacy, employers should be prohibited from unauthorized access to neural and cognitive
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biometric data that may be collected incidentally during routine workplace monitoring. Employers
should be prohibited from using neural and cognitive biometric data for any non-consented
purposes, particularly those that could negatively impact an employee’s job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation
and secure storage of neural and cognitive biometric data, ensure that data is stored securely,
with access limited to authorised personnel only, is deleted once its intended purpose has been
fulfilled. Additionally, upon an employee’s departure, all related records should be fully deleted
or individual data released to the employee, ensuring that no data is retained after the termination
of employment.
144. Member States should ensure that when employees are issued multifunctional devices
(i.e., earbuds or headphones that also include neural sensors) that can be used at work or at
home, employers should be prohibited from collecting neural and cognitive biometric data outside
of workplace settings and working hours and ensure that any data collected during work is used
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right of employees to obtain
a copy of any neural and cognitive biometric data collected about them, along with any
interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise create.
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and
not for enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should
develop stringent regulations against using neural and cognitive biometric data for profiling in the
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive
biometric data to discriminate against candidates, particularly neurodiverse individuals, ensuring
hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or
maintaining employment, to limit such use where such neural and cognitive biometric data are
directly relevant to the specific requirements of the job.
IV.15. CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a regulatory framework that balances
innovation in the recreational and commercial domains with protecting individual rights and well-
being. This framework should be dynamic, allowing for timely updates as technology evolves and
new insights are gained about its impacts on society. This includes providing adequate oversight
to ensure that neurotechnology does not cause harm, are used consensually, and include robust
mechanisms to protect users from potential psychological distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include
clear labelling on commercial neurotechnology products, detailing their effects, limitations, and
risks to prevent misleading claims and ensure transparency. This also includes prohibiting
practices of “tying” or requiring the disclosure of neural and cognitive biometric data as a
condition to access goods or services, and prohibition about third party data sharing or the uses
of this data without affirmative opt-in option.
151. Member States should foster an environment that ensures all claims about consumer,
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non-medical technologies are supported by robust scientific evidence. They should, by
regulation, require that any products claiming to treat, prevent, or diagnose diseases or medical
conditions be validated through rigorous safety and efficacy testing, including clinical trials where
necessary, and be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and
transparent across all neurotechnological interventions, ensuring that participation is fully
voluntary and respects the privacy and autonomy of individuals. This principle should apply
uniformly in various domains such as sports, arts, where robust standards should safeguard
against coercive use and respect athletes’ and artists’ individual autonomy, community interests,
and IP rights.
153. Member States should steer the use and development of neurotechnology in the arts
toward ensuring the enhanced learning and cultural appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of
consumer technology, especially neurogaming and other devices that exploit the dopamine
reward system or seek to induce problematic and unhealthy use and overconsumption. Such
regulations should mandate clear labeling of risks, disclosures on their effects on the nervous
system, enforce game design standards and safety, privacy and age-appropriate design
standards that prevent taking advantage of a person’s physical, mental and emotional
vulnerability to lead to compulsive use or addiction of gaming or digital recreational platforms
combined with neurotechnology, to promote healthy, balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that ‘opt-out’ features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding self-
determination, consent, privacy, and the potential for manipulation raised by neurotechnology
that arise in the contexts of recommender systems, priming and nudging, marketing during sleep
and dream, neuromarketing, and closed-loop environments by adopting comprehensive policies
and regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive
biometric data in recommender systems for manipulative or deceptive purposes,
including in political context. These regulations should require that any use of such
data within these systems be based on explicit, informed opt-in consent from
users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging—
subtly influencing individuals’ decisions or behaviours, often without their explicit
awareness. This is particularly critical in sensitive areas such as political
messaging, commercial advertisement, and healthcare. These frameworks should
require explicit, informed consent for any use of such data to influence decisions
or behaviour, the right to opt out of these systems, and transparency and clear
disclosures at the point of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that
influences or manipulates individuals during sleep, such as marketing during sleep
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and dream. Regulations should strictly prohibit commercial, marketing, or political
applications that target individuals during sleep, using neurotechnology or neural
and cognitive biometric data. Additionally, robust oversight mechanisms should
be required to ensure that any research or application of such technologies
prioritizes the well-being, privacy, and autonomy of individuals, with particular
attention to the potential long-term psychological and cognitive impacts of
manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in
neuromarketing, including by requiring comprehensive disclosures to ensure that
all neuromarketing activities are conducted transparently, with participants’ explicit
informed consent. This includes ensuring that participants in neuromarketing
research or campaigns are fully aware of methods, risks, and intentions and
affirmatively opt-in to participation. The use, storage, and potential reuse of the
collected data should be strictly regulated.
NOTE: The consideration of the combined effects of the different components in
the last sentence is extremely important.
Closed Loop Environments: provide clear regulatory guidelines on the design and
use of closed-loop environments—such as immersive computing devices that
adjust experiences based on detected neural and cognitive biometric data. These
policies should require clear and accessible disclosure about how neural and
cognitive biometric data are used in these environments, prohibit real-time
behavioral modification or manipulation without explicit, informed consent, and
implement safeguards specifically designed to prevent abuses such as
unauthorized surveillance, manipulative interventions, and practices that could
influence voting behavior, political opinions, or exploit psychological and
emotional vulnerabilities in real-time.
IV.16. ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human
mental performance outside of the medical context introduces complex ethical, social, and legal
challenges, which can create new kinds of disparities in the global world. When neurotechnology
is used in these contexts, it raises crucial questions about equity, consent, individual and
community autonomy, and the nature of enhancement of the nervous system itself. Member
States should ensure that any policies, law and regulatory frameworks that govern the use of
neurotechnology in these contexts do not exacerbate social inequalities or lead to discrimination,
address the potential risks (including to reversibility, invasiveness, and risks to self-
determination) and fully comply with human rights and dignity.
NOTE: The concept of enhancement is imprecise and should be clearly defined. It needs to be
specified whether it applies only to neurotechnology applications specifically designed to extend
typical human capacities, or also to therapeutic interventions that could (for example with minor
modifications) be used also for enhancement purposes. This is one of the most important
sections of the recommendation and addresses one of the most significant ethical risks of
neurotechnology. Therefore, it should be discussed in a more thorough manner.
V. IMPLEMENTATION
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158. Member States and all other actors as identified in this Recommendation should
respect, promote and protect the ethical values, principles and standards related to this
Recommendation, and should take all feasible steps to give effect to its implementation.
159. Member States shall, according to their specific contexts, governing structures and
constitutional provisions, credibly and transparently advance the ethics of neurotechnology, in
line with the UNESCO Recommendation. Member States shall monitor and evaluate policies,
programmes and mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance
with national and international standards, and ensuring that data and insights from different
regulatory domains are shared effectively to inform decision-making and policy development.
These bodies should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions in respect of
this Recommendation, by cooperating with all relevant national and international governmental
and non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector’s interests and therefore
UNESCO needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shall contribute by developing a full-fledged program with the following elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States
in identifying their status at specific moments of their readiness trajectory along
a continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of
neurotechnology based on rigorous scientific research and grounded in
international human rights law, along with specific guidance for its implementation
in the whole neurotechnology lifecycle, and capacity-building tools and materials
to support Member States’ efforts to train government officials, policy-makers and
other relevant actors on the methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and
the efficiency of the policies for the ethics of neurotechnology and incentives
against defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
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societies and the environment. This evidence-based analysis will be gathered in
a UNESCO observatory, to become a shared pool of knowledge and awareness
of good practices and innovations available to all Member States and actors, in
the form of research reports, data, and statistics regarding policies for ethics of
neurotechnology. The research program should take into consideration the
converging developments of neurotechnology with other technologies such as
artificial intelligence and quantum technology, work to be conducted in
collaboration with other relevant UNESCO initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global
policy dialogue, including at Ministerial level in the context of a Global Forum on
the ethics of Emerging Technologies. Supporting this effort, UNESCO shall
establish a network of experts, with balanced representation of all UNESCO’s
regional groups, on the neurotechnology.
165. Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, under-represented, vulnerable people or people in vulnerable
situations and ensuring social, cultural and gender diversity. The monitoring and assessment of
the impact of neurotechnology and related ethics policies and practices should be carried out
continuously in a systematic way proportionate to the relevant risks. This should be based on
internationally agreed frameworks and involve evaluations of private and public institutions. Data
collection and processing should be conducted in accordance with international law, national
legislation on data protection and data privacy, and the values and principles outlined in this
Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a whole, and the foundational values
and principles are to be understood as complementary and interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
prejudicing Member States’ obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or
perform any act contrary to human rights, fundamental freedoms, human dignity and concern for
the environment and ecosystems.
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FRANCE
Commentaires sur l’avant-projet de la Recommandation
de l’UNESCO sur l’éthique des neurotechnologies
COMMENTAIRES GENERAUX
La France salue la pertinence du processus d'élaboration du texte et le travail
pluridisciplinaire des membres du groupe ad hoc d'experts assisté par le Secrétariat. Elle
salue aussi la structure du projet qui facilitent nos échanges qui permettront d'aboutir à une
Recommandation acceptée par tous.
Nous avons mis l’accent sur la valorisation des valeurs et principes ayant guidé la présente
rédaction avec le corpus des travaux normatifs de l'UNESCO dans le domaine de la
bioéthique et de l'éthique des sciences tout en tenant compte de l'évolution des questions
éthiques spécifiques aux neurosciences.
Nous nous sommes efforcés de respecter au mieux l'esprit des auteurs du texte
(originellement écrit en anglais) en faisant des propositions pour améliorer sa version
française et écarter tout ce qui aurait pu prêter à confusion ou mauvaise interprétation.
Plusieurs notions gagneraient à être développées. Outre les définitions complémentaires
suggérées ci-dessous, les paragraphes suivants pourraient être enrichis :
- le paragraphe 157 sur l’augmentation des performances du cerveau sur des sujets
ne présentant pas de conditions médicales, qui mériterait d’intégrer des questions
autour des égalités sociales et des risques humains. Il serait par ailleurs souhaitable
que la recommandation invite les Etats à mettre en place des lignes rouges tant que
cette question sensible ne fait pas l’objet d’un consensus au sein de la société ;
- le paragraphe 77 (ancien P76) sur le secteur privé pourrait être étendu aux
mésusages du secteur public.
De même, le champ d’application pourrait être revu comme suit, afin de préciser la définition
du paragraphe 1.
Une définition de « neurodiversité » (P21) pourrait être donnée.
En outre, il est souhaitable que certaines notions et certains paragraphes fassent l’objet
d’une attention particulière au cours des discussions, pour leur caractère sensible et/ou
majeur pour la Recommandation (diversité des personnes ; dimension relationnelle de nos
perspectives, P6-7 ; les définitions, qui sont l’aboutissement de nombreuses discussions ;
le caractère sensible des données cérébrales ; les droits de l’enfant ; l’encadrement des
environnements éducatifs et de travail ; particularité des technologies grand public).
Les modalités de « l’engagement citoyen » évoqué à plusieurs reprises pourraient être
précisées.
Enfin, les priorités de l’UNESCO (santé, DD, égalité de genres, Afrique) pourraient être
rappelées.
Texte de l’avant-projet avec modifications
PRÉAMBULE
Consciente des répercussions profondes et dynamiques des neurotechnologies sur l’esprit,
la vie et l’épanouissement de l’être humain, ainsi que sur les sociétés, l’environnement et les
écosystèmes,
251
Consciente que les neurotechnologies peuvent également être appliquées au monde animal,
au monde végétal ainsi qu’à l’environnement et aux écosystèmes, avec lesquels l’homme
cohabite, et soutenant pleinement les mesures prises pour assurer le respect, la protection et
le développement durables de la biodiversité,
Considérant la prévalence mondiale importante et croissante des troubles neurologiques et
de santé mentale, ainsi que les profondes souffrances qu’ils causent aux individus et aux
sociétés dans le monde entier,
Notant que les neurotechnologies peuvent apporter des solutions innovantes et de meilleurs
traitements préventifs et thérapeutiques à des millions de personnes, au bénéfice de
l’humanité dans son ensemble et avec des possibilités d’amélioration de la santé dans tous
les pays,
Considérant également que les neurotechnologies soulèvent des questions éthiques
fondamentales, notamment en ce qui concerne l’autodétermination, la vie privée, l’identité
personnelle, la liberté de pensée, le risque de discrimination, l’inégalité et les défis posés à la
démocratie,etqu’ilfautmaintenirlajustice,laconfianceetl’équitépourqu’aucunpaysniaucunepersonnenesoientlaisésdecôé
t,qu’ils’agisedejouird’unacèséquia
tbleauxneurotechnologiesetdeprofiterdeleursavantagesoudeseprémunircontrelesirsquesqu’elescomportent,outenreconnaisantlesdiférencesdesiu
tationquipé
rvae
lntenrtelespaysetenrespectantlesouhaitdecertainespesronnesdenepasprendrepartào
tuteslesinnovaitonstechnoo
lgq
iues,
Rappelant que l’UNESCO se propose, aux termes de son Acte constitutif, de contribuer à la
paix et à la sécurité et de resserrer, par l’éducation, les sciences, la culture et la communication
et l’information, la collaboration entre nations, afin d’assurer le respect universel de la justice,
de la loi, des droits de l’homme et des libertés fondamentales reconnus à tous les peuples,
Sachant que l’UNESCO joue un rôle moteur, à l’avant-garde du dialogue international, de la
production de connaissances et de l’action normative en matière d’éthique des sciences et
des technologies et de bioéthique,
Qu’il lui incombe à cet égard de promouvoir un usage pacifique des neurotechnologies et de
sensibiliser aux immenses défis et menaces d’ordre éthique qu’implique la sécurité des
neurotechnologies, en appelant tous les acteurs concernés à agir de façon responsable,
Convaincue que la présente Recommandation, présentée ici, en tant qu’instrument normatif, développée
selon une approche globale, fondée sur le droit international et centrée sur la dignité humaine
et les droits de l’homme, ainsi que sur l’égalité des genres, la justice sociale et mondiale et le
développement, le bien-être et la santé physiques et mentaux, la diversité, l’interdépendance,
la solidarité mondiale, l’équité, la non-discrimination, l’inclusion et la protection de
l’environnement et des écosystèmes, peut donner une orientation responsable aux
neurotechnologies,
Guidée par les objectifs et les principes de la Charte des Nations Unies,
Soulignant qu’il est important de faire progresser la justice, la confiance et l’équité pour
qu’aucun pays ni aucune personne ne soient laissés de côté, qu’il s’agisse de jouir d’un accès
équitable aux neurotechnologies et de profiter de leurs avantages ou de se prémunir contre
les risques qu’elles comportent, tout en reconnaissant les différences de situation qui prévalent
entre les pays et en respectant le souhait de certaines personnes de ne pas prendre part à
toutes les innovations technologiques,
Soulignant également qu’il est nécessaire de prêter une attention particulière aux pays à
revenu intermédiaire de la tranche inférieure (PRITI), y compris, sans s’y limiter, aux pays les
moins avancés (PMA), aux pays en développement sans littoral (PDSL) et aux petits États
insulaires en développement (PEID), car ils disposent de capacités mais sont sous-
représentés dans le développement des neurotechnologies et l’accès à ces dernières,
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Soulignant, par ailleurs, également que la coopération et la solidarité mondiales facilitent un accès
équitable aux neurotechnologies et permettent d’en tirer pleinement parti, tout en relevant les
défis éthiques, en réduisant les risques d’utilisation abusive et en veillant à ce que les
stratégies nationales en matière de neurotechnologies soient guidées par des principes
éthiques dans le plein respect du droit international des droits de l’homme,
Notant que des lignes directrices et des cadres éthiques ainsi qu’une science ouverte
favorisent l’innovation, le développement et les politiques conformes au droit international des
droits de l’homme,
Rappelant également que la Conférence générale de l’UNESCO, à sa 42e session en
novembre 2023, a adopté la résolution 42 C/29, par laquelle elle a chargé la Directrice
générale « d’élaborer un instrument normatif sur l’éthique des neurotechnologies, sous la
forme d’une recommandation », qui doit lui être présenté à sa 43e session en 2025,
Ayant à l’esprit la Déclaration universelle des droits de l’homme (1948), les instruments
internationaux relatifs aux droits de l’homme, dont la Convention relative au statut des réfugiés
(1951), la Convention concernant la discrimination (emploi et profession) (1958), la Convention
internationale sur l’élimination de toutes les formes de discrimination raciale (1965), le Pacte
international relatif aux droits civils et politiques (1966), le Pacte international relatif aux droits
économiques, sociaux et culturels (1966), la Convention sur l’élimination de toutes les formes
de discrimination à l’égard des femmes (1979), la Convention relative aux droits de l’enfant
(1989), la Convention relative aux droits des personnes handicapées (2006), la Convention
concernant la lutte contre la discrimination dans le domaine de l’enseignement (1960), et la
Convention sur la protection et la promotion de la diversité des expressions culturelles (2005),
ainsi que tous autre instruments, recommandations et déclarations internationaux pertinents,
Prenant acte de la Déclaration des Nations Unies sur le droit au développement (1986) ; de
la Déclaration sur les responsabilités des générations présentes envers les générations
futures (1997) ; de la Déclaration universelle sur la bioéthique et les droits de l’homme (2005)
; de la Déclaration des Nations Unies sur les droits des peuples autochtones (2007) ; de la
Déclaration de principes éthiques en rapport avec le changement climatique (2017) ; de la
Recommandation concernant la science et les chercheurs scientifiques (2017) ; de la
Recommandation sur l’éthique de l’intelligence artificielle (2021) ; de la Recommandation sur
une science ouverte (2021) ; de la résolution du Conseil des droits de l’homme sur « Le droit
à la vie privée à l’ère du numérique »
(A/HRC/RES/42/15) (2019) ; de la résolution du Conseil des droits de l’homme « Nouvelles
technologies numériques et droits de l’homme » (A/HRC/RES/41/11) (2019) ; et des Principes
directeurs des Nations Unies relatifs aux entreprises et aux droits de l’homme (2011),
Rappelant en outre que la Recommandation sur l’éthique de l’intelligence artificielle (2021)
reconnaît les questions éthiques posées par les systèmes alimentés par l’IA pour les
neurotechnologies et les interfaces cerveau-ordinateur,
Consciente également qu’il existe des écosystèmes de politiques à l’échelle nationale ainsi
que d’autres cadres et initiatives élaborés par les entités des Nations Unies concernées, par
des organisations intergouvernementales telles que l’OCDE, y compris des organisations
régionales, ainsi que celles du secteur privé, des organisations professionnelles, des
organisations non gouvernementales et de la communauté scientifique, relatifs à l’éthique et
à la réglementation des neurotechnologies,
1. Adopte, en ce XXX jour de novembre 2025, la présente Recommandation sur l’éthique
des neurotechnologies ;
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2. Recommande aux États membres d’appliquer, avec l’appui du Secrétariat de
l’UNESCO, les dispositions de la présente Recommandation en prenant des mesures
appropriées, notamment législatives, conformes aux pratiques constitutionnelles et aux
structures de gouvernance de chaque État, en vue de donner effet, dans leurs
juridictions, aux principes et normes énoncés dans la Recommandation conformément
au droit international, y compris le droit international des droits de l’homme ;
3. Recommande également aux États membres d’impliquer tous les acteurs afin de
veiller à ce qu’ils jouent leurs rôles respectifs dans la mise en oeuvre de la
Recommandation, et de porter la présente Recommandation à la connaissance des
autorités et organismes internationaux, régionaux et nationaux, instituts de recherche
et organismes universitaires, et institutions et organisations des secteurs public, privé
et de la société civile engagés dans les neurotechnologies, afin que le développement
et l’utilisation des neurotechnologies soient guidés par des recherches scientifiques de
qualité ainsi que par une analyse et une évaluation éthiques.
I. CHAMP D’APPLICATION ET DÉFINITIONS
I.1 CHAMP D’APPLICATION
La présente Recommandation :
1. Traite des questions éthiques liées aux neurotechnologies, qui peuvent avoir de nombreux
effets positifs et négatifs sur la santé et l’épanouissement de l’être humain, ainsi que sur
l’exercice des droits de l’homme.
2. Traite du système nerveux humain en tant qu’il constitue le substrat organique de
l’autodétermination de la personne et lui permet d’exercer sa capacité à penser et agir,
individuellement et collectivement, en tant qu’agent moral responsable de ses actes.
3. Considère que l’autonomie n’étant pas seulement individuelle mais aussi relationnelle, les
interactions entre personnes et l’appartenance d’une personne à une communauté ont des
incidences sur sa manière de penser et d’agir de sorte que les conditions relationnelles,
matérielles et culturelles dans lesquelles les êtres humains se développent et
s’épanouissent doivent être prises en compte dans le champ d’application de la présente
recommandation.
4. S’applique aux outils, produits, procédés et activités permettant de mesurer, d’enregistrer
et/ou de modifier le fonctionnement ou la conformation du système nerveux humain,
notamment ceux ayant une incidence sur la cognition ou le comportement humain, ainsi
qu’à la collecte, au traitement (y compris la gestion et l’analyse), à la conservation et au
stockage et à l’utilisation ou réutilisation des données produites par le système nerveux
humain.
Elle s’applique à l’ensemble des étapes de leur développement.
5. Aborde également les questions d’éthique et de droits de l’homme qui découlent de :
a) l’évolution rapide et de la convergence des neurotechnologies avec d’autres
technologies telles que notamment l’intelligence artificielle (IA), la réalité étendue (XR),
les capteurs et semi-conducteurs ainsi que l’utilisation des données biométriques
cognitives,
b) du recueil des données biométriques, au sens de données relatives à la mesure du
vivant, lorsqu’elles sont traitées pour déduire un état sensoriel, moteur ou mental et
soulèvent des préoccupations éthiques du même ordre.
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Porte une attention particulière aux personnes vulnérables lorsqu’ elles recourent aux a mis en forme : Paragraphe de liste, Justifié, Numéros
produits et activités utilisant des neurotechnologies, notamment dans le champ de la santé + Niveau : 1 + Style de numérotation : 1, 2, 3, … +
et dans celui des offres directes aux consommateurs.Prend en considération les Commencer à : 1 + Alignement : Gauche + Alignement :
neurotechnologies pour des personnes de milieux et niveaux d’aptitude divers, et dans 0 cm + Retrait : 0,63 cm
différents domaines, notamment la santé et les applications non médicales directement
destinées au consommateur (telles que les dispositifs de bien-être ou les jeux vidéo pilotés
par ondes cérébrales) et aborde différents contextes dans lesquels les neurotechnologies
peuvent être utilisées.
6.
3. Porte uniquement sur l’être humain, mais prend acte de considérations importantes qui
s’appliquent aux animaux dans le domaine de la recherche.
4. Aborde l’éthique des neurotechnologies en tant que réflexion normative systématique,
basée sur un cadre global, multiculturel, pluridisciplinaire, pluraliste et évolutif de valeurs,
de principes et d’actions interdépendants de nature à orienter les sociétés pour qu’elles
apportent des réponses responsables aux conséquences des impacts des
neurotechnologies sur les êtres humains, les sociétés, l’environnement et les
écosystèmes.
( ) Elle considère l’éthique comme une base pour l’évaluation et l’orientation
normatives des neurotechnologies, ayant pour repères et comme fondement les
droits de l’homme, la dignité humaine, le bien-être et la prévention des dommages.
( ) Elle s’appuie sur un large éventail d’études, de commentaires et de points de vue
issus des neurosciences, de la médecine, de l’ingénierie, de la psychologie, de
l’éthique, des droits de l’homme, du droit, de la sociologie, de l’anthropologie et
d’autres disciplines.
4. Couvre la mesure, l’enregistrement et la modification du système nerveux humain, la
gestion, l’analyse, le traitement, le stockage, l’utilisation et la réutilisation des données
collectées, ainsi que d’autres impacts sociétaux et environnementaux, y compris
l’émergence de nouveaux états cognitifs.
4. Reconnaît que les interventions impliquant le système nerveux sont très sensibles car le
système nerveux humain, très complexe, est le centre de coordination du comportement
et des processus mentaux. Le système nerveux permet l’exercice de l’autodétermination,
ainsi que la capacité d’agir en tant qu’agent moral, d’être responsable de ses actes, de
coopérer avec les autres, de délibérer sur des décisions collectives et de développer la
personnalité.
4. Reconnaît en outre que les êtres humains se développent et s’épanouissent dans leur
interaction avec d’autres êtres humains et dans un environnement matériel et culturel
stimulant, soulignant que l’autonomie n’est pas seulement individuelle, mais aussi
relationnelle, car elle découle des interactions et de l’appartenance d’une personne à une
communauté et a des incidences sur celles-ci.
5. Aborde les préoccupations en matière d’éthique et de droits de l’homme qui découlent de
l’évolution rapide et de la convergence des neurotechnologies avec d’autres technologies
telles que l’informatique spatiale, la réalité étendue (XR), l’intelligence artificielle (IA), et les
capteurs et semiconducteurs. Notamment, d’autres données biométriques, lorsqu’elles
sont traitées pour déduire un état sensoriel, moteur ou mental, soulèvent des
préoccupations éthiques du même ordre. Par conséquent, la présente Recommandation
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s’applique à la fois aux neurotechnologies et à l’utilisation des données biométriques
cognitives, en veillant à ce que des principes et pratiques éthiques soient appliqués de
manière cohérente dans l’ensembles de ces domaines.
5. Aborde également l’intégration de l’IA dans les neurotechnologies, qui peut améliorer la
précision et les capacités de prévision, notamment en accélérant la vitesse de traitement,
en réduisant les coûts ou en optimisant les systèmes neurotechnologiques. Cependant,
elle amplifie également les menaces d’ordre éthique, notamment les problèmes de
cybersécurité, le manque de transparence, le potentiel de biais algorithmique et les risques
pour l’autonomie, la vie privée mentale et la manipulation.
I.2 DÉFINITIONS
7. Le système nerveux. Le système nerveux comprend le système nerveux central
(cerveau, moelle épinière) et périphérique (somatique, autonome, entérique), composé
d’un réseau de nerfs parcourant tout l’organisme. Il commande et contrôle l’ensemble du
corps humain.
Des données scientifiques démontrent que l’activité du système nerveux est à la base des
états sensoriels, moteurs et mentaux (ce qui englobe les états cognitifs, affectifs et
conatifs) et contribue à la conscience, au sommeil et à l’expérience de la douleur.
L’activité et la structure du système nerveux fournissent des informations inhérentes à tous
les êtres humains et à la communauté, indépendamment du genre, de l’appartenance
ethnique, de la langue ou de la religion. L’activité du système nerveux joue également un
rôle dans les interactions sociales et culturelles.
6. Les neurotechnologies. Les neurotechnologies font référence aux appareils, systèmes
et procédures – englobant à la fois le matériel et les logiciels – qui permettent d’accéder
directement au système nerveux, de le surveiller, de l’analyser, d’en prévoir l’activité ou de
le moduler, afin de comprendre, influencer, restaurer ou anticiper sa structure, son activité,
sa fonction ou ses intentions (parole, motricité). Les neurotechnologies combinent des
éléments des neurosciences, de l’ingénierie et de l’informatique, entre autres.
7.8.
8.9. Les neurotechnologies recouvrent des applications médicales et non médicales et
comprennent des outils qui mesurent, déduisent et influencent l’activité du système
nerveux, que ce soit par une interaction directe avec ce dernier ou par une interface avec
des appareils et des systèmes. Cela comprend, sans toutefois s’y limiter :
(a) les outils techniques qui mesurent et analysent les signaux physiques (acoustiques,
électriques, optiques, magnétiques et/ou mécaniques), chimiques et biologiques
associés à la structure et aux signaux fonctionnels du système nerveux. Ils peuvent
être utilisés pour identifier, enregistrer et/ou surveiller les propriétés de l’activité du
système nerveux, en comprendre le fonctionnement, diagnostiquer des pathologies ou
contrôler des dispositifs externes (les interfaces cerveau-machine (ICM), souvent
appelées interfaces cerveau-ordinateur). Il convient de noter que tant les systèmes en
boucle ouverte (par exemple, la stimulation cérébrale à paramètres fixes) que les
systèmes en boucle fermée (par exemple, la stimulation dépendante de l’état)
soulèvent des questions éthiques complexes. ;
Les (i) les exemples incluent, sans toutefois s’y limiter, l’électroencéphalographie
(EEG), la magnétoencéphalographie (MEG), l’imagerie par résonance magnétique
(IRM), l’imagerie par résonance magnétique fonctionnelle (IRMf), la tomographie par
émission de positons (TEP), la spectroscopie proche infrarouge fonctionnelle (fNIRS),
les microélectrodes implantées, l’optogénétique, l’imagerie optique, l’imagerie en
tenseur de diffusion, l’imagerie calcique, les capteurs de couleurs ou la microdialyse ;
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(b) les outils techniques qui interagissent avec le système nerveux pour en modifier
l’activité, par exemple pour rétablir l’influx sensoriel, comme les implants cochléaires
pour restaurer l’audition ou la stimulation cérébrale profonde pour traiter les
tremblements et d’autres affections pathologiques. Ils sont destinés à moduler les
fonctions du système nerveux et/ou à envoyer des signaux directement au système
nerveux en appliquant une stimulation et/ou une inhibition acoustique, électrique,
magnétique ou optique au système nerveux périphérique ou central. ;
Les exemples incluent (i) les microélectrodes implantées, les interfaces cerveau-
machine (ICM), la stimulation cérébrale profonde, la stimulation optogénétique, la
stimulation transcrânienne électrique (TES), la stimulation magnétique transcrânienne
(TMS) ou la perfusion neuropharmacologique sont autant d’exemples de ces
neurotechnologies.
9.10. Il convient de noter que plusieurs technologies de détection recueillent des données
qui renseignent indirectement sur l’activité neurale. Même s’il ne s’agit pas de
neurotechnologies à proprement parler, ces technologies soulèvent des questions en
matière d’éthique et de droits de l’homme similaires aux questions que soulèvent les
neurotechnologies lorsqu’elles sont utilisées pour déduire des états mentaux. Elles
comprennent, sans s’y limiter, l’oculométrie, la vidéooculographie, la dynamique de frappe
au clavier, la reconnaissance vocale et l’analyse de la voix, l’analyse de la démarche, la
conductance cutanée, la variabilité de la fréquence cardiaque, la surveillance des
mouvements du sommeil, la mesure de la tension artérielle ou les systèmes de
reconnaissance des expressions émotionnelles du visage.
10.11. Données neurales. Les données neurales sont des données qualitatives et
quantitatives concernant la structure, l’activité et la fonction du système nerveux. Elles
englobent les données relatives à l’activité d’un système nerveux, y compris des mesures
directes de la structure, de l’activité et/ou de la fonction neurales (par exemple, les
décharges s ou la moyenne des signaux bioélectriques de l’EEG) et des indicateurs
fonctionnels indirects (par exemple, le flux sanguin dans l’IRMf et la fNIRS). Au niveau
neurobiologique, les données neurales sont les corrélats les plus directs d’un état mental.
12. Données cérébrales. Les données cérébrales (ou neuronales) sont une sous-catégorie
de données neurales, concernant plus spécifiquement le cerveau. Elles désignent les
données enregistrées directement ou indirectement à partir du cerveau d’un individu, par
exemple par imagerie cérébrale, enregistrements intracrâniens ou interface cerveau-
machine.
13. Les technologies biométriques cognitives. Il s’agit de technologies de détection (telles
que la reconnaissance vocale et l’analyse de la voix ou les systèmes de reconnaissance
des expressions émotionnelles du visage) qui recueillent des données renseignant
directement sur l’activité mentale.
Bien qu’il ne s’agisse pas de neurotechnologies à proprement parler, elles soulèvent des
questions en matière d’éthique et de droits de l’homme similaires à celles que soulèvent
les neurotechnologies lorsqu’elles sont utilisées pour déduire des états mentaux. De ce
fait, elles entrent dans le champ d’application de la présente Recommandation, comme
indiqué au paragraphe 5 a).
11.14. Données biométriques cognitives. Les données neurales, ainsi que d’autres
données recueillies par le biais de technologies biométriques non neurales peuvent être
traitées pour déduire des états mentaux, ce que la présente Recommandation qualifie de
« données biométriques cognitives ».
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12.15. 17Ensemble du cycle de vie. Les neurotechnologies doivent être considérées dans
l’ensemble de leur cycle de vie, allant des premiers stades de l’extraction de matériaux, du
prototypage, de la recherche, de la conception et du développement au déploiement et à
l’utilisation, et incluant la maintenance, l’exploitation, la commercialisation, le financement,
le suivi et l’évaluation, la validation, la fin de l’utilisation, le démontage, la mise hors service,
l’élimination et le recyclage. L’ensemble du cycle de vie des neurotechnologies comprend
leur convergence avec d’autres technologies et la diversité des acteurs qui interviennent à
chaque étape.
II. BUTS ET OBJECTIFS
13.16. La présente Recommandation a été élaborée dans le but de guider le développement
et l’utilisation des neurotechnologies de manière éthique, sûre et efficace pour le bien de
l’humanité, des individus, des communautés, des sociétés, de l’environnement et des
écosystèmes, ainsi que de prévenir et d’inviter à réparer les préjudices et dommages dans
le présent et l’avenir en se fondant sur le droit international, en particulier la Charte des
Nations Unies et le droit international des droits de l’homme.
1719. Les objectifs de la présente Recommandation sont les suivants :
(a) assurer la protection, la promotion et le respect des droits de l’homme et des libertés
fondamentales, de la dignité humaine et de l’équité, y compris l’égalité des genres, et
favoriser le principe d'inclusion des personnes (accès, opportunités et droits)respecter
la diversité culturelle tout au long du cycle de viedans le champ et tout au long du cycle
de vie des neurotechnologies ;
(b) guider les actions des États membres, des individus, des groupes, des
communautés, des institutions, des entreprises du secteur privé et de tout autre acteur
concerné afin de garantir la prise en compte de l’éthique à tous les stades du cycle de
vie des neurotechnologies ;
(c) faire en sorte que les neurotechnologies soient, tout au long de leur cycle de vie,
fondées sur des données factuelles, fiables et reproductibles ;
(d) offrir un cadre universel, permettant non seulement de définir des valeurs et des
principes, mais qui se concrétise également sous la forme de recommandations
stratégiques et d’une mise en œuvre efficace pour guider les États membres dans leur
action en matière de neurotechnologies dans l’ensemble du cycle de vie de ces
dernières, conformément aux obligations qui leur incombent au regard du droit
international des droits de l’homme et à d’autres normes internationales ;
(e) favoriser un dialogue multipartite, pluridisciplinaire et pluraliste ainsi que la
recherche du consensus au sujet des questions éthiques en lien avec les
neurotechnologies ;
(f) promouvoir la justice et un accès équitable aux progrès et aux connaissances dans
le domaine des neurotechnologies, ainsi que le partage des bienfaits qui en découlent
;
(g) garantir l’obligation de rendre des comptes et la solidarité parmi tous les acteurs
afin de prévenir l’utilisation abusive des neurotechnologies et de faire respecter les
droits de l’homme et les normes éthiques.
III. VALEURS ET PRINCIPES
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III.1 VALEURS
III.1.1 Respect, protection et promotion des droits de l’homme, des libertés
fondamentales et de la dignité humaine
18. La dignité inviolable et intrinsèque de chaque être humain est le fondement des droits
de l’Homme universels et des libertés fondamentales. Le respect, la protection et la
promotion de la dignité humaine établis par le droit international, notamment le droit
international relatif aux droits de l’Homme, tiennent une place essentielle dans
l’ensemble du cycle de viele champ des neurotechnologies. La dignité humaine se
rapporte à la reconnaissance de la valeur intrinsèque et égale de chaque être humain.
Les neurotechnologies ne doivent en aucun cas être utilisées de manière à réduire à :
- intervenir sur la structure, l’activité et le fonctionnement du système nerveux d’une
personne ou de catégories de personnes afin de créer, à l’exception de raisons
médicales, des inégalités de performance entre personnes ou groupes de personnes,
- réduire à l’état d’objet, à exploiter les vulnérabilités des individus, ni à porter atteinte à
la dignité et aux droits d’une personne, notamment les personnes en situation de
vulnérabilité ou en incapacité d’exercer leurs droits.
III.1.2 Promouvoir la santé et le bien-être humains
18.19. Il convient de privilégier le développement et l’application des
neurotechnologies qui favorisent la santé et le bien-être humains dans leur intégralité,
la santé étant considérée comme un état global de bien-être physique, mental et social.
19.20. L’affectation responsable des ressources devrait être orientée à des fins
préventives, diagnostiques, thérapeutiques, d’assistance ou de réparation, qui
bénéficient au plus grand nombre et à ceux qui en ont le plus besoin., plutôt qu’à des
applications commerciales ou destinées au consommateur.
III.1.3 Assurer et respecter la diversité et l’équité
20.21. Il convient de faire prévaloir le respect de la diversité et de l’équité tout au long
du cycle de viedans l’accès aux bienfaits des neurotechnologies tout au long de leur
cycle de vie. Une attention particulière devrait être accordée à la neurodiversité et, aux Commenté [CDBPC1]: La neurodiversité désigne la
groupes minoritaires, aux peuples autochtones et aux voix sous-représentées. reconnaissance et le respect des variations naturelles
dans le fonctionnement neurologique humain, incluant,
mais sans s'y limiter, des conditions telles que le trouble
21.22. Étant donné que l’innovation largement reconnue en matière de
du spectre de l'autisme (TSA), le trouble de déficit de
neurotechnologies se produit en grande partie dans les zones urbaines bien dotées en l'attention avec ou sans hyperactivité (TDAH), la dyslexie,
ressources, il est essentiel d’accorder une attention particulière aux personnes mal la dyspraxie, et d'autres différences neurocognitives. Elle
desservies et marginalisées afin de prévenir les préjugés, les disparités persistantes affirme une approche inclusive dans laquelle ces
en matière de soins de santé, la stigmatisation, la négligence et le manque de respect. variations ne constituent pas uniquement des déficiences
à corriger mais également des expressions dignes
L’assimilation technologique, ou l’utilisation de la technologie comme outil de
d’intérêt de la diversité humaine.
colonisation (notion désignée dans la Recommandation par le terme « colonialisme
technologique »), peut menacer la diversité et le patrimoine culturels et il convient donc
de s’en prémunir.
22.23. L’accès équitable aux neurotechnologies devrait être une priorité au niveau
mondial, en veillant à ce que leurs bienfaits soient accessibles à tous,
indépendamment de la situation socioéconomique ou géographique. Une attention
particulière doit être accordée aux pays à revenu faible ou intermédiaire, aux
environnements aux ressources limitées et aux communautés marginalisées,
notamment aux besoins spécifiques des différents groupes, tranches d’âge, segments,
systèmes culturels, langues, communautés et populations marginalisées et
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vulnérables, ainsi que des personnes présentant un handicap, des troubles
neurologiques ou des troubles mentaux.
24. Les individus et les groupes sont libres de choisir leur mode de vie, d’exprimer leurs
croyances et leurs opinions, de partager leurs expériences au regard des
neurotechnologies et de participer à une réflexion sociétale sur l’utilisation éthique des
neurotechnologies, dans le respect des droits d’autrui.devraient être autorisés à choisir
leur mode de vie, à exprimer leurs croyances et leurs opinions, à partager leurs
expériences personnelles et à participer à la conception conjointe des technologies,
sous réserve que ces choix soient faits dans le respect des droits d’autrui.
En outre, ils doivent pouvoir participer aux processus de réflexion et de délibération
relatifs aux neurotechnologies. A cette fin, les Etats membres devraient veiller à ce que
les questions fondamentales posées par les développements des neurotechnologies
fassent l'objet d'un débat public approprié à la lumière, en particulier, des implications
médicales, sociales, économiques, éthiques et juridiques pertinentes, et que leurs
possibles applications fassent l'objet de consultations appropriées
III.1.4 Prise en compte des perspectives interculturelles sur les connaissances
humaines et leur partage
Un partage des connaissances respectueux concernant le système nerveux humain et ses
fonctions entre les différentes communautés et cultures favorise la confiance et renforce la
cohésion mondiale dans la quête de la santé et de la qualité de vie.
23. En complément du consentement préalablement exprimé des personnes , qui sont a mis en forme : Justifié
sujets de recherche, toute activité de recherche et de développement concernant les
groupes et communautés devrait être menée avec l' autorisation de leurs représentants
et selon des orientations définies avec leur pleine collaboration de manière à servir
leurs intérêts et à respecter leur savoir traditionnel et leurs contributions à l'ensemble
des connaissances.Il est essentiel que toute activité de recherche et de développement
concernant divers groupes et communautés soit menée avec leur autorisation et selon
leurs orientations, ainsi qu’avec leur consentement préalable, donné librement et en
connaissance de cause, et leur pleine collaboration de manière à servir leurs intérêts
et à respecter leur savoir traditionnel et leurs contributions épistémiques.
25.
III.1.5 Engagement en faveur de la paixLiberté cognitive, de l’équité et de laet justice
dans la société
26. La liberté cognitive comprend notamment :
- l’autonomie mentale, qui est la capacité de penser, raisonner et prendre des décisions,
- le respect de l’intégrité de la structure et du fonctionnement du système nerveux.
Elle contribue à la liberté de pensée, de conscience et de religion ainsi qu’à la liberté
d’opinion et d’expression, dont les limites ne peuvent être établies que par la loi
exclusivement dans les conditions fixées par l’article 29 de la Déclaration universelle des
droits de l’homme. L’utilisation des neurotechnologies devrait permettre de promouvoir la
liberté de penséecognitive, et non de lui porter atteinte, en particulier dans les situations
où le refus de recourir à la technologie peut entraîner un désavantage concurrentiel. Ces
ingérences englobent, sans s’y limiter, l’usage de la force, les menaces, l’accès non
déclaré, la manipulation ou tout scénario dans lequel le consentement n’est pas respecté,
y compris du fait de rapports de force défavorables..
260
27. L’utilisation des neurotechnologies devrait prohiber tout usage susceptible d’entrainer
des discriminations
24. Le refus, dans les conditions conformes à la loi, d’une personne de participer à des a mis en forme : Retrait : Gauche : 1,27 cm
interventions ou applications faisant usage des neurotechnologies ou d’autoriser
l’utilisation de ses données personnelles qui en sont issues, doit être
respecté.L’utilisation des neurotechnologies devrait faire l’objet d’un examen
particulièrement attentif afin d’éviter les usages qui entraînent la ségrégation,
l’objectification ou la subordination d’individus ou de communautés, qui réduisent
la cohésion sociale en exacerbant les inégalités préexistantes ou en en générant
de nouvelles, qui divisent les individus et les dressent les uns contre les autres, et
qui compromettent par là-même la coexistence entre les êtres humains, les autres
êtres vivants et le milieu naturel.
III.1.6 Solidarité mondiale et coopération internationale
27. La Recommandation devrait inciteraider tous les acteurs du développement, du
déploiement et de l’utilisation des neurotechnologies à faire preuve de solidarité et à
demander des comptes dans les cas où les neurotechnologies pourraient être utilisées
à mauvais escient et menacer les droits de l’homme.
28.
a mis en forme : Paragraphe de liste
La coopération internationale est essentielle pour aborder les différences de
a mis en forme : Gauche, Retrait : Gauche : 1,27 cm,
réglementation entre pays concernant les neurotechnologies. Une attention
Espacement automatique entre les caractères asiatiques
particulière doit être accordée aux perspectives divergentes sur les usages et latins, Espacement automatique entre les caractères
acceptables afin de prévenir les abus et de préserver les normes éthiques asiatiques et les chiffres
internationalement reconnues.La coopération internationale est essentielle pour
répondre aux enjeux transfrontaliers liés aux neurotechnologies. Une attention
particulière doit être accordée aux différences de points de vue quant à l’utilisation
acceptable afin de prévenir les abus et de respecter les normes éthiques mondiales.
III.1.7 Développement durable urabilité et droit à un environnement sain
28.29. Le principe de durabilité développement durable et le droit à un environnement
sain exigent que les neurotechnologies soient développées et utilisées dans un profond
respect de la bonne gestion de l’environnement, en s’attachant avant tout à réduire au
minimum les préjudices écologiques tout au long du cycle de vie des matériaux utilisés,
notamment pour l’extraction de minerais, le traitement et le stockage des données, le
recyclage et les pratiques d’élimination.
29.30. Le développement non réglementé des neurotechnologies, notamment à des
fins non médicales, pourrait entraîner une consommation disproportionnée de
ressources et d’énergie, ainsi que la production de déchets.
30.31. Le respect des droits des peuples autochtones, conformément à la Déclaration
des Nations Unies sur les droits des peuples autochtones, exige que les
neurotechnologies, tout au long de leur cycle de vie, soient guidées par un profond
respect des droits des peuples autochtones, en veillant à ce que leurs terres (y compris
pendant l’exploitation minière), leurs savoirs, leurs droits communautaires et la
protection de leur vie privée soient respectés dans le cadre de toutes les activités,
notamment celles qui relèvent de l’extraction des ressources.
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III.1.8 Intégrité et responsabilité
31.32. L’intégrité exige de chaque personne impliquée dans le développement et
l’utilisation acteur de l’ensemble du cycle de vie des neurotechnologies qu’elleil agisse
avec une constance conformément aux exigences éthiques de sa discipline, de son
activité et des normes admises dans son ordre juridiqueéthique. Il s’agit notamment
d’adhérer à des principes directeurs éthiques et de veiller à ce que toutes les actions
soient conformes aux normes professionnelles et aux valeurs de la société.
32.33. L’intégrité suppose que l’on s’engage à assumer la responsabilité de ses actes
et à rendre compte de leurs résultats. Il ne s’agit pas seulement de reconnaître les
succès mais aussi de prendre acte des erreurs et de prendre des mesures correctives
si nécessaire.
33.34. L’intégrité scientifique désigne l’engagement en faveur d’une quête rigoureuse
de la vérité selon des pratiques de recherche fondées sur les données factuelles,
objectives et transparentes. Elle garantit que l’ensemble des activités scientifiques
soient menées avec honnêteté, exactitude et dans le respect de la méthode
scientifique des disciplines relevant des neurotechnologies.
III.2 PRINCIPES ÉTHIQUES ET DROITS DE L’HOMME
34.35. La présente Recommandation adopte une approche centrée sur l’être humain
reposant sur des principes éthiques fondamentaux tels que l’autodétermination, la
liberté cognitive, la capacité d’action, la liberté de pensée, le droit à la vie privée, la
liberté cognitive, l’identité personnelle et collective, la confiance, le respect, la
réciprocité et la justice, entre autres. Elle intègre en outre le respect, la promotion et la
protection des droits de l’homme.
III.2.1 Principes de bénéficience, de proportionnalité et d’innocuité
35.36. Les neurotechnologies devraient promouvoir la santé et le bien-être des
individus et leur, et donner aux individus les moyens de prendre des décisions libres
et éclairées concernant leur système nerveux et leur santé mentale, tout en favorisant
une meilleure compréhension d’eux-mêmes.
Les neurotechnologies devraient contribuer à l’épanouissement de l’être humain sans lui faire
subir de préjudice ou d’assujettissement physique, économique, social, politique, culturel,
psychique ou mental. Le principe d’innocuité (« ne pas nuire ») doit guider l’ensemble du cycle
de viedéveloppement et des utilisations des neurotechnologies, assurant ainsi la protection et
la promotion de la qualité de vie.
37.
37.
a mis en forme : Justifié, Numéros + Niveau : 1 + Style
39. Aucune utilisation des neurotechnologies à des fins d’amélioration des capacités de numérotation : 1, 2, 3, … + Commencer à : 27 +
humaines ne peut être réalisée en dehors d’une finalité médicale et sans que n’ai été Alignement : Gauche + Alignement : 0,63 cm + Retrait :
évalués préalablement le risque de dommages au système nerveux et celui de 1,27 cm, Ne pas ajuster l'espace entre le texte latin et
d’accroissement des inégalités entre personnes et groupes de personnes.L’adoption asiatique, Ne pas ajuster l'espace entre le texte et les
des neurotechnologies à des fins d’amélioration peut entraîner non seulement des nombres asiatiques
dommages inattendus du système nerveux, mais aussi un accroissement des
inégalités au sein de la société.
38.
262
39. Les principes de proportionnalité, d’équilibre et de légitimité devraient régir l’utilisation
des neurotechnologies et des données qu’elles permettent d’obtenir, afin de veiller à
ce que leur utilisation : (a) soit appropriée et proportionnelle à l’objectif et aux bienfaits
escomptés ; (b) ne porte pas atteinte aux valeurs fondamentales énoncées dans le
présent document ; (c) soit adaptée au contexte et au groupe d’utilisateurs cible ; (d)
repose sur des principes de sécurité et des éléments de preuve scientifiques rigoureux.
40. Si l’application des principes énoncés dans la présente Recommandation devait être
limitée, ce devrait être par la loi. Toute loi de ce type devrait être compatible avec le
droit international des droits de l’hommeToute restriction des droits de l’homme doit
satisfaire à toutes les exigences applicables en vertu du droit relatif aux droits de
l’homme, notamment les principes de légalité, d’objectif légitime, de nécessité et de
proportionnalité.
27. Les principes de proportionnalité, d’équilibre et de légitimité devraient régir a mis en forme : Numéros + Niveau : 1 + Style de
l’utilisation des neurotechnologies et des données qu’elles permettent d’obtenir, afin numérotation : 1, 2, 3, … + Commencer à : 27 +
de veiller à ce que leur utilisation : (a) soit appropriée et proportionnelle à l’objectif et Alignement : Gauche + Alignement : 0,63 cm + Retrait :
aux bienfaits escomptés ; (b) ne porte pas atteinte aux valeurs fondamentales 1,27 cm
énoncées dans le présent document ; (c) soit adaptée au contexte et au groupe
d’utilisateurs cible ; (d) repose sur des principes de sécurité et des éléments de preuve
scientifiques rigoureux.
III.2.2 Autodétermination et liberté de pensée
41. Tout au long de l’ensemble du cycle de vie des neurotechnologies, la protection et la
promotion des droits à la liberté de pensée et à l’autodétermination des personnes
doivent être assurées.
42. Les individus ont le droit de prendre des décisions libres, éclairées et volontaires quant
à leur participation à l’ensemble du cycle de en matière d’utilisationvie des
neurotechnologies, conformément au droit international des droits de l’homme et à
d’autres normes internationales, notamment le droit de refuser ou d’interrompre le
recours aux neurotechnologies à tout moment, en veillant au respect de leur autonomie
et de leur capacité à prendre des décisions et, en cas de délégation du consentement,
à ce que l’intérêt supérieur de la personne concernée soit pris en compte. Les
personnes qui participent à des recherches devraient être informées des effets
secondaires potentiels et avoir la possibilité de signaler toute contre-indication aux
procédures employées. Les procédures d’obtention du consentement éclairé devraient
être explicites, dynamiques et exiger l’adhésion, tout en étant exhaustives et
transparentes, en fournissant des informations détaillées sur les fins, les risques, les
bénéfices, les solutions de remplacement et les effets possibles de la technologie dans
tous ses domaines d’application, et faire en sorte que les intéressés comprennent
parfaitement les incidences sur leur vie privée, leur autonomie et leur bien-être.
43. Les neurotechnologies ne devraient jamais être utilisées pour exercer une influence ou
une manipulation indue, que ce soit par la force, la coercition ou d’autres moyens qui
compromettent l’autodétermination et la liberté de pensée. Cette protection s’applique
aussi bien à la réflexion intérieure qu’à son expression extérieure, garantissant ainsi la
liberté contre toute interférence.
III.2.3 Protection des données biométriques neurales et cognitives pour la vie privée
mentale
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44. Les neurotechnologies et les technologies biométriques cognitives soulèvent des
questions relatives au droit à la vie privée en raison de leur capacité croissante à
collecter directement et indirectement des données sur le système nerveux, lesquelles
ont un caractère particulièrement sensible car elles peuvent être traitées et analysées
pour apporter un éclairage approfondi sur les processus qui sous-tendent nos états
mentaux et notre comportement, y compris la conscience de soi et l’introspection. Alors
qu’il devient de plus en plus difficile d’anonymiser les données, il subsiste des risques
persistants d’utilisation abusive de ces données, notamment par la révélation de
corrélats neurobiologiques de maladies, de troubles ou d’états mentaux généraux sans
l’autorisation de la personne auprès de laquelle les données ont été recueillies.
45. La protection de la vie privée mentale est fondamentale pour la protection de la dignité
humaine, de l’identité personnelle et de la capacité d’action. La collecte, le traitement,
la modification et le partage de données neurales doivent s’effectuer avec un
consentement libre et éclairé, dans le respect des principes relatifs à l’éthique et aux
droits de l’homme énoncés dans la présente Recommandation. Les données neurales
et les données biométriques cognitives doivent être considérées et traitées comme des
données particulièrement sensibles.
46. Il devrait exister des garanties claires contre l’utilisation abusive des données
biométriques neurales et cognitives ou l’accès non autorisé à celles-ci, notamment le
consentement exprès, la minimisation des données et la spécification des finalités, les
droits sur les données (tels que les droits d’accès, de rectification et d’effacement) et
la sécurité des données, en particulier dans les contextes où ces données peuvent être
agrégées avec d’autres sources.
III.2.4 Non-discrimination et inclusion
47. Tous les acteurs intervenant dans l’ensemble du cycle de vie des neurotechnologies,
en particulier dans leur interface avec d’autres technologies comme l’intelligence
artificielle (IA), doivent s’engager à défendre des principes éthiques qui empêchent la
discrimination, la stigmatisation, la prise pour cible ou l’exploitation de tout individu ou
groupe, en particulier ceux qui se trouvent dans des situations de vulnérabilité. En
particulier, ils devraient mettre en place, selon leur mode d’intervention et leur fonction,
des procédures pour évaluer le risque de biais dans les jeux de données entraînant les
IA.
48. Il existe une responsabilité partagée de veiller à ce que ces technologies ne perpétuent
ni n’amplifient les inégalités existantes, ou ne créent pas de nouvelles formes de
discrimination fondées sur des caractéristiques neurologiques ou mentales, ou sur
d’autres motifs protégés par le droit relatif aux droits de l’homme.
49. Un développement technologique et un travail de normalisation non inclusifs peuvent
entraîner une tendance à l’homogénéisation ainsi que la prédominance de la
neurotypie et des capacités qui pourraient menacer l’identité culturelle et collective.
50. Pour gagner la confiance et susciter l’adhésion des communautés dans l’ensemble du
cycle de vie des neurotechnologies, il faut nouer un dialogue transparent avec le public,
en sollicitant son avis et sa validation afin que ces technologies soient en adéquation
avec les valeurs sociétales et le bien commun.
51. La discrimination, quel qu’en soit le motif, y compris les différences intellectuelles ou
liées à l’atypismela neurodiversité, doit être condamnée. Les neurotechnologies ne
devraient pas servir à étayer, justifier ou réifier de telles discriminations. Il convient
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d’évaluer avec soin les solutions neurotechnologiques promues par les pouvoirs
publics pour des services essentiels tels que l’éducation.
52. Les neurotechnologies ne devraient pas être utilisées pour perpétuer les stéréotypes,
la stigmatisation ou la discrimination à l’égard de toutes personnes âgées.
III.2.5 Responsabilité
53. Le maintien de la confiance et de l’intégrité tout au long de l’ensemble du cycle de vie
des neurotechnologies exige que tous les acteurs adhèrent aux normes éthiques les
plus élevées, restent ouverts au retour d’informations, s’engagent à ajuster leurs
pratiques face à des preuves ou à des préoccupations éthiques nouvelles, et soient
tenus responsables de leurs actions.
54. L’obligation redditionnelle – entendue comme obligation de rendre des comptes en cas
de violation d’un droit ou de réalisation d’un dommage - repose sur la responsabilité,
une communication claire et transparente, et le devoir d’anticiper et de prendre en
compte les dommages potentiels, qu’ils soient à court terme, à long terme ou qu’ils
résultent d’une utilisation ou d’une conséquence imprévue.
55. L’engagement en matière d’obligation redditionnelle exige, le cas échéant, une action
mondiale, gouvernementale, sociétale et collective pour faire en sorte que les
personnes auxquelles les neurotechnologies ont porté préjudice aient accès à la justice
et que les auteurs d’actes répréhensibles soient tenus de prendre des mesures
concrètes pour identifier, prévenir et atténuer les effets négatifs de leurs actions sur les
droits de l’homme, ainsi que pour rendre compte de la manière dont ils y répondent et
y remédient, y compris par des mesures correctives et des réparations.
III.2.6 Confiance et transparence
56. Tous les acteurs de l’ensemble du cycle de vie des neurotechnologies doivent veiller
à ce que leurs activités soient transparentes, fondées sur des preuves scientifiques et
en adéquation avec les principes internationaux de conduite responsable et d’intégrité
scientifique.
Afin de garantir le respect, la promotion et la protection des droits de l’homme et des libertés
fondamentales, tous les acteurs de l’ensemble du cycle de vie des neurotechnologies doivent
veiller à ce que leurs activités soient transparentes, fondées sur des preuves scientifiques et
en adéquation avec les principes internationaux de conduite responsable et d’intégrité
scientifique. Il s’agit notamment d’empêcher la reproduction ou l’amplification des préjugés,
ainsi que de faire en sorte que les neurotechnologies soient traçables et explicables, que leur
potentiel et leurs limites soient présentés avec exactitude, que les conditions en matière
d’obligation redditionnelle soient clairement définies et que les principes éthiques en matière
de recherche et de développement soient respectés, notamment en ce qui concerne
l’enregistrement des essais, la sélection équitable des participants et l’approbation par des
comités d’éthique indépendants.
III.2.7 Justice épistémique, participation inclusive et autonomisation du public
56.57. Il convient d’assurer la création et la diffusion justes et équitables de savoirs sur
les neurotechnologies, notamment en reconnaissant divers modes de connaissance,
et de faire en sorte que tous les individus et toutes les communautés puissent participer
à leur création, à leur partage et à leurs applications.
57.58. Il convient de promouvoir une éducation ouverte et accessible, ainsi que la
participation du public et de la communauté, afin que diverses populations puissent
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acquérir et échanger des connaissances sur le fonctionnement du système nerveux,
la santé mentale, les applications médicales et non médicales des neurotechnologies
et les outils correspondants.
58.59. Une participation efficace du public et de la communauté tout au long de
l’ensemble du cycle de vie des neurotechnologies exige le respect de la diversité,
notamment linguistique, sociale, culturelle, patrimoniale et identitaire, afin de respecter
les différents modes de connaissance et de compréhension. Ce respect de la diversité
permet de faire en sorte que les savoirs et les points de vue de diverses communautés
soient valorisés et pris en compte dans les processus décisionnels, dans le respect de
l’autodétermination.
59.60. Une éducation ancrée dans les droits de l’homme permet de veiller à ce que les
savoirs créés et partagés respectent les droits de tous les individus, évitant ainsi une
injustice épistémique qui ferait que certains groupes seraient marginalisés ou exclus
de la production et de la diffusion de connaissances.
60.61. Toutes les communautés devraient pouvoir faire entendre leur voix pour les
décisions qui les concernent, en particulier lorsqu’il s’agit du développement et de
l’utilisation des neurotechnologies
III.2.8 Intérêt supérieur de l’enfant et protection des générations futures
61.62. Le système nerveux évolue rapidement au cours de l’enfance, puis de manière
décisive lors de l’adolescence. Il est donc essentiel de préserver la vie privée,
l’autodétermination et le droit des enfants et des adolescents à prendre part aux
décisions qui les concernent autant qu’ils acquièrent le discernement nécessaire pour
y participer suivant le droit de la juridiction qui régit leur statut personnel. à prendre part
aux décisions qui les concernent. Les technologies doivent faire l’objet d’une évaluation
rigoureuse pour s’assurer qu’elles servent l’intérêt supérieur, le bienêtre et le
développement sain des enfants, à mesure qu’ils deviennent des individus autonomes,
et qu’elles protègent les droits des générations futures en veillant à ce que les
décisions prises aujourd’hui favorisent leur bien-être à l’avenir.
62.63. D’un point de vue éthique, même s’il faut reconnaître que les neurotechnologies
présentent des avantages potentiels pour le diagnostic précoce, l’instruction,
l’éducation et l’apprentissage continu, il est tout aussi important d’être attaché au
développement global de l’enfant. Il s’agit notamment de stimuler leur vie sociale,
d’encourager les relations enrichissantes et de promouvoir un mode de vie sain
englobant la nutrition et l’activité physique.
III.2.9 Justice mondiale et sociale, et jouissance des bienfaits du progrès scientifique et
de ses applications
63.64. L’accès à la recherche et au développement dans le domaine des
neurotechnologies et les bienfaits qui en découlent doivent être équitablement
partagés entre tous ceux qui y contribuent, en veillant tout particulièrement à assurer
une répartition mondiale qui favorise l’équité et réduise les disparités.
64.65. Les progrès des neurotechnologies devraient être mis à profit pour réduire les
inégalités en matière de santé dans le monde. Ces technologies devraient jouer un
rôle moteur pour l’amélioration de la qualité de vie, en particulier dans les contextes où
les ressources sont limitées.
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65.66. La recherche, le développement et les essais dans le domaine des
neurotechnologies doivent respecter les normes éthiques les plus élevées et garantir
la participation sans exploitation de toutes les personnes concernées. Il s’agit
notamment de protéger les droits et le bien-être des participants, des patients et des
personnes qui en ont la charge, ainsi que de veiller à la collecte et à l’utilisation éthiques
des données. Il convient de veiller tout particulièrement à ce que ceux qui contribuent
à la recherche et au développement bénéficient d’une part équitable des bienfaits et
n’aient pas à en supporter les risques de façon disproportionnée.
66.67. Il conviendrait également de s’efforcer, notamment par la coopération
internationale, de pallier l’absence des infrastructures, formations et compétences
technologiques ou médicales ainsi que des cadres juridiques nécessaires dont
souffrent certaines communautés, en particulier dans les PRITI, les PMA, les PDSL et
les PEID, mais jamais d’en profiter.
67.68. Le développement de nouvelles neurotechnologies et l’évaluation de leur
impact devraient prendre en considération la mise en oeuvre de paradigmes centrés
sur l’humain, dans lesquels les utilisateurs finaux ne sont pas simplement les
destinataires passifs de ces technologies, mais contribuent activement à les façonner,
sur un pied d’égalité dans le respect de leurs droits.
IV. DOMAINES D’ACTION STRATÉGIQUE
IV.1 INVESTISSEMENT, UTILISATION ET RÉGLEMENTATION PUBLICS
68.69. Les États membres, les acteurs privés et les institutions internationales
devraient soutenir activement la recherche sur les neurotechnologies, ainsi que leur
développement et leur déploiement dans l’intérêt du public. Les investissements
devraient porter en priorité sur les applications qui favorisent l’épanouissement humain
et dont l’utilisation respecte, favorise et protège les droits de l’homme individuels et
collectifs. Cet engagement devrait inclure le financement de travaux de recherche
interdisciplinaire visant non seulement à faire progresser l’innovation
neurotechnologique, mais également à étudier les implications éthiques, juridiques,
sociales, environnementales et culturelles de ces technologies et à soutenir la mise en
oeuvre et l’application clinique de prototypes technologiques. Une attention particulière
devrait être accordée à l’élaboration et à la mise en oeuvre de garanties adéquates sur
les plans technique, institutionnel, procédural et autres, afin de s’assurer que la société
en bénéficie de manière équitable et que les droits de l’homme sont respectés.
69. Les États membres devraient interdire les utilisations des neurotechnologies qui
portent atteinte aux droits de l’homme individuels et collectifsétablir des interdictions
claires contre l’utilisation des neurotechnologies dans les contextes où les droits de
l’homme individuels et collectifs sont bafoués. Les États membres devraient faire
preuve de diligence raisonnable en matière de droits humains, notamment en
procédant régulièrement à des études approfondies de l’impact sur les droits humains
des neurotechnologies qu’ils développent, conçoivent, mettent en place, utilisent,
vendent, exploitent ou achètent, afin de prévenir et d’atténuer leurs incidences
négatives sur les droits humains. Plus précisément, les neurotechnologies ne devraient
pas être utilisées à des fins telles que les interrogatoires non consensuels par les
forces de l’ordre et dans le cadre de la justice pénale ou civile, la mise au point ou le
déploiement d’armes attaquant le système nerveux, le contrôle social, les tentatives de
modification forcée des comportements en fonction des croyances ou des opinions
personnelles, des opinions politiques ou autres, de l’identité de genre ou de
l’orientation sexuelle, ou la surveillance des états mentaux, entre autres. Les
gouvernements devraient adopter des législations garantissant que les
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neurotechnologies sont déployées de manière responsable et fondée sur les droits de
l’homme, et assorties de mécanismes de surveillance solides pour faire respecter ces
restrictions et protéger la vie privée mentale et la liberté de pensée de tous les
individus. Ces politiques devraient être élaborées en consultation avec divers acteurs,
notamment la société civile, les utilisateurs finaux, les experts en neurotechnologie, les
déontologues et les défenseurs des droits de l’homme, afin de garantir un large
consensus ainsi que le respect des normes internationales en matière de droits de
l’homme.
70.
a mis en forme : Gauche, Espacement automatique
entre les caractères asiatiques et latins, Espacement
automatique entre les caractères asiatiques et les
chiffres
81.70.
82.71. Les États membres devraient garantir la transparence et l’obligation
redditionnelle dans le soutien qu’ils apportent, le contrôle qu’ils exercent et la
réglementation qu’ils établissent en matière de neurotechnologies, notamment en ce
qui concerne les initiatives bénéficiant de fonds publics telles que les programmes de
recherche-développement sur le cerveau. Tout en pouvant limiter, dans le respect de
finalités légitimes et de façon proportionnée, restreignant la divulgation de certaines
informations sensibles, les gouvernements devraient imposer aux projets de
neurotechnologie subventionnés par l’État de rendreainsi prévoir que soient rendus
publics les objectifs, les méthodes, les finalités et les incidences sur la société de leurs
initiatives en matière de neurotechnologies, lorsque cela est possible. Une telle
transparence est essentielle pour renforcer la confiance du public et garantir que les
progrès des neurotechnologies soient conformes aux normes éthiques et aux droits de
l’homme.
83.72. Les États membres devraient adopter une approche globale concernant les
mesures réglementaires et stratégiques visant à protéger des atteintes aux droits de
l’homme liées aux neurotechnologies élaborées, commercialisées, exploitées ou
utilisées par le secteur privé. Il s’agit notamment des mesures législatives et
réglementaires ainsi que des orientations, des incitations et des exigences de
transparence dont elles sont assorties. Cette approche globale devrait également
exiger de faire preuve de diligence raisonnableenvisager des mesures en matière de
droits de l’homme, pour faire en sorte que les entreprises identifient, préviennent et
atténuent les effets néfastes de leurs activités sur les droits de l’homme et qu’elles en
rendent compte, dans le cadre de processus adaptés au contexte, notamment des
études d’impact sur les droits de l’homme, une participation significative du public et
de la communauté, et des communications transparentes.
84.73. Les États membres devraient veiller à ce que toute utilisation des
neurotechnologies dans le système judiciaire, notamment leur examen par le pouvoir
judiciaire, repose sur des preuves scientifiques solides, soit mise en oeuvre dans le
respect de l’éthique et des droits de l’homme, et vise à promouvoir l’intérêt général et
la bonne administration de la justice la sécurité publique tout en protégeant les droits
et la dignité de toutes les personnes concernées. Cela exige le respect des droits
fondamentaux, tels que la dignité humaine, l’intégrité corporelle, la confidentialité des
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données personnelles, le droit à un procès équitable et à une procédure régulière,
notamment la présomption d’innocence, le droit de ne pas contribuer à sa propre
incrimination, ainsi que le droit de ne pas être soumis à la torture ou à de mauvais
traitements, le droit au respect de la vie privée et le droit à la liberté de pensée.
85.74. Les États membres devraient mettre en place un cadre complet de mesures
d’incitation, telles que des incitations fiscales, des subventions et des prix, en
s’attachant particulièrement à encourager la constitution et le développement des
capacités en matière de fabrication, de ressources informatiques et d’analyse des
données au sein des établissements de recherche et des petites et moyennes
entreprises (PME). Les États membres devraient également encourager et soutenir les
partenariats qui mettent à profit les ressources informatiques et les capacités d’analyse
de données des entreprises privées pour faire avancer les objectifs de la recherche
publique. Ces mesures d’incitation devraient viser en priorité à récompenser la
transparence, les processus de développement participatifs et les contributions aux
avantages sociétaux, afin de favoriser un environnement dans lequel les institutions
publiques et les entreprises innovent de manière responsable et en adéquation avec
les objectifs d’épanouissement humain.
86.75. Les États membres devraient établir une approche coordonnée et
intersectorielle pour évaluer les effets des neurotechnologies tout au long de leur cycle
de vie. Cette approche devrait comporter, sans s’y limiter :
(a) des études d’impact économique : menées par les instances nationales compétentes
chargées des politiques relatives à l’économie et à l’emploi afin de mesurer l’impact
des neurotechnologies sur la croissance économique, les emplois, la justice sociale et
la durabilité environnementale ;
(b) des évaluations du rapport bénéfices-risques : gérées par les entités responsables de
la santé publique, de la recherche médicale et de la protection du consommateur, ces
évaluations devraient permettre de mesurer rigoureusement les bénéfices et les
risques associés au développement, au déploiement et à l’utilisation des
neurotechnologies, notamment en ce qui concerne la recherche, les applications
cliniques et les produits de consommation. Ce processus devrait être solidement étayé
et prévoir une surveillance éthique et un suivi constant pour garantir la sécurité, le bien-
être et le traitement équitable de toutes les personnes concernées ;
(c) des études d’impact sur la vie privée : sous la supervision des autorités nationales
compétentes ou des organismes chargés de la protection des données et de la vie
privée, ces études devraient évaluer et atténuer les risques que les neurotechnologies
font peser sur la vie privée mentale des individus. Il s’agit notamment de veiller à la
mise en place de garanties appropriées pour protéger les données biométriques
neurales et cognitives conformément aux normes nationales et internationales en
matière de vie privée, ainsi qu’aux pratiques en matière de politique des données
mentionnées dans le présent document ;
(d) des études d’impact sur les droits de l’homme : sous la supervision des institutions
nationales et des organisations internationales de défense des droits de l’homme, ces
études visent à recenser les effets potentiels des neurotechnologies sur les droits de
l’homme, à les prévenir et à y remédier. Le processus devrait garantir que les
neurotechnologies respectent et défendent les droits de l’homme, en prêtant une
attention particulière aux personnes vulnérables et aux personnes en situation de
vulnérabilité. Les études d’impact sur les droits de l’homme devraient prévoir la
participation significative du public et de la communauté afin de prendre en compte
différents points de vue.
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(d)(e) chacune de ces études devraient associer les acteurs concernés ainsi que des
citoyens suivant des procédures transparentes afin d’éviter l’influence des groupes de
pression
87.76. Les États membres devraient promouvoir un accès équitable aux
neurotechnologies, eut égard aux domaines de compétence de l’Organisation dans le
monde entier. Pour y parvenir, des efforts devraient être déployés pour soutenir la
réduction du coût total pour l’utilisateur final, poursuivre le développement et l’adoption
de solutions logicielles non propriétaires tout en leur apportant un soutien constant, et
étudier les stratégies de remboursement et les possibilités de subventions à la hauteur
de ce que prévoient les conventions dans les juridictions locales, dans les secteurs où
les avantages potentiels sont cruciaux.
88.77. Les États membres devraient adopter des cadres réglementaires
agilesapproches souples, prévoyant notamment l’utilisation de « bacs à sable »
réglementaires – des environnements contrôlés permettant de développer, de mettre
à l’essai et d’évaluer les neurotechnologies – pour faire face aux progrès rapides des
neurotechnologies et à leur convergence avec d’autres technologies telles que l’IA,
l’informatique spatiale et les technologies immersives. Ces bacs à sable devraient être
utilisés afin d’explorer des applications novatrices, en particulier dans le cadre du lieu
de travail, sous la surveillance éthique appropriée des organismes réglementaires ou
des autorités nationales. Ces cadres devraient faciliter l’innovation, garantir un
traitement éthique des données et protéger les droits en prévoyant des mécanismes
qui permettent de procéder régulièrement au suivi, à l’évaluation et à des ajustements
stratégiques dynamiques en fonction des évolutions technologiques et éthiques.
IV.2 POLITIQUES EN MATIÈRE DE DONNÉES
89.78. Les États membres devraient élaborer un cadre juridique et réglementaire
solide pour régir la collecte, le traitement, le partage et toute autre utilisation des
données biométriques neurales etneurales et des données biométriques cognitives.
Un tel cadre et ceux déjà en place devraient considérer que ces données revêtent un
caractère à la fois personnel et sensible dans les contextes médicaux et non médicaux.
90.79. Les États membres devraient veiller à ce que leurs politiques en vigueur en
matière de protection de la vie privée prévoient systématiquement des garanties
strictes concernant les données biométriques neurales et les données biométriques
cognitives des individus. Si les politiques en vigueur ne répondent pas de manière
adéquate à ces préoccupations, les États membres devraient adopter une législation
ou des cadres réglementaires ciblés pour garantir de telles protections. Les garanties
en question devraient par exemple comprendre le consentement éclairé exprès, la
minimisation des données et la limitation des finalités, les droits en matière de données
(y compris le droit de consulter, de corriger et de supprimer des données), et des
mesures strictes de sécurité en matière de données, comme des protocoles avancés
de cybersécurité permettant de prévenir les accès non autorisés et les violations de
données. Cette législation ou ces cadres devraient interdire la pratique consistant à
conditionner l’accès à des biens ou services à la divulgation de données biométriques
neurales ou cognitives, exiger un consentement explicite pour tout partage de données
et interdire l’utilisation de ces données à des fins de publicité ciblée sans le
consentement explicite, exprès et éclairé de l’intéressé.
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91.80. Les États membres devraient élaborer et mettre en oeuvre des politiques visant
à réduire l’empreinte écologique des neurotechnologies, notamment en ce qui
concerne les centres de données et les ressources informatiques de grande envergure
utilisées pour traiter et stocker les données biométriques neurales et les données
biométriques cognitives. Ces politiques devraient mettre l’accent sur la minimisation
des données, en veillant à ce que seule la quantité nécessaire de données soit
collectée et traitée, et encourager une utilisation proportionnelle des
neurotechnologies, en les déployant selon les besoins réels et en réduisant le plus
possible l’impact environnemental inutile. Les mesures devraient notamment porter sur
l’optimisation de l’efficacité énergétique, le recours aux sources d’énergie
renouvelables, la promotion du recyclage et l’élimination durable de l’équipement relatif
aux neurotechnologies, et la réhabilitation des environnements dégradés.
92.81. Les États membres devraient soutenir et encourager le développement et la
mise en œuvre des innovations technologiques et des normes de conception relatives
aux neurotechnologies qui placent la protection de la vie privée mentale parmi les
priorités, telles que le cryptage de pointe, les bases de données sécurisées par une
authentification multifactorielle, les techniques les plus avancées en matière
d’anonymisation et le traitement et la conservation en périphérie (traitement et
conservation des données au plus près du lieu où elles ont été produites), conduisant
à des résultats plus concrets concernant le stockage en temps réel des données
biométriques neurales et cognitives.
93.82. Les États membres devraient inciter les fabricants de neurotechnologies
produits neurotechnologiques à accorder une attention prioritaire au respect de la vie
privée et à l’éthique dès la conception, en exigeant que des technologies de protection
de la vie privée soient intégrées par défaut dans leurs dispositifs.
94.83. Les États membres devraient encourager le partage éthique des données en
mettant en place des entrepôts de données sécurisés pour les données neurales et les
données biométriques cognitivesles données biométriques neurales et cognitives
utilisées dans la recherche. Ces entrepôts devraient satisfaire à des normes strictes
en matière de cybersécurité, de confidentialité des données et d’utilisation éthique
(dont la minimisation des données et la limitation des finalités), et prévoir un accès
différencié et d’autres approches du renforcement de la protection de la vie privée. Des
mécanismes de financement appropriés devraient être mis en place pour la sélection
et la gestion des données tandis que les processus de gouvernance de données
devraient être simplifiés.
95.84. Les États membres devraient consacrer en priorité leurs efforts à atténuer les
obstacles au partage des données entre pays dans la recherche en neurotechnologie,
grâce à une plus grande harmonisation des normes de protection des données, en
particulier en matière de données biométriques neurales et cognitives, en établissant
des protocoles clairs de transfert de données pour garantir des échanges de données
sûrs et conformes entre pays, ainsi que des normes d’interopérabilité des données, y
compris des cadres de gouvernance concernant le partage de données.
96.85. Les États membres devraient envisager d’adopter des lignes directrices
spécifiques pour l’utilisation éthique des données biométriques neurales et cognitives
dans le développement et la recherche en matière d’IA, notamment des procédures de
consentement concernant l’utilisation des données biométriques neurales et cognitives
en vue d’entraîner et d’appliquer les modèles d’IA, en garantissant la transparence et
en respectant les droits individuels et collectifs
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IV.3 PROPRIÉTÉ INTELLECTUELLE
97.86. Les États membres devraient adopter des politiques garantissant que les
données neurales et les données biométriques cognitives les données biométriques
neurales et cognitives, en tant que dérivés de l’activité humaine individuelle, ne sont
pas soumises à des droits de propriété. La protection de la propriété intellectuelle ne
devrait s’appliquer qu’aux compilations de données originales (créées par un
processus d’agrégation, d’organisation ou de sélection, aboutissant à un nouvel
ensemble de données) qui répondent à des critères stricts en matière d’éthique.
98.87. Les États membres devraient élaborer conjointement des lignes directrices
claires et harmonisées en ce qui concerne les droits de propriété intellectuelle
applicables aux neurotechnologies à l’échelle internationale. Ces lignes directrices
devraient porter sur la brevetabilité des inventions générées par l’intelligence artificielle
ainsi que sur les implications éthiques des lois en matière de propriété intellectuelle,
en veillant à ce que celles-ci favorisent l’accessibilité et l’innovation au niveau mondial.
99.88. Les États membres devraient veiller à ce que l’ensemble des acteurs adoptent
des stratégies de gestion de la propriété intellectuelle qui encouragent l’innovation et
évitent une utilisation trop restrictive des brevets, favorisant ainsi un écosystème
d’innovation ouvert. Cette approche devrait s’adapter en permanence à l’évolution du
paysage des neurotechnologies. L’impact des politiques en matière de propriété
intellectuelle sur le secteur des neurotechnologies devrait faire l’objet d’un suivi continu
afin de s’assurer que ces politiques stimulent l’innovation tout en garantissant une
utilisation éthique et une large accessibilité.
100.89. Les États membres devraient favoriser un environnement de co-création dans
le domaine des neurotechnologies, en proposant des politiques et des incitations qui
facilitent la copropriété et les accords de licence préférentiels afin de garantir une
rémunération et une reconnaissance équitables pour tous les contributeurs.
101.90. Les États membres devraient adopter des politiques de science ouverte
permettant de concilier la protection de la propriété intellectuelle et l’incitation à la
publication immédiate des résultats et au partage des données. Il est essentiel de
trouver cet équilibre, compte tenu en particulier de la convergence des technologies
numériques et de la concentration croissante de ces innovations dans les secteurs
industriels, afin de garantir que les mécanismes de protection de la propriété
intellectuelle n’entravent pas la recherche scientifique, l’innovation et la large diffusion
des connaissances et des nouvelles technologies. Suivant le principe de base d’un
partenariat équitable, les processus de science ouverte et la stratégie de gestion de la
propriété intellectuelle devraient être élaborés dès le départ en collaboration avec les
peuples autochtones associés aux activités de recherche et de développement en
neurotechnologie.
IV.4 CYBERSÉCURITÉ
102.91. Les États membres devraient collaborer à l’échelle internationale pour établir
des normes de cybersécurité détaillées pour tous les domaines neurotechnologiques.
Ces normes devraient englober des mesures de sécurité du matériel, des logiciels et
des données afin de se prémunir contre les cybermenaces potentielles. En mettant en
oeuvre des normes de cybersécurité uniformes, les États membres devraient garantir
l’intégrité, la confidentialité, la sécurité et la disponibilité des données neurales et des
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données biométriques cognitives, et renforcer la confiance des utilisateurs dans les
dispositifs neurotechnologiques. En outre, ces normes devraient évoluer en même
temps que les progrès technologiques et les nouvelles cybermenaces afin de maintenir
une protection solide contre des risques en constante évolution.
92. Les États membres devraient :
(a) renforcer les mesures de protection en matière d’hébergement, de
responsabilités, de cybervigilance des données par la sécurisation des
systèmes d’exploitation via l’usage des antivirus et pares-feux, des mises à jour,
des audits réguliers, de la gestion des vulnérabilités, des sauvegardes de
données hors ligne, des messageries sécurisées, de mots de passe robustes,
des exercices réguliers d’anticipation et de simulation des crises ;
(b) recourir à des exercices de « red-teaming » (méthode dite de l’équipe rouge
: des défis posés par une équipe adverse chargée de mettre à l’épreuve
l’efficacité des systèmes de sécurité) comme mesure proactive pour évaluer et
renforcer la sûreté, la sécurité et la résilience des systèmes
neurotechnologiques. En organisant régulièrement des exercices de « red-
teaming », les États membres devraient identifier et combler de manière
proactive les lacunes en matière de sécurité, mettre à l’essai les procédures de
réponse aux incidents et renforcer la posture globale de sûreté et de
cybersécurité des dispositifs neurotechnologiques.
IV.5 COMMUNICATION, PARTICIPATION ET INFORMATION
103.93. Les États membres devraient promouvoir la communication et élaborer des
politiques de mobilisation en faveur des neurotechnologies qui encouragent un
dialogue éclairé, inclusif et respectueux entre les chercheurs, les développeurs,
différents utilisateurs et le grand public pour respecter les droits individuels et collectifs,
promouvoir la confiance du public et tirer parti de l’intelligence collective et de la
diversité des communautés.
104.94. Les États membres devraient collaborer avec des organisations internationales,
des établissements d’enseignement et des organismes privés et non
gouvernementaux, afin d’élaborer et de diffuser des matériels pédagogiques
accessibles, attrayants et adaptés à divers publics, afin de combler les lacunes en
matière de connaissances, en particulier dans les régions défavorisées, en ce qui
concerne le fonctionnement du système nerveux et de la santé mentale, ainsi que les
bénéfices et les risques des neurotechnologies. Ces programmes devraient viser à
mieux faire comprendre au public les fonctionnalités, la sécurité, l’efficacité et l’impact
sociétal des technologies, afin de permettre aux individus de prendre des décisions
éclairées et de mener une réflexion éthique quant à leur utilisation.
105.95. Les États membres devraient mettre en place des processus de participation
du public et de la communauté qui facilitent un véritable apprentissage mutuel ainsi
que la collaboration tout au long du cycle de vie des neurotechnologies. Ces processus
devraient prévoir des consultations régulières et inclusives auprès d’un large éventail
d’acteurs. Leurs contributions devraient avoir pour objectif d’éclairer l’élaboration des
politiques, d’orienter les principes directeurs éthiques, d’accroître la sensibilisation et
la compréhension du public, d’harmoniser les priorités en matière d’investissement et
de faire en sorte que le déploiement des neurotechnologies coïncide avec les intérêts
et les valeurs du public. Il conviendrait de veiller tout particulièrement à associer les
groupes traditionnellement sous-représentés dans la formulation des politiques
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technologiques, en encourageant ainsi l’innovation responsable dans le domaine des
neurotechnologies.
106.96. Les États membres devraient élaborer conjointement un langage et une
terminologie exacts, précis et accessibles pour parler des neurotechnologies, en
faisant participer des acteurs de divers horizons, afin de garantir que le langage utilisé
est inclusif et non stigmatisant et qu’il reflète fidèlement les capacités et les limites des
technologies. Les États membres devraient mettre en place des cadres réglementaires
qui imposent des normes de communication claires et éthiques en matière de
neurotechnologies. Ces cadres devraient exiger que la présentation des possibilités,
des risques et des limites soit fondée sur des données factuelles pour l’ensemble des
applications, afin d’éviter l’exagération des assertions, notamment pour ce qui est des
applications dans le domaine du sommeil, de l’attention, de la mémoire et de la
régulation émotionnelle. Ces cadres devraient comporter des lignes directrices
spécifiques pour une commercialisation éthique ainsi que des protocoles garantissant
une communication responsable concernant les recherches à un stade précoce et les
nouvelles technologies.
107.97. Les États membres devraient élaborer des politiques encourageant une
collaboration efficace entre les utilisateurs finaux, les chercheurs et les innovateurs
tout au long du cycle de vie du développement des produits de neurotechnologie, en
accordant une attention particulière aux lieux dans lesquels les neurotechnologies sont
développées. Ces politiques devraient prévoir imposer la création de groupes
consultatifs divers, composés de représentants de groupes d’utilisateurs variés et
respectant la neurodiversité. Les États membres devraient également mettre en place
des plates-formes permettant d’assurer un dialogue et un retour d’informations
continus. Les groupes consultatifs devraient être associés au processus d’élaboration
et de mise à l’essai des nouveaux produits technologiques afin d’optimiser l’efficacité,
la facilité d’utilisation, la longévité et la durabilité des dispositifs. Cette approche
collaborative vise à garantir que les innovations neurotechnologiques sont compatibles
avec le contexte et répondent aux besoins des différentes populations d’utilisateurs.
108.98. Les États membres devraient mettre en place un enseignement relatif aux
neurotechnologies qui soit adapté à l’âge, au contexte, à la culture et à la langue. Cet
enseignement pourrait comprendre des modules de formation afin de faciliter
l’utilisation de ces technologies à domicile, à l’intention des utilisateurs, ainsi que des
personnes qui en ont la charge et des membres de leur famille.
PRISE EN COMPTE DES UTILISATEURS SPÉCIFIQUES
IV.6 ENFANTS ET ADOLESCENTS
4427. Les États membres devraient favoriser un développement cérébral sain au a mis en forme : Numéros + Niveau : 1 + Style de
moyen de politiques évaluant les effets des neurotechnologies sur les enfants et les numérotation : 1, 2, 3, … + Commencer à : 27 +
adolescents. Alignement : Gauche + Alignement : 0,63 cm + Retrait :
1,27 cm
99. Les États membres devraient protéger les enfants et les adolescents contre toute
action visant implicitement ou explicitement à les inciter ou les contraindre à recourir à
des neurotechnologies. Les États membres devraient être attentifs à l’autonomie des
enfants et des adolescents en veillant à l’obtention de leur consentement éclairé et de
leur assentiment d’une manière qui soit adaptée à leur âge et à leurs capacités de prise
de décisions, et respectueuse à cet égard. Cet assentiment ou ce consentement ne
saurait toutefois suffire : le consentement des représentants légaux ou des personnes
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en charge de défendre l’intérêt de l’enfant ou de l’adolescent mineur devrait être
également recueilli.
Les Etats membres devraient encourager la recherche visant à mieux connaitre les
mécanismes du développement cérébral et à évaluer les effets des neurotechnologies
sur les enfants et adolescents afin de prévenir des effets délétères à court ou long-
terme.Les États membres devraient favoriser un développement cérébral sain au
moyen de politiques évaluant les effets des neurotechnologies sur les enfants et les
adolescents.
109.100.
110.101. Les États membres devraient financer des subventions pour la recherche-
développement portant sur la création de neurotechnologies d’assistance faciles à
utiliser et adaptées aux enfants et adolescents en situation de handicap. Ces projets
devraient associer les enfants, les adolescents, les personnes qui en ont la
responsabilité et les parents au processus de conception pour faire en sorte que ces
technologies répondent à leurs besoins spécifiques. Des programmes éducatifs
devraient être mis au point pour apprendre aux enfants, aux adolescents et à ceux qui
en ont la responsabilité à utiliser et à entretenir efficacement ces technologies, en
proposant une aide dans différentes langues et dans des formats accessibles, sans
discrimination à l’égard de ceux qui ne peuvent pas recourir à la technologie proposée
ou qui choisissent de ne pas le faire.
111.102. Les États membres devraient veiller à ce que l’ensemble des recherches en
neurotechnologie faisant participer des enfants et des adolescents fassent l’objet d’une
surveillance stricte et d’un suivi étroit. Il est primordial qu’une telle surveillance soit
assurée au cours des phases de développement de l’enfant afin de faire face à tout
effet à long terme imprévu et de l’atténuer. Ces recherches doivent être assorties de
protocoles de suivi complet et d’évaluations périodiques afin de garantir la sécurité et
le bien-être constants des jeunes participants, en tenant compte du caractère
particulier de leurs besoins en matière de développement et de leurs vulnérabilités.
Dans le cadre des recherches faisant participer des enfants et des adolescents en
situation de vulnérabilité sur le plan médical (par exemple, les enfants placés dans des
unités de surveillance de l’épilepsie), une attention particulière sera accordée au
consentement et à l’assentiment, compte tenu notamment de certains aspects de la
recherche (temps, répétitions) afin de prévenir toute forme d’instrumentalisation.
112.103. Les États membres devraient adopter des réglementations spécifiques pour
interdire l’utilisation de techniques de marketing – comme le neuromarketing, l’analyse
biométrique des émotions, la publicité immersive et la publicité en réalité virtuelle ou
augmentée – qui reposent sur des données biométriques neurales et cognitives à
caractère sensible collectées auprès d’enfants et d’adolescents. Compte tenu de la
plus grande vulnérabilité des enfants et des adolescents dans les environnements
numériques, ces réglementations doivent expressément interdire toute pratique
utilisant ces données pour influencer ou exploiter les enfants et les adolescents.
IV.7 PERSONNES ÂGÉES et PERSONNES DEVANT BENEFICIER DE MESURES
SIMILAIRES
104. Les États membres devraient favoriser un vieillissement en bonne santé et
soutenir les personnes âgées en finançant et en mettant en oeuvre des programmes
fondés sur des données factuelles qui intègrent les neurotechnologies dans les soins
courants. Ces programmes devraient impliquer l’ensemble de l’écosystème de soutien,
notamment la famille, les aidants et les équipes médicales, afin d’améliorer la qualité
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de vie. La priorité devrait être donnée à l’élaboration et à la mise en oeuvre d’outils
permettant de prévenir, de retarder et de traiter les problèmes de santé, les déficiences
et les maladies neurodégénératives liés à l’âge. Les États membres devraient garantir
que l’accès à ces programmes de neurotechnologie soient équitables et ne creusent
pas les inégalités socioéconomiques.
Des mesures similaires pourraient être adoptées au profit de certaines personnes, qui,
bien que relativement jeunes et encore en activité, sont atteintes de pathologies
neurodégénératives.
113.105. Les États membres devraient définir des lignes directrices relatives à la
conception des neurotechnologies qui tiennent compte des besoins des personnes
âgées, en considérant avec attention les facteurs de convivialité de l’interface homme-
machine (polices de caractères, boutons, couleurs, etc.) ainsi que les données
d’expérience permettant d’améliorer les repères visuels et auditifs.
114.106. Les États membres devraient protéger, appuyer et favoriser la prise de
décisions autonome chez les personnes âgées qui se servent des neurotechnologies
pour disposer d’un soutien sensorimoteur et cognitif. Le processus d’obtention du
consentement devrait s’adapter aux éventuelles difficultés cognitives rencontrées par
les personnes âgées, en s’assurant que leur consentement est éclairé, toujours actuel
et adaptable selon l’évolution de leur état de santé. Des politiques devraient être mises
en place pour veiller à ce que les neurotechnologies d’assistance tiennent compte de
l’évolution des capacités cognitives dans le temps et respectent les préférences de
l’utilisateur.
115.107. Les États membres devraient élaborer des principes éthiques pour veiller à ce
que les neurotechnologies telles que les robots de soin améliorent les interactions
humaines sans s’y substituer, notamment dans les soins aux personnes atteintes de
neurodégénérescence. Ces principes devraient mettre l’accent sur l’augmentation
l’adaptation des soins humains, et non sur leur remplacement.
IV.8 FEMMES ET GENRE
116.108. Les États membres devraient adopter et appliquer des politiques globales pour
promouvoir et respecter l’égalité des genres et la diversité dans l’ensemble du cycle
de vie des neurotechnologies. Ces politiques devraient donner la priorité aux
recherches inclusives en vue de répondre aux besoins spécifiques et aux différences
des femmes et en fonction des genres, exiger la collecte et l’analyse ciblées des
données, inclure des programmes d’éducation et de formation sur les pratiques de
recherche inclusive, assurer la coopération du public et de la communauté avec les
groupes de défense et les spécialistes de la santé des femmes et des minorités de
genre, et encourager la conception de technologies tenant compte des questions de
genre, afin de répondre aux besoins et à la condition propres aux femmes et aux
minorités de genre. Des politiques d’action positive sont nécessaires pour combler les
écarts entre les genres dans ces domaines, et accroître la représentation, la
mobilisation et le leadership.
117.109. Les États membres devraient établir des orientations et des cadres juridiques
clairs pour veiller à ce que les lieux de travail et le monde de la recherche, tout au long
du cycle de vie des neurotechnologies, soient inclusifs et porteurs, particulièrement
pour les femmes et les minorités de genre, et qu’ils protègent des actes de harcèlement
et des discriminations. Des mécanismes fiables devraient notamment être prévus pour
signaler et traiter les faits de harcèlement et les discriminations, en garantissant que
les auteurs répondent de leurs actes et qu’un soutien soit apporté.
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110. 114. Les États membres devraient adopter une série de mesures donnant la
priorité à la recherche et à l’innovation éthiques et équitables et soutenant les
programmes qui encouragent la participation des femmes et des minorités de genre
aux neurotechnologies. Cela peut passer par des politiques de financement et autres
privilégiant la recherche et l’innovation éthiques et équitables, mais aussi par des
initiatives d’action positive soutenant la participation des femmes et des minorités de
genre dans les neurotechnologies par le biais de programmes éducatifs ciblés, de
possibilités d’emploi, d’un soutien à l’entreprenariat et du développement de leur
leadership au sein du secteur. Les États membres devraient également proposer des
systèmes de soutien tels que des programmes de mentorat, des possibilités de mise
en réseau et des ressources permettant d’aider les femmes et les minorités de genre
à surmonter les obstacles à la participation et à réussir dans le domaine des
neurotechnologies.
IV.9 PERSONNES EN SITUATION DE HANDICAP PHYSIQUE
118.111. Les États membres devraient adopter des politiques qui tirent parti du potentiel
des neurotechnologies en supprimant les obstacles rencontrés par les personnes en
situation de handicap physique et en leur apportant un soutien, contribuant ainsi à ce
qu’elles puissent effectivement exercer leurs droitsexercent leurs droits humains dans
des conditions d’égalité. Ils devraient appliquer des cadres réglementaires qui
imposent la réalisation d’évaluation de l’accessibilité de tous les nouveaux produits
neurotechnologiques, afin de veiller à ce que ces produits ne perpétuent pas les
handicaps ou les disparités en matière de santé qui existent déjà. Ces cadres devraient
prévoir des protocoles d’essai auprès de groupes variés de personnes en situation de
handicap afin que les technologies répondent à un large éventail de besoins, et qu’elles
n’excluent pas ou ne désavantagent pas involontairement tel ou tel sous-groupe.
119.112. Les États membres devraient créer des programmes d’incitation pour
promouvoir le développement de neurotechnologies destinées aux personnes en
situation de handicap afin de favoriser leur qualité de vie et leur indépendance
fonctionnelle. Ces programmes devraient inclure des mesures d’incitation fiscale pour
les entreprises investissant dans la recherche-développement concernant les
neurotechnologies d’assistance, des subventions destinées aux institutions de
recherche s’intéressant aux neurotechnologies d’aide aux personnes porteuses d’un
handicap, des autorisations réglementaires accélérées pour les technologies
représentant de grandes avancées en matière de mobilité, de communication ou
d’assistance dans la vie quotidienne et des prix d’innovation distinguant des progrès
décisifs en faveur de solutions neurotechnologiques abordables et accessibles.
113. Les États membres devraient, autant que possible, financer les coûts liés aux
dispositifs neurotechnologiques indispensables, tels que les neuroprothèses, pour les
personnes en situation de handicap physique. Ils pourraient encourager les
partenariats public-privé afin de rendre les neurotechnologies accessibles et faire en
sorte que les neurotechnologies soient couvertes pour les personnes en situation de
handicap physique dans les régimes nationaux d’assurance maladie et autres
systèmes de remboursement. Une base de données nationale des ressources et des
services de soutien disponibles en matière de neurotechnologies devrait être mise en
place pour faciliter l’accès et le partage des informations.
120.114. Les Etats devraient mettre en place des dispositifs de repérage et d’aide ainsi
que des moyens de protection pour les personnes susceptibles de souffrir des
conséquences de leurs choix modifiés par un traitement ( par exemple, les
conséquences d’une addiction à un agoniste dopaminergique, utilisé pour les patients
atteints de la maladie de Parkinson.
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IV.10 PERSONNES SOUFFRANT DE TROUBLES MENTAUX
121.115. Les États membres devraient encourager la recherche et promouvoir des
initiatives de sensibilisation pour faire face à la proportion croissante et aux besoins
spéciaux des personnes souffrant de troubles mentaux, notamment les victimes et les
survivants de traumatismes et de violences, et examiner l’importance des
neurotechnologies pour ces populations.
122.116. Les États membres devraient allouer des fonds aux efforts de plaidoyer à long
terme et aux études d’efficacité, au contrôle après mise sur le marché et à la
surveillance à plusieurs niveaux, en portant une attention particulière au caractère
invasif et à la réversibilité des interventions neurotechnologiques. Il est important de
veiller à ce que les personnes souffrant de troubles mentaux soient bien informées et
que leurs attentes à l’égard du processus soient raisonnables.
123.117. Les États membres devraient financer en priorité les neurotechnologies
conçues pour améliorer la qualité de vie et le fonctionnement quotidien des individus
souffrant de troubles mentaux. Il s’agit notamment des technologies qui aident à gérer
les symptômes, à améliorer les fonctions cognitives et à apporter un soutien
émotionnel à domicile, au travail, au sein de la communauté et dans la société. La
recherche-développement devrait être guidée par des retours d’information et en
coopérant avec des personnes atteintes de troubles mentaux et ceux qui défendent
leurs intérêts.
118. Les États membres devraient mettre en place des politiques visant à améliorer
l’accès des personnes souffrant de troubles mentaux aux avancées récentes en
matière de neurotechnologies, afin que leur coût ne représente pas un obstacle pour
avoir accès à des traitements et à des aides susceptibles de transformer l’existence.
124.119. Les Etats membres devraient établir des procédures permettant d’exprimer des
préférences avant les phases critiques du traitement et en dehors des phases de crise
pathologique devraient être mises en place, à l’instar de ce qui existe pour la fin de vie
afin de permettre aux personnels soignants de prendre les mesures les plus conformes
possibles aux souhaits et préférences des patients.
ÉTHIQUE DE LA SANTÉ ET DE LA RECHERCHE
IV.11 SANTÉ
125.120. Les États membres devraient encourager le développement d’applications de
soins de santé qui répondent en priorité aux besoins non satisfaits en termes d’offre
de services de santé neurologique et mentale. Il s’agit notamment de mettre en place
des programmes de financement de la recherche visant spécifiquement à combler les
lacunes identifiées dans les soins du système nerveux.
126.121. Les États membres devraient renforcer et entretenir la solidarité internationale
en vue de répondre aux risques et incertitudes mondiaux en matière de santé, et veiller
à ce que la mise en oeuvre de leurs soins de santé du système nerveux soit conforme
au droit international et aux obligations strictes qui leur incombent en matière de droits
de l’homme. Il pourrait s’agir de créer des forums internationaux pour l’échange des
meilleures pratiques dans la mise en oeuvre des neurotechnologies dans les soins de
santé.
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127.122. Les États membres devraient établir des mécanismes de contrôle afin d’évaluer
les effets de l’utilisation à long terme des dispositifs neurotechnologiques sur la santé
physique et mentale, en prêtant une attention particulière au degré d’intrusion et de
réversibilité des interventions neurotechnologiques. Il s’agit notamment de mettre en
oeuvre des mesures réglementaires exigeant des études de suivi à long terme pour
les dispositifs neurotechnologiques approuvés et d’établir des critères clairs pour le
maintien de l’approbation sur la base des résultats de ces études.
128.123. Les États membres devraient prendre en considération l’importance du coût et
de l’impact que représentent les pathologies liées au système nerveux, ainsi que les
avantages potentiels du diagnostic précoce et de l’accès aux neurotechnologies de
prévention et d’assistance. Les politiques publiques devraient promouvoir en priorité
l’accès à ces technologies et assurer la prise en charge des frais de santé des
personnes qui en ont besoin.
129.124. Les États membres devraient promouvoir le développement de
neurotechnologies fiables et durables pour les applications de soins de santé. Il s’agit
notamment d’encourager la conception de dispositifs et de systèmes qui nécessitent
un minimum d’entretien, en veillant à ce qu’ils restent fonctionnels et efficaces dans les
conditions de la vie quotidienne. Les organismes de réglementation ou les autorités
désignées devraient superviser l’application de normes de qualité, de sécurité et de
longévité rigoureuses, afin de réduire la charge pesant sur les utilisateurs et d’améliorer
la fiabilité et la durabilité des solutions neurotechnologiques.
130.125. Les États membres devraient élaborer des systèmes de communication
d’informations exhaustives sur les dispositifs médicaux neurotechnologiques qui
permettent de suivre les effets indésirables et d’y remédier, ou renforcer ceux qui
existent déjà. Dans les contextes où de tels systèmes n’existent pas, les États
membres devraient les mettre en place. Lorsque des systèmes sont déjà en place, ils
devraient être actualisés pour inclure spécifiquement les neurotechnologies. Ces
systèmes devraient être interopérables et contribuer à l’établissement d’une base de
données internationale centralisée, publique et transparente, gérée en collaboration
avec des organisations internationales afin de garantir le respect des normes
mondiales, et accessible aux fins de l’information du public, du contrôle international et
de la recherche.
IV.12 ÉTHIQUE DE LA RECHERCHE
131.126. Les États membres devraient renforcer les cadres éthiques régissant les
recherches en neurotechnologie afin de garantir une protection solide efficace des
participants humainspersonnes humaines impliquées dans une recherche. Les États
membres devraient adopter des politiques ou des principes directeurs clairs pour
définir les qualifications afin de s’assurer que les travaux de recherche sont conduits
par des professionnels disposant des connaissances adéquates sur la structure et le
fonctionnement du système nerveux, ainsi que sur les troubles du cerveau, et menés
dans des environnements de recherche appropriés. En outre, les protocoles de
recherche, publics ou privés, dans le domaine médical ou non, devraient être
soigneusement évalués par des conseils d’éthique agréés (comités d’éthique) et une
attention particulière devrait être portée aux personnes se trouvant dans des situations
particulières de vulnérabilité, telles qu’une diminution de la faculté à donner son
consentement ou à prendre des décisions. Les États membres devraient veiller à ce
que tous les établissements de recherche proposent aux chercheurs une formation
obligatoire en matière d’éthique.
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132.127. Les États membres devraient encourager une recherche internationale
multicentrique, associant différentes cultures et différents groupes ethniques. Les États
membres devraient promouvoir la coopération internationale en vue d’élaborer des
normes et des protocoles d’interopérabilité communs pour la communication des
informations, notamment en ce qui concerne les dispositifs neurotechnologiques
implantables. Une telle coopération devrait viser à améliorer la comparabilité et l’utilité
des travaux de recherche à l’échelle mondiale, en améliorant à la fois leur efficacité et
leur intégrité éthique.
133.128. Les États membres devraient veiller à ce que l’ensemble du cycle de vie des
neurotechnologies soit pris en compte lors de la conception d’un essai clinique, y
compris les politiques de protection des patients en cas de cessation des activités du
commanditaire ou du promoteur de l’essai. Les États membres devraient imposer
l’obligation pour les essais cliniques d’être inscrits sur les registres adéquats approuvés
au niveau national ou international, et encourager l’inscription sur des registres
communautaires et des registres de patients. Par ailleurs, les essais cliniques
devraient faire état des systèmes appropriés de communication d’informations sur les
dispositifs médicaux élaborés au sein des États membres.
134.129. Les développeurs de technologies devraient garantir que la validation des
algorithmes d’IA dans la recherche en neurotechnologie repose sur des tests rigoureux
pour déceler les biais, les risques d’erreurs et d’hallucinations ainsi que sur des
mesures visant à instaurer un contrôle humain et à améliorer l’explicabilité et la
transparence, notamment la provenance des ensembles de données d’entraînement.
Des techniques adaptées devraient être employées pour atténuer tout biais, erreur ou
hallucination présent dans les modèles d’IA utilisés dans les applications
neurotechnologiques.
135.130. Les États membres devraient veiller à ce que les efforts de recherche ne se
limitent pas aux risques biomédicaux associés aux neurotechnologies, mais examinent
également les effets potentiels sur l’expérience subjective, la capacité d’action et
l’identité personnelle de l’individu. Il est essentiel de comprendre la façon dont les
neurotechnologies peuvent influencer certains aspects de la perception de soi, de la
conscience et de l’identité pour répondre aux préoccupations éthiques et garantir le
bien-être des individus qui utilisent ces technologies.
136.131. Les États membres devraient veiller à ce que les personnes participant à
desque des instances indépendantes aux travaux de recherche procèdent
régulièrement à des audits et au suivi des pratiques de recherche afin de garantir le
respect des normes éthiques. Il convient notamment d’évaluer la conformité du
consentement éclairé à ces normes, en particulier en ce qui concerne la réutilisation
des données et l’éventuelle commercialisation des données neurales.
132. Les États membres devraient prendre des mesures législatives et
réglementaires pour que les personnes humaines impliquées dans les recherches
soient informées avec clarté et précisions des risques et bénéfices encourus afin
qu’elles puissent, elles ou, le cas échéant, leur représentant légal, donner leur
consentement et/ou assentiment tel que prévu par la loi.
22. Les États membres devraient exiger des chercheurs en neurotechnologie qu’ils a mis en forme : Justifié, Retrait : Gauche : 0,63 cm,
établissent des protocoles clairs et transparents pour communiquer aux participants les Sans numérotation ni puces
découvertes fortuites importantes sur le plan clinique, et qui appellent une action. Ces
protocoles devraient garantir la transmission rapide de ces résultats, dans le respect des
droits et de l’autonomie des participants. En outre, les États membres devraient exiger que
les chercheurs apportent le soutien nécessaire aux prestataires de soins de santé et qu’ils
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assurent la coordination avec ces derniers pour remédier à tout problème de santé
découlant de ces découvertes.
137.133. Les États membres devraient veiller à ce que les personnes participant à des
travauhumaines impliquées dans unex de recherche en neurotechnologie ou subissant
des interventions neurotechnologiques soient dûment informées des risques de
découvertes fortuites, en particulier celles qui entraînent des répercussions
importantes sur la santé. Le processus de consentement éclairé devrait indiquer
clairement ce que ces découvertes pourraient impliquer, donner aux participants le
droit de choisir s’ils souhaitent être informés ou non de ces découvertes, et garantir
que leurs décisions à cet égard seront respectées tout au long de l’étude ou du
traitement.
DOMAINES D’APPLICATION SPÉCIFIQUES EN DEHORS DE LA SANTÉ
IV.13 ENVIRONNEMENTS ÉDUCATIFS
138.134. Les États membres devraient aborder avec prudence la question de l’intégration
des neurotechnologies dans l’éducation, en veillant à ce que leur utilisation soit fondée
sur des données probantes, qu’elle corresponde aux objectifs éducatifs et qu’elle
complète les méthodes d’apprentissage traditionnelles. Il importe en particulier de
promouvoir le développement holistique des élèves, en mettant l’accent non seulement
sur leurs résultats scolaires, mais aussi sur leur santé mentale, leur bien-être et leur
intérêt général. Pour garantir l’inclusivité, les États membres devraient élaborer des
lignes directrices adaptées à l’âge pour l’utilisation des neurotechnologies à différents
stades de l’éducation et dans différents styles d’apprentissage. Des évaluations
régulières de l’impact des neurotechnologies sur le développement des élèves,
notamment leur santé mentale, devraient être réalisées, et des processus d’examen
éthique devraient être mis en place pour superviser le déploiement de ces
technologies. Il convient de s’attacher avant tout à favoriser la réflexion critique, la
créativité et l’intelligence émotionnelle, plutôt que de s’employer uniquementen plus de
rechercher l’amélioration des à améliorer les résultats scolaires.
139.135. Les États membres devraient adopter des politiques garantissant le
déploiement volontaire des neurotechnologies dans l’éducation, sur la base d’un
consentement libreplein et éclairé. Ces politiques doivent inclure des informations
claires et adaptées à l’âge sur les objectifs, les avantages et les risques de ces
technologies, ainsi que des délais de réflexion adéquats. Étant donné qu’il est de plus
en plus difficile d’obtenir un consentement volontaire dans ce contexte, les procédures
de consentement et d’assentiment devraient associer les enfants, les adolescents, les
parents, les tuteurs et tous les acteurs nécessaires pour obtenir l’approbation exigée
pour les mineurs. Il convient de mettre en place des mécanismes de contrôle éthique,
y compris le renouvellement régulier du consentement et l’arrêt immédiat de l’utilisation
des neurotechnologies en cas de rétractation, ainsi que des canaux de retour
d’information anonymes. Les politiques doivent interdire les mesures incitatives
injustifiées ou les sanctions scolaires en cas de non-participation, et prévoir des
mesures pour éviter de créer ou de renforcer des inégalités entre les élèves. En outre,
les États membres devraient encourager la participation des élèves à la prise de
décisions concernant l’intégration des neurotechnologies et financer des programmes
de formation sur leur utilisation éthique, en donnant aux éducateurs et aux élèves les
moyens d’évaluer leur application de manière critique.
140.136. Les États membres devraient mettre en place un mécanisme de surveillance
unifié et efficacsolide pour l’utilisation des neurotechnologies dans les environnements
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éducatifs, qui devrait inclure des audits réguliers ainsi que des retours d’information du
public et des communautés, être adapté à la culture et conforme aux conventions
locales, et garantir un respect strict des normes de sécurité et d’éthique, notamment
par une évaluation de la réversibilité des effets sur le système nerveux. Des efforts
continus de recherche devraient être financés pour évaluer les effets psychologiques
et cognitifs à long terme de ces technologies. Le contrôle devrait comporter des
examens périodiques fondés sur des données empiriques afin d’adapter l’utilisation
des neurotechnologies en fonction des besoins, en veillant à ce qu’elle serve le
développement de l’élève et à ce qu’elle tienne compte des risques tels que la
dépendance ou l’appauvrissement des compétences. Cette approche globale
contribuera à maintenir la sécurité et l’efficacité des neurotechnologies ainsi que leur
alignement sur les meilleures pratiques en faveur du bien-être et des résultats
d’apprentissage des élèves.
141.137. Les États membres devraient investir dans des programmes d’éducation et de
développement professionnel visant à doter les innovateurs et les chefs d’entreprise et
autres acteurs concernés des compétences nécessaires pour intégrer les
considérations éthiques tout au long de l’ensemble du cycle de vie des
neurotechnologies. Ces formations devraient porter notamment sur la conception
éthique, le droit relatif aux droits de l’homme et l’évaluation de l’impact sociétal, afin de
préparer la prochaine génération de technologues à évaluer de manière critique les
incidences de leurs travaux.
IV.14 TRAVAIL ET EMPLOI
142.138. Les États membres devraient mettre en place des politiques et des mesures
incitatives sur le lieu de travail qui donnent la priorité à la santé et au bien-être des
employés dans l’utilisation des neurotechnologies. Ces politiques devraient garantir
que tout déploiement de neurotechnologies repose sur des données probantes, en
mettant l’accent sur les applications qui ont été scientifiquement validées pour
promouvoir le bien-être des employés, comme la réduction du stress ou l’amélioration
des conditions de travail (c’est-à-dire des environnements adaptatifs et réactifs qui
ajustent la charge de travail en fonction de la charge cognitive). Le déploiement doit se
faire sur une base volontaire et les employés doivent avoir la possibilité de refuser
d’utiliser les neurotechnologies sans subir de conséquences négatives ou de
discrimination. Ces technologies ne doivent en aucun cas être utilisées à des fins
punitives ou de surveillance mentale, ou d’une manière qui pourrait compromettre la
santé des employés.
143.139. Les États membres devraient exiger des employeurs qu’ils fournissent aux
employés des informations claires et complètes sur le fonctionnement des
neurotechnologies utilisées sur leur lieu de travail, sur les avantages qu’elles offrent,
sur la transparence quant au type de données collectées, sur la manière dont elles
sont utilisées et sur les personnes qui y ont accès, et qu’ils annoncent clairement tous
les risques pouvant découler de leur utilisation.
144.140. Les États membres devraient exiger des employeurs qui utilisent les
neurotechnologies sur le lieu de travail qu’ils adoptent des politiques transparentes
précisant l’objectif de leur utilisation et limitant leur champ d’application à des fins
légitimes, dans l’intérêt des employés et des tiers (c’est-à- dire, la sécurité, la
surveillance de la fatigue chez les conducteurs commerciaux ou le suivi de l’attention
chez les contrôleurs aériens). Afin de respecter la vie privée mentale des employés,
les employeurs devraient se voir interdire l’accès sans autorisation aux données
biométriques neurales et cognitives pouvant être recueillies fortuitement dans le cadre
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de la surveillance de routine sur le lieu de travail. Il devrait être interdit aux employeurs
d’utiliser les données biométriques neurales et cognitives à des fins non consenties,
en particulier celles qui pourraient nuire à la sécurité de l’emploi ou à la vie privée d’un
employé.
145.141. Les États membres devraient exiger des employeurs qu’ils adoptent les
meilleures pratiques en matière de minimisation des données et de conservation
sécurisée des données biométriques neurales et cognitives, en veillant à ce que les
données soient conservées en toute sécurité, que leur accès soit limité uniquement au
personnel autorisé et qu’elles soient supprimées aussitôt atteint l’objectif pour lequel
elles ont été recueillies. En outre, lors du départ d’un employé, tous les dossiers
connexes doivent être entièrement supprimés ou les données personnelles doivent
être communiquées à l’employélui être transférées, de sorte qu’aucune donnée ne soit
conservée après la cessation de service.
146.142. Les États membres devraient veiller à ce que, lorsque les employés reçoivent
des dispositifs multifonctionnels (c’est-à-dire, des oreillettes ou des casques d’écoute
comprenant également des capteurs neuronaux) qui peuvent être utilisés au travail ou
à domicile, il soit interdit aux employeurs de recueillir des données biométriques
neurales et cognitives en dehors du cadre et des heures de travail, et garantir que toute
donnée recueillie pendant le travail est utilisée exclusivement aux fins convenues. Les
employeurs devraient mettre en place des mesures de protection technologiques pour
désactiver automatiquement la collecte de données en dehors des heures de travail.
147.143. Les États membres devraient veiller à ce que les employeurs respectent le droit
des employés d’obtenir une copie de toutes les données biométriques neurales et
cognitives recueillies à leur sujet, ainsi que de toutes les interprétations qui en sont
tirées, d’une manière accessible et compréhensible. L’utilisation de ces outils sans
consentement constitue un abus de confiance, qui remet en question la valeur qu’ils
pourraient autrement créermanquement au principe de loyauté, qui doit être
sanctionné.
148.144. Les États membres devraient exiger, par le biais de réglementations strictes,
que toute utilisation des neurotechnologies sur le lieu de travail nécessite le
consentement explicite des employés, et que celles-ci ne soient utilisées qu’à des fins
qui améliorent manifestement la sécurité sur le lieu de travail, ainsi que le bien-être et
la dignité des employés, et non pour accroître la productivité au détriment de la santé
de ces derniers.
149.145. Les États membres devraient se prémunir contreprévenir l’exploitation des
employés et élaborer des réglementations strictes contre l’utilisation des données
biométriques neurales et cognitives à des fins de profilage sur le lieu de travail,
notamment lors du recrutement. Ces réglementations devraient interdire l’utilisation
des données biométriques neurales et cognitives pour discriminer les candidats, en
particulier les personnes neurodivergentes, afin de garantir des pratiques de
recrutement équitables et inclusives.
150.146. Les États membres devraient réglementer strictement l’utilisation des
neurotechnologies à des fins de recrutement ou de maintien de l’emploi, afin de limiter
cette utilisation aux cas où les données biométriques neurales et cognitives ont un
rapport direct avec les exigences spécifiques de l’emploi.
IV.15 DOMAINES DE LA CONSOMMATION ET DU COMMERCE
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151. Les États membres devraient mettre en place de façon proactive un cadre
réglementaire qui assure un équilibre entre l’innovation dans les domaines récréatif et
commercial et la protection des droits et du bien-être des individus. Ce cadre devrait
être dynamique et devrait pouvoir être actualisé de manière opportune, à mesure que
les technologies évoluent et que de nouvelles connaissances sont acquises quant à
leur impact sur la société. Il s’agit notamment d’assurer une surveillance adéquate pour
garantir que les neurotechnologies ne causent pas de dommages, qu’elles sont
utilisées de manière consensuelle et qu’elles comportent des mécanismes
efficacessolides pour protéger les utilisateurs contre tout risque de détresse
psychologique ou de manipulation.
152.
153.147.
154.148. Les États membres devraient renforcer les législations en matière de protection
globale des consommateurs afin d’inclure un étiquetage clair sur les produits
neurotechnologiques commerciaux, détaillant leurs effets, leurs limites et leurs risques
afin d’éviter les allégations trompeuses et de garantir la transparence. Il s’agit
également d’interdire les pratiques de « vente liée » ou celles exigeant la divulgation
de données neurales et de données biométriques cognitives de données biométriques
neurales et cognitives comme condition d’accès à des biens ou à des services, ainsi
que le partage de données avec des tiers ou l’utilisation de ces données sans que les
individus aient la possibilité de formuler leur consentement exprès.
155.149. Les États membres devraient créer un environnement qui garantisse que toutes
les allégations concernant les technologies grand public, non médicales, soient
étayées par des preuves scientifiques solides. Ils devraient, par voie réglementaire,
exiger que tout produit prétendant traiter, prévenir ou diagnostiquer des maladies ou
des problèmes médicaux soit validé parsoumises à des tests rigoureux de sécurité, de
toxicité et d’efficacité, y compris des essais cliniques, le cas échéant, et qu’il soit utilisé
sous contrôle d’une instance agréée par les autorités publiquesmédical approprié. Le
consommateur doit être informé de la nature non-médicale des produits concernés.
Les États membres doivent mettre en oeuvre des procédures de consentement éclairé
approfondies et transparentes pour toutes les interventions neurotechnologiques, en veillant
à ce que la participation soit pleinement volontaire et respecte la vie privée et l’autonomie des
individus. Ce principe devrait s’appliquer uniformément dans divers domaines tels que le sport
ou les arts, où des normes solides devraient protéger les individus contre une utilisation
coercitive et respecter l’autonomie individuelle des athlètes et des artistes, les intérêts de la
communauté et les droits de propriété intellectuelle.
156.150. Les États membres devraient orienter l’encourager les acteurs concernés à
mettre en place une utilisation et unle développement des neurotechnologies dans le
domaine des arts afin d’améliorer l’apprentissage et l’éducationappréciation culturelle
sans compromettre l’autonomie individuelle ou entraîner une homogénéisation
culturelle.
157.151. Les États membres devraient adopter des politiques visant à prévenir
l’utilisation abusive des neurotechnologies dans les technologies grand public, en
particulier les jeux vidéo pilotés par ondes cérébrales (neurogaming) et autres
dispositifs qui exploitent le circuit de la récompense de la dopamine ou qui cherchent
à susciter une utilisation problématique et malsaine ainsi qu’une surconsommation.
Ces réglementations devraient imposer de fournir une indication claire des risques
associés à ces produits ainsi que des informations concernant leurs effets sur le
système nerveux, et faire appliquer des normes de conception des jeux et des normes
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de sécurité, de respect de la vie privée et de conception adaptée à l’âge, visant à
empêcher que l’on profite de la vulnérabilité physique, mentale et émotionnelle d’une
personne pour la conduire à une utilisation compulsive ou à une dépendance à l’égard
des jeux ou des plates-formes récréatives numériques combinées aux
neurotechnologies, afin de promouvoir une utilisation saine et équilibrée, en particulier
chez les enfants.
158.152. Les États membres devraient veiller à ce que les dispositifs comportant des
fonctions multiples, tels que les lunettes XR ou les écouteurs intelligents dotés de
capteurs neuronaux, soient équipés de commandes matérielles permettant aux
utilisateurs de désactiver sélectivement les fonctions neurotechnologiques tout en
conservant les fonctionnalités de base. Les réglementations devraient garantir que les
options de désactivation sont accessibles et pratiques, afin de promouvoir une
utilisation saine et équilibrée, en particulier chez les enfants et les populations
vulnérables.
159.153. Les États membres devraient se pencher sur les questions éthiques profondes
relatives à l’autodétermination, au consentement, à la vie privée et au risque de
manipulation soulevées par les neurotechnologies dans le contexte des systèmes de
recommandation, de l’amorçage et de l’incitation, du marketing du sommeil et du rêve,
du neuromarketing et des environnements en boucle fermée, en adoptant des
politiques et des réglementations globales qui :
(a) systèmes de recommandation : interdisent explicitement l’utilisation des données
neurales et des données biométriques cognitives des données biométriques
neurales et cognitives dans les systèmes de recommandation à des fins de
manipulation ou de tromperie, notamment dans un contexte politique. Ces
réglementations devraient exiger que toute utilisation de ces données dans ces
systèmes soit fondée sur le consentement explicite et éclairé des utilisateurs ;
(b) incitation : régissent l’utilisation des données neurales et des données biométriques
cognitives des données biométriques neurales et cognitives à des fins d’incitation
– c’est-à-dire pour influencer subtilement les décisions ou les comportements des
individus, souvent sans qu’ils en aient effectivement conscience. Ces
réglementations sont particulièrement importantes dans des domaines sensibles
tels que la diffusion « publicitaire » de les messages politiques, la publicité
commerciale et les soins de santé. Ces cadres devraient exiger un consentement
explicite et éclairé pour toute utilisation de ces données visant à influencer les
décisions ou les comportements, le droit de se retirer de ces systèmes, ainsi que
la transparence et la fourniture d’informations claires au moment de la collecte des
données, et imposer des limites strictes s’agissant de l’utilisation des données à
des fins autres que celles explicitement mentionnées ;
(c) marketing du sommeil et du rêve : interdisent l’utilisation des neurotechnologies qui
influencent ou manipulent les individus pendant leur sommeil, comme le marketing
du sommeil et du rêve. Les réglementations devraient interdire strictement les
applications commerciales, de marketing ou politiques qui ciblent les individus
pendant leur sommeil, en utilisant les neurotechnologies ou les données neurales
et les données biométriques cognitives les données biométriques neurales et
cognitives. En outre, des mécanismes de contrôle solides devraient être exigés
pour garantir que toute recherche portant sur ces technologies ou toute application
de celles-ci donne la priorité au bien-être, à la vie privée et à l’autonomie des
individus, en accordant une attention particulière aux effets psychologiques et
cognitifs potentiels à long terme de la manipulation des états de sommeil ;
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(d) neuromarketing : visent à se prémunir contre les objectifs et les pratiques contraires
à l’éthique dans le domaine du neuromarketing, notamment en imposant la
fourniture d’informations exhaustives pour garantir que toutes les activités de
neuromarketing sont menées de manière transparente, avec le consentement
éclairé explicite des participants. Il s’agit notamment de s’assurer que les
participants aux campagnes de neuromarketing ou aux travaux de recherche dans
ce domaine sont pleinement conscients des méthodes, des risques et des
intentions et qu’ils consentent expressément à participer. L’utilisation, la
conservation et la réutilisation potentielle des données recueillies devraient être
strictement réglementées ;
(e) environnements en boucle fermée : fournissent des directives réglementaires
claires sur la conception et l’utilisation des environnements en boucle fermée – tels
que les systèmes informatiques immersifs qui ajustent les expériences en fonction
des données biométriques neurales et cognitives détectées. Ces politiques
devraient imposer la fourniture d’informations claires et accessibles sur la manière
dont les données neurales et les données biométriques cognitives données
biométriques neurales et cognitives sont utilisées dans ces environnements,
interdire la modification ou la manipulation des comportements en temps réel sans
consentement explicite et éclairé, et mettre en oeuvre des garanties spécifiquement
conçues pour prévenir les abus tels que la surveillance non autorisée, les
interventions manipulatrices et les pratiques susceptibles d’influencer le
comportement électoral ou les opinions politiques, ou d’exploiter les vulnérabilités
psychologiques et émotionnelles en temps réel.
IV.16 AMÉLIORATIONUTILISATIONS NON MEDICALES
160.154. L’utilisation des neurotechnologies pour améliorer la mémoire, l’attention ou
d’autres aspects des performances mentales humaines en dehors du contexte médical
pose des défis éthiques, sociaux et juridiques complexes, qui sont susceptibles de
créer de nouveaux types de disparités dans le monde. Lorsque les neurotechnologies
sont utilisées dans ces contextes, elles soulèvent des questions cruciales concernant
l’équité, le consentement, l’autonomie individuelle et communautaire, ainsi que la
nature même de l’amélioration du système nerveux. Les États membres devraient
veiller à ce que les politiques, les lois et les cadres réglementaires qui régissent
l’utilisation des neurotechnologies dans ces contextes n’exacerbent pas les inégalités
sociales ou n’entraînent pas de discrimination, qu’ils tiennent compte des risques
potentiels (notamment la réversibilité des effets, le degré d’intrusion et les risques pour
l’autodétermination) et qu’ils respectent pleinement les droits de l’homme et la dignité
humaine.
V. MISE EN OEUVRE
161.155. Les États membres et tous les autres acteurs identifiés dans la présente
Recommandation devraient respecter, promouvoir et protéger les valeurs, principes et
normes éthiques qui y sont énoncés, et prendre toutes les mesures en leur pouvoir
pour garantir sa mise en oeuvre.
162.156. Les États membres – en fonction des contextes, des structures de gouvernance
et des dispositions constitutionnelles qui sont les leurs – devront faire progresser de
manière crédible et transparente l’éthique des neurotechnologies, conformément à la
Recommandation de l’UNESCO. Les États membres devront assurer le suivi et
l’évaluation des politiques, programmes et mécanismes relatifs aux neurotechnologies
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et à leur éthique. Le suivi des progrès pourrait s’appuyer sur une combinaison
d’approches quantitatives et qualitatives.
163.157. Les États membres devraient développer les capacités des institutions
gouvernementales et aider les responsables gouvernementaux à orienter le
développement technologique de manière éthique.
164.158. Les États membres devraient créer ou désigner des organismes nationaux
chargés de superviser et de coordonner la réglementation, le contrôle et la surveillance
des neurotechnologies au sein des organismes gouvernementaux concernés. Ces
organes de coordination devraient être chargés de veiller à ce que les cadres juridiques
et réglementaires soient appliqués de manière cohérente, à ce que la santé et la
sécurité publiques soient protégées et à ce que les normes éthiques et les droits de
l’homme soient respectés dans l’ensemble du cycle de vie des neurotechnologies. Il
s’agit notamment de faciliter la collaboration interinstitutions, de veiller au respect des
normes nationales et internationales, et de s’assurer que les données et les
connaissances issues des différents domaines réglementaires sont partagées
efficacement afin d’éclairer la prise de décisions et l’élaboration des politiques. Ces
organismes devraient également contribuer à coordonner la participation du public et
de la communauté.
165.159. Les États membres devraient s’efforcer d’élargir et de compléter leur propre
action en ce qui concerne la présente Recommandation en coopérant avec toutes les
organisations nationales et internationales, gouvernementales et non
gouvernementales concernées, ainsi qu’avec les sociétés transnationales et les
organisations scientifiques dont les activités sont en rapport avec le champ
d’application et les objectifs de la présente Recommandation. La société civile jouera
un rôle important pour défendre les intérêts du secteur public. L’UNESCO doit par
conséquent asseoir et mettre en avant sa légitimité.
166.160. L’UNESCO devrait faire largement connaître et circuler la présente
Recommandation par tous les moyens disponibles, et la communiquer aux États
membres, aux commissions nationales pour l’UNESCO, aux partenaires
internationaux et régionaux concernés, aux institutions de défense des droits de
l’homme ainsi qu’aux organes consultatifs de l’UNESCO en matière d’éthique, afin
qu’ils la diffusent à tous les niveaux et auprès de tous les acteurs dans ce domaine.
167.161. Pour aider les États membres à mettre en oeuvre la Recommandation en
élaborant des programmes et des politiques concrets et en développant les capacités
institutionnelles dans le domaine de l’éthique des neurotechnologies, l’UNESCO
contribuera à l’élaboration d’un programme à part entière comportant les éléments
suivants :
(a) une méthodologie d’évaluation de l’état de préparation (RAM) pour aider les États
membres à déterminer leur état d’avancement, à divers égards, à des moments précis
de leur parcours de préparation ;
(b) une méthodologie UNESCO d’évaluation de l’impact éthique (EIE) des
neurotechnologies reposant sur des travaux scientifiques rigoureux, et basée sur le
droit international des droits de l’homme, accompagnée de lignes directrices
spécifiques concernant sa mise en oeuvre dans l’ensemble du cycle de vie des
neurotechnologies, ainsi que d’outils et de matériels de renforcement des capacités
destinés à soutenir les initiatives des États membres visant à former des responsables
gouvernementaux, les responsables politiques et autres acteurs concernés à la
méthodologie ;
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(c) une méthodologie UNESCO pour évaluer en amont et en aval l’efficacité et l’efficience
des politiques et des mesures d’incitation relatives à l’éthique des neurotechnologies
par rapport aux objectifs fixés ;
(d) un programme de recherche de l’UNESCO qui mettra l’accent sur l’éthique des
neurotechnologies, reposant sur une évaluation fondée sur l’état actuel des
développements technologiques, afin d’évaluer l’impact actuel et futur des
neurotechnologies sur les sociétés et l’environnement. Ces analyses fondées sur des
éléments factuels seront rassemblées dans un observatoire de l’UNESCO, qui
constituera un réservoir commun de connaissances et d’informations sur les bonnes
pratiques et les innovations à la disposition de tous les États membres et acteurs, sous
la forme de rapports de recherche, de données et de statistiques concernant les
politiques en matière d’éthique des neurotechnologies. Le programme de recherche
devrait prendre en considération les développements convergents des
neurotechnologies avec d’autres technologies telles que l’intelligence artificielle et la
technologie quantique, les travaux devant être menés en collaboration avec d’autres
initiatives pertinentes de l’UNESCO ;
(e) une plate-forme de collaboration de l’UNESCO visant à favoriser l’établissement
d’échanges fructueux et à faciliter la collaboration entre les États membres ainsi
qu’entre tous les acteurs concernés afin de promouvoir un dialogue politique mondial,
y compris au niveau ministériel, dans le cadre d’un Forum mondial sur l’éthique des
technologies émergentes. Pour soutenir cette initiative, l’UNESCO mettra en place un
réseau d’experts sur les neurotechnologies, au sein duquel tous les groupes régionaux
de l’UNESCO seront représentés de manière équilibrée.
168.162. Les processus de suivi et d’évaluation devraient assurer une large participation
de tous les acteurs, notamment, mais pas exclusivement, des personnes sous-
représentées, vulnérables ou en situation de vulnérabilité, et garantir une diversité sur
les plans social, culturel et du genre. Le suivi et l’évaluation de l’impact des
neurotechnologies et des politiques et pratiques connexes relatives à l’éthique
devraient être assurés en permanence et de façon systématique, proportionnellement
aux risques correspondants. Ce processus devrait s’appuyer sur des cadres convenus
au niveau international et s’accompagner d’évaluations des établissements privés et
publics. La collecte et le traitement des données devraient être menés conformément
au droit international, à la législation nationale sur la protection et la confidentialité des
données, ainsi qu’aux valeurs et principes énoncés dans la présente
Recommandation.
V. DISPOSITIONS FINALES
169.163. La présente Recommandation doit s’entendre comme un tout, et les valeurs et
principes fondamentaux comme étant complémentaires et interdépendants.
170.164. Aucune disposition de la présente Recommandation ne peut être interprétée
comme remplaçant, modifiant ou portant atteinte de toute autre manière aux
obligations ou aux droits des États membres en vertu du droit international, ni comme
autorisant un État, tout autre acteur de la vie politique, économique ou sociale, un
groupe ou un individu à se livrer à une activité ou à accomplir un acte contraire aux
droits de l’homme, aux libertés fondamentales, à la dignité humaine et au souci de
l’environnement et des écosystèmes.
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GERMANY/ALLEMAGNE
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First Draft of the Recommendation on the Ethics of Neurotechnology
Comments and Observations of the Federal Republic of Germany
Germany greatly appreciates and commends the enormous work of the Ad Hoc Expert Group and the UNESCO Secretariat in preparing this
excellent first draft of the Recommendation on the Ethics of Neurotechnology. Germany particularly supports the strong human rights focus of the
document and its comprehensive approach to providing concrete policy recommendations based on universal values and relevant principles.
However, in order to ensure that the document can become an effective and concise global instrument, Germany proposes to adapt the current draft
in the following aspects:
- A clear and consistent distinction should be made between challenges, values, ethical principles, human rights and recommendations
for action throughout the text. The current draft sometimes mixes these different categories (in particular in chapter III) which weakens the
comprehensiveness of the Recommendation and may therefore be detrimental to its implementation. Germany therefore proposes to focus on
those values and principles that are particularly relevant to neurotechnology.
- The text should be as clear and concise as possible. Germany proposes to shorten the Recommendation by avoiding repetition and
strengthening its focus on specific ethical challenges raised by neurotechnology. Overarching issues that refer not exclusively to
neurotechnology should be moved to an introductory section or an explanatory document where relevant international conventions should be
cited.
- It would be beneficial to highlight the potential of neurotechnologies upfront and address possible challenges subsequently.
In addition to the concrete comments and propositions to the text, Germany hereby highlights the following points that need to be taken into
account (referred to as “red lines” in the German comments on the draft text).
1. The protection of freedom of research is one of the core values of UNESCO and should therefore be clearly enshrined in the text.
Provisions that hamper the freedom of research should be revised.
2. The Recommendation should carefully balance the ethical chances and risks of developing/using neurotechnologies, and the ethical
chances and risks of not developing/not using these technologies. The current draft focuses mainly on the concerns about
neurotechnologies, while the principle of beneficence, an ethical argument for the use of neurotechnologies, is not yet sufficiently addressed.
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Germany recommends a stronger focus on the opportunities (especially when developed for medical and assistive purposes) and benefits (for
disabled or ill people) of neurotechnologies and for the inclusion of more technology-open and innovation-friendly provisions and language
(e.g. concerning the potential of combining AI with neurotechnologies).
3. The text would greatly profit from a clearer distinction between medical and assistive neurotechnologies on the one hand, and non-
medical/consumer neurotechnologies on the other (consistent terminology is also needed regarding "non-medical" and "consumer" not to
be confused with “commercial” as currently sometimes used in the text). Another important distinction to be made is between invasive and
non-invasive neurotechnologies. Ethical and legal concerns differ in degree and quality with view to different types of neurotechnologies.
The draft should distinguish between them more systematically, and provide greater nuances. Germany strongly supports the development
and use of medical and assistive neurotechnologies, provided they respect fundamental ethical values (such as dignity, autonomy,
beneficence and solidarity) and human rights and are properly regulated.
4. Section IV.3 (“Intellectual Property”) and corresponding formulations on IP elsewhere in the text should be deleted. Firstly, because
the mandate and competencies of international organisations in the field of IP, namely WTO and WIPO, should be fully respected. Secondly,
also for substantial reasons. The protection of IP is a driver of innovation and competitiveness. The vague wording in the Recommendation,
on the other hand, implies that the protection of IP is an obstacle that needs to be revised in the light of ethical considerations. Germany
rejects such suggestions.
5. A classification or distinction between different types of human rights is not agreed language and is not acceptable.
6. The text should use established language - particularly with regard to definitions. The definition in paragraph 16 introduces new
terminology that is not known or used in the relevant scientific community. The term "cognitive biometric data" should be replaced by a
more precise term (Germany suggests e.g. the term “non-neural biometric data”; see comment in text for more details).
7. Section IV.14 on "Labour and Employment" should include clear provisions stating that consent cannot be the sole legal basis for far-
reaching data processing in the context of employment. Due to the asymmetrical relationship between employer and employee, high
requirements must be placed on the voluntary nature of the employee's approval to data processing by the employer.
In addition, Germany has a number of comments and proposed amendments to specific paragraphs of the text (see following pages).
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Preamble
Draft Text Comment
Recognizing the profound and dynamic impacts of neurotechnology on human
mind, lives and flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and
mental health conditions, along with the profound suffering they cause for
individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions
and deliver better preventive and therapeutic treatments for millions, benefitting
humanity as a whole and providing opportunities for health improvements in all
countries,
Also considering that neurotechnology raises fundamental ethical as well as Mostly clarifying changes on key aspects of NT and
legal issues for instance regarding self-determinationautonomy, privacy, replacement of the term “self-determination” with the
personal identity, freedom of thought, mental and physical integrity, risk of term “autonomy”, since „self-determination“ is used
discrimination, inequality and challenges to democracy, and that justice, trust throughout the document in the sense of personal
and fairness must be upheld so that no country and no one should be left behind, autonomy, to decide matters for oneself, and not in the
either by having fair access to the development and use of neurotechnology and usage of international law as self-determination of the
enjoying their benefits or in the protection against their risks, while recognizing peoples. This sometimes leads to phrases that sound
the different circumstances of different countries and respecting different awkward in the context of international law.
assessments of the advantages and disadvantages of technological
developmentsthe desire of some people not to take part in all technological It is also inconsistent because „autonomy“ is used
developments, elsewhere in the text, and the differences are not clear;
Germany strongly suggests using the term „autonomy“
rather than „self-determination“ throughout the text for
consistency.
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to
peace and security by promoting collaboration among nations through
education, the sciences, culture, and communication and information, in order
to further universal respect for justice, for the rule of law and for the human
rights and fundamental freedoms which are affirmed for the peoples of the
world,
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Given the leading role of UNESCO, at the forefront of the international
dialogue, knowledge production and standard setting on the ethics of science
and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting
instrument developed through a global approach, based on international law,
focusing on human dignity and human rights, as well as gender equality, social
and global justice and development, physical and mental well-being and health,
diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide
neurotechnology in a responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income
countries (LMICs), including but not limited to least developed countries
(LDCs), landlocked developing countries (LLDCs) and small island developing
States (SIDS), as they have their capacity but have been underrepresented in the
development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to
neurotechnology and enables the realization of the full potential of
neurotechnology, while addressing the ethical challenges, mitigating against
potential misuse, and ensuring that national neurotechnology strategies are
guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote
innovation, development and policies aligned with international human rights
law,
Also recalling that in November 2023, the General Conference of UNESCO, at
its 42nd session, adopted 42 C/Resolution 29, by which it mandated the
Director-General “to prepare a standard-setting instrument on the ethics of
neurotechnology in the form of a recommendation”, which is to be submitted to
the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the
instruments of the international human rights framework, including the
Convention Relating to the Status of Refugees (1951), the Discrimination
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(Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965),
the International Covenant on Civil and Political Rights (1966), the
International Covenant on Economic, Social and Cultural Rights (1966), the
Convention on the Elimination of All Forms of Discrimination against Women
(1979), the Convention on the Rights of the Child (1989), and the Convention
on the Rights of Persons with Disabilities (2006), the Convention against
Discrimination in Education (1960), the Convention on the Protection and
Promotion of the Diversity of Cultural Expressions (2005), as well as any other
relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development
(1986); the Declaration on the Responsibilities of the Present Generations
Towards Future Generations (1997); the Universal Declaration on Bioethics and
Human Rights (2005); the United Nations Declaration on the Rights of
Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to
Climate Change (2017); the Recommendation on Science and Scientific
Researchers (2017); the Recommendation on the Ethics of Artificial
Intelligence (2021); the Recommendation on Open Science (2021); the Human
Rights Council’s resolution on “The right to privacy in the digital age”
(A/HRC/RES/42/15) (2019); the Human Rights Council’s resolution on “New
and emerging digital technologies and human rights” (A/HRC/RES/41/11)
(2019), and the UN Guiding Principles on Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial
Intelligence, recognizes ethical questions related to AI-powered systems for
neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other
frameworks and initiatives elaborated by relevant United Nations entities,
intergovernmental organizations such as OECD, including regional
organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the
ethics and regulation of neurotechnology,
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1. Adopts the present Recommendation on the Ethics of neurotechnology on Germany suggests to incorporate a new provision that
this XXX day of November 2025; calls for adaptive and flexible governance structures in
2. Recommends that Member States, with the support of UNESCO’s the context of NT.
Secretariat, apply the provisions of this Recommendation by taking appropriate
steps, including whatever legislative or other measures may be required, in
conformity with the constitutional practice and governing structures of each
State, to give effect within their jurisdictions to the principles and norms of the
Recommendation in conformity with international law, including international
human rights law;
3. Also recommends that Member States, when implementing the provisions of
this Recommendation, establish flexible and adaptable governance structures in
order to respond quickly to new developments in the dynamically evolving field
of neurotechnology.
43. Also recommends that Member States engage all actors, to ensure that they
play their respective roles in the implementation of this Recommendation; and
bring the Recommendation to the attention of international, regional and
national authorities and bodies, research and academic organizations,
institutions and organizations in public, private and civil society sectors
involved in neurotechnology, so that the development and use of
neurotechnology are guided by both sound scientific research as well as ethical
analysis and evaluation.
I. Scope of Application and Definitions
I.1. Scope
This Recommendation:
Draft Text Comments
1. Addresses ethical issues related to neurotechnology, as it can have many
positive and adverse impacts on human health, human flourishing and on the
enjoyment of human rights.
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2. Considers neurotechnology for people of diverse backgrounds and abilities, Germany proposes not to use examples here and to use
and various fields, including health, and non-medical direct-to-consumer more precise language
(DTC) applications, such as wellness devices, neurogaming), addressing
various settings where neurotechnology may be utilised.
3. Focuses on the benefits and risks of neurotechnology for humansFocuses on Germany questions whether animals are part of
humans only but acknowledges important considerations that apply to animals UNESCO’s mandate and suggests rewording.
in research.
4. Regards ethical reflections on. Approaches neurotechnology ethics as a
systematic normative reflection approach based on a holistic, multicultural,
multidisciplinary, pluralistic and evolving framework of interdependent values,
principles, and actions that can guide societies in dealing responsibly with the
impacts of neurotechnology on human beings, societies, and the environment
and ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of Germany proposes a slight extension of the
neurotechnology, with human rights, human dignity, human health, well-being, Recommendation's ethical target categories;
beneficence, the prevention of harm and freedom of research as a compass and Inclusion of freedom of research is key (Red Line for
foundationwell-being, and the prevention of harm as a compass and foundation. Germany)
(b) It draws upon a full range of scholarship, commentary and views from
neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology and other disciplines.
5. Covers the measurement, recording, and modification modulation of the Germany suggests to move the section on data to the
human nervous system, as well as the handling, analysis, treatment, storage, use definition part of the Recommendation
and reuse of the data collected, along with other societal and environmental
impacts, including the emergence of new cognitive states. “Modulation” is the correct technical term to describe
changes in nervous system functions after electric
stimulation
6. Recognizes that interventions involving the nervous system are very sensitive See comment on 4th paragraph in Preamble: Germany
because the highly complex human nervous system is the coordinating centre of strongly proposes to replace the term “self-
behaviour and mental processes. It enables autonomythe exercise of self- determination” with the term “autonomy” throughout
determination, the capacity to act as moral agents, to be responsible for actions, the whole document
cooperate with others, deliberate about collective decisions and develop
personality.
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7. Further recognizes that humans develop and flourish in their interaction with
other human beings and a nurturing material and cultural environment,
highlighting that autonomy is not just individual but also relational, as it arises
from and impacts one’s interactions and belonging with the community.
8. Addresses the ethical and human rights concerns that arise from the rapid Germany suggests to delete “the” in the first sentence as
developments and the convergence of neurotechnology with other technologies the draft addresses some but not all human rights
such as spatial computing, extended reality (XR), artificial intelligence (AI), concerns associated with NT.
sensors and semi-conductors or robotic systems. Notably, other biometric data
when processed to infer sensory, motor, autonomic function and mental states In this paragraph, terms are introduced that have not
raises similar ethical concerns. Therefore, this Recommendation applies to both been defined before (biometric data and cognitive
neurotechnology and the use of cognitive non-neural biometric data, ensuring biometric data)
that ethical principles and practices are consistently applied across these
domains. Regarding the term “non-neural biometric data” see
comment at paragraph 16.
9. Further addresses the integration of AI with neurotechnology, which can Germany proposes a slight revision to make the effect of
enhance precision and predictive capabilities, such as improving processing the integration of AI into NT clearer.
speed, reducing cost, optimizing robustness, performance and individualization
of neurotechnology systems and thereby reducing costs. However, it also
magnifies ethical threats, including cybersecurity concerns, lack of
transparency, the potential for algorithmic bias, and risks to autonomy, mental
privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness
on the profound ethical challenges and threats that come with the military and
security applications of neurotechnology. Calls on all concerned to act
responsibly with regard to neurotechnology.
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I.2. Definitions
Draft Text Comments
Germany insists on a clearer distinction between
medical or assistive NT on the one hand and non-
medical / consumer NT (e.g. for human enhancement)
on the other (consistent terminology regarding “non-
medical” and “consumer” also needed). Another
important distinction is between invasive and non-
invasive NT. Different types of NT raise different
ethical and legal concerns. The Draft does not
systematically distinguish between them, which
deprives it of the potential for often needed nuance.
In addition to the comments made in this and the
following sections, the entire text needs to be revised
accordingly.
(Red Line for Germany)
11. Nervous system. The nervous system includes the central (brain, spinal cord) Germany strongly proposes to reflect in the text that the
and peripheral (somatic, autonomic, enteric) nervous system. Scientific nervous system activity and structure provides not only
evidence demonstrates that nervous system activity is the basis of sensory, information inherent to all human beings, but also
motor, autonomic and mental states (which include cognitive, affective, and information that is specific to the individual, since this is
conative states), and supports e. g. consciousness, sleep and the experience of the source of most of the ethical risks of NT.
pain. The nervous system activity and structure provide information inherent to
all human beings and the community, regardless of gender, ethnicity, language,
or religion as well as information that is specific to the individual. The nervous
system activity is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, and Germany suggest to delete „intentions” as it is a mental
procedures—encompassing both hardware and software—that directly access, state (as many others, e.g. thoughts, anger, sadness) and
monitor, analyze, predict or modulate the function of nervous system through therefore in a different category than structure, activity
electrical, magnetic, optogenetic and other means to understand, influence, and function.
restore, or anticipate its structure, activity or, function, or intentions (e.g.
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decisions, speech, motor). Neurotechnology combines elements of
neuroscience, engineering, and computing, among others, and the precise
definition and understanding of neurotechnologies will need to change over
time due to the rapid technological developments.
13. Neurotechnology spans medical and non-medical applications and includes Germany strongly suggests adding a new paragraph on
tools that measure, infer, and influence nervous system activity, whether the distinction between medical or assistive NT and
through direct interaction with the nervous system or by interfacing it with non-medical / consumer NT (e.g. for human
devices and systems. It includes but is not limited to: enhancement). The paragraph should also describe the
distinction between invasive NT and non-invasive NT.
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical,
optical, magnetic and/or mechanical), chemical and biological signals
associated with the structure of and functional signals from the nervous system.
These may be used to identify, record, and/or monitor properties of nervous
system activity, understand how the nervous system works, diagnose
pathological conditions, or control external devices (brain machine interfaces
(BMI), often referred to as brain computer interfaces (BCI)). Of note, both
open-loop (i.e., fixed-parameter brain stimulation) and closed-loop systems
(i.e., state dependent stimulation) introduce complex ethical issues.
(i). Examples include but are not limited to signal acquisition methods as Germany suggests adding “signal acquisition methods”
Electroencephalography (EEG), Magnetoencephalography (MEG), Magnetic for clarity of definition
resonance imaging (MRI), Functional Magnetic resonance imaging (fMRI),
Positron emission tomography (PET), Functional Near-infrared spectroscopy
(fNIRS), Implanted microelectrodes, Optogenetics, Optical imaging, Diffusion
weighted imaging, Calcium imaging, Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, Germany suggests adding “change brain activity by” for
for example, to restore sensory input, such as hearing (e.g. i.e., cochlear clarity of definition
implants) or change brain activity by Deep Brain Stimulation (DBS) to treat
tremors and other pathological conditions. They are meant to either modulate
the functions of the nervous system and/or send signals directly to the nervous
system by applying acoustic, electrical, magnetic or optical stimulation and/or
inhibition of the peripheral or central nervous system.
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(i). Examples of this neurotechnology are implanted microelectrodes for, BMI Germany suggests slight technical changes for clarity of
and, DBS, Optogenetic or infrared optical stimulation, Transcranial electrical definition
stimulation (tES), Transcranial Magnetic Stimulation (TMS) or
Neuropharmacological infusion.
14. Non-neural Biometric Technologies. Non-neural Biometric Technologies Germany strongly proposes a clearer definition of
refer to the use of Of note, several sensor technologies that are not per se paragraph 14 and suggests concrete wording
neurotechnologies, but indirectly inform about neural activity, to collect data
about mental states, with or without use of Artificial Intelligence based
applications.collect data indirectly informing about neural activity. Even if they
are not neurotechnology per se, they raise similar ethical and human rights
issues as neurotechnology when used to infer mental states. They include but
are not limited to tracking of eye-tracking and muscle movements, Video
Oculography, Typing dynamics, Voice recognition and analysis, Gait analysis,
Skin conductance, Heart rate variability, measuring physiological responses
such as perspiration, Sleep movement monitoring, Blood pressure
measurement, or facial- emotion recognition systems.
15. Neural data. Neural data refer to the most direct correlates of mental states Germany suggests revisions for clarity of definition.
at the neurobiological level. Neural data are include qualitative and quantitative
data about the structure, activity and function of the nervous system gathered
through neurotechnologies defined under paragraph 12. They encompass data
relating to a nervous system’s activity, including both direct measurements of
neuronal structure, activity and/or function (i.e.,e.g. neuronal firing or averaged
bioelectric signals from EEG) and indirect functional indicators (e.g. i.e., blood
oxygenation level (BOLD) flow in fMRI and fNIRS). The level of sensitivity of
the neural data and the risks associated with their creation or use may be
contextually defined. Particular attention must be paid to neural data that allow
inferences to be made about mental states. At the neurobiological level, neural
data are the most direct correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non- Germany insists on a reformulation of this definition
neural biometric technologies can be processed to infer mental states, which this and not to use the term “Cognitive Biometric Data”
Recommendation refers to as “cognitive biometric data”. (Red Line for Germany).
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Reasons include:
- The term “Cognitive Biometric Data” not used in
science, it is too narrow and conceptually inadequate
- The term is misleading, e.g. it is not clear whether
affective technologies are included
- The definition does not clarify what “non-neural
biometric technologies” are or how they relate to
neural data
A rephrasing option could be:
“Non-neural biometric data, collected through
technologies such as eye-tracking, facial recognition,
and gait analysis, can be processed via advanced data
analytics and machine learning to infer a broad spectrum
of mental states, including cognitive, emotional,
affective, perceptual, and reflexive processes.”
Throughout the document, we have changed "cognitive
biometric data" to "non-neural biometric data" to make
it clear that we insist on changing the original term
(however, we do not insist on the new term).
17. Whole lifecycle. Neurotechnology should be considered from the early
stages of mining for materials, prototyping, research, design and development
to deployment and use, including software, maintenance, operation, trade,
financing, monitoring and evaluation, validation, end-of-use, disassembly,
termination, disposal and recycling. The whole lifecycle of neurotechnology
includes its convergence with other technologies and the diversity of actors who
are involved in every stage.
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II. Aims and objectives
Draft Text Comments
18. This Recommendation has been created with the aim of guiding the Germany suggests a reference to the whole lifecycle of
neurotechnology lifecycle development and use of neurotechnology in ways neurotechnology since the objectives below are also
that are ethical, safe and effective for the good of humanity, individuals, valid (and important) for the determination stage of NT
communities, societies, the environment and ecosystems, and to prevent harm
in the present and the future based on international law, in particular the Charter
of the United Nations and international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and
fundamental freedoms, human dignity and equality, including gender equality,
and to respect cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities,
institutions, private sector companies and every other relevant actor to ensure
the embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to promote the responsible development and use of neurotechnology to For Germany, it is of utmost importance that the
provide innovative healthcare and the best possible therapy options for those Recommendation also focuses on the opportunities of
affected by neurological or mental health conditions; NT and contains formulations that promote a
technology-open and innovation-friendly development
of neurotechnologies (here and throughout the whole
document). (Red Line for Germany)
(cd) to ensure that neurotechnology in its whole lifecycle is applied evidence- Germany proposes revision as suggested.
based, reliable and reproducible;
(de) to provide a universal framework that not only articulates values and
principles, but also translates into concrete policy recommendations and
effective implementation to guide Member States in their engagement with
neurotechnology in its whole lifecycle, consistent with their obligations under
international human rights law and other international standards;
(ef) to encourage research on neurotechnology respecting ethical principles by Germany attaches great importance to open and
proper funding and removal of obstacles to research innovation-friendly research infrastructures.
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(fg) to allow the development of neurotechnologies in accordance with existing Germany suggests a reference to existing research and
research and clinical ethics as well as rights. They should be developed to treat clinical ethics and rights
the symptoms of certain disorders, to promote and ensure the independence,
social or professional integration as well participation of certain vulnerable
groups (e.g. disabled people, children, older people).
(he) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and
consensus building about ethical issues relating to neurotechnology;
(if) to promote justice and equitable access to developments and knowledge in
the field of neurotechnology and the sharing of benefits;
(jg) to ensure accountability and solidarity among all actors to prevent misuse Germany insists on a strong reference to international IP
of neurotechnology and to uphold human rights, and ethical standards and. protection law
benefit sharing in conformity with international IP protection law.
III. Values and Principles
III.1. Values
III.1.1. Respect, protection and promotion of human rights, fundamental freedoms and human dignity
Draft Text Comments
20. The inviolable and inherent dignity of every human being is the foundation
of universal human rights and fundamental freedoms. Respect, protection, and
promotion of human dignity, as established by international human rights law,
are essential in the whole lifecycle of neurotechnology. Dignity encompasses
the recognition of the intrinsic and equal worth of each person.
Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including
people living in vulnerable situations.
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III.1.2. Promoting human health and well-being
Draft Text Comments
21. Prioritizing the development and application of neurotechnology that
promotes comprehensive human health and well-being, viewing health as a
holistic state of physical, mental, and social well-being.
22. The responsible allocation of public resources (such as financial and Germany proposes revisions to make clear that this
government support) to for neurotechnology should be directed promote paragraph is about public and not private resources.
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that
benefit the largest number of people and those who stand to gain the most Germany insists in deleting “the largest number of
people in need, especially the least well off, rather than consumer -driven or people and those who stand to gain the most”. The
commercial applications. current formulation implies a utilitarian understanding
of ethics.
Germany strongly suggests to talk about commercial
interests instead of commercial applications, because
also medical NT applications can be commercial.
Neurotechnologies hold great potential to improve the quality of life of people Germany suggests adding this new paragraph to
with disabilities. Member States and other stakeholders should join forces and illustrate the immense potential of NT to improve the
mobilize resources for innovative developments and wide accessibility of lives of people with disabilities (in line with other
devices for a great number of affected people international obligations, e.g. in the CRPD).
III.1.3. Ensuring and respecting diversity and fairness
Draft Text Comments
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of
neurotechnology. Special consideration should be given to neurodiversity,
minority groups, Indigenous Peoples, and underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs Germany strongly objects to the uncritical and unclear
in the urban well-resourced sector, specific attention to underserved and use of the term “colonisation” in this context and
marginalised people is crucial to prevent bias, ongoing disparities in healthcare, proposes to delete this passage.
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stigma, neglect, and disrespect. Technological assimilation, or using technology
as a tool of colonisation (a term the Recommendation refers to as “technological
colonialism”), can threaten cultural diversity and heritage, therefore must be
protected against.
25. Equitable access to medical neurotechnology should be prioritized globally, Germany insists on inserting “medical”
ensuring that its benefits are accessible to all, regardless of socioeconomic
status or geographical location. Special attention must be given to low- and Reasoning: “Equitable access“ combines two aspects:
middle-income countries, resource-constrained settings, and marginalised Access and equality. It is not clear that both deserve to
communities, including the specific needs of different groups, ages, segments, be prioritized globally. While this is certainly true for
cultural systems, languages, communities, and marginalised and vulnerable MEDICAL neurotechnologies, many people would say
populations, people with disabilities, neurological disorders, and mental health it is not true for non-medical neurotech such as gaming,
conditions. entertainment, enhancement.
Germany strongly proposes to streamline the first part of
the paragraph with established language of the
UNESCO Declaration on Bioethics and Human Rights.
Art. 2 of the Declaration: The aim of this Declaration is
“(f) to promote equitable access to medical, scientific
and technological developments as well as the greatest
possible flow and the rapid sharing of knowledge
concerning those developments and the sharing of
benefits, with particular attention to the needs of
developing countries;”
26. Individuals and groups should be allowed to make lifestyle choices, express Germany suggests to insert the proposed text in order to
beliefs and opinions, share personal experiences, and participate in co-designing avoid the socialisation of health care costs resulting
technologies, provided that these choices are made in ways that respect the from medical treatment following the use of "do-it-
rights of others and established safety standards when applying technologies to yourself" implants
themselves.
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III.1.4. Consideration for cross-cultural perspectives on human knowledge and its sharing
Draft Text Comments
27. Respectful knowledge sharing on the human nervous system and its
functions as well as on (neuro-) technologies across communities and cultures
fosters trust and strengthens global cohesion in the pursuit of health and quality
of life.
28. It is essential that any research and development involving diverse groups
and communities is done with their permission and guidance, and conducted
with their full prior and informed consent and partnership in ways that serve
their interests and respect their traditional knowledge and epistemic
contributions.
III.1.5. Commitment to peace, fairness and justice in societySafeguarding the freedom of thought
Draft Text Comments
Germany proposes to reformulate the title of the section
as the current title does not fit the content of the
paragraph 29. Fairness is already coved in chapter
III.1.3.
29. The use of nNeurotechnology should be used to promote, not undermine Germany proposes a rewording for a more positive and
freedom of thought especially in situations where refusal to use the technology less technology-averse tone.
could lead to competitive disadvantage. Such interferences include but are not
limited to the use of force, threats, undisclosed access, manipulation, or and
should never be used in any scenario where consent is compromised, including
as a result of power imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses Germany suggests moving this paragraph to III.1.3.
that segregate, objectify or subordinate individuals or communities, reduce (Ensuring and respecting diversity and fairness) where it
social cohesion by exacerbating pre-existing inequalities or generating novel fits better.
inequalities that divide and antagonize individuals against each other, and
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thereby threaten the coexistence between humans, other living beings and the
natural environment.
III.1.6. Global Solidarity and International Cooperation
Draft Text Comments
31. The Recommendation should guide all actors in the development,
deployment and use of neurotechnology to act in solidarity and call for
accountability in instances where neurotechnology may be misused in ways that
threaten human rights.
32. International cooperation is essential to addressing cross-border issues
related to neurotechnology. Particular attention must be given to differing
perspectives on acceptable use to prevent abuse and uphold global ethical
standards.
III.1.7. Sustainability
Draft Text Comments
33. Considering that sustainability requires that neurotechnology be developed Germany would suggest to include concrete examples of
and used with a deep respect for environmental stewardship, prioritizing the the most pressing environmental challenges associated
minimisationgiving priority to minimising of ecological harm throughout the with the production and use of NT in this paragraph.
lifecycle of the materials used, including, for mining extraction, data processing
and storage, recycling and disposal practices, and avoiding disproportionate
consumption of resources and energy and waste production.
34. The unregulated development of neurotechnology, especially for non- Since this paragraph is very generic, Germany suggests
medical purposes, might lead to disproportionate consumption of resources and to include its content into paragraph 33.
energy and waste production.
35. Respect for Indigenous rights, in accordance with the United Nations
Declaration on the Rights of Indigenous Peoples (UNDRIP), requires that
neurotechnology, through its whole lifecycle, be guided by a profound respect
for Indigenous rights, ensuring that their lands (including during mining),
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knowledge, communal rights, and privacy are honoured in all activities,
including those related to resource extraction.
III.1.8. Integrity and Responsibility
Draft Text Comments
36. Integrity requires that all actors in the whole lifecycle of neurotechnology This paragraph lacks clear references to NT. Germany
field act with ethical steadfastness, taking responsibility for their actions and suggests naming these clearly.
being accountable for their outcomes. It includes adhering to ethical guidelines
and ensuring that all actions align with both professional standards and societal
values.
37. Integrity includes a commitment to taking responsibility for one’s actions Germany proposes to delete this paragraph since it is
and being accountable for their outcomes. This involves not only very generic and as there is no reference to NT. The
acknowledging successes but also owning up to mistakes and taking corrective main aspects of this paragraph can be included in
actions when necessary. paragraph 36 (see suggestion in the text).
38. Scientific integrity is the commitment to the rigorous pursuit of truth Germany suggests including a clear reference to NT in
through evidence-based, objective and transparent research practices. It ensures this paragraph, as it is very general and has little added
that all scientific endeavours are conducted with honesty, accuracy, and respect value in its current form. A stronger link to the
for the scientific method of disciplines relevant for neurotechnology. UNESCO Recommendation on Open Science should be
made. (“as open as possible”).
III.2. Ethical Principles and Human Rights
Draft Text Comments
39. This Recommendation embraces a human-centred approach through
fundamental ethical principles including but not limited to self-
determinationautonomy, agency, freedom of thought, privacy, cognitive liberty,
personal and collective identity, trustworthiness, respect, reciprocity, and
justice. Furthermore, it aims to promote incorporates the respect, promotion and
protection of human rights.
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III.2.1. Beneficence, Proportionality and Do No Harm
Draft Text Comment
40. Innovation in neurotechnology can play an important role in the promotion Since NT can contribute to social participation and
of health and well-being, as well as the treatment of certain neurological and/or autonomy of patients with certain neurological / mental
mental disorders, thereby promoting social participation and the ability of disorders, Germany proposes a more positive wording.
patients to lead an autonomous life. Neurotechnology should promote health
and well-being, and contribute to empower individuals to make informed
decisions about their nervous system and mental health while fostering a better
understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing Germany proposes specifying the no-harm principle to
harm or subordination, whether physically, economically, socially, politically, clarify that it requires a careful weighing of options,
culturally, or mentally. The “do no harm” principle must guide the whole recognizing that the complete avoidance of harm may
lifecycle of neurotechnology, ensuring that the quality of life is protected and not always be feasible.
promoted.
Neurotechnology should contribute to human flourishing while carefully
balancing the "do no harm" principle with the rights and autonomy of the users
of neurotechnology. This principle shall be interpreted in a way encompassing
the physical, economic, social, political, cultural, and mental aspects of well-
being, which must be considered throughout the entire lifecycle of
neurotechnology, ensuring that the quality of life is protected and promoted.
42. Embracing neurotechnology for human enhancement may lead to the risk of Germany strongly proposes to make a clear distinction
not only unexpected damage to the nervous system, but also to amplified between the medical use of NT and the use of NT for
inequalities within society. human enhancement (using NT without clinical need to
improve human performance beyond natural biological
limits). A clear definition for human enhancement is
needed. The draft text is still lacking this definition
43. Any restrictions to human rights must meet all applicable requirements
under human rights law, including the principles of legality, legitimate aim,
necessity and proportionality.
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44. The principles of proportionality, balance and legitimacy should govern the
use of neurotechnology and the data it enables, to ensure their use by public
authorities is: (a) appropriate and proportional to the objective and expected
benefits that are aimed to be achieved; (b) do not infringe upon the foundational
values of this document; (c) appropriate to the context and target user group; (d)
based on safety principles and rigorous scientific evidence.
III.2.2. Self-determinationAutonomy, and Freedom of Thought, and Mental and Physical
Integrity
Draft Text Comments
45. Throughout the whole lifecycle of neurotechnology, the protection and
promotion of the rights of autonomy, freedom of thought, and self-
determinationas well as mental and integrityphysical integrity must be secured.
46. Individuals have the right to make free, informed, and voluntary decisions Germany strongly proposes to use clear language: The
about their engagement withusing neurotechnology throughout the whole first sentence should be about individuals’ use of NT
lifecycle, in accordance with international human rights law, ethical and legal and not their engagement with NT (unclear what
standards for informed consent and other international standards. This includes “engagement” means in this context).
, including the right to refuse or withdraw from its useusing neurotechnology, at
any time, ensuring their individuals’ autonomy as well as and respect for their Germany suggests a clearer structure to make the
decision-making capacity and their mental and physical integrity is upheld. In paragraph easier to read.
cases of and where surrogate consent is used, the best interests of the affected
individual are consideredshould be pursued. Individuals who are enrolled in Germany also suggest to include a new sentence on
research should be informed of potential side effects and given the opportunity informed consent on the processing and transfer of
to disclose if they have any contraindications for the procedures used. personal data (last sentence).
Informed consent procedures should be affirmative, dynamic, and require opt-
in, comprehensive and transparent providing detailed information about the Germany suggests adding a new paragraph on physical
purposes, risks, benefits, alternatives, and possible outcomes of the and mental integrity to make this point stronger.
neurotechnology in all its application domains, ensuring that consent is
voluntary and that individuals fully understand the implications for their
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privacy, autonomy, and well-being. Informed consent procedures should also be
followed for the processing and transfer of personal data.
------- (new paragraph)
Neurotechnologies have the promises and the potential to substantively
intervene into and alter the functioning of the nervous and the mental system.
These interventions may interfere with the rights to physical and mental
integrity in virtue of their physical and mental effects, respectively.
Interventions thus require consent of the person. Less invasive interventions
must have priority over intervention in body or mind.
47. The potential of neurotechnology to play an enabling role in the capacity for Germany suggests starting the paragraph with a positive
human autonomy and decision-making should be put to good use. To the extent reference on NT’s enabling potential for autonomy and
that autonomy has been made possible through the use of neurotechnology, the decision-making.
dependency on technology demands special attention and procedures.
Neurotechnology should never be used to exert undue influence or Germany proposes three additional sentences to clarify
manipulation, whether through force, coercion, or other means that compromise what the fundamental right of “freedom of thought”
self-determinationautonomy and freedom of thought. Freedom of thought is an encompasses.
unconditional and non-derogable human right. Neurotechnologies may not
interfere with freedom of thought by revealing or altering thoughts and thinking
processes of persons without their consent. The inner realm of thought should
only be accessed by others with consent of the person. Neurotechnologies
should never be used to intrude into this realm without consent or to manipulate
the internal processing of thought, or the decision about their outward
expression. This protection covers both the internal processing of thoughts and
their external expression, ensuring freedom from any unwanted and harmful
interference with thoughts, thinking, or the expression of thoughts.
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III.2.3. Protection of Neural and Cognitive Non-Neural Biometric Data for Mental
Privacy
Draft Text Comments
48. Neurotechnologies may interfere with privacy by measuring neural data, Germany strongly suggests a reformulation of the
especially when it allows inferences about mental properties. This grave paragraph to better grasp the topic of privacy.
interference requires the consent of the individual. Without such consent, the
content of thought should never be revealed through neurotechnologies. Germany reserves the right to check that this paragraph
Neurotechnology and cognitive biometric technologies raise issues pertaining to does not conflict with the requirements of the following
the right to privacy due to their increasing ability to collect direct and indirect four regulations: Regulation (EU) 2016/679 (General
data about the nervous system thatSome neural data about the nervous system Data Protection Regulation, GDPR) (particularly Article
are uniquely sensitive because they can be processed and analysed to provide 9(2)), Regulation (EU) 2024/… to be published in early
deep insights into the processes that underpin our mental states and behaviour, 2025) on the European Health Data Space (EHDS),
including self-awareness and introspection. As it becomes increasingly difficult Regulation (EU) 2022/868 on European data
to anonymize data, tThere remains persistent risks of misuse of this data by governance) (Data Governance Act), Regulation (EU)
revealing neurobiological correlates of diseases, disorders, or general mental 2023/2854 (Data Act).
states without the authorization of the person from whom data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal Germany suggests replacing “must be conducted with”
identity, and a gency. The collection, processing, modification, and sharing of as this implies that exceptions are not possible
neural data and non-neural biometric data must be conducted withrequires free (replacement e.g. with “requires” as suggested).
and informed consent of the person concerned, in ways that respect the ethical However, the processing of such sensitive data can also
and human rights principles outlined in this Recommendation. be based on other specific grounds as foreseen by Art. 9
of the GDPR.
50. There should be clear safeguards against the misuse or unauthorised access Germany suggests a reformulation of the paragraph for
of neural and cognitive non-neural biometric data, including affirmative more clarity (see suggestions in text). “Affirmative”
consent, data minimization and purpose specificationlimitation, data rights consent should not be used here nor throughout the rest
(such as rights to access, correct rectification and deleteerasure), privacy of the Recommendation as this is not standard language
enhancing technologies and data security, particularly in contexts where such in international law. Maybe “explicit” would be a
data might be aggregated with other sources. possible alternative (it is used in Art. 9(2)a) GDPR).
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III.2.4. Non-Discrimination and Inclusivity
Draft Text Comments
51. All actors involved in the whole lifecycle of neurotechnology, particularly Germany suggests to replace “must” by “should” since
in its interface with other technologies like AI, must should commit to this is more appropriate language for a
upholding ethical principles that prevent discrimination, stigmatisation, Recommendation.
targeting, or exploitation of any individuals or groups, particularly those in
vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not Germany suggests to compare with para 30 for
perpetuate or amplify existing inequalities or create new forms of congruency and potential avoidance of repetition.
discrimination based on neurological or mental characteristics, or other grounds
protected under human rights law.
53. Non-inclusive technological development and standardisation may drive a Germany proposes to reword this paragraph as it does
trend toward homogenisation and the dominance of neurotypicality and not describe an ethical principle, nor a human right but a
capacities that may threaten cultural and collective identity. challenge.
The development and standardisation of neurotechnologies should be inclusive
in order to contribute to the protection of cultural and collective identity and to
prevent homogenisation and the dominance of neurotypicality.
54. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their
input and validation to align these technologies with societal values and the
common good.
55. Discrimination on any grounds, including intellectual differences or those Germany proposes a modest rewording of the paragraph
related to atypicality, should be condemnednot be justifiedlegitimised or to make the link to NT clearer. The last sentence (Care
intensifiedexacerbated by neurotechnology. Neurotechnology should not be should be...) is not a principle and should therefore be
usedcontribute to inform, justify, or reify such discrimination. Care should be moved to IV.13. (Educational settings).
taken to evaluate neurotechnology solutions promoted through governments for
essential services such as education.
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56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or Germany strongly suggests moving this paragraph to
discrimination against older persons. IV.7. (Older Persons) as it is inconsistent to mention
only the group of older persons (but not women,
vulnerable groups, etc).
III.2.5. Accountability
Draft Text Comments
57. Maintaining trust and integrity throughout the whole lifecycle of
neurotechnology requires all actors to adhere to the highest ethical standards,
remain open to feedback, be committed to adjusting practices in response to
new evidence or ethical concerns, and be held accountable for their actions.
58. Accountability is grounded in responsibility, clear and transparent
communication, and a duty to anticipate and address potential harms—whether
short-term, long-term or arising from unintended use and impact.
59. A commitment to accountability requires global, governmental, societal and
collective action to ensure those harmed by neurotechnology have access to
justice, and that those responsible for wrongdoing are required to take
meaningful steps to identify, prevent, mitigate and account for how they address
and redress their adverse human rights impacts, including through corrective
actions and reparations.
III.2.6. Trustworthiness and Transparency
Draft Text Comments
60. To guarantee the respect, promotion and protection of human rights and Germany insists that a clear distinction be made
fundamental freedoms, all actors throughout the whole lifecycle of between NT for medical purposes and NT for non-
neurotechnology must ensure that their activities are transparent, grounded in medical purposes, both in this paragraph and throughout
scientific evidence, and aligned with international principles of responsible the whole document.
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conduct and scientific integrity – in particular when neurotechnologies are used
in medical contexts or when devices interfere with mental states. This includes Germany strongly believes that NT should be subject to
preventing the replication or amplification of biases, ensuring that different ethical standards and rules/standards
neurotechnology is traceable and explainable, its capacities and limitations are depending on the field of application (e.g. regarding
accurately portrayed, the conditions for accountability are clearly defined, transparency in the development of NT or
adhering to ethical guidelines in research and development, including the explainability). For example, it is not clear why all
registration of trials, fair participant selection, and approval by independent neurotechnology, including that used for non-medical
ethics committees. purposes, should be approved by ethics committees.
For Germany, it is crucial that this Recommendation
clearly defines ethical standards for the medical
application of NT and to identify applications of NT
outside medicine, where different authorisation
standards / regulations may be needed (e.g. for NT
which is able to draw conclusions about mental
characteristics and to influence mental states).
Especially the last part of the paragraph (“the conditions
for accountability are clearly defined, adhering to ethical
guidelines in research and development, including the
registration of trials, fair participant selection, and
approval by independent ethics committees”) seems to
be guided towards medical applications of NT.
III.2.7. Epistemic Justice, Inclusive Engagement and Public Empowerment
Draft Text Comments
61. Ensuring fair and equitable distribution and creation of knowledge about Germany considers the statement in this paragraph to be
neurotechnology, including recognizing diverse ways of knowing, and that all unclear and too far-reaching to be implementable.
individuals and communities can participate in its creation, sharing, and Furthermore, the provisions of the WTO Agreement on
applications. Trade-Related Aspects of Intellectual Property Rights
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(TRIPS) must be respected (applies to the entire text).
Germany proposes to delete this paragraph.
62. Promoting open and accessible education, along with public and community Germany proposes to delete this paragraph as this is not
engagement, to ensure diverse populations can gain and exchange knowledge the place to make provisions on how to organise the
about nervous system functioning, mental health, and medical and non-medical education (“open and accessible”)
applications and tools of neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle Germany proposes to use in this paragraph the
of neurotechnology requires respect for diversity, including linguistic, social, established language of other relevant UNESCO
cultural, heritage, and identity, to respect different ways of knowing and instruments (e.g. OS Recommendation, AI
understanding. This respect for diversity ensures that the knowledge and Recommendation, Convention on the Diversity of
perspectives of diverse communities are valued and included in decision- Cultural Expressions), and not to introduce new
making processes, and respects autonomy self-determination. language (e.g. “different ways of knowing” is not
established language and its meaning is unclear).
64. Grounding education in human rights ensures that the knowledge shared and Germany proposes to move this paragraph to IV.13.
produced respects the rights of all individuals, preventing epistemic injustice (Educational settings) and to add a clear link to NT – in
where certain groups may be marginalized or excluded from knowledge its current form this paragraph is far to generic and not
production and dissemination. related to NT.
65. CAll communities should have a voice in decisions on the development and Germany proposes a rewording of the paragraph as the
use of neurotechnology thatwhere it affects them in a relevant way, particularly original version is too far-reaching and not
when it comes to the development and use of neurotechnology. implementable.
III.2.8. Best Interests of the Child and Protection of future generations
Draft Text Comments
66. The nervous system is rapidly evolving during childhood and critically Germany suggests a clearer focus on neurotechnology
changing during adolescence, which makes it crucial to preserve the privacy, and proposes to delete the last part of the paragraph as
self-determinationautonomy and the right of children and adolescents to the link to neurotechnology is too weak.
participate in decisions that affect them. Technology Neurotechnology should
be rigorously assessed to ensure it serves the best interests, well-being and
healthy development of children., as they grow into autonomous individuals and
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safeguard the rights of future generations by ensuring that today’s decisions
promote their future wellbeing.
67. From an ethical perspective, wWhile recognizing the potential benefits of Germany suggests deleting the introduction of the
neurotechnology for early diagnosis, instruction, education, and continuous paragraph as the “ethical perspective” should be the
learning, it is equally important to make a commitment to the holistic perspective of the whole document (unnecessary to
development of the child. The use of neurotechnology must not interfere mention).
withimpair children’s ability to maintain to This includes nurtureing their social
life, fosterforming meaningful relationships, and promoteinglead a healthy Germany insists on clarifying the content of the second
lifestyle, encompassing including nutrition and physical activity. sentence, the meaning of which is not unclear
(suggestion in text).
Germany insits on clearly linking values, principles and
(in the sections to come) policy actions to specific
modes of NT application (especially with a view to
medical / non-medial use). Here, the first sentence refers
primarily to medical use, while the second sentence
implicitly refers to non-medical use, e.g.
gaming/entertainment. These should not be confused.
III.2.9. Global and social justice, enjoying the benefits of scientific progress and its
applications
Draft Text Comments
68. Access to and benefits arising from research and development in Germany insists on a reformulation of the first part of
neurotechnology must should be shared equitably fairly among with all the paragraph (especially with regard to the “fair”
contributors to that research and development, with a particular focus on distribution as this is not “equal” in any case of research
ensuring global distribution that promotes fairness and reduces disparities. cooperation).
Germany suggest to link this para to the UNESCO
Recommendation on Open Science by using the
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established language on open access agreed in this
document.
Germany strongly suggests deleting the second part of
the paragraph as it raises a completely different issue:
The first part of the paragraph is about fair sharing
between all contributors, the second part is about a
global perspective. It is very unclear, what this could
mean in practice.
69. Neurotechnology developments should be leveraged to reduce global health Germany suggests a slight rewording of the paragraph.
inequities and to. These technologies should serve as catalysts for improveing
the quality of life, particularly in resource-limited settings.
70. Research, development, and trials in neurotechnology must adhere to the Germany suggests moving this paragraph to IV.12.
highest ethical standards, ensuring the non-exploitative participation of all Research Ethics as its content is too specific for the
individuals involved. This includes safeguarding the rights and well-being of Principle Section. Please avoid duplications.
participants, and patients and their caregivers, as well as ensuring the ethical
collection and use of data. Special attention should be given to ensure that those
contributing to research and development have their fair share of the benefits
and do not bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, Germany suggests adding a reference to NT in the
and never take advantage of, the lack of necessary technological or medical paragraph.
infrastructure, education and skills, as well as ethical-legal frameworks in
neurotechnology, particularly in LMICs, LDCs, LLDCs and SIDS, affecting
communities.
72. The development and impact assessment of novel neurotechnology should Germany strongly proposes to expand the paragraph
consider the implementation of human-centred paradigms in which end-users with reference to the Ruggie Principles as suggested in
are not merely passive recipients of the technologies but active co-shapers on an the text and to move it to IV.1. Government Investment,
equal footing. Thus, member states should encourage their national Use and Regulation (e.g. paragraph 76). Point (e) goes
neurotechnology businesses to beyond the Ruggie Principles. Germany strongly
suggests that this important point should also be
included in the Recommendation.
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(a) respect human rights. This means that they should avoid infringing on the
human rights of others and should address adverse human rights impacts with
which they are involved;
(b) avoid causing or contributing to adverse human rights impacts through their
neurotechnologies and other activities, and address such impacts when they
occur;
(c) seek to prevent or mitigate adverse human rights impacts that are directly
linked to their operations, products or services by their business relationships,
even if they have not contributed to those impacts;
(d) have policies and processes appropriate to their size and circumstances in
place, including a policy commitment to meet their responsibility to respect
human rights and a due-diligence process to identify, prevent, mitigate and
account for how they address their impacts on human rights;
(e) communicate potential implications of a withdrawal of a neurotechnological
product, for example through stopping maintenance due to insolvency, to the
users of this device and to alleviate the potential harm and sorrow that such an
action causes to the patients.
IV. Areas of Policy Action
IV.1. Government Investment, Use and Regulation
Draft Text Comments
73. Member States, private actors and international institutions should actively Germany strongly suggests a rewording of the second
support the research, development, and deployment of neurotechnology for the sentence, as the sentence currently conflicts with
public good. Investments should prioritize medical and assistive applications obligations under the CRPD. The proposed rewording is
that foster preventative, diagnostic, therapeutic, assistive, and rehabilitative
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purposes that benefit people in needhuman flourishing, and the use of which in line with Germany's proposal to adapt paragraph 22
respects, promotes and protects individual and collective human rights. This (both paragraphs should be consistent in substance).
commitment should include funding for interdisciplinary research that not only
advances neurotechnological innovation but also studies the ethical, legal, Germany insists that "human rights" should not be
social, environmental and cultural implications of these technologies, and categorised in any way throughout the whole document,
supports the implementation and clinical translation of technological especially in relation to "collective" human rights. (Red
prototypes. Particular attention should be given to the development and line for Germany)
implementation of adequate technical, institutional, procedural and other
safeguards to ensure that they equitably benefit society and that human rights
are upheld.
74. Member States should, as appropriate, establish clear prohibitions against Germany proposes the textual changes in paragraph 74,
the use of neurotechnology in contexts that violate individual and collective sentence 2 and will deliver its comments on this
human rights. Member States should conduct human rights due diligence, sentence at a later stage.
including regular, comprehensive human rights impact assessments, concerning
neurotechnology that they develop, design, deploy, use, sell, operate or procure, Germany suggests to include a sentence to strictly limit
in order to prevent and mitigate their possible adverse human rights impacts. the use of NT for mind reading to clearly defined
Specifically, mind reading by means of neurotechnologies should only be medical applications (see suggestion in para).
allowed in the medical field and only in clearly regulated exceptional cases.
Furthermore, neurotechnology should not be used for purposes such as non- Germany suggests a more precise definition of
consensual interrogation in law enforcement, criminal and civil justice, “coercive behavioural conformity”, e.g. to make clear
development or deployment of weapons targeted at the nervous system, social that the use of NT in a forensic psychiatric ward to avert
control, attempts at coercive behavioural conformity based on personal beliefs danger to self or others is not permitted (the current
or thoughts, political or other opinion, gender identity or sexual orientation, or wording "on the basis of" would not exclude the use of
surveillance of mental states, among others. Governments should adopt NT in this context).
legislation that ensures that neurotechnology is deployed responsibly, and based
on human rights, with robust oversight mechanisms to enforce adherence to
these restrictions and protect mental privacy and freedom of thought for all
individuals. These policies should be developed in consultation with diverse
actors, including civil society, end-users, neurotechnology experts, ethicists,
and human rights advocates, to ensure broad consensus and respect for global
human rights norms.
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75. Member States should ensure transparency and accountability in their
support, oversight, and regulation of neurotechnology, particularly in publicly
funded initiatives such as brain research and development programs. While
recognizing the limitations in disclosing certain sensitive information,
governments should require government sponsored neurotechnology projects to
publicly disclose the objectives, methodologies, intended uses, and societal
impacts of their neurotechnology initiatives wherever possible. This
transparency is crucial for fostering public trust and ensuring that
neurotechnology advances are aligned with ethical standards and human rights.
76. Member States should apply a comprehensive approach to regulatory and Germany strongly suggests that the Ruggie Principles
policy measures to protect against human rights harms related to (which are accepted soft law, see comments on
neurotechnology developed, marketed, operated or used by the private sector. paragraph 72) should be included here or that the
This includes legislative and regulatory measures and accompanying guidance, principles should be included in a separate paragraph
incentives, and transparency requirements. This comprehensive approach setting out the obligations of private actors / companies.
should also require human rights due diligence, ensuring that businesses
identify, prevent, mitigate, and account for their adverse human rights impacts On the human rights impact assessment please see
through context-dependent processes, including human rights impact comment on paragraph 74.
assessments, meaningful public, stakeholder and community engagement, and
transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice Germany proposes to delete the reference to “public
system, including its consideration by the judiciary should be grounded in safety” in the first sentence, as the human rights-based
robust scientific evidence, be implemented ethically in accordance with human use of NT in the justice system does not necessarily
rights, and be aimed at promoting public safety while protecting the rights and have to be aimed at public safety (e.g. in criminal
dignity of all those involved. This requires respect for fundamental rights, such proceedings).
as human dignity, bodilyphysical integrity, confidentiality of personal data, due
process and fair trial rights, including the presumption of innocence, and the
right against self-incrimination, as well as freedom from torture and ill-
treatment, the right to privacy, and the right to freedom of thought.
78. Member States should consider establishing comprehensive incentive Germany strongly suggests softening this paragraph,
structures, such as tax incentives, grants, and awards, with a particular focus on partly because the current wording restricts scientific
encouraging the construction and development of manufacturing, computational freedom and innovation. In general, there is no clear
resources, and data analytics capabilities within public research institutions and reference to NT.
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small and medium enterprises (SMEs), particularly for the development of
neurotechnology for medical and assistive purposes. Member States should also
consider incentivizinge and supporting partnerships that leverage the
computational resources and data analytics capabilities of private firms to
advance public research goals. These incentives should prioritize rewarding
transparency, participatory development processes, and contributions to societal
benefits, aiming to foster an environment where public institutions and
companies innovate responsibly and align with human flourishing goalsrights.
79. Member States should establish a coordinated, cross-sectoral approach to In line with our comments on paragraph 74, Germany
assessing the impacts of neurotechnology across the whole lifecycle support the does not support the requirement of an ethical impact
development of policy frameworks promoting the benefits of the technologies, assessment for every neurotechnology (in its current
as well as mitigating potential associated risk. A thorough and comprehensive, formulation). Such far-reaching assessment
multidisciplinary technology assessment includes analysis of both benefits and requirements are unrealistic and are unlikely to be
risks regarding but not limited to societal, economic, ethical and legal impacts. implemented in practice.
This approach should include, but is not limited to:
In addition, Germany insists on a thorough revision of
(a)-(d). All points should be shortened and critically
examined with regard to their specific objectives and
their implementation potential. Less specific and shorter
provisions would both increase the potential for
implementation of the Recommendation in different
national contexts and prolong its regulatory life. The
current wording carries a high risk of only increasing
reporting obligations without adding value.
(a) Economic Impact Assessments: Conducted by relevant national bodies
responsible for economic and labor policies to assess how neurotechnology
impacts economic growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by entities responsible for public
health, medical research, and consumer protections, these assessments should
rigorously evaluate the risks and benefits associated with the development,
deployment, and use of neurotechnology, including research, clinical
applications, and consumer products. The process should include thorough
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documentation, ethical oversight, and continuous monitoring to ensure the
safety, well-being, and equitable treatment of all individuals involved;
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these
assessments should evaluate and mitigate risks to individuals’ mental privacy
posed by neurotechnology. This includes ensuring that appropriate safeguards
are in place to protect neural and cognitive non-neural biometric data in
compliance with national and international privacy standards, and the data
policy practices discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant On the human rights impact assessment, please see
national human rights institutions or other competent national or international comment on paragraph 74.
bodies, identify, prevent, and address potential human rights impacts of
neurotechnology. The process should ensure that neurotechnology respects and
promotes human rights, with particular attention to vulnerable people and
people living in vulnerable situations. HRIAs should involve meaningful public,
stakeholder and community engagement to incorporate diverse perspectives.
80. Member States should promote equitable access to medical and assistive Germany proposes to give priority to medical and
neurotechnology worldwide. To achieve such goals, efforts should be made to assistive applications of NT over consumer applications.
support the reduction of final costs for end users, pursue the development,
adoption and continuous support of non-proprietary software solutions, and
explore reimbursement strategies or subsidisation commensurate with
conventions in local jurisdictions, in sectors of crucial potential benefits.
81. Member States should adoptconsider adopting agile appropriate regulatory Germany does not consider these very detailed
frameworks., These may include including the use of regulatory sandboxes— provisions on the use of sandboxes to be appropriate or
controlled environments for developing, testing, and evaluating relevant in the context of this Recommendation and
neurotechnology—in response to rapid advancements in neurotechnology and strongly suggests that they be reworded (see proposal).
its convergence with other technologies such as AI, spatial computing, and
immersive technologies. These sandboxes should be used to explore innovative
applications, particularly in workplace settings, with appropriate ethical
oversight provided by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure ethical data processing, and
safeguard rights by incorporating mechanisms for regular monitoring,
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evaluation, and dynamic policy adjustments in line with technological and
ethical developments.
IV.2. Data Policy
Draft Text Comments
82. Member States should develop a robust regulatory and legal framework to Germany insists on a revision of the second sentence in
govern the collection, processing, sharing, and all other uses of neural and this paragraph (see suggestion).
cognitive non-neural biometric data. Existing frameworks should consider both
neural and non-neural biometric data as sensitive data.This and existing
frameworks should recognize this data to be both personal and sensitive data in
medical and non-medical contexts.
83. Member States should ensure that their existing privacy policies Germany strongly suggests deleting the word
comprehensively cover stringent safeguards for individuals’ neural and “affirmative” in connection with “informed consent”
cognitive non-neural biometric data. If current policies do not adequately here and throughout the document, as this is not an
address these areas, Member States should adopt targeted legislation or established term in international law.
regulatory frameworks to secure these protections. These frameworks
safeguards should for example include affirmative informed consent, data
minimization and purpose limitation, data rights (including the right to access,
correctrectify, and erasedelete data), privacy enhancing technologies and
stringent data security measures, such as advanced cybersecurity protocols to
prevent unauthorized access and breaches. Such legislation or frameworks
should prohibit the practice of tying access to goods or services to the
disclosure of neural and cognitive non-neural biometric data, require explicit
opt-in for any data sharing, and forbid the use of such data for targeted
advertising without the individual’s explicit, affirmative informed consent.
84. Member States should develop and implement specific policies to reduce
the ecological footprint of neurotechnology, particularly in relation to large-
scale data centers and computing resources used for processing and storage of
neural and cognitive non-neural biometric data. These policies should
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emphasise data minimisation, ensuring that only the necessary amount of data is
collected and processed, and promote the proportional use of neurotechnology,
aligning its deployment with genuine needs and minimising unnecessary
environmental impact. Measures should include optimising energy efficiency,
using renewable energy sources, promoting the recycling and sustainable
disposal of neurotechnology-related equipment, and ensuring the rehabilitation
of affected environments.
85. Member States should support and incentivise the development and Germany suggests a slight revision of the paragraph.
implementation of technological innovations and design standards for
neurotechnology that prioritize improve the protection of mental privacyneural
and non-neural biometric data, such as state-of-the-art encryption, secure
databases with multi-factor authentication, cutting-edge anonymization
techniques, and edge-processing and storage (processing and storing data closer
to where it is being generated)., leading to greater action-led results in real time
storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to Germany suggests a slight revision of the paragraph.
prioritize privacy and ethics by design, requiring facilitating the incorporation
of privacy-preserving technologies as default features in their devices.
87. Member States should encourage ethical data sharing, in compliance with Germany suggests using established language on data
relevant data protection law, by establishing secure, data repositories for neural sharing from the UNESCO Recommendation on Open
and cognitive non-neural biometric data used in research. These repositories Science. In particular, the meaning of the term 'ethical
should meet stringent cybersecurity, data privacy, and ethical use standards data sharing' is unclear and should be replaced by an
(including data minimisation and purpose limitations), tiered access and other appropriate term.
privacy-enhancing approaches. Appropriate funding mechanisms should be
established for the curation and maintenance of data and data governance
processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border
data sharing in neurotechnology research, in compliance with relevant data
protection law, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive non-neural biometric data, by
establishing clear protocols for data transfer that ensure secure and compliant
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data exchanges across borders, and standards for interoperability of data,
including governance frameworks for data sharing.
89. Member States should consider specific guidelines for the ethical use of
neural and cognitive non-neural biometric data in AI development and research,
including consent procedures for uses of neural and non-neural cognitive
biometric data in training and application of AI models, ensuring transparency
and respecting individual and community rights.
IV.3. Intellectual Property (IP)
Draft Text Comments
90. Member States should adopt policies to ensure that neural and cognitive Germany strongly suggests to delete this section as the
biometric data, as individual human activity derivatives, are not subject to WTO an WIPO represent the responsible institutions for
proprietary rights. IP protection should only apply to original data compilations IP issues.
(created through a process of aggregation, organization, or selection, resulting
in a new dataset) that meet strict and ethical criteria.
91. Member States should collaboratively establish clear, harmonised guidelines
for IP rights applicable to neurotechnology on an international scale. These
guidelines should address the patentability of AI-generated inventions and the
ethical implications of IP laws, ensuring they promote global accessibility and
innovation.
92. Member States should ensure that all actors adopt IP management strategies
that encourage innovation and avoid overly restrictive patent use, fostering an
open innovation ecosystem. This approach should continuously adapt to the
evolving landscape of neurotechnology. The impact of IP policies on the
neurotechnology sector should be continuously monitored to ensure they
stimulate innovation while ensuring enabling ethical use and broad
accessibility.
93. Member States should foster an environment of co-creation in
neurotechnology, by facilitating policies and incentives for co-ownership and
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preferential licensing agreements to ensure equitable compensation and
recognition for all contributors.
94. Member States should adopt policies with respect to open science that
balance the protection of IP with the promotion of immediate publication of
results and data sharing. Particularly with the convergence of digital
technologies and the increasing concentration of those innovations in industry
sectors, this balance is crucial to ensure that IP protection mechanisms do not
hinder scientific research, innovation, and the wide dissemination of knowledge
and new technologies. As a basic rule of equitable partnership, when
Indigenous Peoples are involved in neurotechnology research and development,
open science processes, IP management strategy, should be developed in
collaboration with them from the beginning.
IV.4. Cybersecurity
Draft Text Comments
95. Member States should collaborate internationally to establish
comprehensive standards for cybersecurity across all neurotechnology domains.
These standards should encompass hardware, software, and data security
measures to protect against potential cyber threats. By implementing uniform
cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data, as well as enhance user
trust and confidence in neurotechnology devices. Additionally, these standards
should evolve in tandem with technological advancements and emerging cyber
threats to maintain robust protection against evolving risks.
96. Member States should encourage neurotechnology developers and Since it is not the Member States that develop and
manufactures to employ red-teaming exercises—adversarial challenges to test produce NT, a slight rewording is necessary (see
the efficacy of security systems—as a proactive measure to assess and enhance proposal).
the safety, security, and resilience of neurotechnology systems. By conducting
regular red-teaming exercises, Member States should proactively identify and
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address security gaps, test incident response procedures, and strengthen the
overall safety and cybersecurity posture of neurotechnology devices.
IV.5. Communication, Participation, and Information
Draft Text Comments
97. Member States should promote communication and develop engagement
policies for neurotechnology that foster informed, inclusive, and respectful
dialogue between researchers, developers, diverse users, and the broader public
to respect individual and community rights, promote public trust, and harness
the collective intelligence and diversity of communities.
98. Member States should collaborate with international organizations, Since there is a large overlap between paragraphs 98
educational institutions, and private and non-governmental entities to develop und 102, Germany strongly suggests merging the two.
and disseminate accessible and engaging educational materials tailored to
diverse audiences to bridge knowledge gaps, particularly in underserved regions
about the nervous system and mental health functioning, as well as the benefits
and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies’ functionality, safety, efficacy, and societal
impact, empowering individuals to make informed decisions and to enable their
ethical reflection about their use of neurotechnology.
99. Member States should implement public and community engagement
processes that facilitate genuine mutual learning and collaboration throughout
the whole lifecycle of neurotechnology. These processes should include regular
and inclusive consultations with a wide array of actors. The aim of these
engagements should be to inform policy development, shape ethical guidelines,
increase public awareness and understanding, align investment priorities, and
ensure that neurotechnology deployment aligns with public interests and values.
Special attention should be given to involving groups traditionally
underrepresented in technological policymaking, thereby fostering responsible
innovation in the field.
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100. Member states should collaborate in the co-creation of accurate, precise,
and accessible language and terminology for discussing neurotechnology that
involves actors from diverse backgrounds to ensure that the language used is
inclusive, non-stigmatizing, and accurately reflects the technologies’
capabilities and limitations. Member States should establish regulatory
frameworks that requireencourage clear and ethical communication standards
for neurotechnology. These frameworks standards should require evidence-
based reporting of capabilities, risks, and limitations across all applications to
avoid exaggeration of claims, including but not limited to applications in sleep,
attention, memory, and emotional regulation. Within these frameworks should
be specific guidelines for ethical marketing and protocols for responsible
communications about early-stage research and emerging technologies.
101. Member States should develop policies that foster effective collaboration Germany proposes to delete the second sentence as it is
between end-users, researchers and innovators throughout the whole lifecycle of too detailed.
neurotechnology product development, with special focus given to the places
where the neurotechnology is being developed, e.g. through establishing. These
policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity.
Member States should also establish platforms for ongoing dialogue and
feedback between users, researchers and developers. Advisory panels should be
involved in the process of developing and testing new neurotechnology
products to optimize device efficacy, usability, longevity, and sustainability.
This collaborative approach aims to ensure that innovations in neurotechnology
are context-compatible and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, Since there is a large overlap between paragraphs 98
culturally- appropriate, and linguistically-appropriate education about und 102, Germany strongly suggests merging the two.
neurotechnology. This should include training modules to aid in the supportive
use of these technologies at home, both for the user and for caregivers and
family members.
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Consideration for specific users
IV.6. Children and Adolescents
Draft Text Comments
103. Member States should promote healthy brain development through policies
that evaluate the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit
and explicit coercion to use neurotechnology. Member States should pay
attention to the autonomy of children and adolescents through informed consent
and assent that is adapted to and respectful of age and decision-making
capacity.
105. Member States should fund promote research and development grants
focused on creating user- friendly assistive neurotechnology tailored for
children and adolescents with disabilities. These projects should involve
children, adolescents, parents and caregivers in the design process to ensure the
technologies meet their specific needs. Educational programs should be
developed to teach children and adolescents and their caregivers how to
effectively use and maintain these technologies, with support available in
multiple languages and accessible without discriminating against those who
either cannot or choose not to engage with the proposed technology.
106. Member States should ensure research involves strict oversight and close
follow-up of all neurotechnology research involving children and adolescents.
This oversight is crucial during the developmental phases of childhood to
address and mitigate any unforeseen long- term effects. Such research must
include comprehensive monitoring protocols and periodic evaluations to ensure
the ongoing safety and well-being of young participants, taking into account
their unique developmental needs and vulnerabilities. In the framework of
research, involving children and adolescents in medically vulnerable situations
(i.e., children in epilepsy monitoring units), special attention will be given to
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consent and assent, particularly considering particular aspects of research (time,
iterations) to prevent any form of instrumentalization.
107. Member States should ensure that children and adolescents are protected
fromenact specific regulations that prohibit the use of marketing techniques—
such as neuromarketing, biometric emotional analytics, immersive advertising,
and virtual or augmented reality advertising – that rely on sensitive neural and
non-neuralcognitive biometric data collected from children and adolescents.
Recognizing the heightened vulnerability of children and adolescents in digital
environments, these regulations must explicitlyit is very important to forbid any
practices that the use of such data to influence or exploit children and
adolescents.
IV.7. Older Persons
Draft Text Comments
108. Member States should promote healthy aging and support elderly
individuals by funding and implementing evidence-based programs that
integrate neurotechnology into routine care. These programs should involve the
entire support ecosystem, including family, caregivers, and medical teams, to
enhance quality of life. Priority should be given to developing and
implementing tools that prevent, delay, and treat age-related health conditions,
impairments, and neurodegenerative diseases. Member States should ensure that
access to these neurotechnology programs, especially those for medical and
assistive purposes, is equitable and does not exacerbate socioeconomic
inequalities.
109. Member States should establish guidelines for neurotechnology design
sensitive to the needs of older adults, carefully considering human-computer
interface factors for usability (such as fonts, buttons, and colour) and experience
for enhanced visual and auditory cues.
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110. Member States should preserve, support, and promote autonomous
decision-making for older people using neurotechnology for sensorimotor and
cognitive support. The consent process should accommodate potential cognitive
challenges faced by older adults, ensuring that consent is informed, ongoing,
and adaptable to changing health conditions. Policies should be in place to
ensure that assistive neurotechnology recognize changing cognitive capacities
over time and respect users’ preferences.
111. Member States should develop ethical guidelines to ensure that Since robotic caregivers are not neurotechnologies as
neurotechnology such as robotic caregivers enhance rather than replace human defined in this Recommendation, Germany proposes to
interaction, particularly in the care of individuals with neurodegeneration. delete this paragraph
These guidelines should emphasize the augmentation of human care, not its
replacement.
IV.8. Women and Gender
Draft Text Comments
112. Member States should adopt and enforce comprehensive policies that
promote and respect gender equality and diversity in the whole lifecycle of
neurotechnology. The policies should prioritize inclusive research for
addressing women and gender specific needs and differences, require targeted
data collection and analysis, include education and training programmes on
inclusive research practices, ensure public and community engagement with
women and gender health experts and advocacy groups and, incentivise gender
responsive technology design, to meet the needs and conditions specific to
women and gender minorities. Affirmative action policies are necessary to close
gender gaps in these fields, increase representation, engagement and leadership.
113. Member States should establish clear guidelines and legal frameworks to
ensure that workplaces and research environment, throughout the whole
lifecycle of neurotechnology, are inclusive and supportive, particularly for
women and gender minorities, and safeguard against harassment and
discrimination. This should include robust mechanisms for reporting and
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addressing incidents of harassment and discrimination, ensuring accountability
and support.
114. Member States should adopt a range of measures that prioritize ethical and
equitable research and innovation and support programs that foster women’s
and gender minorities’ participation in neurotechnology. This includes funding
and other policies that prioritize ethical and equitable research and innovation,
but also affirmative action initiatives to support the participation of women and
gender minorities in neurotechnology through targeted education programs,
employment opportunities, entrepreneurship support, and leadership
development within the sector. Member States should also provide support
systems such as mentorship programs, networking opportunities, and resources
to help women and gender minorities overcome barriers to participation and
succeed in the neurotechnology field.
IV.9. Persons with physical disabilities
Draft Text Comments
According to the CRPD, member states are already
obliged to finance assistive technologies or to make
them available as cheaply as possible for persons with
disabilities. The Recommendation should not fall short
of this high standard.
Germany suggests that this chapter be scrutinised to
better reflect the obligations set out in the CRPD that
apply to NT, as the proposed wording in paragraphs 115
to 117 seem to fall short of the standard of the CRPD
(e.g. States have obligations to fund research and
provision of assistive technologies). The lessons of the
CRPD, e.g. to speak of "persons with disabilities" and
not to distinguish between the "type" of disability, are
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not yet reflected in this section and in the
Recommendation as a whole.
The Recommendation should refer to the CRPD’s
definition of “persons with disabilities” at some place
(Art. 1): “Persons with disabilities include those who
have long-term physical, mental, intellectual or sensory
impairments which in interaction with various barriers
may hinder their full and effective participation in
society on an equal basis with others.”
115. Member States should adopt policies that harness the potential of
neurotechnology by removing barriers experienced by persons with physical
disabilities and providing support thereby contributing to achieving equal
enjoyment of human rights. They should implement regulatory frameworks that
require accessibility assessments for all new neurotechnology products to
ensure these products do not perpetuate existing disabilities or health
disparities. These frameworks should include protocols for testing with diverse
groups of persons with disabilities to ensure technology meets a wide range of
needs and does not unintentionally exclude or disadvantage any subgroup.
116. Member States should create incentive programs to promote the
development of neurotechnology for people with disabilities to promote their
quality of life and functional independence. These programs should include tax
incentives for companies investing in assistive neurotechnology research and
development, grants for research institutions focusing on neurotechnology for
disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living
assistance, and innovation prizes for breakthroughs in affordable, accessible
neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential
neurotechnology devices, such as neuroprosthetics, for persons with physical
disabilities. They could encourage public-private partnerships to make
advanced neurotechnology affordable and integrate neurotechnology coverage
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into national health insurance and other reimbursement schemes for persons
with physical disabilities. A national database of available neurotechnology
resources and support services should be developed to facilitate access and
information sharing.
IV.10. Persons with mental health conditions
Draft Text Comments
118. Member States should foster research and promote awareness-raising While these are indeed important populations, it is
initiatives to address the increasing prevalence and special needs of people with unclear why victims and survivors are prioritised as they
mental health conditions, including victims and survivors of trauma and represent only a small percentage of people with mental
violence, and the relevance of neurotechnology for these communities. illness.
119. Member States should allocate funding for long-term advocacy and Since this paragraph is not specific to people with
efficacy studies, post-market oversight, and tiered scrutiny with special mental health conditions, Germany suggests moving this
attention to invasiveness and reversibility of neurotechnology interventions. It is paragraph to the chapter on health (e.g. merging it with
important to ensure that people with mental health conditions are well-informed paragraph 124)
and have reasonable expectations about the process.
120. Member States should prioritize funding for neurotechnology that is Here – and in other paragraphs – the verb “prioritize”
designed to improve quality of life and daily functioning of individuals with does not seem to fit the context, since ‘prioritize’ is
mental health conditions. This includes technologies that assist in managing relative and gives A priority over B. Here B is missing.
symptoms, improving cognitive functions, and providing emotional support at Germany suggests to replace the verb “prioritize”
home, in the workplace, in their communities, and in society. Research and throughout the text with a more appropriate alternative.
development should be guided by feedback and engagement with persons with
mental health conditions and their advocates.
121. Member States should establish policies that improve access to timely Germany proposes to delete this paragraph because of
advances in neurotechnology for those with mental health conditions to ensure the substantial overlap with paragraph 125.
that cost is not a barrier to accessing potentially life-altering treatments and
supports.
Health and Research Ethics
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IV.11. Health
Draft Text Comments
122. Member States should support the development of health applications that Here – and in other paragraphs – the verb “prioritize”
prioritize the unmet needs in the provision of neurological and mental health. does not seem to fit the context, since ‘prioritize’ is
This should include establishing research funding programs specifically relative and gives A priority over B. Here B is missing.
targeted at addressing identified gaps in nervous system care. Germany suggests to replace the verb “prioritize”
throughout the text with a more appropriate alternative.
123. Member States should build and maintain international solidarity to
address global health risks and uncertainties, and ensure that their
implementation of healthcare for the nervous system is consistent with
international law and rigorous human rights obligations. This could involve
creating international forums for sharing best practices in the implementation of
neurotechnology in healthcare.
124. Member States should establish oversight mechanisms, if they do not In some Member States these mechanisms may already
already exist, to evaluate the physical and mental health impacts of long-term exist.
use of neurotechnological devices, with special attention to invasiveness and
reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved
neurotechnology devices and establishing clear criteria for continued approval
based on these studies results.
125. Member States should consider the significant cost and impact associated See paragraph 122 on “prioritize”
with pathologies related to the nervous system, as well as the potential benefits
of early diagnosis and access to preventive and assistive neurotechnology.
Public policies should prioritize the promotion of access to these technologies
and ensure health cost coverage for individuals in need.
126. Member States should promote the development of reliable and durable
neurotechnology for healthcare applications. This includes encouraging the
design of devices and systems that require minimal maintenance, ensuring they
remain functional and effective under everyday conditions. Regulatory bodies
or designated authorities should oversee the enforcement of rigorous standards
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for quality, safety, and longevity, thereby reducing the burden on users and
enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States should ensure the development or strengthening of existing The last sentence should be less demanding in order to
comprehensive neurotechnology medical device reporting systems that track be feasible. The regulatory systems for medical devices
and address adverse effects. In contexts where such systems do not exist, seem to work, the need for a centralised and public
Member States should establish them. Where systems are already in place, they database is not stated, there are interests of
should be updated to specifically include neurotechnology. These systems manufacturers, trade secrets, etc. that could argue
should be interoperable and, where appropriate, contribute to a centralised, against it, and the involvement of international
public, and transparent international database, managed in collaboration with organisations may not be necessary.
international organizations, to ensure that global standards are met and
accessible for public knowledge, international oversight and research.
IV.12. Research Ethics
Draft Text Comments
128. Member States should reinforce the ethical ethics frameworks governing Germany suggests to delete “that define the
neurotechnology research to ensure robust protection of human participants. qualifications” as much research in psychology will be
Member States should adopt clear guidelines or policies that define the carried out via EEG or similar largely harmless methods
qualifications to ensure that research is conducted by professionals with by psychologists, who may not qualify as experts in
appropriate knowledge about the nervous system structure and function in „brain disorders“ (typically the neurologist and now the
addition to brain disorders and is performed in adequate research settings. neuroscientist), which is not problematic. Germany also
Furthermore, research protocols, public or private, in the medical as well as the suggests specifying the last sentence.
non-medical domain, should be carefully evaluated by registered certified ethics
boards (ethics committees) and specific attention dedicated to individuals with
special situations regarding vulnerability such as diminished capacity to consent
or to make decisions. Member States should ensure that all research institutions
working on or with neurotechnology have mandatory ethics training for
researchers.
129. Member States should encourage multicentre international research that
involves various cultures and ethnic groups. Member States should promote
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international cooperation to develop common reporting standards and protocols
for interoperability, particularly for implantable neurotechnology devices. This
cooperation should aim to enhance the comparability and utility of research
globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology
is considered in the design of a clinical trial, including policies to protect
patients in case of cessation of activities of the trial sponsor or promoter.
Member States should establish requirements for clinical trials to be included in
relevant nationally or internationally approved registries, and encourage
registration with community and patient registries. Also, clinical trials should
report on appropriate medical device reporting systems developed within
Member States.
131. Technology developers should ensure that the validation of AI algorithms
in neurotechnology research include rigorous testing for biases, as well as
measures to enhance explainability and transparency, including the provenance
of training datasets. Suitable techniques should be employed to mitigate any
biases present in AI models used in neurotechnology applications.
132. Member States should ensure that research efforts not only focus on Germany proposes to address this important aspect of
biomedical risks associated with neurotechnology but also investigate potential subjective experience within the established framework
effects on an individual’s subjective experience, agency and personal identity. as a matter of „safety“ of the devices (which has to be
Understanding how neurotechnology may impact aspects of self-perception, assessed anyway for medical devices).
consciousness, and identity is essential for addressing the safety of devices
ethical concerns and ensuring the well-being of individuals using these
technologies.
133. Member States should ensure those engaged in research in Germany proposes to clarify/specify why
neurotechnology implement regular auditing and monitoring of research commercialisation is problematic (end of second
practices to ensure adherence to ethical standards. This should include sentence) and what exactly researchers should be
evaluating the adequacy of informed consent, particularly concerning data reuse looking for in relation to commercialisation.
and the potential commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish
clear and transparent protocols for communicating clinically significant and
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actionable incidental findings to participants. These protocols should ensure that
such findings are conveyed promptly, respecting participants’ rights and
autonomy. Additionally, Member States should mandate that researchers
provide the necessary support and coordination with healthcare providers to
address any health concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology
research or receiving neurotechnological interventions are adequately informed
about the potential for incidental findings, particularly those with significant
health implications. The informed consent process should clearly outline what
these findings might entail, the participants’ right to choose whether they wish
to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
Specific Domains of Application outside of Health
IV.13. Educational Settings
Draft Text Comments
Germany considers this section to be very important and
proposes to include it in the general section. If this
section remains, Germany suggests that its importance
should be better emphasised.
136. Member States should approach with caution the integration of
neurotechnology in education, ensuring that its use is evidence-based and
aligned with the education goals and complements traditional learning methods.
Emphasis should be placed on promoting the holistic development of students,
focusing not just on academic performance but also on mental health, well-
being, and overall interests. To ensure inclusivity, Member States should
develop age-appropriate guidelines for neurotechnology use across different
educational stages and learning styles. Regular assessments of
neurotechnology’s impact on student development, including mental health,
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should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking,
creativity, and emotional intelligence rather than solely enhancing academic
performance.
137. Member States should adopt policies ensuring the voluntary deployment of
neurotechnology in education, grounded in fully informed consent. These
policies must include clear, age-appropriate information about the technology’s
purpose, benefits, and risks, with adequate consideration periods. Considering
the increased complexity of obtaining voluntary consent in this context, consent
and assent procedures should involve children, adolescents, parents, guardians
and all actors necessary to obtain approval required for minors. Ethical
oversight mechanisms should be established, including regular consent renewal
and immediate cessation of neurotechnology use upon withdrawal, and ensure
anonymous feedback channels. Policies must prohibit undue incentives or
academic penalties for non-participation and take measures to avoid creating or
reinforcing inequalities among students. Additionally, Member States should
support student involvement in decision-making about neurotechnology
integration and fund training programs on its ethical use, empowering educators
and students to critically assess its application.
138. Member States should establish a unified, robust oversight mechanism for
neurotechnology use in educational settings, incorporating regular audits, public
and community feedback, culturally appropriate and according to local
conventions, and strict adherence to safety and ethical standards, including an
assessment of reversibility on the nervous system. Continuous research should
be funded to assess the long-term psychological and cognitive impacts of these
technologies. Oversight should involve periodic reviews based on empirical
evidence to adjust neurotechnology usage as needed, ensuring it serves student
development and addresses risks like dependency or de-skilling. This
comprehensive approach will help maintain the safety, effectiveness, and
alignment of neurotechnology with best practices for student well-being and
learning outcomes.
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139. Member States should invest in educational and professional development
programs to equip innovators and business leaders with the skills to integrate
ethical considerations throughout the neurotechnology whole lifecycle. This
training should include ethical design, human rights law, and societal impact
assessment, preparing the next generation of technologists to critically evaluate
the implications of their work.
IV.14. Labour and Employment
Draft Text Comments
140. Member States should establish workplace policies that govern and Germany suggests deleting the examples in the second
incentives that prioritize the health and well-being of employees in the use of sentence, as they may be problematic when personal
neurotechnology. These policies should ensure that any deployment of data of employees are processed by the employer.
neurotechnology is evidence-based and, with a focus on applications that hasve
been scientifically validated to promote the health and employee well-being, Germany also suggests adding a reference to the right to
such as reducing stress or enhancing workplace conditions (i.e., adaptive and privacy and making it clear that consent should not be
responsive environments that adjust workloads based on cognitive load). the sole legal basis for the use of NT in the workplace.
Deployment must be on a voluntary basis and employees must have the option (Red Line for Germany)
to opt out of using neurotechnology without facing any negative consequences
or discrimination. If personal data of employees is processed by the employer
using neurotechnology, the right to privacy of employees must be protected.
Particular attention must be paid to the relationship of subordination between
employer and employee which leads to high requirements with regard to the
voluntary nature of consent. In principle, consent should not constitute a
sufficient sole legal basis for intrusive processing using neurotechnology. The
processing should only be carried out if there is a legal basis, for a legitimate
purpose and only to the extent necessary. Under no circumstances should these
technologies be used for performance evaluation, punitive measures,
unconsented mental surveillance, profiling or in ways that could compromise
employee health.
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141. Member States should require employers to clearly provide employees
with comprehensive information about how neurotechnology used in their
workplace works, the benefits it offers, transparency about what data are
collected, how it is used, and who has access to it, and clearly disclose any
potential risks of their use.
142. Member States should require employers who use neurotechnology in the
workplace to adopt transparent policies that disclose the purpose of the use,
limit the scope of its use to legitimate purposes in the interest of the employee
and third parties (i.e., safety, monitoring fatigue in commercial drivers or
tracking attention in air traffic controllers). To respect employees’ mental
privacy, employers should be prohibited from unauthorized access to neural and
cognitive non-neural biometric data that may be collected incidentally during
routine workplace monitoring and from further processing it for other purposes.
Employers should be prohibited from using neural and cognitive non-neural
biometric data for any non-consented agreed or illegitimate purposes,
particularly those that could negatively impact an employee’s job security or
privacy.
143. Member States should require employers to adopt best practices for data
minimisation and secure storage of neural and cognitive non-neural biometric
data, ensure that data is stored securely, with access limited to authorised
personnel only, is deleted once its intended purpose has been fulfilled.
Additionally, upon an employee’s departure, all related records should be fully
deleted or individual data released to the employee, ensuring that no data is
retained after the termination of employment.
144. Member States should ensure that when employees are issued
multifunctional devices (i.e.g., earbuds or headphones that also include neural
sensors) that can be used at work or at home, employers should be prohibited
from collecting neural and cognitive non-neural biometric data outside of
workplace settings and working hours and ensure that any data collected during
work is used exclusively for legitimate and agreed-upon purposes. Employers
should implement technological safeguards to automatically disable data
collection during non-work hours.
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145. Members States should ensure that employers respect the right of Germany suggests deleting the last sentence as its
employees to obtain a copy of any neural and cognitive non-neural biometric meaning is not clear.
data collected about them, along with any interpretations drawn from it in an
accessible and comprehensible manner. To use these tools without consent
constitutes a breach of trust, undermining the value they would otherwise
create.
146. Member States should require, through stringent regulations, that any use This paragraph must be differentiated. In the context of
of neurotechnology in the workplace is clearly regulated, requires the explicit healthcare, the use of neurotechnology may benefit the
prior approval of employees consent, and be is used only to the extent necessary (consenting) patient resp. person in need of care but may
for purposes that demonstrably enhance workplace safety, and respect employee be problematic for caregivers/employees. If they do not
well-being and dignity., and not for The use of neurotechnology to enhance consent that could create an ethical dilemma which must
enhancing productivity is a legitimate purpose only if it is done with the full be discussed with a view to describe viable ways of
prior approval of employees and does not threaten workplace safety, or solving of such dilemmata. A benefit-risk assessment as
employee well-being and dignityat the expense of employee health. it demanded earlier might be an element in dealing with
such conflicting views and interests.
In addition, consent should not be a sufficient sole legal
basis for intrusive data processing using
neurotechnology. Germany suggests a different wording
where an explicit approval should be obtained as an
additional requirement (see suggestion in the text).
Germany considers increasing productivity is a
legitimate goal of using technology - at least in cases
where negative effects on job security, well-being and
dignity are excluded and the use remains voluntary.
Germany suggests a clearer wording (see suggestion in
the text). Where appropriate, technology could also
support people with disabilities in their work or open up
new activities for them; these uses should be kept open.
147. Member States should guard against the exploitation of employees, and
they should develop stringent regulations against using neural and cognitive
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non-neural biometric data for profiling in the workplace, including in hiring.
These regulations should prohibit the use of neural and cognitive non-neural
biometric data to discriminate against candidates, particularly neurodiverse
individuals, ensuring hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for Germany suggests deleting this paragraph as it is very
hiring or maintaining employment, to limit such use where such neural and broad and leaves too much room for interpretation as to
cognitive biometric data are directly relevant to the specific requirements of the when neural and cognitive biometric data could be
job. considered relevant for hiring or maintaining
employment.
IV.15. Consumer and Commercial Domains
Draft Text Comments
Germany strongly suggest to revising this section (and
reviewing the whole document) to ensure consistent
wording (e.g. “commercial”, “non-medical” and “ DTC”
seem to be used as synonyms). The heading should be
adjusted accordingly as commercial devices can be both
medical and non-medical (=consumer). This section
should be about consumer devices to be meaningful,
otherwise it applies to all neurotech except experimental
devices in clinics or perhaps research. For the revision
the UN Guidelines for Consumer Protection should be
taken into account.
149. Member States should proactively establish a regulatory framework that
balances innovation in the recreational and commercial domains with protecting
individual rights and well-being. This framework should be dynamic, allowing
for timely updates as technology evolves and new insights are gained about its
impacts on society. This includes providing adequate oversight to ensure that
neurotechnology does not cause harm, are used consensually, and include
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robust mechanisms to protect users from potential psychological distress risk or
manipulation.
150. Member States should strengthen comprehensive consumer protection
laws to include clear labelling on commercial neurotechnology products,
detailing their effects, limitations, and risks to prevent misleading claims and
ensure transparency, and provide detailed instructions of use. This also includes
prohibiting practices of “tying” or requiring the disclosure of neural and
cognitive non-neural biometric data as a condition to access goods or services,
and prohibition about third party data sharing or the uses of this data without
affirmative opt-in option.
151. Member States should foster an environment that ensures all claims about The second sentence clearly relates to medical devices
consumer, non-medical technologies are supported by robust scientific and is not a provision in the context of
evidence. They should, by regulation, require that any products claiming to consumer/commercial applications. Germany strongly
treat, prevent, or diagnose diseases or medical conditions be validated through suggests moving this part of the paragraph to another
rigorous safety and efficacy testing, including clinical trials where necessary, section as it does not fit in this section.
and be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough
and transparent across all neurotechnological interventions, ensuring that
participation is fully voluntary and respects the privacy and autonomy of
individuals. This principle should apply uniformly in various domains such as
sports, arts, where robust standards should safeguard against coercive use and
respect athletes’ and artists’ individual autonomy, community interests, and IP
rights.
153. Member States should steer the use and development of neurotechnology
in the arts toward ensuring the enhanced learning and cultural appreciation
without compromising individual autonomy or leading to cultural
homogenisation.
154. Member States should adopt policies to prevent the misuse of
neurotechnology of consumer technology, especially neurogaming and other
devices that exploit the dopamine reward system or seek to induce problematic
and unhealthy use and overconsumption. Such regulations should mandate clear
labeling of risks, disclosures on their effects on the nervous system, enforce
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game design standards and safety, privacy and age-appropriate design standards
that prevent taking advantage of a person’s physical, mental and emotional
vulnerability to lead to compulsive use or addiction of gaming or digital
recreational platforms combined with neurotechnology, to promote healthy,
balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions,
such as XR glasses or smart earbuds with neural sensors, include hardware-
based controls that allow users to selectively disable neurotechnology features
while maintaining basic functionality. Regulations should ensure that ‘opt-out’
features are accessible and straightforward, promoting healthy, balanced use
especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding
self-determinationautonomy, consent, privacy, and the potential for
manipulation raised by neurotechnology that arise in the contexts of
recommender systems, priming and nudging, marketing during sleep and
dream, neuromarketing, and closed-loop environments by adopting
comprehensive policies and regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive
non-neural biometric data in recommender systems for manipulative or
deceptive purposes, including in political context. These regulations should
require that any use of such data within these systems be based on explicit,
informed opt-in consent from users.
(b) Nudging: govern the use of neural and cognitive non-neural biometric data
for nudging—subtly influencing individuals’ decisions or behaviours, often
without their explicit awareness. This is particularly critical in sensitive areas
such as political messaging, commercial advertisement, and healthcare. These
frameworks should require explicit, informed consent for any use of such data
to influence decisions or behaviour, the right to opt out of these systems, and
transparency and clear disclosures at the point of data collection, with strict
limitations on using data for purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that
influences or manipulates individuals during sleep, such as marketing during
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sleep and dream. Regulations should strictly prohibit commercial, marketing, or
political applications that target individuals during sleep, using neurotechnology
or neural and cognitive non-neural biometric data. Additionally, robust
oversight mechanisms should be required to ensure that any research or
application of such technologies prioritizes the well-being, privacy, and
autonomy of individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in
neuromarketing, including by requiring comprehensive disclosures to ensure
that all neuromarketing activities are conducted transparently, with participants’
explicit informed consent. This includes ensuring that participants in
neuromarketing research or campaigns are fully aware of methods, risks, and
intentions and affirmatively opt-in to participation. The use, storage, and
potential reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the
design and use of closed-loop environments—such as immersive computing
devices that adjust experiences based on detected neural and cognitive non-
neural biometric data. These policies should require clear and accessible
disclosure about how neural and cognitive non-neural biometric data are used in
these environments, prohibit real-time behavioral modification or manipulation
without explicit, informed consent, and implement safeguards specifically
designed to prevent abuses such as unauthorized surveillance, manipulative
interventions, and practices that could influence voting behavior, political
opinions, or exploit psychological and emotional vulnerabilities in real-time.
IV.16. Enhancement
Draft Text Comments
157. The use of neurotechnology to improve memory, attention, or other aspects Human enhancement is a highly controversial topic/area
of human mental performance outside of the medical context introduces of application in the context of NT, which this short and
complex ethical, social, and legal challenges, which can create new kinds of rather general paragraph does not do justice to. Even
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disparities in the global world. When neurotechnology is used in these contexts, though States may have different views on the subject,
it raises crucial questions about equity, consent, individual and community the aim should be to find as much common ground as
autonomy, and the nature of enhancement of the nervous system itself. Member possible.
States should ensure that any policies, law and regulatory frameworks that
govern the use of neurotechnology in these contexts do not exacerbate social
inequalities or lead to discrimination, address the potential risks (including to
reversibility, invasiveness, and risks to self-determinationautonomy) and fully
comply with human rights and dignity.
V. Implementation
Draft Text Comments
158. Member States and all other actors as identified in this Recommendation
should respect, promote and protect the ethical values, principles and standards
related to this Recommendation, and should take all feasible steps to give effect
to its implementation.
159. Member States shall, according to their specific contexts, governing
structures and constitutional provisions, credibly and transparently advance the
ethics of neurotechnology, in line with the UNESCO Recommendation.
Member States shall monitor and evaluate policies, programmes and
mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and
support government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations
responsible for overseeing and coordinating the regulation, vigilance, and
oversight of neurotechnology across relevant government agencies. These
coordinating bodies should be tasked with ensuring that legal and regulatory
frameworks are consistently applied, that public health and safety are protected,
and that ethical standards and human rights are upheld throughout the whole
lifecycle of neurotechnology. This includes facilitating inter-agency
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collaboration, monitoring compliance with national and international standards,
and ensuring that data and insights from different regulatory domains are shared
effectively to inform decision-making and policy development. These bodies
should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions
in respect of this Recommendation, by cooperating with all relevant national
and international governmental and non-governmental organizations, as well as
transnational corporations and scientific organizations, whose activities fall
within the scope and objectives of this Recommendation. Civil society will be
an important actor to advocate for the public sector’s interests and therefore
UNESCO needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely
through all available means, and share it with Member States, National
Commissions for UNESCO, relevant international and regional partners, human
rights institutions as well as with UNESCO ethics advisory bodies and national,
regional and local ethics committees for dissemination to all levels and actors in
this field.
164. To support Member States implementing this Recommendation by
developing concrete programs and policies and developing institutional
capacities in the ethics of neurotechnology, UNESCO shall contribute by
developing a full-fledged program with the following elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member
States in identifying their status at specific moments of their readiness trajectory
along a continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of
neurotechnology based on rigorous scientific research and grounded in
international human rights law, along with specific guidance for its
implementation in the whole neurotechnology lifecycle, and capacity-building
tools and materials to support Member States’ efforts to train government
officials, policy-makers and other relevant actors on the methodology;
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(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness
and the efficiency of the policies for the ethics of neurotechnology and
incentives against defined objectives;
(d) a UNESCO research program that will focus on the ethics of
neurotechnology, grounded on an appraisal that is informed by the current state
of technological developments, to assess the current and future impact of
neurotechnology on societies and the environment. This evidence-based
analysis will be gathered in a UNESCO observatory, to become a shared pool of
knowledge and awareness of good practices and innovations available to all
Member States and actors, in the form of research reports, data, and statistics
regarding policies for ethics of neurotechnology. The research program should
take into consideration the converging developments of neurotechnology with
other technologies such as artificial intelligence and quantum technology, work
to be conducted in collaboration with other relevant UNESCO initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and
facilitating collaboration among Member States and among all actors to
promote a global policy dialogue, including at Ministerial level in the context of
a Global Forum on the ethics of Emerging Technologies. Supporting this effort,
UNESCO shall establish a network of experts, with balanced representation of
all UNESCO’s regional groups, on the neurotechnology.
165. Processes for monitoring and evaluation should ensure broad participation To strengthen the role of UNESCO’s ethics advisory
of all actors, including, but not limited to, under-represented, vulnerable people bodies and networks, including the Intergovernmental
or people in vulnerable situations and ensuring social, cultural and gender Bioethics Committee, Germany suggests to mention
diversity. their role in the text.
In this effort and generally, UNESCO will form synergies between its existing
wide-reaching networks through the International Bioethics Committee, the
Intergovernmental Bioethics Committee, and the International Chair in
Bioethics to disseminate information and effectively monitor the impact of
neurotechnologies, especially in the contexts of medical and research usages.
The monitoring and assessment of the impact of neurotechnology and related
ethics policies and practices should be carried out continuously in a systematic
way proportionate to the relevant risks. This should be based on internationally
349
62
agreed frameworks and involve evaluations of private and public institutions.
Data collection and processing should be conducted in accordance with
international law, national legislation on data protection and data privacy, and
the values and principles outlined in this Recommendation.
VI. Final Provisions
Draft Text Comments
166. This Recommendation needs to be understood as a whole, and the
foundational values and principles are to be understood as complementary and
interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering
or otherwise prejudicing Member States’ obligations or rights under
international law, or as approval for any State, other political, economic or
social actor, group or person to engage in any activity or perform any act
contrary to human rights, fundamental freedoms, human dignity and concern for
the environment and ecosystems.
350
INDIA/INDE
351
352
353
JAPAN/JAPON
24 December 2024
Comments on the First Draft of the Recommendation on the Ethics of
Neurotechnology
Japan appreciates the efforts undertaken by the Secretariat and the members of
the Ad Hoc Expert Group for the preparation of the first draft of the
Recommendation on the Ethics of Neurotechnology. In reply to the request
made by the Secretariat, Japan hereby submits the following overall comments on
the draft Recommendation, and comments on individual paragraphs as attached
to this document with track changes.
[Overall Comments]
1. It should attract attention that each Member State situate at various circumstances
concerning neurotechnology development. In this respect, it is inevitable to raise
a question whether the aim of this draft Recommendation is clear or not.
2. This draft Recommendation refers to ethics (e.g., paragraphs 73-75, 77, 79, 81,
86-92, 98-100, 111, 114, 128, 129, 132, 133, 136-189, 156-161, 163-165), whilst
it is contaminated with descriptions concerning the promotion of development
and use of neurotechnology (e.g., paragraphs 73, 78, 85, 103, 105, 106, 108, 116,
117, 118, 119, 120, 122, 126, 129). This draft Recommendation should be
simplified and focused on descriptions related to the ethics of neurotechnology
as stated in the title.
3. The draft Recommendation includes descriptions calling on each Member State to
regulate neurotechnology at the national level (e.g., paragraphs 74-76, 81-83, 100,
107, 113, 115, 116, 124, 126, 146-150, 154-157, 161), which is an inappropriate
approach. Additionally, it is in particular impractical in terms of legal principles to
impose regulations on technologies that have not yet reached a practical stage.
Therefore, upon accurate comprehension of the status concerning
1
354
neurotechnology development, such descriptions should be revised so as to be
appropriate as an ethical guideline of neurotechnology to be developed by
Member States. In that case, each Member State should be encouraged to prepare
appropriate and flexible ethical guidelines for the technologies included in this
draft Recommendation, recognising that the circumstances concerning the
development of technology and relevant ethical guidelines vary in each Member
State as mentioned in 1. above, and that the issues to be considered and the degree
of risk vary depending on the nature of technology (e.g., invasive or non-invasive
medical act).
4. When neurotechnology involves invasive and non-invasive medical acts on the
human body (e.g., the invasive and non-invasive medical technologies exemplified
in paragraph 13), it is usually regarded as a medical act or something equivalent to
it, including during the research stage, and an institutional system including ethical
guidelines has already been established in certain Member States. Therefore,
descriptions of this draft Recommendation should be carefully examined so as not
to overlap with such systems. However, for Member States without ethical
guidelines for medical use, it is necessary to include descriptions encouraging them
to develop such guidelines.
5. The ethics of technologies that are to be newly developed based on analysis of
data of individual neural activities collected by non-invasive methods are to be
considered in the framework of AI/computational science technology (e.g. the
Recommendation on the Ethics of AI) rather than neurotechnology.
6. Sections IV. 6-8 (Children and Adolescence/Older Persons/Women and Gender)
do not focus on neurotechnology, but rather describe matters that need to be
considered in the context of general technology development. Therefore, they
should be either deleted or revised to refer to other general guidelines for
technology development.
7. Others
A) Since this draft Recommendation is not legally-binding at the international level,
term “PREAMBLE” should be replaced with ”INTRODUCTION” or deleted
(the title of paragraphs before ” Ⅰ . SCOPE OF APPLICATION AND
2
355
DEFINITIONS”), term "shall" should be replaced with "should" or deleted
(paragraphs 159, 164, 164 (e)) and term “provisions” should be replaced with
“items” or “contents” (item 2 in the 16th paragraph of “PREAMBLE”).
B) The text includes phrases concerning collective rights, such as the communal
rights in paragraph 35 and the individual and collective rights in paragraphs 73
and 74, but since collective rights are not necessarily established rights under
international law, it is appropriate to delete words concerning collective rights.
3
356
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
INTRODUCTIONPREAMBLE Commented [J1]: 【Comments of Japan】
"PREAMBLE"should be "INTRODUCTION" or deleted,
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and for this Recommendation is not legally binding.
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health conditions,
along with the profound suffering they cause for individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better
preventive and therapeutic treatments for millions, benefitting humanity as a whole and providing
opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
self-determination, privacy, personal identity, freedom of thought, risk of discrimination, inequality
and challenges to democracy, and that justice, trust and fairness must be upheld so that no country
and no one should be left behind, either by having fair access to neurotechnology and enjoying
their benefits or in the protection against their risks, while recognizing the different circumstances
of different countries and respecting the desire of some people not to take part in all technological
developments,
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security
by promoting collaboration among nations through education, the sciences, culture, and
communication and information, in order to further universal respect for justice, for the rule of law
and for the human rights and fundamental freedoms which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human rights,
as well as gender equality, social and global justice and development, physical and mental well-
being and health, diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide neurotechnology in a
responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development and
policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General “to prepare a standard-
setting instrument on the ethics of neurotechnology in the form of a recommendation”, which is to
be submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
357
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration Commented [J2]: 【Comments of Japan】
on the Responsibilities of the Present Generations Towards Future Generations (1997); the Government of Japan (GoJ) would like to suggest that
Universal Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on UNDRD should be deleted, because the right to
development is not necessarily established by
the Rights of Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate
international law.
Change (2017); the Recommendation on Science and Scientific Researchers (2017); the
Recommendation on the Ethics of Artificial Intelligence (2021); the Recommendation on Open
Science (2021); the Human Rights Council’s resolution on entitled “The right to privacy in the digital Commented [J3]: 【Comments of Japan】
age” (A/HRC/RES/42/15) (2019); the Human Rights Council’s resolution on entitled “New and Resolutions mentioned here are not necessarily
emerging digital technologies and human rights” (A/HRC/RES/41/11) (2019), and the UN Guiding supported by all Member States because they often
focus on the rights which are not established by
Principles on Business and Human Rights (2011),
international law. Thus, GoJ prefer replacing "on" with
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical "entitled."
questions related to AI-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX day
of November 2025;
2. Recommends that Member States, with the support of UNESCO’s Secretariat, apply the
items/contentsprovisions of this Recommendation by taking appropriate steps, including Commented [J4]: 【Comments of Japan】
whatever legislative or other measures may be required, in conformity with the "provisions"should be "items" or "contents", for this
constitutional practice and governing structures of each State, to give effect within their Recommendation is not legally binding.
jurisdictions to the principles and norms of the Recommendation in conformity with
international law, including international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development and
use of neurotechnology are guided by both sound scientific research as well as ethical
analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
I.1. SCOPE
This Recommendation:
1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing and on the enjoyment of human rights.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (DTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to
animals in research.
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4. Approaches neurotechnology ethics as a systematic normative reflection based on a
holistic, multicultural, multidisciplinary, pluralistic and evolving framework of interdependent
values, principles, and actions that can guide societies in dealing responsibly with the impacts of
neurotechnology on human beings, societies, and the environment and ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the
prevention of harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from
neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology and other disciplines.
5. Covers the measurement, recording, and modification of the human nervous system,
the handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because
the highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to
be responsible for actions, cooperate with others, deliberate about collective decisions and
develop personality.
7. Further recognizes that humans develop and flourish in their interaction with other
human beings and a nurturing material and cultural environment, highlighting that autonomy is
not just individual but also relational, as it arises from and impacts one’s interactions and
belonging with the community.
8. Addresses the ethical and human rights concerns that arise from the rapid
developments and the convergence of neurotechnology with other technologies such as spatial
computing, extended reality (XR), artificial intelligence (AI), sensors and semi-conductors.
Notably, other biometric data when processed to infer sensory, motor, and mental states raises
similar ethical concerns. Therefore, this Recommendation applies to both neurotechnology and
the use of cognitive biometric data, ensuring that ethical principles and practices are consistently
applied across these domains.
9. Further addresses the integration of AI with neurotechnology, which can enhance
precision and predictive capabilities, such as improving processing speed, reducing cost,
optimizing neurotechnology systems. However, it also magnifies ethical threats, including
cybersecurity concerns, lack of transparency, the potential for algorithmic bias, and risks to
autonomy, mental privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications of
neurotechnology. Calls on all concerned to act responsibly with regard to neurotechnology.
I.2. DEFINITIONS
11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include
cognitive, affective, and conative states), and supports consciousness, sleep and the experience
of pain. The nervous system activity and structure provide information inherent to all human
beings and the community, regardless of gender, ethnicity, language, or religion. The nervous
system activity is also instrumental in social and cultural interactions.
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12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures—
encompassing both hardware and software—that directly access, monitor, analyze, predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity,
function, or intentions (speech, motor). Neurotechnology combines elements of neuroscience,
engineering, and computing, among others.
13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction with the
nervous system or by interfacing it with devices and systems. The degree of risk varies
depending on whether the technique is invasive or non-invasive. It includes but is not limited to: Commented [J5]: 【Comments of Japan】
Added point that degree of risk depends on the
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical, technology.
optical, magnetic and/or mechanical), chemical and biological signals associated
with the structure of and functional signals from the nervous system. These may
be used to identify, record, and/or monitor properties of nervous system activity,
understand how the nervous system works, diagnose pathological conditions, or
control external devices (brain machine interfaces (BMI), often referred to as brain
computer interfaces (BCI)). Of note, both open-loop (i.e., fixed-parameter brain
stimulation) and closed-loop systems (i.e., state dependent stimulation) introduce
complex ethical issues.
(i). Examples include but are not limited to Electroencephalography
(EEG), Magnetoencephalography (MEG), Magnetic resonance
imaging (MRI), Functional Magnetic resonance imaging (fMRI),
Positron emission tomography (PET), Functional Near-infrared
spectroscopy (fNIRS), Implanted microelectrodes, Optogenetics,
Optical imaging, Diffusion weighted imaging, Calcium imaging,
Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for
example, to restore sensory input, such as hearing (i.e., cochlear implants) or
Deep Brain Stimulation (DBS) to treat tremors and other pathological conditions.
They are meant to either modulate the functions of the nervous system and/or
send signals directly to the nervous system by applying acoustic, electrical,
magnetic or optical stimulation and/or inhibition of the peripheral or central
nervous system.
(i). Examples of this neurotechnology are implanted microelectrodes,
BMI, DBS, Optogenetic optical stimulation, Transcranial electrical
stimulation (tES), Transcranial Magnetic Stimulation (TMS) or
Neuropharmacological infusion.
14. Of note, several sensor technologies collect data indirectly informing about neural
activity. Even if they are not neurotechnology per se, they raise similar ethical and human rights
issues as neurotechnology when used to infer mental states. They include but are not limited to
eye-tracking, Video Oculography, Typing dynamics, Voice recognition and analysis, Gait
analysis, Skin conductance, Heart rate variability, Sleep movement monitoring, Blood pressure
measurement, or facial- emotion recognition systems.
15. Neural data. Neural data are qualitative and quantitative data about the structure,
activity and function of the nervous system. They encompass data relating to a nervous system’s
activity, including both direct measurements of neuronal structure, activity and/or function (i.e.,
neuronal firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e.,
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blood flow in fMRI and fNIRS). At the neurobiological level, neural data are the most direct
correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non-neural
biometric technologies can be processed to infer mental states, which this Recommendation
refers to as “cognitive biometric data”.
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining
for materials, prototyping, research, design and development to deployment and use, including
maintenance, operation, trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology
includes its convergence with other technologies and the diversity of actors who are involved in
every stage.
II. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the development and
use of neurotechnology in ways that are ethical, safe and effective for the good of humanity,
individuals, communities, societies, the environment and ecosystems, and to prevent harm in the
present and the future based on international law, in particular the Charter of the United Nations
and international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity and equality, including gender equality, and to respect
cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities,
institutions, private sector companies and every other relevant actor to ensure the
embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable
and reproducible;
(d) to provide a universal framework that not only articulates values and principles,
but also translates into concrete policy recommendations and effective
implementation to guide Member States in their engagement with
neurotechnology in its whole lifecycle, consistent with their obligations under
international human rights law and other international standards; Commented [J6]: 【Comments of Japan】
"international human rights law" and "international
(e) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and standard" cannot be paralleled.
consensus building about ethical issues relating to neurotechnology;
(f) to promote justice and equitable access to developments and knowledge in the
field of neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.
III. VALUES AND PRINCIPLES
III.1. VALUES
III.1.1. Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
20. The inviolable and inherent dignity of every human being is the foundation of universal
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human rights and fundamental freedoms. Respect, protection, and promotion of human dignity,
as established by international human rights law, are essential in the whole lifecycle of
neurotechnology. Dignity encompasses the recognition of the intrinsic and equal worth of each
person. Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including thosepeople living in Commented [J7]: 【Comments of Japan】
vulnerable situations. As this comes after "any individual, including", using
"those" (meaning "some individuals") is appropriate.
III.1.2. Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical,
mental, and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the
largest number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
III.1.3. Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of
neurotechnology. Special consideration should be given to neurodiversity, minority groups,
Indigenous Peoples, and underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban
well-resourced sector, specific attention to underserved and marginalised people is crucial to
prevent bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological
assimilation, or using technology as a tool of colonisation (a term the Recommendation refers to
as “technological colonialism”), can threaten cultural diversity and heritage, therefore must be
protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its
benefits are accessible to all, regardless of socioeconomic status or geographical location.
Special attention must be given to low- and middle-income countries, resource-constrained
settings, and marginalised communities, including the specific needs of different groups, ages,
segments, cultural systems, languages, communities, and marginalised and vulnerable
populations, personpeople with disabilities, neurological disorders, and mental health conditions. Commented [J8]: 【Comments of Japan】
Consistenty with the wording of the Convention on the
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and Rights of Persons with Disabilities.
opinions, share personal experiences, and participate in co-designing technologies, provided
that these choices are made in ways that respect the rights of others.
III.1.4. Consideration for cross-cultural perspectives on human knowledge and its sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
28. It is essential that any research and development involving diverse groups and
communities is done with their permission and guidance, and conducted with their full prior and
informed consent and partnership in ways that serve their interests and respect their traditional
knowledge and epistemic contributions.
III.1.5. Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of
thought especially in situations where refusal to use the technology could lead to competitive
362
disadvantage. Such interferences include but are not limited to the use of force, threats,
undisclosed access, manipulation, or any scenario where consent is compromised, including as
a result of power imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that
segregate, objectify or subordinate individuals or communities, reduce social cohesion by
exacerbating pre-existing inequalities or generating novel inequalities that divide and antagonize
individuals against each other, and thereby threaten the coexistence between humans, other
living beings and the natural environment.
III.1.6. Global Solidarity and International Cooperation
31. The Recommendation should guide all actors in the development, deployment and use
of neurotechnology to act in solidarity and call for accountability in instances where
neurotechnology may be misused in ways that threaten human rights.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use
to prevent abuse and uphold global ethical standards.
III.1.7. Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used
with a deep respect for environmental stewardship, prioritizing the minimisation of ecological
harm throughout the lifecycle of the materials used, including, for mining extraction, data
processing and storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
35. Respect for Indigenousthe rights of Iindigenous personsrights, in accordance line with Commented [J9]: 【Comments of Japan】
the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), requires that "Indigenous rights" is not necessarily recognised. GoJ
proposes "the rights of indigenous persons" to make
neurotechnology, through its whole lifecycle, be guided by a profound respect for the enjoyment clear that this paragraph talks about their individual
of rights by Indigenous persons rights, ensuring that pertaining to their lands (including during rights.
mining), knowledge, communal rights, and privacy are honoured in all activities, including those Commented [J10]: 【Comments of Japan】
related to resource extraction. Since the UNDRIP is not a treaty, the expression "in
accordance with," which is usually used for legally
III.1.8. Integrity and Responsibility binding documents, is not appropriate.
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with Commented [J11]: 【Comments of Japan】
Not all the Member States consider that the groups of
ethical steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align persons can collectively be a subject of human rights.
with both professional standards and societal values.
37. Integrity includes a commitment to taking responsibility for one’s actions and being
accountable for their outcomes. This involves not only acknowledging successes but also owning
up to mistakes and taking corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-
based, objective and transparent research practices. It ensures that all scientific endeavours are
conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant
for neurotechnology.
III.2. ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred approach through fundamental
ethical principles including but not limited to self-determination, agency, freedom of thought,
privacy, cognitive liberty, personal and collective identity, trustworthiness, respect, reciprocity,
363
and justice. Furthermore, it incorporates the respect, promotion and protection of human rights.
III.2.1. Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and well-being, and empower individuals to
make informed decisions about their nervous system and mental health while fostering a better
understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally. The
“do no harm” principle must guide the whole lifecycle of neurotechnology, ensuring that the
quality of life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only
unexpected damage to the nervous system, but also to amplified inequalities within society.
43. Any restrictions to human rights must meet all applicable requirements under
international human rights law, including the principles of legality, legitimate aim, necessity and Commented [J12]: 【Comments of Japan】
proportionality. GoJ understands that there is no such national law as
"human rights law." If it simply indicates the national
44. The principles of proportionality, balance and legitimacy should govern the use of law, it is appropriate to edit it to "under domestic laws
and regulations on human rights." or insert
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional "international" before "human rights law."
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon
the foundational values of this document; (c) appropriate to the context and target user group;
(d) based on safety principles and rigorous scientific evidence.
III.2.2. Self-determination and Freedom of Thought
45. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the
rights of freedom of thought, and self-determination must be secured.
46. Individuals have the right to make free, informed, and voluntary decisions about their
engagement with neurotechnology throughout the whole lifecycle, in lineaccordance with Commented [J13]: 【Comments of Japan】
international human rights law and other international standards, including the right to refuse or "accordance" should be "line", for international
standards is not necessarily legally binding.
withdraw from its use, at any time, ensuring their autonomy and respect for their decision-making
capacity is upheld and where surrogate consent is used, the best interests of the affected
individual are considered. Individuals who are enrolled in research should be informed of
potential side effects and given the opportunity to disclose if they have any contraindications for
the procedures used. Informed consent procedures should be affirmative, dynamic, and require
opt-in, comprehensive and transparent providing detailed information about the purposes, risks,
benefits, alternatives, and possible outcomes of the technology in all its application domains,
ensuring that consent is voluntary and that individuals fully understand the implications for their
privacy, autonomy, and well-being.
47. Neurotechnology should never be used to exert undue influence or manipulation,
whether through force, coercion, or other means that compromise self-determination and
freedom of thought. This protection covers both the internal processing of thoughts and their
external expression, ensuring freedom from any interference.
III.2.3. Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the
right to privacy due to their increasing ability to collect direct and indirect data about the nervous
system that is uniquely sensitive because they can be processed and analysed to provide deep
insights into the processes that underpin our mental states and behaviour, including self-
awareness and introspection. As it becomes increasingly difficult to anonymize data, there
364
remains persistent risks of misuse of this data by revealing neurobiological correlates of
diseases, disorders, or general mental states without the authorization of the person from whom
data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural data must be conducted
with free and informed consent, in ways that respect the ethical and human rights principles
outlined in this Recommendation.
50. There should be clear safeguards against the misuse or unauthorised access of neural
and cognitive biometric data, including affirmative consent, data minimization and purpose
specification, data rights (such as rights to access, correct and delete), and data security,
particularly in contexts where such data might be aggregated with other sources.
III.2.4. Non-Discrimination and Inclusivity
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface
with other technologies like AI, must commit to upholding ethical principles that prevent
discrimination, stigmatisation, targeting, or exploitation of any individuals or groups, particularly
those in vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or
mental characteristics, or other grounds protected under international human rights law. Commented [J14]: 【Comments of Japan】
GoJ understands that there is no such national law as
53. Non-inclusive technological development and standardisation may drive a trend toward "human rights law." If it simply indicates the national
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural law, it is appropriate to edit it to "under domestic laws
and regulations on human rights." or insert
and collective identity. "international" before "human rights law."
54. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their input and
validation to align these technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or
discrimination against older persons.
III.2.5. Accountability
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology
requires all actors to adhere to the highest ethical standards, remain open to feedback, be
committed to adjusting practices in response to new evidence or ethical concerns, and be held
accountable for their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and
a duty to anticipate and address potential harms—whether short-term, long-term or arising from
unintended use and impact.
59. A commitment to accountability requires global, governmental, societal and collective
action to ensure those harmed by neurotechnology have access to justice, and that those
responsible for wrongdoing are required to take meaningful steps to identify, prevent, mitigate
and account for how they address and redress their adverse human rights impacts, including
through corrective actions and reparations.
365
III.2.6. Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection of human rights and fundamental
freedoms, all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international
principles of responsible conduct and scientific integrity. This includes preventing the replication
or amplification of biases, ensuring that neurotechnology is traceable and explainable, its
capacities and limitations are accurately portrayed, the conditions for accountability are clearly
defined, adhering to ethical guidelines in research and development, including the registration of
trials, fair participant selection, and approval by independent ethics committees.
III.2.7. Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about
neurotechnology, including recognizing diverse ways of knowing, and that all individuals and
communities can participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community
engagement, to ensure diverse populations can gain and exchange knowledge about nervous
system functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and
identity, to respect different ways of knowing and understanding. This respect for diversity
ensures that the knowledge and perspectives of diverse communities are valued and included in
decision-making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may be
marginalized or excluded from knowledge production and dissemination.
65. All communities should have a voice in decisions that affect them, particularly when it
comes to the development and use of neurotechnology.
III.2.8. Best Iinterests of the cChild and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right of
the childchildren and adolescents to participate in decisions that affect them. Technology should Commented [J15]: 【Comments of Japan】
be rigorously assessed to ensure it serves the best interests, well-being and healthy development Assuming that the "child" in the heading implies the
children protected under the Convention on the Rights
of the children, as they grow into autonomous individuals and safeguard the rights of future of the Child, the subject of the rights here should be
generations by ensuring that today’s decisions promote their future wellbeing. "the child", not "children and adolescents." (Children
and adolescents are different in definition; the
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology Convention only stipulates the rights of children under
for early diagnosis, instruction, education, and continuous learning, it is equally important to make 18 year-old, and the adolescents are defined as those
aged between 10-19 according to the WHO.)
a commitment to the holistic development of the child. This includes nurturing their social life,
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and
physical activity.
III.2.9. Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must
be shared equitably among all contributors to that research and development, with a particular
focus on ensuring global distribution that promotes fairness and reduces disparities.
366
69. Neurotechnology developments should be leveraged to reduce global health inequities.
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings.
70. Research, development, and trials in neurotechnology must adhere to the appropriate
highest ethical standards for each technology,, ensuring the non-exploitative participation of all Commented [J16]: 【Comments of Japan】
individuals involved. This includes safeguarding the rights and well-being of participants, and Amended to state that ethical standards should be
observed according to the circumstances of each
patients and their caregivers, as well as ensuring the ethical collection and use of data. Special technology rather than being followed with uniform
attention should be given to ensure that those contributing to research and development have strictness.
their fair share of the benefits and do not bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never
take advantage of, the lack of necessary technological or medical infrastructure, education and
skills, as well as ethical-legal frameworks, particularly in LMICs, LDCs, LLDCs and SIDS,
affecting communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive
recipients of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1. GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
promotes and protects individual and collective human rights. This commitment should include Commented [J17]: 【Comments of Japan】
funding for interdisciplinary research that not only advances neurotechnological innovation but Not all the Member States consider that the groups of
persons can collectively be a subject of human rights.
also studies the ethical, legal, social, environmental and cultural implications of these
technologies, and supports the implementation and clinical translation of technological
prototypes. Particular attention should be given to the development and implementation of
adequate technical, institutional, procedural and other safeguards to ensure that they equitably
benefit society and that human rights are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology
in contexts that violate individual and collective human rights. Member States should conduct Commented [J18]: 【Comments of Japan】
human rights due diligence, including regular, comprehensive human rights impact assessments, See the above comment.
concerning neurotechnology that they develop, design, deploy, use, sell, operate or procure, in
order to prevent and mitigate their adverse human rights impacts. Specifically, neurotechnology
should not be used for purposes such as non-consensual interrogation in law enforcement,
criminal and civil justice, development or deployment of weapons targeted at the nervous system,
social control, attempts at coercive behavioural conformity based on personal beliefs or thoughts,
political or other opinion, gender identity or sexual orientation, or surveillance of mental states,
among others. Governments should adopt legislation that ensures neurotechnology is deployed
responsibly, and based on human rights, with robust oversight mechanisms to enforce
adherence to these restrictions and protect mental privacy and freedom of thought for all
individuals. These policies should be developed in consultation with diverse actors, including civil
society, end-users, neurotechnology experts, ethicists, and human rights advocates, to ensure
broad consensus and respect for global human rights norms.
75. Member States should ensure transparency and accountability in their support,
oversight, and regulation of neurotechnology, particularly in publicly funded initiatives such as
367
brain research and development programs. While recognizing the limitations in disclosing certain
sensitive information, governments should require government sponsored neurotechnology
projects to publicly disclose the objectives, methodologies, intended uses, and societal impacts
of their neurotechnology initiatives wherever possible. This transparency is crucial for fostering
public trust and ensuring that neurotechnology advances are aligned with ethical standards and
human rights.
76. Member States should apply a comprehensive approach to regulatory and policy
measures to protect against human rights harms related to neurotechnology developed,
marketed, operated or used by the private sector. This includes legislative and regulatory
measures and accompanying guidance, incentives, and transparency requirements. This
comprehensive approach should also require human rights due diligence, ensuring that
businesses identify, prevent, mitigate, and account for their adverse human rights impacts
through context-dependent processes, including human rights impact assessments, meaningful
public and community engagement, and transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, be
implemented ethically in accordance with their relevant human rights obligations, and be aimed Commented [J19]: 【Comments of Japan】
at promoting public safety while protecting the rights and dignity of all those involved. This It's appropriate to use "in accordance with "with the
terms such as "obligations" and "law."
requires respect for fundamental rights, such as human dignity, bodily integrity, confidentiality of
personal data, right to due process and fair trial rights, including the presumption of innocence,
and the right against self-incrimination, as well as right not to be subjected to freedom from torture
or to cruel, inhuman or degrading treatment or punishment and ill-treatment, the right to privacy,
and the right to freedom of thought. Commented [J20]: 【Comments of Japan】
Althoguh the rights listed here include the rights which
78. Member States should establish comprehensive incentive structures, such as tax are not stated in the ICCPR, the wordings should be
incentives, grants, and awards, with a particular focus on encouraging the construction and used in the Covenant in principle.
~~~~~~~~~~~
development of manufacturing, computational resources, and data analytics capabilities within Ref. ICCPR Article 7
public research institutions and small and medium enterprises (SMEs). Member States should No one shall be subjected to torture or to cruel,
also incentivize and support partnerships that leverage the computational resources and data inhuman or degrading treatment or punishment. In
particular, no one shall be subjected without his free
analytics capabilities of private firms to advance public research goals. These incentives should consent to medical or scientific experimentation.
prioritize rewarding transparency, participatory development processes, and contributions to
societal benefits, aiming to foster an environment where public institutions and companies
innovate responsibly and align with human flourishing goals.
79. Member States should establish a coordinated, cross-sectoral approach to assessing
the impacts of neurotechnology across the whole lifecycle. This approach should include, but is
not limited to:
(a) Economic Impact Assessments: Conducted by relevant national bodies
responsible for economic and labor policies to assess how neurotechnology
impacts economic growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by entities responsible for public health,
medical research, and consumer protections, these assessments should
rigorously evaluate the risks and benefits associated with the development,
deployment, and use of neurotechnology, including research, clinical applications,
and consumer products. The process should include thorough documentation,
ethical oversight, and continuous monitoring to ensure the safety, well-being, and
equitable treatment of all individuals involved;
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
368
authorities or agencies responsible for data protection and privacy, these
assessments should evaluate and mitigate risks to individuals’ mental privacy
posed by neurotechnology. This includes ensuring that appropriate safeguards
are in place to protect neural and cognitive biometric data in compliance with
national and international privacy standards, and the data policy practices
discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions, where it exists [where they exist], or international bodies, Commented [J21]: 【Comments of Japan】
identify, prevent, and address potential human rights impacts of neurotechnology. Since not all Member States have established national
human rights institutions (it does not exist in Japan),
The process should ensure that neurotechnology respects and promotes human the words "where it exists" are necessary.
rights, with particular attention to vulnerable people and people living in vulnerable
Commented [J22]: 【Comments of Japan】
situations. HRIAs should involve meaningful public and community engagement Please explain what the term 'international bodies'
to incorporate diverse perspectives. means.
80. Member States should promote equitable access to neurotechnology worldwide. To
achieve such goals, efforts should be made to support the reduction of final costs for end users,
pursue the development, adoption and continuous support of non-proprietary software solutions,
and explore reimbursement strategies or subsidisation commensurate with conventions in local
jurisdictions, in sectors of crucial potential benefits.
81. Member States should adopt agile regulatory frameworks, including the use of
regulatory sandboxes—controlled environments for developing, testing, and evaluating
neurotechnology—in response to rapid advancements in neurotechnology and its convergence
with other technologies such as AI, spatial computing, and immersive technologies. These
sandboxes should be used to explore innovative applications, particularly in workplace settings,
with appropriate ethical oversight provided by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure ethical data processing, and safeguard rights by
incorporating mechanisms for regular monitoring, evaluation, and dynamic policy adjustments in
line with technological and ethical developments.
IV.2. DATA POLICY
82. Member States should develop an robust appropriate regulatory and legal framework to Commented [J23]: 【Comments of Japan】
govern the collection, processing, sharing, and all other uses of neural and cognitive biometric Rather than calling for strictly regulating everything,
how about stating that appropriate data policies will be
data. This and existing frameworks should recognize this data to be both personal and sensitive ensured, taking into account individual circumstances?
data in medical and non-medical contexts, and .should be appropriate in terms of the sensitivity
of the data.
83. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals’ neural and cognitive biometric data. If current policies do not
adequately address these areas, Member States should adopt targeted legislation or regulatory
frameworks to secure these protections. These safeguards should for example include
affirmative informed consent, data minimization and purpose limitation, data rights (including the
right to access, correct, and delete data), and stringent data security measures, such as
advanced cybersecurity protocols to prevent unauthorized access and breaches. Such
legislation or frameworks should prohibit the practice of tying access to goods or services to the
disclosure of neural and cognitive biometric data, require explicit opt-in for any data sharing, and
forbid the use of such data for targeted advertising without the individual’s explicit, affirmative
informed consent.
84. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and computing
369
resources used for processing and storage of neural and cognitive biometric data. These policies
should emphasise data minimisation, ensuring that only the necessary amount of data is
collected and processed, and promote the proportional use of neurotechnology, aligning its
deployment with genuine needs and minimising unnecessary environmental impact. Measures
should include optimising energy efficiency, using renewable energy sources, promoting the
recycling and sustainable disposal of neurotechnology-related equipment, and ensuring the
rehabilitation of affected environments.
85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, such as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy
and ethics by design, requiring the incorporation of privacy-preserving technologies as default
features in their devices.
87. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories should
meet stringent cybersecurity, data privacy, and ethical use standards (including data
minimisation and purpose limitations), tiered access and other privacy-enhancing approaches.
Appropriate funding mechanisms should be established for the curation and maintenance of data
and data governance processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing
in neurotechnology research, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive biometric data, by establishing clear protocols for
data transfer that ensure secure and compliant data exchanges across borders, and standards
for interoperability of data, including governance frameworks for data sharing.
89. Member States should consider specific guidelines for the ethical use of neural and
cognitive biometric data in AI development and research, including consent procedures for uses
of neural and cognitive biometric data in training and application of AI models, ensuring
transparency and respecting individual and community rights.
IV.3. INTELLECTUAL PROPERTY (IP)
90. Member States should adopt policies to ensure that neural and cognitive biometric data,
as individual human activity derivatives, are not subject to proprietary rights. IP protection should
only apply to original data compilations (created through a process of aggregation, organization,
or selection, resulting in a new dataset) that meet strict and ethical criteria.
91. Member States should collaboratively establish clear, harmonised guidelines for IP
rights applicable to neurotechnology on an international scale. These guidelines should address
the patentability of AI-generated inventions and the ethical implications of IP laws, ensuring they
promote global accessibility and innovation.
92. Member States should ensure that all actors adopt IP management strategies that
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility.
370
93. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors.
94. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing.
Particularly with the convergence of digital technologies and the increasing concentration of
those innovations in industry sectors, this balance is crucial to ensure that IP protection
mechanisms do not hinder scientific research, innovation, and the wide dissemination of
knowledge and new technologies. As a basic rule of equitable partnership, when Indigenous
Peoples are involved in neurotechnology research and development, open science processes,
IP management strategy, should be developed in collaboration with them from the beginning.
IV.4. CYBERSECURITY
95. Member States should collaborate internationally to establish comprehensive standards
for cybersecurity across all neurotechnology domains. These standards should encompass
hardware, software, and data security measures to protect against potential cyber threats. By
implementing uniform cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data, as well as enhance user trust and
confidence in neurotechnology devices. Additionally, these standards should evolve in tandem
with technological advancements and emerging cyber threats to maintain robust protection
against evolving risks.
96. Member States should employ red-teaming exercises—adversarial challenges to test
the efficacy of security systems—as a proactive measure to assess and enhance the safety,
security, and resilience of neurotechnology systems. By conducting regular red-teaming
exercises, Member States should proactively identify and address security gaps, test incident
response procedures, and strengthen the overall safety and cybersecurity posture of
neurotechnology devices.
IV.5. COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, patients, and the broader public to respect individual and community Commented [J24]: 【Comments of Japan】
rights, promote public trust, and harness the collective intelligence and diversity of communities. Added that communication with the parties directly
involved is also important.
98. Member States should collaborate with international organizations, educational
institutions, and private and non-governmental entities to develop and disseminate accessible
and engaging educational materials tailored to diverse audiences to bridge knowledge gaps,
particularly in underserved regions about the nervous system and mental health functioning, as
well as the benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies’ functionality, safety, efficacy, and societal impact,
empowering individuals to make informed decisions and to enable their ethical reflection about
their use of neurotechnology.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a
wide array of actors. The aim of these engagements should be to inform policy development,
shape ethical guidelines, increase public awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment aligns with public interests and values.
371
Special attention should be given to involving groups traditionally underrepresented in
technological policymaking, thereby fostering responsible innovation in the field.
100. Member states should collaborate in the creation and dissemination co-creation of Commented [J25]: 【Comments of Japan】
accurate, precise, and accessible language and terminology for discussing neurotechnology that It would be better to change it to “collaborate in the
creation and dissemination."
involves actors from diverse backgrounds to ensure that the language used is inclusive, non-
stigmatizing, and accurately reflects the technologies’ capabilities and limitations. Member States
should establish regulatory frameworks that require clear and ethical communication standards
for neurotechnology. These frameworks should require evidence-based reporting of capabilities,
risks, and limitations across all applications to avoid exaggeration of claims, including but not
limited to applications in sleep, attention, memory, and emotional regulation. Within these
frameworks should be specific guidelines for ethical marketing and protocols for responsible
communications about early-stage research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end-
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-
compatible and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally-
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user
and for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6. CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that
evaluate the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit and explicit
coercion to use neurotechnology. Member States should pay attention to the autonomy of
children and adolescents through informed consent and assent that is adapted to and respectful
of age and decision-making capacity.
105. Member States should fund research and development grants focused on creating user-
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children, adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed
to teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
106. Member States should ensure research involves strict oversight and close follow-up of
all neurotechnology research involving children and adolescents. This oversight is crucial during
the developmental phases of childhood to address and mitigate any unforeseen long- term
effects. Such research must include comprehensive monitoring protocols and periodic
372
evaluations to ensure the ongoing safety and well-being of young participants, taking into account
their unique developmental needs and vulnerabilities. In the framework of research, involving
children and adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring
units), special attention will be given to consent and assent, particularly considering particular
aspects of research (time, iterations) to prevent any form of instrumentalization.
107. Member States should enact specific regulations that prohibit the use of marketing
techniques—such as neuromarketing, biometric emotional analytics, immersive advertising, and
virtual or augmented reality advertising—that rely on sensitive neural and cognitive biometric
data collected from children and adolescents. Recognizing the heightened vulnerability of
children and adolescents in digital environments, these regulations must explicitly forbid any
practices that use such data to influence or exploit children and adolescents.
IV.7. OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by funding
and implementing evidence-based programs that integrate neurotechnology into routine care.
These programs should involve the entire support ecosystem, including family, caregivers, and
medical teams, to enhance quality of life. Priority should be given to developing and implementing
tools that prevent, delay, and treat age-related health conditions, impairments, and
neurodegenerative diseases. Member States should ensure that access to these
neurotechnology programs is equitable and does not exacerbate socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making
for older personpeople using neurotechnology for sensorimotor and cognitive support. The Commented [J26]: 【Comments of Japan】
consent process should accommodate potential cognitive challenges faced by older adults, Ensuring consistency with the title (IV.7. OLDER
PERSONS)
ensuring that consent is informed, ongoing, and adaptable to changing health conditions. Policies
should be in place to ensure that assistive neurotechnology recognize changing cognitive
capacities over time and respect users’ preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such
as robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8. WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive policies that promote and
respect gender equality and diversity in the whole lifecycle of neurotechnology. The policies
should prioritize inclusive research for addressing women and gender specific needs and
differences, require targeted data collection and analysis, include education and training
programmes on inclusive research practices, ensure public and community engagement with
women and gender health experts and advocacy groups and, incentivise gender responsive
technology design, to meet the needs and conditions specific to women and gender minorities.
Affirmative action policies are necessary to close gender gaps in these fields, increase
representation, engagement and leadership.
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women and gender minorities, and safeguard against
373
harassment and discrimination. This should include robust mechanisms for reporting and
addressing incidents of harassment and discrimination, ensuring accountability and support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women’s and gender minorities’
participation in neurotechnology. This includes funding and other policies that prioritize ethical
and equitable research and innovation, but also affirmative action initiatives to support the
participation of women and gender minorities in neurotechnology through targeted education
programs, employment opportunities, entrepreneurship support, and leadership development
within the sector. Member States should also provide support systems such as mentorship
programs, networking opportunities, and resources to help women and gender minorities
overcome barriers to participation and succeed in the neurotechnology field.
IV.9. PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support
thereby contributing to achieving equal enjoyment of human rights. They should implement
regulatory frameworks that require accessibility assessments for all new neurotechnology
products to ensure these products do not perpetuate existing disabilities or health disparities.
These frameworks should include protocols for testing with diverse groups of persons with
disabilities to ensure technology meets a wide range of needs and does not unintentionally
exclude or disadvantage any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people persons with disabilities to promote their quality of life and functional Commented [J27]: 【Comments of Japan】
independence. These programs should include tax incentives for companies investing in Consistenty with the wording of the Convention on the
Rights of Persons with Disabilities.
assistive neurotechnology research and development, grants for research institutions focusing
on neurotechnology for disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living assistance, and innovation
prizes for breakthroughs in affordable, accessible neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential
neurotechnology devices, such as neuroprosthetics, for persons with physical disabilities. They
could encourage public-private partnerships to make advanced neurotechnology affordable and
integrate neurotechnology coverage into national health insurance and other reimbursement
schemes for persons with physical disabilities. A national database of available neurotechnology
resources and support services should be developed to facilitate access and information sharing.
IV.10. PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to
address the increasing prevalence and special needs of people persons with mental health Commented [J28]: 【Comments of Japan】
conditions, including victims and survivors of trauma and violence, and the relevance of Even though it is not talking about the persons with
disabilities, the term "persons" is appropriate as stated
neurotechnology for these communities. in the previous comment (people> persons.)
119. Member States should allocate funding for long-term advocacy and efficacy studies,
post-market oversight, and tiered scrutiny with special attention to invasiveness and reversibility
of neurotechnology interventions. It is important to ensure that people persons with mental health
conditions are well-informed and have reasonable expectations about the process. Commented [J29]: 【Comments of Japan】
See the comments of paragraph 118.
120. Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
374
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11. HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
123. Member States should build and maintain international solidarity to address global
health risks and uncertainties, and ensure that their implementation of healthcare for the nervous
system is consistent with international law and rigorous human rights obligations. This could Commented [J30]: 【Comments of Japan】
involve creating international forums for sharing best practices in the implementation of It seems there's no special reason for inserting the
word "rigorous."
neurotechnology in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and
mental health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results.
125. Member States should consider the significant cost and impact associated with
pathologies related to the nervous system, as well as the potential benefits of early diagnosis
and access to preventive and assistive neurotechnology. Public policies should prioritize the
promotion of access to these technologies and ensure health cost coverage for individuals in
need.
126. Member States should promote the development of reliable and durable
neurotechnology for healthcare applications. This includes encouraging the design of devices
and systems that require minimal maintenance, ensuring they remain functional and effective
under everyday conditions. Regulatory bodies or designated authorities should oversee the
enforcement of rigorous standards for quality, safety, and longevity, thereby reducing the burden
on users and enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States should ensure the development or strengthening of existing
comprehensive neurotechnology medical device reporting systems that track and address
adverse effects. In contexts where such systems do not exist, Member States should establish
them. Where systems are already in place, they should be updated to specifically include
neurotechnology. These systems should be interoperable and contribute to a centralised, public,
and transparent international database, managed in collaboration with international
organizations, to ensure that global standards are met and accessible for public knowledge,
international oversight and research.
IV.12. RESEARCH ETHICS
128. Member States should reinforce the ethical frameworks governing neurotechnology
research to ensure robust protection of human participants. Member States should bear in
375
mindadopt clear guidelines or policies that define the qualifications to ensure that research
should beis conducted by professionals with appropriate knowledge about the nervous system
structure and function in addition to brain disorders and is performed in adequate research
settings. Furthermore, research protocols, public or private, in the medical as well as the non- Commented [J31]: 【Comments of Japan】
medical domain, should be carefully evaluated by registered ethics boards (ethics committees) Given that neurotechnology research is being
conducted from various perspectives, it would be
and specific attention dedicated to individuals with special situations regarding vulnerability such difficult to formulate guidelines that stipulate the areas
as diminished capacity to consent or to make decisions. Member States should ensure that all of expertise of researchers. Thus perhaps it would be
research institutions have mandatory ethics training for researchers. better to delete the line and simply state that it should
be noted.
129. Member States should encourage multicentre international research that involves
various cultures and ethnic groups. Member States should promote international cooperation to
develop common reporting standards and protocols for interoperability, particularly for
implantable neurotechnology devices. This cooperation should aim to enhance the comparability
and utility of research globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered
in the design of a clinical trial, including policies to protect patients in case of cessation of
activities of the trial sponsor or promoter. Member States should establish requirements for
clinical trials to be included in relevant nationally or internationally approved registries, and
encourage registration with community and patient registries. Also, clinical trials should report on
appropriate medical device reporting systems developed within Member States. Commented [J32]: 【Comments of Japan】
It is our understanding that medical device reporting at
131. Technology developers should ensure that the validation of AI algorithms in the FDA means the reporting on the surveillance of
neurotechnology research include rigorous testing for biases, as well as measures to enhance medical devices after commercialization. It is unclear
from the wording why reporting is limited to medical
explainability and transparency, including the provenance of training datasets. Suitable devices and what aspects of clinical trials should be
techniques should be employed to mitigate any biases present in AI models used in reported on (adverse events in clinical trials of medical
neurotechnology applications. devices?). This should be clarified.
https://www.fda.gov/medical-devices/medical-device-
132. Member States should ensure that research efforts not only focus on biomedical risks safety/medical-device-reporting-mdr-how-report-
medical-device-problems
associated with neurotechnology but also investigate potential effects on an individual’s
subjective experience, agency and personal identity. Understanding how neurotechnology may
impact aspects of self-perception, consciousness, and identity is essential for addressing ethical
concerns and ensuring the well-being of individuals using these technologies.
133. Member States should ensure those engaged in research implement regular auditing
and monitoring of research practices to ensure adherence to ethical standards. This should
include evaluating the adequacy of informed consent, particularly concerning data reuse and the
potential commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings
to participants. These protocols should ensure that such findings are conveyed promptly,
respecting participants’ rights and autonomy. Additionally, Member States should mandate that
researchers provide the necessary support and coordination with healthcare providers to address
any health concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants’ right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
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SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13. EDUCATIONAL SETTINGS
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age-
appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology’s impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
137. Member States should adopt policies ensuring the voluntary deployment of
neurotechnology in education, grounded in fully informed consent. These policies must include
clear, age-appropriate information about the technology’s purpose, benefits, and risks, with
adequate consideration periods. Considering the increased complexity of obtaining voluntary
consent in this context, consent and assent procedures should involve children, adolescents,
parents, guardians and all actors necessary to obtain approval required for minors. Ethical
oversight mechanisms should be established, including regular consent renewal and immediate
cessation of neurotechnology use upon withdrawal, and ensure anonymous feedback channels.
Policies must prohibit undue incentives or academic penalties for non-participation and take
measures to avoid creating or reinforcing inequalities among students. Additionally, Member
States should support student involvement in decision-making about neurotechnology integration
and fund training programs on its ethical use, empowering educators and students to critically
assess its application.
138. Member States should establish a unified, robust oversight mechanism for
neurotechnology use in educational settings, incorporating regular audits, public and community
feedback, culturally appropriate and according to local conventions, and strict adherence to
safety and ethical standards, including an assessment of reversibility on the nervous system.
Continuous research should be funded to assess the long-term psychological and cognitive
impacts of these technologies. Oversight should involve periodic reviews based on empirical
evidence to adjust neurotechnology usage as needed, ensuring it serves student development
and addresses risks like dependency or de-skilling. This comprehensive approach will help
maintain the safety, effectiveness, and alignment of neurotechnology with best practices for
student well-being and learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations
throughout the neurotechnology whole lifecycle. This training should include ethical design,
human rights law, and societal impact assessment, preparing the next generation of
technologists to critically evaluate the implications of their work.
IV.14. LABOUR AND EMPLOYMENT
140. Member States should establish workplace policies and incentives that prioritize the
health and well-being of employees in the use of neurotechnology. These policies should ensure
that any deployment of neurotechnology is evidence-based, with a focus on applications that
have been scientifically validated to promote employee well-being, such as reducing stress or
enhancing workplace conditions (i.e., adaptive and responsive environments that adjust
377
workloads based on cognitive load). Deployment must be on a voluntary basis and employees
must have the option to opt out of using neurotechnology without facing any negative
consequences or discrimination. Under no circumstances should these technologies be used for
punitive measures, mental surveillance, or in ways that could compromise employee health.
141. Member States should require employers to clearly provide employees with
comprehensive information about how neurotechnology used in their workplace works, the
benefits it offers, transparency about what data are collected, how it is used, and who has access
to it, and clearly disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring
fatigue in commercial drivers or tracking attention in air traffic controllers). To respect employees’
mental privacy, employers should be prohibited from unauthorized access to neural and cognitive
biometric data that may be collected incidentally during routine workplace monitoring. Employers
should be prohibited from using neural and cognitive biometric data for any non-consented
purposes, particularly those that could negatively impact an employee’s job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation
and secure storage of neural and cognitive biometric data, ensure that data is stored securely,
with access limited to authorised personnel only, is deleted once its intended purpose has been
fulfilled. Additionally, upon an employee’s departure, all related records should be fully deleted
or individual data released to the employee, ensuring that no data is retained after the termination
of employment.
144. Member States should ensure that when employees are issued multifunctional devices
(i.e., earbuds or headphones that also include neural sensors) that can be used at work or at
home, employers should be prohibited from collecting neural and cognitive biometric data outside
of workplace settings and working hours and ensure that any data collected during work is used
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right of employees to obtain
a copy of any neural and cognitive biometric data collected about them, along with any
interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise create.
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and
not for enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should
develop stringent regulations against using neural and cognitive biometric data for profiling in the
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive
biometric data to discriminate against candidates, particularly neurodiverse individuals, ensuring
hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or
maintaining employment, to limit such use where such neural and cognitive biometric data are
directly relevant to the specific requirements of the job.
IV.15. CONSUMER AND COMMERCIAL DOMAINS
378
149. Member States should proactively establish a regulatory framework that balances
innovation in the recreational and commercial domains with protecting individual rights and well-
being. This framework should be dynamic, allowing for timely updates as technology evolves and
new insights are gained about its impacts on society. This includes providing adequate oversight
to ensure that neurotechnology does not cause harm, are used consensually, and include robust
mechanisms to protect users from potential psychological distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include
clear labelling on commercial neurotechnology products, detailing their effects, limitations, and
risks to prevent misleading claims and ensure transparency. This also includes prohibiting
practices of “tying” or requiring the disclosure of neural and cognitive biometric data as a
condition to access goods or services, and prohibition about third party data sharing or the uses
of this data without affirmative opt-in option.
151. Member States should foster an environment that ensures all claims about consumer,
non-medical technologies are supported by robust scientific evidence. They should, by
regulation, require that any products claiming to treat, prevent, or diagnose diseases or medical
conditions be validated through rigorous safety and efficacy testing, including clinical trials where
necessary, and be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and
transparent across all neurotechnological interventions, ensuring that participation is fully
voluntary and respects the privacy and autonomy of individuals. This principle should apply
uniformly in various domains such as sports, arts, where robust standards should safeguard
against coercive use and respect athletes’ and artists’ individual autonomy, community interests,
and IP rights.
153. Member States should steer the use and development of neurotechnology in the arts
toward ensuring the enhanced learning and cultural appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of
consumer technology, especially neurogaming and other devices that exploit the dopamine
reward system or seek to induce problematic and unhealthy use and overconsumption. Such
regulations should mandate clear labeling of risks, disclosures on their effects on the nervous
system, enforce game design standards and safety, privacy and age-appropriate design
standards that prevent taking advantage of a person’s physical, mental and emotional
vulnerability to lead to compulsive use or addiction of gaming or digital recreational platforms
combined with neurotechnology, to promote healthy, balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that ‘opt-out’ features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding self-
determination, consent, privacy, and the potential for manipulation raised by neurotechnology
that arise in the contexts of recommender systems, priming and nudging, marketing during sleep
and dream, neuromarketing, and closed-loop environments by adopting comprehensive policies
and regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive
biometric data in recommender systems for manipulative or deceptive purposes,
379
including in political context. These regulations should require that any use of such
data within these systems be based on explicit, informed opt-in consent from
users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging—
subtly influencing individuals’ decisions or behaviours, often without their explicit
awareness. This is particularly critical in sensitive areas such as political
messaging, commercial advertisement, and healthcare. These frameworks should
require explicit, informed consent for any use of such data to influence decisions
or behaviour, the right to opt out of these systems, and transparency and clear
disclosures at the point of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that
influences or manipulates individuals during sleep, such as marketing during sleep
and dream. Regulations should strictly prohibit commercial, marketing, or political
applications that target individuals during sleep, using neurotechnology or neural
and cognitive biometric data. Additionally, robust oversight mechanisms should
be required to ensure that any research or application of such technologies
prioritizes the well-being, privacy, and autonomy of individuals, with particular
attention to the potential long-term psychological and cognitive impacts of
manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in
neuromarketing, including by requiring comprehensive disclosures to ensure that
all neuromarketing activities are conducted transparently, with participants’ explicit
informed consent. This includes ensuring that participants in neuromarketing
research or campaigns are fully aware of methods, risks, and intentions and
affirmatively opt-in to participation. The use, storage, and potential reuse of the
collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and
use of closed-loop environments—such as immersive computing devices that
adjust experiences based on detected neural and cognitive biometric data. These
policies should require clear and accessible disclosure about how neural and
cognitive biometric data are used in these environments, prohibit real-time
behavioral modification or manipulation without explicit, informed consent, and
implement safeguards specifically designed to prevent abuses such as
unauthorized surveillance, manipulative interventions, and practices that could
influence voting behavior, political opinions, or exploit psychological and
emotional vulnerabilities in real-time.
IV.16. ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human
mental performance outside of the medical context introduces complex ethical, social, and legal
challenges, which can create new kinds of disparities in the global world. When neurotechnology
is used in these contexts, it raises crucial questions about equity, consent, individual and
community autonomy, and the nature of enhancement of the nervous system itself. Member
States should ensure that any policies, law and regulatory frameworks that govern the use of
neurotechnology in these contexts do not exacerbate social inequalities or lead to discrimination,
address the potential risks (including to reversibility, invasiveness, and risks to self-
380
determination) and fully comply withrespect human rights and human dignity. Commented [J33]: 【Comments of Japan】
It's appropriate to use the term "respect" here for
V. IMPLEMENTATION human rights and human dignity. "Complied with"
should be used with the terms such as "obligations"
and "law."
158. Member States and all other actors as identified in this Recommendation should
respect, promote and protect the ethical values, principles and standards related to this
Recommendation, and should take all feasible steps to give effect to its implementation.
159. Member States shouldshall, according to their specific contexts, governing structures Commented [J34]: 【Comments of Japan】
and constitutional provisions, credibly and transparently advance the ethics of neurotechnology, "Shall" should be "should" or deleted for this
Recommendation is not legally binding.
in line with the UNESCO Recommendation. Member States should shall monitor and evaluate
policies, programmes and mechanisms related to neurotechnology and its ethics. Progress Commented [J35]: 【Comments of Japan】
See the above comment.
monitoring could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance
with national and international standards, and ensuring that data and insights from different
regulatory domains are shared effectively to inform decision-making and policy development.
These bodies should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions in respect of
this Recommendation, by cooperating with all relevant national and international governmental
and non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector’s interests and therefore
UNESCO needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions, where it exists, as well as with
UNESCO ethics advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shouldshall contribute by developing a full-fledged program with the following Commented [J36]: 【Comments of Japan】
elements: "Shall" should be "should" or deleted for this
Recommendation is not legally binding.
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States
in identifying their status at specific moments of their readiness trajectory along
a continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of
neurotechnology based on rigorous scientific research and grounded in
international human rights law, along with specific guidance for its implementation
in the whole neurotechnology lifecycle, and capacity-building tools and materials
to support Member States’ efforts to train government officials, policy-makers and
other relevant actors on the methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and
381
the efficiency of the policies for the ethics of neurotechnology and incentives
against defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in
a UNESCO observatory, to become a shared pool of knowledge and awareness
of good practices and innovations available to all Member States and actors, in
the form of research reports, data, and statistics regarding policies for ethics of
neurotechnology. The research program should take into consideration the
converging developments of neurotechnology with other technologies such as
artificial intelligence and quantum technology, work to be conducted in
collaboration with other relevant UNESCO initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global
policy dialogue, including at Ministerial level in the context of a Global Forum on
the ethics of Emerging Technologies. Supporting this effort, UNESCO
shouldshall establish a network of experts, with balanced representation of all Commented [J37]: 【Comments of Japan】
UNESCO’s regional groups, on the neurotechnology. "Shall" should be "should" or deleted for this
Recommendation is not legally binding.
165. Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, under-represented, vulnerable people or people in vulnerable
situations and ensuring social, cultural and gender diversity. The monitoring and assessment of
the impact of neurotechnology and related ethics policies and practices should be carried out
continuously in a systematic way proportionate to the relevant risks. For example, invasive/non-
invasive technologies have different risks and benefits. This should be based on internationally Commented [J38]: 【Comments of Japan】
agreed frameworks and involve evaluations of private and public institutions. Data collection and “Invasive technologies” and “non-invasive
technologies” are grouped together within a single
processing should be conducted in lineaccordance with international law, national legislation on framework of ethical guidelines for neurotechnology,
data protection and data privacy, and the values and principles outlined in this Recommendation. but they should be considered separately. Specifically,
the balance between risks and benefits is important
when considering ethical guidelines, and this phrase
VI. FINAL MATTERSPROVISIONS was added to underline that.
166. This Recommendation needs to be understood as a whole, and the foundational values Commented [J39]: 【Comments of Japan】
and principles are to be understood as complementary and interrelated. "agree" should be "consented" or "concurred", or
"internationally agreed frameworks" should be
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise "international frameworks", for there is no legally-
binding frameworks of this field.
prejudicing Member States’ obligations or rights under international law, or as approval for any
Commented [J40]: 【Comments of Japan】
State, other political, economic or social actor, group or person to engage in any activity or "accordance" should be "line", for international
perform any act contrary to human rights, fundamental freedoms, human dignity and concern for standards is not necessarily legally binding.
the environment and ecosystems. Commented [J41]: 【Comments of Japan】
"PROVISIONS" should be "MATTERS," for this
Recommendation is not legally binding.
382
JORDAN/JORDANIE
383
384
385
386
LITHUANIA/LITUANIE
RECOMMENDATION ON THE ETHICS OF NEUROTECHNOLOGY
(first draft)
Comments and recommendations
on behalf of the
Research Council of Lithuania
No. Reference to the point Comment
1 2 3
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
1 73. Member States, private actors and international institutions 1. Mentioned ethical, legal, social, environmental, cultural implications and
should actively support the research, development, and neurotechnology often operate with different methodologies which makes
deployment of neurotechnology for the public good. Investments the proposed model of interdisciplinary research very complex and difficult
should prioritize applications that foster human flourishing, and to put into practice. We suggest changing the wording to make it clear that
the use of which respects, promotes and protects individual and the research does not have to cover all the implications mentioned.
collective human rights. This commitment should include 2. The mentioned commitment should include funding longitudinal research
funding for interdisciplinary research that not only advances on the impact of neurotechnology on people using it.
neurotechnological innovation but also studies the ethical, legal, 3. Not only safeguards, but also oversight mechanisms for the developed and
social, environmental and cultural implications of these implemented safeguards are needed.
technologies, and supports the implementation and clinical
translation of technological prototypes. Particular attention
should be given to the development and implementation of
adequate technical, institutional, procedural and other safeguards
to ensure that they equitably benefit society and that human
rights are upheld.
2 75. Member States should ensure transparency and 1. It should be clearly stated that only complete, clear and non-complex
accountability in their support, oversight, and regulation of information can be publicly disclosed, avoiding public misunderstanding,
neurotechnology, particularly in publicly funded initiatives such fear, or opposition based on incomplete or misinterpreted data.
as brain research and development programs. While recognizing
the limitations in disclosing certain sensitive information,
387
governments should require government sponsored 2. The phrase “whenever possible” weakens this recommendation. We
neurotechnology projects to publicly disclose the objectives, suggest rephrasing it “as soon as this information is suitable for public
methodologies, intended uses, and societal impacts of their disclosure”.
neurotechnology initiatives whenever possible. This
transparency is crucial for fostering public trust and ensuring that
neurotechnology advances are aligned with ethical standards and
human rights.
3 76. Member States should apply a comprehensive approach to 1. Neurotechnology research protocols like any other clinical research
regulatory and policy measures to protect against human rights protocols are supposed to be reviewed by national research ethics
harms related to neurotechnology developed, marketed, operated committees and other responsible authorities before the beginning of
or used by the private sector. This includes legislative and research-related actions to reduce the likelihood of human rights violations.
regulatory measures and accompanying guidance, incentives, 2. The private sector’s drive for profit often conflicts with public interests
and transparency requirements. This comprehensive approach and a more critical approach should be suggested to ensure stronger
should also require human rights due diligence, ensuring that oversight, including independent audits and penalties for non-compliance.
businesses identify, prevent, mitigate, and account for their
adverse human rights impacts through context-dependent
processes, including human rights impact assessments,
meaningful public and community engagement, and transparent
communications.
4 78. Member States should establish comprehensive incentive 1. This recommendation could prove to be a logistical, bureaucratic and
structures, such as tax incentives, grants, and awards, with a financial challenge for Member States. Moreover, incentive and awarding
particular focus on encouraging the construction and programs can sometimes be gamed by institutions and companies that simply
development of manufacturing, computational resources, and fulfill the minimum requirements to secure rewards without genuinely
data analytics capabilities within public research institutions and embracing the spirit of responsible innovation.
small and medium enterprises (SMEs). Member States should 2. Specific criteria to assess whether an institution or a company is truly
also incentivize and support partnerships that leverage the transparent, or whether its development process is sufficiently participatory
computational resources and data analytics capabilities of private should be set and there would likely need to be independent oversight bodies
firms to advance public research goals. These incentives should to evaluate whether companies and institutions are meeting these standards.
prioritize rewarding transparency, participatory development
processes, and contributions to societal benefits, aiming to foster
an environment where public institutions and companies
innovate responsibly and align with human flourishing goals.
5 80. Member States should promote equitable access to 1. Governments and international bodies could subsidize the cost of
neurotechnology worldwide. To achieve such goals, efforts neurotechnology, but this might be difficult to sustain in the long term
388
should be made to support the reduction of final costs for end- without private sector involvement. Moreover, in some countries,
users, pursue the development, adoption and continuous support neurotechnology may be classified as experimental or high-risk, limiting
of non-proprietary software solutions, and explore reimbursement eligibility, while in others, it may be qualified as standard
reimbursement strategies or subsidization commensurate with treatment and covered fully by health insurance.
conventions in local jurisdictions, in sectors of crucial potential 2. Measures to identify the risk of overuse or inappropriate use of
benefits. neurotechnology should be taken (individuals may be interested in using
neurotechnology only because it’s subsidized or covered by insurance).
6 81. Member States should adopt agile regulatory frameworks, 1. We suggest clarifying that while agility is needed the core principles that
including the use of regulatory sandboxes – controlled protect individuals from potentially harmful or invasive technologies (human
environments for developing, testing, and evaluating rights protection, safety, fairness, etc.) must remain stable.
neurotechnology – in response to rapid advancements in 2. Clear oversight mechanisms for suggested regulatory sandboxes should be
neurotechnology and its convergence with other technologies set for them not to become a loophole for companies to bypass full
such as AI, spatial computing, and immersive technologies. regulatory scrutiny or testing. Moreover, it should be highlighted that
These sandboxes should be used to explore innovative regulatory sandboxes may not accurately reflect the real-world complexities
applications, particularly in workplace settings, with appropriate of deploying and using neurotechnology.
ethical oversight provided by regulatory bodies or national
authorities. These frameworks should facilitate innovation,
ensure ethical data processing, and safeguard rights by
incorporating mechanisms for regular monitoring, evaluation,
and dynamic policy adjustments in line with technological and
ethical developments.
IV.5 COMMUNICATION, PARTICIPATION, AND INFORMATION
7 97. Member States should promote communication and develop 1. It should be mentioned that while adjusting scientific concepts or
engagement policies for neurotechnology that foster informed, terminology of neurotechnology for the diverse users and the broader public
inclusive, and respectful dialogue between researchers, it is important to highlight the risk of misrepresentation or omission of key
developers, diverse users, and the broader public to respect nuances (health risks, certain ethical concerns, possible inconveniences,
individual and community rights, promote public trust, and etc.). This is especially important for mentally disabled or older people, who
harness the collective intelligence and diversity of communities. most likely to be neurotechnology users.
2. This dialogue should not be limited to early-stage discussions but should
also include long-term monitoring of the social, psychological, and ethical
impacts of neurotechnology.
389
8 98. Member States should collaborate with international To make informed decisions about the use of neurotechnology, a list of
organizations, educational institutions, and private and non- aspects related to possible risks of neurotechnology should be set (risks of
governmental entities to develop and disseminate accessible and harm to health, possible inconveniences, the risks of handling health
engaging educational materials tailored to diverse audiences to information, etc.). All the listed aspects should be described in detail in
bridge knowledge gaps, particularly in underserved regions educational materials mentioned in this recommendation.
about the nervous system and mental health functioning, as well
as the benefits and risks of neurotechnology. These programs
should aim to increase public understanding of the technologies’
functionality, safety, efficacy, and societal impact, empowering
individuals to make informed decisions and to enable their
ethical reflection about their use of neurotechnology.
9 105. Member States should fund research and development 1. Clear criteria for neurotechnology research and development to be funded
grants focused on creating user-friendly assistive should be set out in this recommendation (scientific evidence, efficiency,
neurotechnology tailored for children and adolescents with etc.).
disabilities. These projects should involve children, adolescents, 2. Neurotechnology should be affordable and accessible to families with
parents and caregivers in the design process to ensure the children or adolescents with disabilities despite their financial situation, so
technologies meet their specific needs. Educational programs subsidization programs, public-private partnerships, and reimbursement
should be developed to teach children and adolescents and their schemes to be included to this recommendation.
caregivers how to effectively use and maintain these 3. It should be clearly stated that children, adolescents, parents and
technologies, with support available in multiple languages and caregivers should be included in the design process of neurotechnology only
accessible without discriminating against those who either with informed and voluntary consent or assent. Children, adolescents,
cannot or choose not to engage with the proposed technology. parents and caregivers must be informed that neurotechnology involves the
collection and processing of highly sensitive data, including neural data that
reflects a child's cognitive and emotional states and that they have a
possibility to withdraw whenever they want without explaining the reasons.
IV.7 OLDER PERSONS
10 108. Member States should promote healthy aging and support 1. Training programs and education campaigns for elderly users, as well as
elderly individuals by funding and implementing evidence-based their families, caregivers and medical teams to ensure smooth adoption of
programs that integrate neurotechnology into routine care. These new tools should be also included into this recommendation.
programs should involve the entire support ecosystem, including 2. The recommendation should emphasize that priority should be given not
family, caregivers, and medical teams, to enhance quality of life. only preventing age-related conditions, but also protection of the data and
Priority should be given to developing and implementing tools
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that prevent, delay, and treat age-related health conditions, safety of the elderly using neurotechnology, moreover obtaining voluntary
impairments, and neurodegenerative diseases. Member States and informed consent for data collection, data sharing, health impacts, etc.
should ensure that access to these neurotechnology programs is
equitable and does not exacerbate socioeconomic inequalities.
IV.9 PERSONS WITH PHYSICAL DISABILITIES
11 116. Member States should create incentive programs to promote 1. The importance of meeting rigorous safety standards and effectiveness of
the development of neurotechnology for people with disabilities neurotechnology rather than rapid validation should be emphasized in this
to promote their quality of life and functional independence. recommendation (Quality before Quantity principal).
These programs should include tax incentives for companies 2. Clear ethical guidelines should be incorporated into the suggested
investing in assistive neurotechnology research and incentive programs to ensure that any neurotechnology developed adheres to
development, grants for research institutions focusing on strong ethical principles related to privacy, informed consent, data protection,
neurotechnology for disability support, expedited regulatory etc.
reviews for technologies offering significant advancements in
mobility, communication, or daily living assistance, and
innovation prizes for breakthroughs in affordable, accessible
neurotechnology solutions.
IV.10 PERSONS WITH MENTAL HEALTH CONDITIONS
12 120. Member States should prioritize funding for 1. Prioritized funding should also be allocated to support measures to ensure
neurotechnology that is designed to improve quality of life and equitable access of neurotechnology to all persons with mental health
daily functioning of individuals with mental health conditions. conditions.
This includes the technologies that assist in managing symptoms, 2. Longitudinal studies should be conducted to evaluate whether used
improving cognitive functions, and providing emotional support neurotechnology provide lasting benefits and whether there are any negative
at home, in the workplace, in their communities, and in society. side effects or unintended consequences over time.
Research and development should be guided by feedback and
engagement with persons with mental health conditions and their
advocates.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
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13 122. Member States should support the development of health The suggested funding should also cover strategies to make developed
applications that prioritize the unmet needs in the provision of neurotechnology tools available and affordable to the people that need them.
neurological and mental health. This could include establishing Overwise the identified gaps will not be addressed.
research funding programs specifically targeted at addressing
identified gaps in nervous system care.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.15 CONSUMER AND COMMERCIAL DOMAINS
14 Entire chapter The "Consumer and Commercial Domains" chapter is of critical importance;
however, it appears to serve as a catch-all category, encompassing topics that
do not neatly fit into other chapters of the recommendation. This broad scope
risks diluting the focus on key areas that require deeper analysis and dedicated
attention.
15 153. Member States should steer the use and development of This recommendation urging Member States to guide the use and development
neurotechnology in the arts toward ensuring the enhanced of neurotechnology in the arts is of profound importance. However, the unique
learning and cultural appreciation without compromising ethical, societal, and cultural implications of neurotechnology in artistic
individual autonomy or leading to cultural homogenization. contexts are too complex to be adequately addressed within one specific
measure. In our considered opinion, by dedicating a separate chapter to
neurotechnology in the arts, the recommendation would provide the depth and
clarity needed to address the complex interplay of aspects mentioned in the
text.
16 156. Member States should address the profound ethical The ethical challenges raised by neurotechnology (from fundamental human
questions regarding self-determination, consent, privacy, and the rights issues to the risk of manipulation) in contexts listed in this
potential for manipulation raised by neurotechnology that arise recommendation (politics, marketing, healthcare, etc.) are both profound and
in the contexts of recommender systems, priming and nudging, diverse, therefore, demand careful and thorough consideration.
marketing during sleep and dream, neuromarketing, and closed- To adequately address these critical issues, it is essential to dedicate at least
loop environments by adopting comprehensive policies and one separate chapter providing Member States with the detailed
regulations that: recommendations for measures necessary to navigate the ethical complexities
(a) Recommender systems: explicitly prohibit the use of neural of neurotechnological innovation in the contexts mentioned, giving utmost
and cognitive biometric data in recommender systems for priority to politics.
manipulative or deceptive purposes, including in political
context. These regulations should require that any use of such
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data within these systems be based on explicit, informed opt-in
consent from users.
(b) Nudging: govern the use of neural and cognitive biometric
data for nudging – subtly influencing individuals’ decisions or
behaviours, often without their explicit awareness. This is
particularly critical in sensitive areas such as political messaging,
commercial advertisement, and healthcare. These frameworks
should require explicit, informed consent for any use of such
data to influence decisions or behaviour, the right to opt out of
these systems, and transparency and clear disclosures at the point
of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of
neurotechnology that influences or manipulates individuals
during sleep, using neurotechnology or neural and cognitive
biometric data. Additionally, robust oversite mechanisms should
be required to ensure that any research or application of such
technologies prioritizes the well-being, privacy, and autonomy of
individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep
states.
(d) Neuromarketing: safeguard against unethical aims and
practices in neuromarketing, including by requiring
comprehensive disclosures to ensure that all neuromarketing
activities and conducted transparently, with participants’ explicit
informed consent. This includes ensuring that participants in
neuromarketing research or campaigns are fully aware of
methods, risks, and intentions and affirmatively opt-in to
participation. The use, storage and potential reuse of the
collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory
guidelines on the design and use of closed-loop environments –
such as immersive computing devices that adjust experiences
based on detected neural and cognitive biometric data. These
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policies should require clear and accessible disclosure about how
neural and cognitive biometric data are used in these
environments, prohibit real-time behavioural modification or
manipulation without explicit, informed consent, and implement
safeguards specifically designed to prevent abuses such as
unauthorized surveillance, manipulative interventions, and
practices that could influence voting behaviour, political
opinions, or exploit psychological and emotional vulnerabilities
in real-time.
IV.16 ENHANCEMENT
17 157. The use of neurotechnology to improve memory, attention The issue of inequality discussed in this recommendation is highly
or other aspects of human mental performance outside of the significant and requires particular attention. Therefore, in our considered
medical context introduces complex ethical, social and legal opinion separate chapter containing more than one action measure should be
challenges, which can create new kinds of disparities in the dedicated to this matter. However, the title of the chapter “Enhancement” is
global world. When neurotechnology is used in these contexts, it not appropriate as it does not reflect the core issue of exacerbation of social
raises crucial questions about equity, consent, individual and and economic inequalities worldwide. Hence, from our standpoint it would
community autonomy, and the nature of enhancement of the be more suitable to change the title of the chapter to something that explicitly
nervous system itself. Member States should ensure that any highlights the key challenge, such as “Social Inequality and the Use of
policies, law and regulatory frameworks that govern the use of Neurotechnology” or something similar.
neurotechnology in these contexts do not exacerbate social
inequalities of lead to discrimination, address the potential risks
(including the reversibility invasiveness, and risks to self-
determination) and fully comply with human rights and dignity.
GENERAL COMMENTS
18 Entire text In order to ensure a comprehensive and ethical approach to the development
and application of neurotechnology, it is crucial to include social and human
sciences as a standalone chapter or at least as a separate point in the chapter
“IV.5 Communication, Participation and Information“. It should emphasize
394
the importance of these disciplines in the above-mentioned context and stress
that the ethical, social, legal, and even psychological implications of rapidly
advancing neurotechnology must be thoroughly addressed.
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Elektroninio dokumento nuorašas
OFFICE OF THE OMBUDSPERSON
FOR ACADEMIC ETHICS AND PROCEDURES
OF THE REPUBLIC OF LITHUANIA
Budget office, Švitrigailos st. 7, 03110 Vilnius, tel. 8 694 43992, email: [email protected], https://etikostarnyba.lt
Code in the Register of Legal Entities 303118754
________________________________________________________________________________________________________________________
Assistant Director-General 2024-12- Nr. S-
for the Social and Human Sciences Sector
Gabriela Ramos
[email protected]
Cc. Ministry of Education Science and Sport
of the Republic of Lithuania
[email protected]
COMMENTS AND OBSERVATIONS ON THE FIRST DRAFT OF THE RECOMMEN-
DATION ON THE ETHICS OF NEUROTECHNOLOGY
Office of the Ombudsperson for Academic ethics and Procedures of the Republic of
Lithuania sending you comments and observations on the first draft of the Recommendation on the
Ethics of Neurotechnology (hereinafter referred to as Recommendation).
It is noteworthy that comments and observations on Recommendation were made by
working gruop consisting of the specialists of various fields, such as neurotechnology, law and
health research. The group was concluded by the order 13 November 2024 No. V-40 of the
Ombudsperson for Academic ethics and Procedures of the Republic of Lithuania.
All the comments and observations are made in the text of the Recommendation.
Enclosure. First draft of the Recommendation on the Ethics of Neurotechnology with comments and
observations.
Ombundsperson for Academic Ethics and Procedures Reda Cimmperman
of the Republic of Lithuania
Tadas Sobenka
396
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
PREAMBLE
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health
conditions, along with the profound suffering they cause for individuals and societies
worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver
better preventive and therapeutic treatments for millions, benefiting humanity as a whole and
providing opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
self-determination, privacy, personal identity, freedom of thought, risk of discrimination,
inequality and challenges to democracy, and that justice, trust and fairness must be upheld so
that no country and no one should be left behind, either by having fair access to
neurotechnology and enjoying their benefits or in the protection against their risks, while
recognizing the different circumstances of different countries and respecting the desire of some
people not to take part in all technological developments,
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and
security by promoting collaboration among nations through education, the sciences, culture,
and communication and information, in order to further universal respect for justice, for the rule
of law and for the human rights and fundamental freedoms which are affirmed for the peoples
of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument
developed through a global approach, based on international law, focusing on human dignity
and human rights, as well as gender equality, social and global justice and development,
physical and mental wellbeing and health, diversity, interconnectedness, global solidarity,
fairness, non-discrimination, inclusiveness, and environmental and ecosystem protection, can
guide neurotechnology in a responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries
(LMlCs), including but not limited to least developed countries (LDCs), landlocked developing
countries (LLDCs) and small island developing States (SIDS), as they have their capacity but
have been underrepresented in the development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology
and enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development
and policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCQ at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General "to prepare a standard-
setting instrument on the ethics of neurotechnology in the form of a recommendation", which is
to be submitted to the General Conference at its 43rd session in 2025,
397
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of
Refugees (1951), the Discrimination (Employment and Occupation) Convention (1958), the
International Convention on the Elimination of All Forms of Racial Discrimination (1965), the
International Covenant on Civil and Political Rights (1 966), the International Covenant on
Economic, Social and Cultural Rights (1966)) the Convention on the Elimination of All Forms
of Discrimination against Women (1 979), the Convention on the Rights of the Child (1 989),
and the Convention on the Rights of Persons with Disabilities (2006), the Convention against
Discrimination in Education (1960), the Convention on the Protection and Promotion of the
Diversity of Cultural Expressions (2005), as well as any other relevant international
instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the
Declaration on the Responsibilities of the Present Generations Towards Future Generations
(1997); the Universal Declaration on Bioethics and Human Rights (2005); the United Nations
Declaration on the Rights of Indigenous Peoples (2007); the Declaration of Ethical Principles in
relation to Climate Change (201 7); the Recommendation on Science and Scientific Researchers
(2017); the Recommendation on the Ethics of Artificial Intelligence (2021); the
Recommendation on Open Science (2021); the Human Rights Council's resolution on "The
right to privacy in the digital age" (A/HRC/RES/42/15) (201 9); the Human Rights Council's
resolution on "New and emerging digital technologies and human rights" (A/HRC/RES/41/11)
(2019), and the UN Guiding Principles on Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes
ethical questions related to Al-powered systems for neurotechnology and brain-computer
interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and
initiatives elaborated by relevant United Nations entities, intergovernmental organizations such
as OECD, including regional organizations, as well as those by the private sector, professional
organizations, non-governmental organizations, and the scientific community, related to the
ethics and regulation of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this
XXX day of November 2025.
2. Recommends that Member States, with the support of UNESCO's Secretariat,
apply the provisions of this Recommendation by taking appropriate steps,
including whatever legislative or other measures may be required, in conformity
with the constitutional practice and governing structures of each State, to give
effect within their jurisdictions to the principles and norms of the
Recommendation in conformity with international law, including international
human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play
their respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities
and bodies, research and academic organizations, institutions and organizations in
public, private and civil society sectors involved in neurotechnology, so that the
development and use of neurotechnology are guided by both sound scientific
research as well as ethical analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
I.1 SCOPE
This Recommendation:
398
1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing and on the enjoyment of human rights.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (DTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to animals
in research.
4. Approaches neurotechnology ethics as a systematic normative reflection based on a
holistic, multicultural, multidisciplinary, pluralistic and evolving framework of
interdependent values, principles, and actions that can guide societies in dealing responsibly
with the impacts of neurotechnology on human beings, societies, and the environment and
ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the
prevention of harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from
neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology and other disciplines.
5. Covers the measurement, recording, and modification of the human nervous system, the
handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because the
highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to
be responsible for actions, cooperate with others, deliberate about collective decisions and
develop personality.
7. Further recognizes that humans develop and flourish in their interaction with other human
beings and a nurturing material and cultural environment, highlighting that autonomy is not
just individual but also relational) as it arises from and impacts one's interactions and
belonging with the community.
8. Addresses the ethical and human rights concerns that arise from the rapid developments
and the convergence of neurotechnology with other technologies such as spatial computing,
extended reality (XR), artificial intelligence (AI), sensors and semi-conductors. Notably,
other biometric data when processed to infer sensory, motor, and mental states raises similar
ethical concerns. Thereforey this Recommendation applies to both neurotechnology and the
use of cognitive biometric data, ensuring that ethical principles and practices are consistently
applied across these domains.
9. Further addresses the integration of AI with neurotechnology, which can enhance
precision and predictive capabilities, such as improving processing speed, reducing cost,
optimizing neurotechnology systems. However, it also magnifies ethical threats, including
cybersecurity concerns, lack of transparency, the potential for algorithmic bias, and risks to
autonomy, mental privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications
of neurotechnology. Calls on all concerned to act responsibly with regard to
neurotechnology.
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I.2 DEFINITIONS
11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates
that nervous system activity is the basis of sensory, motor, and mental states (which include
cognitive, affective, and conative states), and supports consciousness, sleep and the
experience of pain. The nervous system activity and structure provide information inherent to
all human beings and the community, regardless of gender, ethnicity, language, or religion.
The nervous system activity is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures
encompassing both hardware and software that directly access, monitor, analyze, predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure,
activity, function, or intentions (speech, motor). Neurotechnology combines elements of
neuroscience, engineering, and computing, among others.
13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction
with the nervous system or by interfacing it with devices and systems. It includes but is not
limited to:
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical,
optical, magnetic and/or mechanical), chemical and biological signals associated
with the structure of and functional signals from the nervous system. These may
be used to identify, record, and/or monitor properties of nervous system activity,
understand how the nervous system works, diagnose pathological conditions, or
control external devices (brain-machine interfaces (BMI), often referred to as
brain-computer interfaces (BCI)). Of note, both open-loop (i.e., fixed-parameter
brain stimulation) and closed-loop systems (i.e., state dependent stimulation)
introduce complex ethical issues.
(i) Examples include but are not limited to Electroencephalography (EEG),
Magnetoencephalography (MEG), Magnetic resonance imaging (MRI),
Functional Magnetic resonance imaging (fMRI), Positron emission
tomography (PET), Functional Near-infrared spectroscopy (fNIRS),
Implanted microelectrodes, Optogenetics, Optical imaging, Diffusion
weighted imaging, Calcium imaging, Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for
example, to restore sensory input, such as hearing (i.e., cochlear implants) or
Deep Brain Stimulation (DBS) to treat tremors and other pathological conditions.
They are meant to either modulate the functions of the nervous system and/or
send signals directly to the nervous system by applying acoustic, electrical,
magnetic or optical stimulation and/or inhibition of the peripheral or central
nervous system.
(i) Examples of this neurotechnology are implanted microelectrodes, BMI,
DBS, Optogenetic optical stimulation, Transcranial electrical stimulation
(tES), Transcranial Magnetic Stimulation (TMS) or Neuropharmacological
infusion.
14. Of note, several sensor technologies collect data indirectly informing about neural
activity. Even if they are not neurotechnology per se, they raise similar ethical and human
rights issues as neurotechnology when used to infer mental states. They include but are not
limited to eye-tracking, Video Oculography, Typing dynamics, Voice recognition and
analysis, Gait analysis, Skin conductance, Heart rate variability, Sleep movement
monitoring, Blood pressure measurement, or facial- emotion recognition systems.
400
15. Neural data. Neural data are qualitative and quantitative data about the structure,
activity and function of the nervous system. They encompass data relating to a nervous
system's activity, including both direct measurements of neuronal structure, activity and/or
function (i.e., neuronal firing or averaged bioelectric signals from EEG) and indirect
functional indicators (i.e., blood flow in fMRl and fNlRS). At the neurobiological level,
neural data are the most direct correlates of mental states.
16. Cognitive biometric Data. Neural data, along with data collected by non-neural
biometric technologies can be processed to infer mental states, which this
Recommendation refers to as “cognitive biometric data”.
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining
for materials, prototyping, research, design and development to deployment and use,
including maintenance, operation, trade, financing, monitoring and evaluation, validation,
end-of-use, disassembly, termination, disposal and recycling. The whole lifecycle of
neurotechnology includes its convergence with other technologies and the diversity of actors
who are involved in every stage.
II. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the development and use
of neurotechnology in ways that are ethical, safe and effective for the good of humanity,
individuals, communities, societies, the environment and ecosystems, and to prevent harm in
the present and the future based on international law, in particular the Charter of the United
Nations and international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity and equality, including gender equality, and to respect
cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities,
institutions, private sector companies and every other relevant actor to ensure the
embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable
and reproducible;
(d) to provide a universal framework that not only articulates values and principles,
but also translates into concrete policy recommendations and effective
implementation to guide Member States in their engagement with
neurotechnology in its whole lifecycle, consistent with their obligations under
international human rights law and other international standards;
to foster multi-stakeholder) multidisciplinary and pluralistic dialogue and consensus
building about ethical issues relating to neurotechnology;
(f) to promote justice and equitable access to developments and knowledge in the field
of neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.
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III. VALUES AND PRINCIPLES
III.1 VALUES
III.1.1 Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
20. The inviolable and inherent dignity of every human being is the foundation of universal
human rights and fundamental freedoms. Respect, protection, and promotion of human
dignity, as established by international human rights law, are essential in the whole lifecycle
of neurotechnology. Dignity encompasses the recognition of the intrinsic and equal worth of
each person. Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including people living
in vulnerable situations.
III.1.2 Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical,
mental, and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the
largest number of people and those who stand to gain the most, rather than consumer-driven
or commercial applications.
III.1.3 Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of
neurotechnology. Special consideration should be given to neurodiversity, minority groups,
Indigenous Peoples, and underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban
wellresourced sector, specific attention to underserved and marginalised people is crucial to
prevent bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological
assimilation, or using technology as a tool of colonisation (a term the Recommendation
refers to as "technological colonialism"), can threaten cultural diversity and heritage,
therefore must be protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its
benefits are accessible to all, regardless of socioeconomic status or geographical location.
Special attention must be given to low- and middle-income countries resource-constrained
settings, and marginalised communities, including the specific needs of different groups,
ages, segments, cultural systems, languages, communities, and marginalised and vulnerable
populations, people with disabilities, neurological disorders, and mental health conditions,
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided
that these choices are made in ways that respect the rights of others.
III.1.4 Consideration for cross-cultural perspectives on human knowledge and its
sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of
health and quality of life.
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28. It is essential that any research and development involving diverse groups and
communities is done with their permission and guidance, and conducted with their full prior
and informed consent and partnership in ways that serve their interests and respect their
traditional knowledge and epistemic contributions.
III. 1.5 Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of
thought especially in situations where refusal to use the technology could lead to competitive
disadvantage. Such interferences include but are not limited to the use of force, threats,
undisclosed access, manipulation, or any scenario where consent is compromised, including
as a result of power imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that
segregate, objectify or subordinate individuals or communities, reduce social cohesion by
exacerbating preexisting inequalities or generating novel inequalities that divide and
antagonize individuals against each other, and thereby threaten the coexistence between
humans, other living beings and the natural environment.
III.1.6 Global Solidarity and International Cooperation
31. The Recommendation should guide all actors in the development, deployment and use of
neurotechnology to act in solidarity and call for accountability in instances where
neurotechnology may be misused in ways that threaten human rights.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable
use to prevent abuse and uphold global ethical standards.
III.1.7 Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used with
a deep respect for environmental stewardship, prioritizing the minimisation of ecological
harm throughout the lifecycle of the materials used, including, for mining extraction, data
processing and storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP), requires that neurotechnology, through its whole
lifecycle, be guided by a profound respect for Indigenous rights, ensuring that their lands
(including during mining), knowledge, communal rights, and privacy are honoured in all
activities, including those related to resource extraction.
III.1.8 Integrity and Responsibility
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with
ethical steadfastness. It includes adhering to ethical guidelines and ensuring that all actions
align with both professional standards and societal values.
37. Integrity includes a commitment to taking responsibility for one's actions and being
accountable for their outcomes. This involves not only acknowledging successes but also
owning up to mistakes and taking corrective actions when necessary.
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38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-
based, objective and transparent research practices. It ensures that all scientific endeavours
are
conducted with honesty, accuracy, and respect for the scientific method of disciplines
relevant for neurotechnology.
III.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred approach through fundamental ethical
principles including but not limited to self-determination, agency, freedom of thought,
privacy, cognitive liberty, personal and collective identity, trustworthiness, respect,
reciprocity, and justice. Furthermore, it incorporates the respect, promotion and protection of
human rights.
III.2.1 Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and well-being, and empower individuals to
make informed decisions about their nervous system and mental health while fostering a
better understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally.
The "do no harm" principle must guide the whole lifecycle of neurotechnology, ensuring that
the quality of life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only
unexpected damage to the nervous system, but also to amplified inequalities within society.
43. Any restrictions to human rights must meet all applicable requirements under human
rights law, including the principles of legality, legitimate aim, necessity and proportionality.
44. The principles of proportionality, balance and legitimacy should govern the use of
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and
proportional to the objective and expected benefits that are aimed to be achieved; (b) do not
infringe upon the foundational values of this document; (c) appropriate to the context and
target user group; (d) based on safety principles and rigorous scientific evidence.
III.2.2 Self-determination and Freedom of Thought
45. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the
rights of freedom of thought, and self-determination must be secured.
46. Individuals have the right to make free, informed, and voluntary decisions about their
engagement with neurotechnology throughout the whole lifecycle, in accordance with
international human rights law and other international standards, including the right to refuse
or withdraw from its use, at any time, ensuring their autonomy and respect for their decision-
making capacity is upheld and where surrogate consent is used, the best interests of the
affected individual are considered. Individuals who are enrolled in research should be
informed of potential side effects and given the opportunity to disclose if they have any
contraindications for the procedures used. Informed consent procedures should be
affirmative, dynamic, and require opt-in, comprehensive and transparent providing detailed
information about the purposes, risks, benefits, alternatives, and possible outcomes of the
technology in all its application domains, ensuring that consent is voluntary and that
individuals fully understand the implications for their privacy, autonomy, and well-being.
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47. Neurotechnology should never be used to exert undue influence or manipulation,
whether through force, coercion, or other means that compromise self-determination and
freedom of thought. This protection covers both the internal processing of thoughts and their
external expression, ensuring freedom from any interference.
III.2.3 Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the right
to privacy due to their increasing ability to collect direct and indirect data about the nervous
system that is uniquely sensitive because they can be processed and analysed to provide
deep insights into the processes that underpin our mental states and behaviour, including
self-awareness and introspection. As it becomes increasingly difficult to anonymize data,
there remains persistent risks of misuse of this data by revealing neurobiological correlates of
diseases, disorders, or general mental states without the authorization of the person from
whom data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural data must be
conducted with free and informed consent, in ways that respect the ethical and human rights
principles outlined in this Recommendation
50. There should be clear safeguards against the misuse or unauthorised access of neural and
cognitive biometric data, including affirmative consent, data minimization and purpose
specification, data rights (such as rights to access, correct and delete), and data security,
particularly in contexts where such data might be aggregated with other sources.
III.2.4 Non-Discrimination and Inclusivity
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface
with other technologies like Al, must commit to upholding ethical principles that prevent
discrimination, stigmatisation, targeting, or exploitation of any individuals or groups,
particularly those in vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or
mental characteristics, or other grounds protected under human rights law.
53. Non-inclusive technological development and standardisation may drive a trend toward
homogenisation and the dominance of neurotypicality and capacities that may threaten
cultural and collective identity.
54. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their input and
validation to align these technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or
reify such discrimination. Care should be taken to evaluate neurotechnology solutions
promoted through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or discrimination
against older persons.
III.2.5 Accountability
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology
requires all actors to adhere to the highest ethical standards, remain open to feedback, be
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committed to adjusting practices in response to new evidence or ethical concerns, and be
held accountable for their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and a
duty to anticipate and address potential harms whether short-term, long-term or arising from
unintended use and impact.
59. A commitment to accountability requires global, governmental, societal and collective
action to ensure those harmed by neurotechnology have access to justice, and that those
responsible for wrongdoing are required to take meaningful steps to identify, prevent,
mitigate and account for how they address and redress their adverse human rights impacts,
including through corrective actions and reparations.
III.2.6 Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection of human rights and fundamental
freedom all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international
principles of responsible conduct and scientific integrity. This includes preventing the
replication or amplification of biases, ensuring that neurotechnology is traceable and
explainable, its capacities and limitations are accurately portrayed, the conditions for
accountability are clearly defined, adhering to ethical guidelines in research and
development, including the registration of trials, fair participant selection, and approval by
independent ethics committees.
III.2.7 Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about
neurotechnology, including recognizing diverse ways of knowing, and that all individuals
and communities can participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community
engagement, to ensure diverse populations can gain and exchange knowledge about nervous
system functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage,
and identity, to respect different ways of knowing and understanding. This respect for
diversity ensures that the knowledge and perspectives of diverse communities are valued and
included in decision making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may
be marginalized or excluded from knowledge production and dissemination.
65. All communities should have a voice in decisions that affect them, particularly when it
comes to the development and use of neurotechnology.
III.2.8 Best Interests of the Child and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right
of children and adolescents to participate in decisions that affect them. Technology should be
rigorously assessed to ensure it serves the best interests, well-being and healthy development
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of children, as they grow into autonomous individuals and safeguard the rights of future
generations by ensuring that today's decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology
for early diagnosis, instruction, education, and continuous learning, it is equally important to
make a commitment to the holistic development of the child. This includes nurturing their
social life, fostering meaningful relationships, and promoting a healthy lifestyle
encompassing nutrition and physical activity.
III.2.9 Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must
be shared equitably among all contributors to that research and development, with a
particular focus on ensuring global distribution that promotes fairness and reduces
disparities.
69. Neurotechnology developments should be leveraged to reduce global health inequities.
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings.
70. Research, development, and trials in neurotechnology must adhere to the highest ethical
standards, ensuring the non-exploitative participation of all individuals involved. This
includes safeguarding the rights and well-being of participants, and patients and their
caregivers, as well as ensuring the ethical collection and use of data. Special attention should
be given to ensure that those contributing to research and development have their fair share
of the benefits and do not bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never take
advantage of, the lack of necessary technological or medical infrastructure, education and
skills, as well as ethical-legal frameworks, particularly in LMICs, LDC* LLDCs and SIDS,
affecting communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive
recipients of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
promotes and protects individual and collective human rights. This commitment should
include funding for interdisciplinary research that not only advances neurotechnological
innovation but also studies the ethical, legal, social, environmental and cultural implications
of these technologies, and supports the implementation and clinical translation of
technological prototypes. Particular attention should be given to the development and
implementation of adequate technical, institutional, procedural and other safeguards to
ensure that they equitably benefit society and that human rights are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology in
contexts that violate individual and collective human rights. Member States should conduct
human rights due diligence, including regular, comprehensive human rights impact
assessments, concerning neurotechnology that they develop, design, deploy, use, sell, operate
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or procure, in order to prevent and mitigate their adverse human rights impacts. Specifically,
neurotechnology should not be used for purposes such as non-consensual interrogation in
law enforcement, criminal and civil justice, development or deployment of weapons targeted
at the nervous system, social control, attempts at coercive behavioural conformity based on
personal beliefs or thoughts, political or other opinion, gender identity or sexual orientation,
or surveillance of mental states, among others. Governments should adopt legislation that
ensures neurotechnology is deployed responsibly, and based on human rights, with robust
oversight mechanisms to enforce adherence to these restrictions and protect mental privacy
and freedom of thought for all individuals. These policies should be developed in
consultation with diverse actors, including civil society, end-users, neurotechnology experts,
ethicists, and human rights advocates, to ensure broad consensus and respect for global
human rights norms.
75. Member States should ensure transparency and accountability in their support, oversight,
and regulation of neurotechnology, particularly in publicly funded initiatives such as brain
research and development programs. While recognizing the limitations in disclosing certain
sensitive information, governments should require government sponsored neurotechnology
projects to publicly disclose the objectives, methodologies, intended uses, and societal
impacts of their neurotechnology initiatives wherever possible. This transparency is crucial
for fostering public trust and ensuring that neurotechnology advances are aligned with
ethical standards and human rights.
76. Member States should apply a comprehensive approach to regulatory and policy
measures to protect against human rights harms related to neurotechnology developed,
marketed, operated or used by the private sector. This includes legislative and regulatory
measures and accompanying guidance, incentives, and transparency requirements. This
comprehensive approach should also require human rights due diligence, ensuring that
businesses identify, prevent, mitigate, and account for their adverse human rights impacts
through context-dependent processes, including human rights impact assessments,
meaningful public and community engagement, and transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence,
be implemented ethically in accordance with human rights, and be aimed at promoting
public safety while protecting the rights and dignity of all those involved. This requires
respect for fundamental rights, such as human dignity, bodily integrity, confidentiality of
personal data, due process and fair trial rights, including the presumption of innocence, and
the right against self-incrimination, as well as freedom from torture and ill-treatment, the
right to privacy, and the right to freedom of thought.
78. Member States should establish comprehensive incentive structures, such as tax
incentives, grants, and awards, with a particular focus on encouraging the construction and
development of manufacturing, computational resources, and data analytics capabilities
within public research institutions and small and medium enterprises (SMEs). Member
States should also incentivize and support partnerships that leverage the computational
resources and data analytics capabilities of private firms to advance public research goals.
These incentives should prioritize rewarding transparency, participatory development
processes, and contributions to societal benefits, aiming to foster an environment where
public institutions and companies innovate responsibly and align with human flourishing
goals.
79. Member States should establish a coordinated, cross-sectoral approach to assessing the
impacts of neurotechnology across the whole lifecycle. This approach should include, but is
not limited to:
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(a) Economic Impact Assessments: Conducted by relevant national bodies
responsible for economic and labor policies to assess how neurotechnology
impacts economic growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by entities responsible for public health,
medical research, and consumer protections, these assessments should rigorously
evaluate the risks and benefits associated with the development, deployment, and
use of neurotechnology, including research, clinical applications, and consumer
products. The process should include thorough documentation, ethical oversight,
and continuous monitoring to ensure the safety, well-being, and equitable
treatment of all individuals involved;
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these
assessments should evaluate and mitigate risks to individuals' mental privacy
posed by neurotechnology, This includes ensuring that appropriate safeguards are
in place to protect neural and cognitive biometric data in compliance with
national and international privacy standards, and the data policy practices
discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant
national human rights institutions or international bodies, identify, prevent, and
address potential human rights impacts of neurotechnology. The process should
ensure that neurotechnology respects and promotes human rights, with particular
attention to vulnerable people and people living in vulnerable situations. HRIAs
should involve meaningful public and community engagement to incorporate
diverse perspectives.
80. Member States should promote equitable access to neurotechnology worldwide. To
achieve such goals, efforts should be made to support the reduction of final costs for end
users, pursue the development, adoption and continuous support of non-proprietary software
solutions, and explore reimbursement strategies or subsidisation commensurate with
conventions in local jurisdictions, in sectors of crucial potential benefits.
81.Member States should adopt agile regulatory frameworks, including the use of regulatory
sandboxes—controlled environments for developing, testing, and evaluating
neurotechnology—in response to rapid advancements in neurotechnology and its
convergence with other technologies such as Al, spatial computing, and immersive
technologies. These sandboxes should be used to explore innovative applications,
particularly in workplace settings, with appropriate ethical oversight provided by regulatory
bodies or national authorities. These frameworks should facilitate innovation, ensure ethical
data processing, and safeguard rights by incorporating mechanisms for regular monitoring,
evaluation, and dynamic policy adjustments in line with technological and ethical
developments.
IV.2 DATA POLICY
82. Member States should develop a robust regulatory and legal framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data.
This and existing frameworks should recognize this data to be both personal and sensitive
data in medical and non-medical contexts.
83. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals' neural and cognitive biometric data. If current policies
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do not adequately address these areas, Member States should adopt targeted legislation or
regulatory frameworks to secure these protections. These safeguards should for example
include affirmative informed consent, data minimization and purpose limitation, data rights
(including the right to access, correct, and delete data), and stringent data security measures,
such as advanced cybersecurity protocols to prevent unauthorized access and breaches. Such
legislation or frameworks should prohibit the practice of tying access to goods or services to
the disclosure of neural and cognitive biometric data, require explicit opt-in for any data
sharing, and forbid the use of such data for targeted advertising without the individual's
explicit, affirmative informed consent.
84. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and
computing resources used for processing and storage of neural and cognitive biometric data.
These policies should emphasise data minimisation, ensuring that only the necessary amount
of data is collected and processed, and promote the proportional use of neurotechnology,
aligning its deployment with genuine needs and minimising unnecessary environmental
impact. Measures should include optimising energy efficiency, using renewable energy
sources, promoting the recycling and sustainable disposal of neurotechnology-related
equipment, and ensuring the rehabilitation of affected environments.
85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the
protection of mental privacy, such as state-of-the-art encryption, secure databases with multi-
factor authentication, cutting-edge anonymization techniquest and edge-processing and
storage (processing and storing data closer to where it is being generated), leading to greater
action-led results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy
and ethics by design, requiring the incorporation of privacy-preserving technologies as
default features in their devices.
87. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories
should meet stringent cybersecurity, data privacy, and ethical use standards (including data
minimisation and purpose limitations), tiered access and other privacy-enhancing
approaches. Appropriate funding mechanisms should be established for the curation and
maintenance of data and data governance processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing
in neurotechnology research, working towards greater alignment of data protection
standards, particularly concerning neural and cognitive biometric data, by establishing clear
protocols for data transfer that ensure secure and compliant data exchanges across borders,
and standards for interoperability of data, including governance frameworks for data sharing
89. Member States should consider specific guidelines for the ethical use of neural and
cognitive biometric data in Al development and research, including consent procedures for
uses of neural and cognitive biometric data in training and application of Al models, ensuring
transparency and respecting individual and community rights.
IV.3 INTELLECTUAL PROPERTY (IP)
90. Member States should adopt policies to ensure that neural and cognitive biometric data,
as individual human activity derivatives, are not subject to proprietary rights. IP protection
should only apply to original data compilations (created through a process of aggregation,
organization, or selection, resulting in a new dataset) that meet strict and ethical criteria.
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91. Member States should collaboratively establish clear, harmonised guidelines for IP rights
applicable to neurotechnology on an international scale. These guidelines should address the
patentability of Al-generated inventions and the ethical implications of IP laws, ensuring
they promote global accessibility and innovation.
92. Member States should ensure that all actors adopt IP management strategies that
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be
continuously monitored to ensure they stimulate innovation while ensuring ethical use and
broad accessibility.
93. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for alt contributors.
94. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing.
Particularly with the convergence of digital technologies and the increasing concentration of
those innovations in industry sectors, this balance is crucial to ensure that IP protection
mechanisms do not hinder scientific research, innovation, and the wide dissemination of
knowledge and new technologies. As a basic rule of equitable partnership, when Indigenous
Peoples are involved in neurotechnology research and development, open science processes,
IP management strategy, should be developed in collaboration with them from the
beginning.
IV.4 CYBERSECURITY
95. Member States should collaborate internationally to establish comprehensive standards
for cybersecurity across all neurotechnology domains. These standards should encompass
hardware, software, and data security measures to protect against potential cyber threats. By
implementing uniform cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data, as well as enhance user trust and
confidence in neurotechnology devices. Additionally, these standards should evolve in
tandem with technological advancements and emerging cyber threats to maintain robust
protection against evolving risks.
96. Member States should employ red-teaming exercises—adversarial challenges to test the
efficacy of security systems—as a proactive measure to assess and enhance the safety,
security, and resilience of neurotechnology systems. By conducting regular red-teaming
exercises, Member States should proactively identify and address security gaps, test incident
response procedures, and strengthen the overall safety and cybersecurity posture of
neurotechnology devices.
IV.5 COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between
researchers, developers, diverse users, and the broader public to respect individual and
community rights, promote public trust, and harness the collective intelligence and diversity
of communities.
98. Member States should collaborate with international organizations, educational
institutions, and private and non-governmental entities to develop and disseminate accessible
and engaging educational materials tailored to diverse audiences to bridge knowledge gaps,
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particularly in underserved regions about the nervous system and mental health functioning,
as well as the benefits and risks of neurotechnology. These programs should aim to increase
public understanding of the technologies' functionality, safety, efficacy, and societal impact,
empowering individuals to make informed decisions and to enable their ethical reflection
about their use of neurotechnology.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a
wide array of actors. The aim of these engagements should be to inform policy development,
shape ethical guidelines, increase public awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment aligns with public interests and
values. Special attention should be given to involving groups traditionally underrepresented
in technological policymaking, thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation of accurate, precise, and accessible
language and terminology for discussing neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is inclusive, non-stigmatizing, and accurately
reflects the technologies' capabilities and limitations. Member States should establish
regulatory frameworks that require clear and ethical communication standards for
neurotechnology. These frameworks should require evidence-based reporting of capabilities,
risks, and limitations across all applications to avoid exaggeration of claims, including but
not limited to applications in sleep, attention, memory, and emotional regulation. Within
these frameworks should be specific guidelines for ethical marketing and protocols for
responsible communications about early-stage research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end-
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States
should also establish platforms for ongoing dialogue and feedback between users,
researchers and developers. Advisory panels should be involved in the process of developing
and testing new neurotechnology products to optimize device efficacy, usability, longevity,
and sustainability, This collaborative approach aims to ensure that innovations in
neurotechnology are context-compatible and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally
appropriate, and linguistically-appropriate education about neurotechnology. This should
include training modules to aid in the supportive use of these technologies at home, both for
the user and for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that
evaluate the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit and explicit
coercion to use neurotechnology. Member States should pay attention to the autonomy of
children and adolescents through informed consent and assent that is adapted to and
respectful of age and decision-making capacity.
105. Member States should fund research and development grants focused on creating user
friendly assistive neurotechnology tailored for children and adolescents with disabilities.
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These projects should involve children, adolescents, parents and caregivers in the design
process to ensure the technologies meet their specific needs. Educational programs should be
developed to teach children and adolescents and their caregivers how to effectively use and
maintain these technologies, with support available in multiple languages and accessible
without discriminating against those who either cannot or choose not to engage with the
proposed technology.
106. Member States should ensure research involves strict oversight and close follow-up of
all neurotechnology research involving children and adolescents. This oversight is crucial
during the developmental phases of childhood to address and mitigate any unforeseen long-
term effects. Such research must include comprehensive monitoring protocols and periodic
evaluations to ensure the ongoing safety and well-being of young participants, taking into
account their unique developmental needs and vulnerabilities. In the framework of research,
involving children and adolescents in medically vulnerable situations (i.e., children in
epilepsy monitoring units), special attention will be given to consent and assent, particularly
considering particular aspects of research (time, iterations) to prevent any form of
instrumentalization.
107. Member States should enact specific regulations that prohibit the use of marketing
techniques—such as neuromarketing, biometric emotional analytics, immersive advertising,
and virtual or augmented reality advertising—that rely on sensitive neural and cognitive
biometric data collected from children and adolescents. Recognizing the heightened
vulnerability of children and adolescents in digital environments, these regulations must
explicitly forbid any practices that use such data to influence or exploit children and
adolescents.
IV.7 OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by
funding and implementing evidence-based programs that integrate neurotechnology into
routine care. These programs should involve the entire support ecosystem, including family,
caregivers, and medical teams, to enhance quality of life. Priority should be given to
developing and implementing tools that prevent, delay, and treat age-related health
conditions, impairments, and neurodegenerative diseases. Member States should ensure that
access to these neurotechnology programs is equitable and does not exacerbate
socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability
(such as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making for
older people using neurotechnology for sensorimotor and cognitive support. The consent
process should accommodate potential cognitive challenges faced by older adults, ensuring
that consent is informed, ongoing, and adaptable to changing health conditions. Policies
should be in place to ensure that assistive neurotechnology recognize changing cognitive
capacities over time and respect users' preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such as
robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
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IV.8 WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive policies that promote and
respect gender equality and diversity in the whole lifecycle of neurotechnology. The policies
should prioritize inclusive research for addressing women and gender specific needs and
differences, require targeted data collection and analysis include education and training
programmes on inclusive research practices, ensure public and community engagement with
women and gender health experts and advocacy groups and, incentivise gender responsive
technology design, to meet the needs and conditions specific to women and gender
minorities. Affirmative action policies are necessary to close gender gaps in these fields,
increase representation, engagement and leadership.
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology,
are inclusive and supportive, particularly for women and gender minorities, and safeguard
against harassment and discrimination, This should include robust mechanisms for reporting
and addressing incidents of harassment and discrimination, ensuring accountability and
support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women's and gender minorities'
participation in neurotechnology. This includes funding and other policies that prioritize
ethical and equitable research and innovation, but also affirmative action initiatives to
support the participation of women and gender minorities in neurotechnology through
targeted education programs, employment opportunities, entrepreneurship support, and
leadership development within the sector. Member States should also provide support
systems such as mentorship programs, networking opportunities, and resources to help
women and gender minorities overcome barriers to participation and succeed in the
neurotechnology field.
IV.9 PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support
thereby contributing to achieving equal enjoyment of human rights. They should implement
regulatory frameworks that require accessibility assessments for all new neurotechnology
products to ensure these products do not perpetuate existing disabilities or health disparities.
These frameworks should include protocols for testing with diverse groups of persons with
disabilities to ensure technology meets a wide range of needs and does not unintentionally
exclude or disadvantage any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their quality of life and functional
independence. These programs should include tax incentives for companies investing in
assistive neurotechnology research and development, grants for research institutions
focusing on neurotechnology for disability support, expedited regulatory reviews for
technologies offering significant advancements in mobility, communication, or daily living
assistance, and innovation prizes for breakthroughs in affordable, accessible
neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential
neurotechnology devices, such as neuroprosthetics, for persons with physical disabilities.
They could encourage public-private partnerships to make advanced neurotechnology
affordable and integrate neurotechnology coverage into national health insurance and other
reimbursement schemes for persons with physical disabilities. A national database of
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available neurotechnology resources and support services should be developed to facilitate
access and information sharing.
IV.10 PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to
address the increasing prevalence and special needs of people with mental health conditions,
including victims and survivors of trauma and violence, and the relevance of
neurotechnology for these communities.
119. Member States should allocate funding for long-term advocacy and efficacy studies,
postmarket oversight, and tiered scrutiny with special attention to invasiveness and
reversibility of neurotechnology interventions. It is important to ensure that people with
mental health conditions are well-informed and have reasonable expectations about the
process.
120. Member States should prioritize funding for neurotechnology that is designed to
improve quality of life and daily functioning of individuals with mental health conditions.
This includes technologies that assist in managing symptoms, improving cognitive functions,
and providing emotional support at home, in the workplace, in their communities, and in
society. Research and development should be guided by feedback and engagement with
persons with mental health conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.II HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include
establishing research funding programs specifically targeted at addressing identified gaps in
nervous system care.
123. Member States should build and maintain international solidarity to address global
health risks and uncertainties, and ensure that their implementation of healthcare for the
nervous system is consistent with international law and rigorous human rights obligations.
This could involve creating international forums for sharing best practices in the
implementation of neurotechnology in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and
mental health impacts of long-term use of neurotechnological devices, with special attention
to invasiveness and reversibility of neurotechnology interventions. This includes
implementing regulatory measures requiring long-term follow-up studies for approved
neurotechnology devices and establishing clear criteria for continued approval based on
these studies results.
125. Member States should consider the significant cost and impact associated with
pathologies related to the nervous system, as well as the potential benefits of early diagnosis
and access to preventive and assistive neurotechnology. Public policies should prioritize the
promotion of access to these technologies and ensure health cost coverage for individuals in
need.
126. Member States should promote the development of reliable and durable
neurotechnology for healthcare applications. This includes encouraging the design of devices
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and systems that require minimal maintenance, ensuring they remain functional and effective
under everyday conditions. Regulatory bodies or designated authorities should oversee the
enforcement of rigorous standards for quality, safety, and longevity, thereby reducing the
burden on users and enhancing the dependability and sustainability of neurotechnological
solutions.
127. Member States should ensure the development or strengthening of existing
comprehensive neurotechnology medical device reporting systems that track and address
adverse effects. In contexts where such systems do not exist, Member States should establish
them. Where systems are already in place, they should be updated to specifically include
neurotechnology. These systems should be interoperable and contribute to a centralised,
public, and transparent international database, managed in collaboration with international
organizations, to ensure that global standards are met and accessible for public knowledge,
international oversight and research.
IV.12 RESEARCH ETHICS
128. Member States should reinforce the ethical frameworks governing neurotechnology
research to ensure robust protection of human participants. Member States should adopt clear
guidelines or policies that define the qualifications to ensure that research is conducted by
professionals with appropriate knowledge about the nervous system structure and function in
addition to brain disorders and is performed in adequate research settings. Furthermore,
research protocols, public or private, in the medical as well as the non-medical domain,
should be carefully evaluated by independent, multidisciplinary and pluralist research ethics
committees registered ethics boards (ethics committees) and specific attention dedicated to
individuals with special situations regarding vulnerability such as diminished capacity to
consent or to make decisions. Member States should ensure that all research institutions have
mandatory research ethics research integrity training for researchers.
129. Member States should encourage multicentre international research that involves
various cultures and ethnic groups. Member States should promote international cooperation
to develop common reporting standards and protocols for interoperability, particularly for
implantable neurotechnology devices. This cooperation should aim to enhance the
comparability and utility of research globally, improving both the efficacy and ethical
integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered
in the design of a clinical trial, including policies to protect patients in case of cessation of
activities of the trial sponsor or promoter. Member States should establish requirements for
clinical trials to be included in relevant nationally or internationally approved registries, and
encourage registration with community and patient registries. Also, clinical trials should
report on appropriate medical device reporting systems developed within Member States.
131. Technology developers should ensure that the validation of Al algorithms jn
neurotechnology research include rigorous testing for biases, as well as measures to enhance
explainability and transparency, including the provenance of training datasets. Suitable
techniques should be employed to mitigate any biases present in Al models used in
neurotechnology applications.
132. Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual's
subjective experience, agency and personal identity. Understanding how neurotechnology
may impact aspects of self-perception, consciousness, and identity is essential for addressing
ethical concerns and ensuring the well-being of individuals using these technologies.
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133. Member States should ensure those engaged in research implement regular auditing and
monitoring of research practices to ensure adherence to ethical standards. This should
include evaluating the adequacy of informed consent, particularly concerning data reuse and
the potential commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental
findings to participants. These protocols should ensure that such findings are conveyed
promptly, respecting participants' rights and autonomy. Additionally, Member States should
mandate that researchers provide the necessary support and coordination with healthcare
providers to address any health concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those with significant health implications. The informed
consent process should clearly outline what these findings might entail, the participants' right
to choose whether they wish to be informed about such findings, and guarantee that their
decisions in this regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13 EDUCATIONAL SETTINGS
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the
holistic development of students, focusing not just on academic performance but also on
mental health, well-being, and overall interests. To ensure inclusivity, Member States should
develop age appropriate guidelines for neurotechnology use across different educational
stages and learning styles. Regular assessments of neurotechnology's impact on student
development, including mental health, should be conducted, with ethical review processes
established to oversee deployment. The primary focus should be on fostering critical
thinking, creativity, and emotional intelligence rather than solely enhancing academic
performance.
137. Member States should adopt policies ensuring the voluntary deployment of
neurotechnology in education, grounded in fully informed consent. These policies must
include clear, age appropriate information about the technology's purpose, benefits, and
risks, with adequate consideration periods. Considering the increased complexity of
obtaining voluntary consent in this context, consent and assent procedures should involve
children adolescents, parents, guardians and all actors necessary to obtain approval required
for minors. Ethical oversight mechanisms should be established, including regular consent
renewal and immediate cessation of neurotechnology use upon withdrawal, and ensure
anonymous feedback channels. Policies must prohibit undue incentives or academic
penalties for non-participation and take measures to avoid creating or reinforcing inequalities
among students. Additionally, Member States should support student involvement in
decision-making about neurotechnology integration and fund training programs on its ethical
use, empowering educators and students to critically assess its application.
138. Member States should establish a unified, robust oversight mechanism for
neurotechnology use in educational settings, incorporating regular audits, public and
community feedback, culturally appropriate and according to local conventions, and strict
adherence to safety and ethical standards, including an assessment of reversibility on the
nervous system, Continuous research should be funded to assess the long-term psychological
and cognitive impacts of these technologies. Oversight should involve periodic reviews
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based on empirical evidence to adjust neurotechnology usage as needed, ensuring it serves
student development and addresses risks like dependency or de-skilling. This comprehensive
approach will help maintain the safety, effectiveness, and alignment of neurotechnology with
best practices for student well-being and learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations
throughout the neurotechnology whole lifecycle. This training should include ethical design,
human rights law, and societal impact assessment, preparing the next generation of
technologists to critically evaluate the implications of their work.
IV.14 LABOURAND EMPLOYMENT
140. Member States should establish workplace policies and incentives that prioritize the
health and well-being of employees in the use of neurotechnology. These policies should
ensure that any deployment of neurotechnology is evidence-based, with a focus on
applications that have been scientifically validated to promote employee well-being, such as
reducing stress or enhancing workplace conditions (i.e., adaptive and responsive
environments that adjust workloads based on cognitive load). Deployment must be on a
voluntary basis and employees must have the option to opt out of using neurotechnology
without facing any negative consequences or discrimination. Under no circumstances should
these technologies be used for punitive measures, mental surveillance, or in ways that could
compromise employee health.
141. Member States should require employers to clearly provide employees with
comprehensive information about how neurotechnology used in their workplace works, the
benefits it offers, transparency about what data are collected, how it is used, and who has
access to it, and clearly disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring
fatigue in commercial drivers or tracking attention in air traffic controllers). To respect
employees' mental privacy, employers should be prohibited from unauthorized access to
neural and cognitive biometric data that may be collected incidentally during routine
workplace monitoring. Employers should be prohibited from using neural and cognitive
biometric data for any non-consented purposes, particularly those that could negatively
impact an employee's job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation
and secure storage of neural and cognitive biometric data, ensure that data is stored securely,
with access limited to authorised personnel only, is deleted once its intended purpose has
been fulfilled. Additionally, upon an employee's departure, all related records should be fully
deleted or individual data released to the employee, ensuring that no data is retained after the
termination of employment.
144. Member States should ensure that when employees are issued multifunctional devices
(i.e., earbuds or headphones that also include neural sensors) that can be used at work or at
home, employers should be prohibited from collecting neural and cognitive biometric data
outside of workplace settings and working hours and ensure that any data collected during
work is used exclusively for agreed-upon purposes. Employers should implement
technological safeguards to automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right of employees to obtain a
copy of any neural and cognitive biometric data collected about them, along with any
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interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise
create.
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and
not for enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should
develop stringent regulations against using neural and cognitive biometric data for profiling
in the workplace, including in hiring. These regulations should prohibit the use of neural and
cognitive biometric data to discriminate against candidates, particularly neurodiverse
individuals, ensuring hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or
maintaining employment, to limit such use where such neural and cognitive biometric data
are directly relevant to the specific requirements of the job.
IV.15 CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a regulatory framework that balances
innovation in the recreational and commercial domains with protecting individual rights and
well-being. This framework should be dynamic, allowing for timely updates as technology
evolves and new insights are gained about its impacts on society. This includes providing
adequate oversight to ensure that neurotechnology does not cause harm, are used
consensually, and include robust mechanisms to protect users from potential psychological
distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include
clear labelling on commercial neurotechnology products, detailing their effects, limitations,
and risks to prevent misleading claims and ensure transparency. This also includes
prohibiting practices of "tying" or requiring the disclosure of neural and cognitive biometric
data as a condition to access goods or services, and prohibition about third party data sharing
or the uses of this data without affirmative opt-in option,
151. Member States should foster an environment that ensures all claims about consumer,
nonmedical technologies are supported by robust scientific evidence. They should, by
regulation, require that any products claiming to treat, prevent, or diagnose diseases or
medical conditions be validated through rigorous safety and efficacy testing, including
clinical trials where necessary, and be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and
transparent across all neurotechnological interventions, ensuring that participation is fully
voluntary and respects the privacy and autonomy of individuals. This principle should apply
uniformly in various domains such as sports, arts, where robust standards should safeguard
against coercive use and respect athletes' and artists' individual autonomy, community
interests, and IP rights.
153. Member States should steer the use and development of neurotechnology in the arts
toward ensuring the enhanced learning and cultural appreciation without compromising
individual autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of
consumer technology, especially neurogaming and other devices that exploit the dopamine
reward system or seek to induce problematic and unhealthy use and overconsumption. Such
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regulations should mandate clear labeling of risks, disclosures on their effects on the nervous
system, enforce game design standards and safety, privacy and age-appropriate design
standards that prevent taking advantage of a person's physical, mental and emotional
vulnerability to lead to compulsive use or addiction of gaming or digital recreational
platforms combined with neurotechnology, to promote healthy, balanced use, especially
among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow
users to selectively disable neurotechnology features while maintaining basic functionality.
Regulations should ensure that 'opt-out' features are accessible and straightforward,
promoting healthy, balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding self-
determination, consent, privacy, and the potential for manipulation raised by
neurotechnology that arise in the contexts of recommender systems, priming and nudging,
marketing during sleep and dreamt neuromarketing, and closed-loop environments by
adopting comprehensive policies and regulations that:
Recommender systems: explicitly prohibit the use of neural and cognitive
biometric data in recommender systems for manipulative or deceptive purposes,
including in political context. These regulations should require that any use of
such data within these systems be based on explicit, informed opt-in consent from
users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging subtly
influencing individuals' decisions or behaviours, often without their explicit
awareness. This is particularly critical in sensitive areas such as political
messaging, commercial advertisement, and healthcare. These frameworks should
require explicit, informed consent for any use of such data to influence decisions
or behaviour, the right to opt out of these systems, and transparency and clear
disclosures at the point of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that
influences or manipulates individuals during sleep, such as marketing during sleep
and dream. Regulations should strictly prohibit commercial, marketing, or
political applications that target individuals during sleep, using neurotechnology
or neural and cognitive biometric data. Additionally, robust oversight mechanisms
should be required to ensure that any research or application of such technologies
prioritizes the well-being, privacy, and autonomy of individuals, with particular
attention to the potential long-term psychological and cognitive impacts of
manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in
neuromarketing, including by requiring comprehensive disclosures to ensure that
all neuromarketing activities are conducted transparently, with participants'
explicit informed consent. This includes ensuring that participants in
neuromarketing research or campaigns are fully aware of methods, risks, and
intentions and affirmatively opt-in to participation. The use, storage, and potential
reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design
and
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use of closed-loop environments such as immersive computing devices that
adjust experiences based on detected neural and cognitive biometric data. These
policies should require clear and accessible disclosure about how neural and
cognitive biometric data are used in these environments, prohibit real-time
behavioral modification or manipulation without explicit, informed consent, and
implement safeguards specifically designed to prevent abuses such as
unauthorized surveillance, manipulative interventions, and practices that could
influence voting behavior, political opinions, or exploit psychological and
emotional vulnerabilities in real-time.
IV.16 ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human
mental performance outside of the medical context introduces complex ethical, social, and
legal challenges, which can create new kinds of disparities in the global world. When
neurotechnology is used in these contexts, it raises crucial questions about equity, consent,
individual and community autonomy, and the nature of enhancement of the nervous system
itself. Member States should ensure that any policies, law and regulatory frameworks that
govern the use of neurotechnology in these contexts do not exacerbate social inequalities or
lead to discrimination, address the potential risks (including to reversibility, invasiveness,
and risks to self-determination) and fully comply with human rights and dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in this Recommendation should
respect, promote and protect the ethical values, principles and standards related to this
Recommendation, and should take all feasible steps to give effect to its implementation.
159. Member States shall, according to their specific contexts, governing structures and
constitutional provisions, credibly and transparently advance the ethics of neurotechnology,
in line with the UNESCO Recommendation. Member States shall monitor and evaluate
policies, programmes and mechanisms related to neurotechnology and its ethics. Progress
monitoring could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology
across relevant government agencies. These coordinating bodies should be tasked with
ensuring that legal and regulatory frameworks are consistently applied, that public health and
safety are protected, and that ethical standards and human rights are upheld throughout the
whole lifecycle of neurotechnology. This includes facilitating inter-agency collaboration,
monitoring compliance with national and international standards, and ensuring that data and
insights from different regulatory domains are shared effectively to inform decision-making
and policy development. These bodies should also help coordinate public and community
engagement.
162. Member States should strive to extend and complement their own actions in respect of
this Recommendation, by cooperating with all relevant national and international
governmental and non-governmental organizations, as well as transnational corporations and
scientific organizations, whose activities fall within the scope and objectives of this
Recommendation. Civil society will be an important actor to advocate for the public sector's
interests and therefore UNESCO needs to ensure and promote its legitimacy.
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163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO,
relevant international and regional partners, human rights institutions as well as with
UNESCO ethics advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of
neurotechnology, UNESCO shall contribute by developing a full-fledged program with the
following elements:
a UNESCO Readiness Assessment Methodology (RAM) to assist Member States
in identifying their status at specific moments of their readiness trajectory along a
continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of
neurotechnology based on rigorous scientific research and grounded in
international human rights law, along with specific guidance for its
implementation in the whole neurotechnology lifecycle, and capacity-building
tools and materials to support Member States' efforts to train government
officials} policy-makers and other relevant actors on the methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and
the efficiency of the policies for the ethics of neurotechnology and incentives
against defined objectives;
a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of knowledge and awareness of
good practices and innovations available to all Member States and actors, in the
form of research reports, data, and statistics regarding policies for ethics of
neurotechnology. The research program should take into consideration the
converging developments of neurotechnology with other technologies such as
artificial intelligence and quantum technology, work to be conducted in
collaboration with other relevant UNESCO initiatives.
a UNESCO collaborative platform fostering meaningful exchanges and
facilitating collaboration among Member States and among all actors to promote a
global policy dialogue, including at Ministerial level in the context of a Global
Forum on the ethics of Emerging Technologies. Supporting this effort, UNESCO
shall establish a network of experts, with balanced representation of all
UNESCO's regional groups, on the neurotechnology.
165. Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, under-represented, vulnerable people or people in vulnerable
situations and ensuring social, cultural and gender diversity. The monitoring and assessment
of the impact of neurotechnology and related ethics policies and practices should be carried
out continuously in a systematic way proportionate to the relevant risks. This should be
based on internationally agreed frameworks and involve evaluations of private and public
institutions. Data collection and processing should be conducted in accordance with
international law, national legislation on data protection and data privacy, and the values and
principles outlined in this Recommendation.
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VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a whole, and the foundational values
and principles are to be understood as complementary and interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
prejudicing Member States' obligations or rights under international law, or as approval for
any State, other political, economic or social actor, group or person to engage in any activity
or perform any act contrary to human rights, fundamental freedoms, human dignity and
concern for the environment and ecosystems.
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MALAYSIA/MALAISIE
Inputs on Preliminary Report on the first draft of the Recommendation on the Ethics
of Neurotechnology
Comprehensive Scope of the Report
The UNESCO preliminary report on the recommendations for ethics of neurotechnology
is a well-crafted and detailed document that holistically addresses the lifecycle of
neurotechnology. Its seven key objectives outlined in paragraph 19 ensure that the
ethical, societal, and technical aspects of neurotechnology are considered inclusively. For
Malaysia, this framework aligns with the need to involve stakeholders from various levels,
including government, academia, industry, and civil society, ensuring a broad and
collaborative approach that resonates with the nation’s diverse governance and societal
structure.
Localized Adoption of Recommendations
The report's recommendations are robust and adaptable. For Malaysia, adopting these
recommendations requires careful consideration of the country's socioeconomic realities
and cultural diversity. By aligning these ethical guidelines with local traditions, values, and
the population's socioeconomic conditions, the nation can ensure a practical yet culturally
sensitive approach to neurotechnology development and deployment.
Establishing a National Committee
Successful adoption of these recommendations calls for establishing a national ethics
committee on neurotechnology. This committee should comprise a balanced
representation of stakeholders, including:
• Government ministries (e.g., Ministry of Health, Ministry of Science, Technology,
and Innovation, Ministry of Digital, Ministry of Justice, and Ministry of Natural
Resources and Environmental Sustainability and more).
• Academic and research institutions provide scientific and ethical insights.
• Industry leaders for practical and technological implementation perspectives.
• Civil society representatives to ensure inclusivity and address public concerns.
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Subcommittees or working groups can then be formed under this committee to tackle
specific areas such as regulatory frameworks, public awareness, research ethics, R&D
grants/funding, cybersecurity, and data governance. These groups will foster inter-
ministerial collaborations to streamline policy implementation and address the multi-
faceted implications of neurotechnology.
Alignment with Malaysia's Future Technological Goals
Neurotechnology is one of the five emerging technologies identified in the Science and
Technology Foresight Malaysia 2050 report. The UNESCO recommendations serve as a
crucial guide to ethically shaping and accelerating the development of this field. By
adhering to these ethical principles, Malaysia can ensure that advancements in
neurotechnology are equitable, sustainable, and beneficial to society. Moreover, this
alignment can enhance Malaysia’s position as a regional leader in ethical innovation,
promoting responsible progress in neuroscience and neurotechnology.
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NORWAY/NORVÈGE
Scientific and Cultural Organization United
Nations Educational
7, place de Fontenoy
FRANCE
Your ref Our ref Date
24/5285- 19 December 2024
Comments from Norway on UNESCO’s first draft of the Recommendation
on the Ethics of Neurotechnology
Thank you for giving us the opportunity to comment on the first draft of UNESCO’s
Recommendation on the Ethics of Neurotechnology.
The potential of neurotechnologies is immense, but their responsible implementation
demands careful consideration of both their transformative potential and potential risks.
While aware of the positive effects of neurotechnologies, we will focus our comments on the
ethics of research, development and use of these technologies as well as the human rights
dimension. We are also in support of promoting equitable access, as long as it is
accompanied by regulations and guidelines that ensure safety for patients and other users.
We do recognize that it is a challenging task to design a normative instrument in an area as
novel as neurotechnology, whose development, direction, impact, and scope are difficult to
predict at this stage.
We welcome the approach to include all actors in this field. The document does, however,
focus almost exclusively on Member States. The document should therefore put a stronger
emphasis on shared responsibilities and underline the responsibilities of each actor and the
multistakeholder approach. We find for instance that the ethical responsibility of the
researchers and research institutions is not sufficiently underlined in the draft. This
responsibility is in accordance with academic self-regulation and the independence of
research, which are important principles to secure the quality and trustworthiness of
research.
We would like to comment on the wording used when referring to the principle of individual
free and informed consent. There is a diversity of wording when referring to this principle.
Postal address Office address Telephone Department Reference
Postboks 8119 Dep Kirkeg. 18 +47 22 24 90 90 Department for Higher Hanne Hvatum
0032 Oslo Org. nr. Education, Research +47 22 24 75 02
[email protected] www.kd.dep.no 872 417 842 and International
Affairs
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Some examples: “free informed”, only ”informed consent”, fully informed consent”,
“affirmative consent”, “voluntary consent”, “free, informed and voluntary consent”.
The Universal Declaration on human rights and biomedicine (UDHRB) article 6 uses the
wording "free and informed consent" in relation to individuals, and correspondingly in relation
to research, “free, informed and express consent". It would be appropriate to use the same
wording as in the UDHRB throughout the text. Also, a reference could be made to Article 7 of
the UDHRB to clarify the situation where a person is not able to consent.
In some sectors mentioned in the draft, we assume that the use of neurotechnologies is less
known to the broader audience. Here we see that UNESCO may play a vital role in informing
the general public where and how – in concrete and practical terms - they may meet these
technologies, so that they more easily can make informed choices.
I. SCOPE OF APPLICATIONS AND DEFINITIONS
We agree that ongoing research and public discourse on neurotechnologies are essential to:
• Develop strong regulatory guidelines
• Protect individual rights and privacy
• Ensure responsible and equitable development of neurotechnological innovations
The development and use of neurotechnologies requires careful, interdisciplinary
approaches that balance scientific innovation with robust ethical frameworks. Collaborative
efforts involving neuroscientists, ethicists, policymakers, social scientists, humanities experts,
legal and human rights expertise as well as technology experts will be crucial in navigating
the complex landscape of neurotechnologies.
We, therefore, support that approaches to neurotechnology ethics shall be based on “a
holistic, multicultural, multidisciplinary, pluralistic and evolving framework of interdependent
values, principles, and actions that can guide societies in dealing responsibly with the
impacts of neurotechnology on human beings, societies, and the environment and
ecosystems”.
Furthermore, we support that views from various disciplines should be included. However,
when listing up “neuroscience, medicine, engineering, psychology, ethics, human rights, law,
sociology, anthropology”, we risk excluding important disciplines – such as pedagogics and
economics. The document might therefore benefit from adopting a more general approach.
In our understanding of paragraph 5 of the scope, it expresses that measurement, recording,
modification of and data collection from the human nervous system should be given the
same level of protection, regardless of the circumstances where the technologies are used or
data collected (i.e. inside or outside of a healthcare situation etc). This could be clarified,
either in the scope, or in relevant paragraphs. For instance, paragraph 82 could clarify that
this will apply to all data. This may also be reflected in section III.2.3 (Protection of neural
and cognitive biometric data for mental privacy), as it may it might be appropriate to clarify
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that these principles will apply to all collection and use of neural and cognitive data,
regardless of how they are obtained or for what purpose they are used.
It might be appropriate to include a point on capacity building, information and raising
awareness under 1.1, Scope, to stress the importance of the recommendation on these
aspects later in the document. References to this can be found for instance in paragraph 54,
63 and chapter IV.5. Also, a reference to the importance of building health literacy might be
included somewhere in the document.
The text sometimes deviates from the normative UN language, which needs to be adjusted.
When established concepts are used, they should be consistent with recognized meanings
and applications. If/when deviations are justified, they should be followed by clarifications.
Generally, we see no reason for this Recommendation to establish its own concepts that are
synonymous with established concepts. Norway relies on the UNESCO secretariat to adjust
the terminology to better reflect normative UN language.
PARTS II, III and IV
The references to human rights and equality are both comprehensive and relevant. This
applies to both the preambular part (especially paragraph 13 and 14) and the operative part.
In the operative part, we particularly appreciate the overall approach to human rights in Part
II (Aims and Objectives) and Part III (Values and Principles). The more specific references in
Part IV, including the mention of Human Rights Impact Assessments (HRIA), are also
important.
We assume that the Office of the UN High Commissioner for Human Rights (OHCHR) has
been and will be consulted while developing the text. We would like to highlight the contents
of the OHCHR report on the topic as particularly relevant: Neurotechnology and human rights
| OHCHR.
We would also like to point out that basic research ethical values and principles are the same
for all areas mentioned in Part III.
The descriptions of the values and principles are at a rather abstract level. We would suggest
including more examples to make this part of the document more understandable. For
instance, what does explainability and transparency mean in this context, when we are
dealing with technologies that to most people are incomprehensible and opaque?
It might be appropriate to add a paragraph on technology assessment (TA) in the document.
The TA should be required, independent of the planned used of the technology (requirement
of Health Technology Assessment in the area of health).
Paragraph 60 implies that all member states should have systems for ethical approvals of all
neurotechnology research by independent ethics committees. In some countries, as Norway,
there is no formal requirement for an ethical approval by an ethics committee, except for
projects covered by The Health Research Act or research involving the use of animals. The
Norwegian Research Ethics Act of 2017 (§§ 4-5) points out the responsibility for ensuring
good research ethics to the research institutions and researchers themselves. According to
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the Act, research institutions have an obligation to ensure that all research is conducted in
accordance with recognized research ethical norms. Such norms are expressed in research
ethical guidelines developed by the National Research Ethics Committees in Norway.
GENERAL COMMENT ON THE DOCUMENT
The text appears quite lengthy and complex. It would likely benefit from being streamlined by
shortening long and complicated sentences and using simpler language. While the document
is of high quality, its length and comprehensiveness may cause it to lose its audience and,
consequently, its impact.
Still, Norway finds this an important and timely endeavor, and we are looking forward to
following the process leading up to a finalised recommendation at the General Conference
next autumn.
Further comments and suggested text edits are to be found in the attached table.
Yours sincerely
Niclas Lindahl Trosdahl
Acting Director
Hanne Hvatum
Senior Adviser
This document is signed electronically and has therefore no handwritten signature
1 attachment: Comments and suggested text edits
Page 4
429
COMMENTS AND SUGGESTED TEXT EDITS
ORIGINAL TEXT NEW PROPOSED TEXT COMMENTS
I. SCOPE OF APPLICATIONS AND DEFINITIONS I. SCOPE OF APPLICATIONS AND DEFINITIONS I. SCOPE OF APPLICATIONS AND
DEFINITIONS
New pre -OP1 This recommendation applies an ethical, Human
Rights based approach to all stages of the life
cycles of neurotechnology, and, as such:
III. VALUES AND PRINCIPLES
23. Respect for diversity and fairness, must be upheld in the Consider adding “gender”?
whole lifecycle of neurotechnology. Special consideration
should be given to neurodiversity, minority groups,
indigenous peoples, and underrepresented voices.
25. Equitable access to neurotechnology should be 25. Equitable access to evidence-based and In order to mirror the objectives in chapter II,
prioritized globally, ensuring that its benefits are reliable neurotechnology that promote health it might be appropriate to add evidence-
accessible to all, regardless of socioeconomic status or and well-being neurotechnology should be based and reliable neurotechnology that
geographical location. Special attention must be given to prioritized globally, ensuring that its benefits are promote health and well-being where
low-and middle-income countries, resource-constrained accessible to all, regardless of socioeconomic equitable access is mentioned.
settings, and marginalised communities, including the status or geographical location. Special attention
specific needs of different groups, ages, segments, cultural must be given to low-and middle-income
systems, languages, communities, and marginalised countries, resource-constrained settings, and
and vulnerable populations, people with disabilities, marginalised communities, including the specific
neurological disorders, and mental health conditions. needs of different groups, ages, segments,
cultural systems, languages, communities, and
marginalised and vulnerable populations, people
with disabilities, neurological disorders, and
mental health conditions.
39. This Recommendation embraces a human-centred 39. This Recommendation embraces a human- Para 39 lists fundamental ethical principles
approach through fundamental ethical principles including centred approach through fundamental ethical that should guide the use of
but not limited to self-determination, agency, freedom of principles including but not limited to self- neurotechnology. Although the list is not
exhaustive, it might be appropriate to add
430
thought, privacy, cognitive liberty, personal and collective determination, non-discrimination, agency, non-discrimination, since this principle is also
identity, trustworthiness, respect, reciprocity, and justice. freedom of thought, privacy, cognitive liberty, highlighted in the preamble and other parts
Furthermore, it incorporates the respect, promotion and personal and collective identity, of the recommendation.
protection of human rights. trustworthiness, respect, reciprocity, and
justice. Furthermore, it incorporates the respect,
promotion and protection of human rights.
49. Mental privacy is fundamental for the protection of 49. Mental privacy is fundamental for the
human dignity, personal identity, and agency. The collection, protection of human dignity, personal identity,
processing, modification, and sharing of neural data must be and agency. The collection, processing,
conducted with free and informed consent, in ways that modification, and sharing of neural data must be
respect the ethical and human rights principles outlined in conducted with free and informed consent, in
this Recommendation. ways that safeguards and respect the ethical
and human rights principles outlined in this
Recommendation.
51. All actors involved in the whole lifecycle of Consider adding “subordination”?
neurotechnology, particularly in its interface with other
technologies like Al, must commit to upholding ethical
principles that prevent discrimination, stigmatisation,
targeting, or exploitation of any individuals or groups,
particularly those in vulnerable situations.
IV. AREAS OF POLICY ACTIONS
77. Member States should ensure that any use of
neurotechnology in the justice system, including its
consideration by the judiciary should be grounded in robust
scientific evidence, be implemented ethically in accordance
with human rights, and be aimed at promoting public safety
while protecting the rights and dignity of all those involved.
This requires respect for fundamental rights, such as human
dignity, bodily integrity, confidentiality of personal data, due
process and fair trial rights, including the presumption of
innocence, and the right against self-incrimination, as well as
431
freedom from torture and ill-treatment, the right to privacy,
and the right to freedom of thought.
80. Member States should promote equitable access to 80.Member States should promote equitable In order to mirror the objectives in chapter II,
neurotechnology worldwide. To achieve such goals, efforts access to evidence-based and reliable it might be appropriate to add evidence-
should be made to support the reduction of final costs for neurotechnology that promote health and well- based and reliable neurotechnology that
end users, pursue the development, adoption and being, neurotechnology worldwide. To achieve promote health and well-being where
continuous support of non-proprietary software solutions, such goals, efforts should be made to support equitable access is mentioned.
and explore reimbursement strategies or subsidisation the reduction of final costs for end users, pursue
commensurate with conventions in local jurisdictions, in the development, adoption and continuous
sectors of crucial potential benefits. support of non-proprietary software solutions,
and explore reimbursement strategies or
subsidisation commensurate with conventions
in local jurisdictions, in sectors of crucial
potential benefits.
90. Member States should adopt policies to ensure that Can neural and cognitive biometric data be
neural and cognitive biometric data, as individual human the property of the individuals who’s, data
activity derivatives, are not subject to proprietary rights. IP has been collected? If yes, why should it not
protection should only apply to original data compilations remain that way?
(created through a process of aggregation, organization, or
selection, resulting in a new dataset) that meet strict and
ethical criteria.
CONSIDERATION FOR SPECIFIC USERS
Also consider moving this section to a
separate chapter.
IV.8 WOMEN AND GENDER IV.8 WOMEN AND GENDER GENDER EQUALITY We find the section with the title Women and
gender problematic. The current text risks
framing women as inherently vulnerable and
in need of protection and help, which may
unintentionally reinforce gender stereotypes.
Instead, the text would benefit from a more
general approach that focuses on gender
432
equality in the development and introduction
of new technologies. This shift would allow
for a more neutral narrative that accurately
represents the various social, economic, and
health-related factors contributing to
inequality among individuals of different
genders, and thus, would align better with
contemporary perspectives on equality and
human rights. In line with this, the section
should be re-titled ‘Gender equality’.
112. Member States should adopt and enforce 112. Member States should adopt and enforce
comprehensive policies that promote and respect gender comprehensive policies that promote and
equality and diversity in the whole lifecycle of respect gender equality and diversity in the
neurotechnology. The policies should prioritize inclusive whole lifecycle of neurotechnology. The policies
research for addressing women and gender specific needs should prioritize inclusive research for
and differences, require targeted data collection and addressing women and gender specific needs
analysis, include education and training programmes an and differences, require targeted data collection
inclusive research practices, ensure public and community and analysis, include education and training
engagement with women and gender health experts and programmes and inclusive research practices
advocacy groups and, incentivise gender responsive that ensure gender equality, ensure public and
technology design, to meet the needs and conditions specific community engagement with women and
to women and gender minorities. Affirmative action policies gender health experts and advocacy groups and,
are necessary to close gender gaps in these fields, increase incentivise gender responsive technology
representation, engagement and leadership. design, to meet the needs and conditions specific
to women and gender minorities LGBTQI
persons. Affirmative action policies are
necessary to close gender gaps in these fields,
increase representation, engagement and
leadership.
433
PALESTINE (STATE OF)/PALESTINE (ÉTAT DE)
State of Palestine
Ministry of Health
A> ,"'lt c..) !)j
Minister's Office .._)..J_jj.11 I ..� 4
03/11/2024
Subiect: neurotcchnology ethics
Following our review of the UNESCO document on the Principles and Ethics of
Neurotechnology Applications, we at the Palestinian Ministry of Health thank you
for sharing this important resource. We kindly request that the following remarks
be considered for inclusion in the relevant sections. Once the document is
finalized and adopted, we would appreciate receiving a copy to assist in
developing regulatory frameworks and safeguards to protect individual rights,
including legislation to ensure privacy, prevent the misuse of neuro data, and
promote responsible research. Additionally, we will focus on raising public
awareness of these technologies and encouraging international cooperation to
establish ethical standards and protect humanity from unforeseen risks.
I. We recommend including a statement in specific cases where clinical trial participants
are unable to make fully conscious decisions or distinguish between the real and virtual
,vorlds because experiments involving individuals who cannot fully control their
decisions or discern between the real and virtual worlds necessitate that the subjects
assign authority to a person or governmental body before the experiment. This lowers the
possible risks to the participant by guaranteeing the freedom to withdraw from the
experiment when it endangers their life, independence, health, or general well-being.
2. We recommend includin8 the following statement about children: (For non-medical
devices, their use should be prohibited without standards that ensure the technology is not
used to influence children's thoughts in a way that directs them to carry out agendas in
favor of the company or individual behind the technology, whether those agendas are in
the form of political, economic, ideological, or violent acts.).
3. The ethical issue of using a human organ (such as the brain) to store data if technology
advanced to that stage is not mentioned, hence we propose that this issue be brought up.
Ministry of Health - Nablus- Tel.: 09/238477 l/6 - Fax: 09/2384777 09/2384777: �u -09/2384771/6 : .:,� - �1.,; - ,L,....:,Jf 0Jlj9
Ministry of Health -Ramallah- Behind Palestine Medical Complex �I�� ....L. • ...iJI plJ - .i..,....,Jf 0Jlj9
Tel.: 02/2964183 - Fax: 02-2964182 0212964182, �u
0212964183: 0 �
Ministry of Health - Gaza- Tel. : 08/2846949 - Fax : 08/2826295 08/2826295 : �u 08/2846949 : 0� • •:,i. • ,L,....:,JJ "J 'i 9
434
PERU/PÉROU Firmado digitalmente por IZAGUIRRE
PASQUEL Victor Luis FAU
20135727394 soft
Consejo Nacional de Ciencia, Dirección de Políticas y Motivo: Soy el autor del documento
Tecnología e Innovación Programas de CTI Fecha: 20.12.2024 10:09:43 -05:00
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
San Borja, 20 de Diciembre del 2024
INFORME N° D000476-2024-CONCYTEC-DPP
A : ANMARY GUISELA NARCISO SALAZAR
SECRETARIO GENERAL(e)
De : VÍCTOR LUIS IZAGUIRRE PASQUEL
DIRECTOR DE LA DIRECCIÓN DE POLITICAS Y PROGRAMAS DE CTI
Asunto : Comentarios y observaciones sobre el Informe Preliminar del primer borrador
acerca de la Recomendación sobre Ética de la Neurotecnología.
Referencia : a) OFICIO N° 00216-2024-MINEDU/SG-OGCI-COMIUNESCO
b) INFORME N° D000094-2024-CONCYTEC-DPP-SDITT-ZMC
c) INFORME N° D000649-2024-CONCYTEC-DPP-SDITT (20DIC2024)
Fecha Elaboración : San Borja, 20 de diciembre de 2024
Tengo el agrado de dirigirme a usted para saludarlo cordialmente, y a través del presente se remite el informe
de la especialista Zenia Julieta Medina Contreras en relación a la referencia a), mediante el cual se solicita
comentarios y observaciones sobre el Informe Preliminar del primer borrador acerca de la Recomendación
sobre Ética de la Neurotecnología.
Al respecto, tal como indica el informe de la referencia b), y elaborado por la especialista Zenia Julieta Medina
Contreras al cual expreso mi conformidad y hago mío en todos sus extremos, concluye lo siguiente:
• La neurotecnología representa una herramienta transformadora con un gran potencial en sectores
como la salud, la educación y la productividad. El borrador de Recomendación sobre Ética de la
neurotecnología constituye un insumo valioso para orientar el desarrollo de esta tecnología bajo
principios éticos y responsables. En este contexto, el presente informe incluye recomendaciones tanto
sobre el informe preliminar del primer borrador de la Recomendación como sobre la Recomendación
en sí, con el fin de garantizar que su implementación priorice la equidad y la ética. Esto resulta
especialmente relevante en países en desarrollo como Perú, donde las desigualdades
socioeconómicas y regionales podrían agravarse si no se toman medidas adecuadas para garantizar
un acceso inclusivo y equitativo.
• Asimismo, se enfatizó la importancia de la participación activa de comunidades vulnerables, incluidas
las rurales e indígenas, en los procesos de consulta, diseño y desarrollo de estas tecnologías,
respetando sus derechos, culturas y necesidades específicas. Finalmente, se subrayó la necesidad
de establecer marcos normativos sólidos, participativos y culturalmente adecuados que fomenten un
uso seguro, equitativo y ético de la neurotecnología, abordando riesgos asociados a la explotación de
datos, exclusión social y violaciones de derechos humanos.
Por lo tanto, se remite el documento de la referencia elaborado por la especialista Zenia Julieta
Medina Contreras, cuyo correo es [email protected], para realizar las consultas necesarias.
435
Página 1 de 2
Consejo Nacional de Ciencia, Dirección de Políticas y
Tecnología e Innovación Programas de CTI
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
Es cuanto tengo que informar para los fines que considere conveniente,
Sin otro particular, quedo de usted.
Atentamente
Documento firmado digitalmente
VÍCTOR LUIS IZAGUIRRE PASQUEL
DIRECTOR DE LA DIRECCIÓN DE POLITICAS Y PROGRAMAS DE CTI
VIP/frs
cc.:
436 Página 2 de 2
Firmado digitalmente por
MALDONADO CARBAJAL Karina
FAU 20135727394 soft
Consejo Nacional de Ciencia, Dirección de Políticas y Motivo: Soy el autor del documento
Tecnología e Innovación Programas de CTI Fecha: 20.12.2024 07:52:19 -05:00
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
San Borja, 20 de Diciembre del 2024
INFORME N° D000649-2024-CONCYTEC-DPP-SDITT
A : VÍCTOR LUIS IZAGUIRRE PASQUEL
DIRECTOR DE LA DIRECCIÓN DE POLITICAS Y PROGRAMAS DE CTI
De : KARINA MALDONADO CARBAJAL
SUB DIRECTOR DE LA SUB DIRECCIÓN DE INNOVACIÓN Y TRANSFERENCIA
TECNOLÓGICA
Asunto : Comentarios y observaciones sobre el Informe Preliminar del primer borrador acerca de la
Recomendación sobre Ética de la Neurotecnología.
Referencia : a) Oficio N° 00216-2024-MINEDU/SG-OGCI-COMIUNESCO
b) Informe N° D000094-2024-CONCYTEC-DPP-SDITT-ZMC
Fecha Elaboración : San Borja, 19 de Diciembre de 2024
Es grato dirigirme a usted en atención a los documentos a), de la referencia, mediante el cual se solicita comentarios y
observaciones sobre le Informe Preliminar del primer borrador acerca de la Recomendación sobre Ética de la
Neurotecnología.
Al respecto, se remite el informe b), mencionado en la referencia y elaborado por la especialista Zenia Julieta Medina
Contreras al cual expreso mi conformidad y hago mío en todos sus extremos, concluye lo siguiente:
• La neurotecnología representa una herramienta transformadora con un gran potencial en sectores como la salud,
la educación y la productividad. El borrador de Recomendación sobre Ética de la neurotecnología constituye un
insumo valioso para orientar el desarrollo de esta tecnología bajo principios éticos y responsables. En este contexto,
el presente informe incluye recomendaciones tanto sobre el informe preliminar del primer borrador de la
Recomendación como sobre la Recomendación en sí, con el fin de garantizar que su implementación priorice la
equidad y la ética. Esto resulta especialmente relevante en países en desarrollo como Perú, donde las
desigualdades socioeconómicas y regionales podrían agravarse si no se toman medidas adecuadas para garantizar
un acceso inclusivo y equitativo.
• Asimismo, se enfatizó la importancia de la participación activa de comunidades vulnerables, incluidas las rurales e
indígenas, en los procesos de consulta, diseño y desarrollo de estas tecnologías, respetando sus derechos, culturas
y necesidades específicas. Finalmente, se subrayó la necesidad de establecer marcos normativos sólidos,
participativos y culturalmente adecuados que fomenten un uso seguro, equitativo y ético de la neurotecnología,
abordando riesgos asociados a la explotación de datos, exclusión social y violaciones de derechos humanos.
• Se recomienda remitir el presente informe a la DPP para su derivación a la Secretaria General y continuar con los
trámites correspondientes.
Es cuanto tengo que informar para los fines que considere conveniente,
Atentamente,
Documento firmado digitalmente
KARINA MALDONADO CARBAJAL
SUB DIRECTOR DE LA SUB DIRECCIÓN DE INNOVACIÓN Y
TRANSFERENCIA TECNOLÓGICA
KMC/ifa
cc.:
437 Página 1 de 1
Firmado digitalmente por MEDINA
CONTRERAS Zenia Julieta FAU
20135727394 soft
Consejo Nacional de Ciencia, Dirección de Políticas y Motivo: Soy el autor del documento
Tecnología e Innovación Programas de CTI Fecha: 19.12.2024 18:33:19 -05:00
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
San Borja, 19 de Diciembre del 2024
INFORME N° D000094-2024-CONCYTEC-DPP-SDITT-ZMC
A : KARINA MALDONADO CARBAJAL
SUB DIRECTORA DE LA SUB DIRECCIÓN DE INNOVACIÓN Y
TRANSFERENCIA TECNOLÓGICA
De : ZENIA JULIETA MEDINA CONTRERAS
SUB DIRECCIÓN DE INNOVACIÓN Y TRANSFERENCIA TECNOLÓGICA
Asunto : Comentarios y observaciones sobre el Informe Preliminar del primer borrador acerca
de la Recomendación sobre Ética de la Neurotecnología.
Referencia : a) Oficio N° 00216-2024-MINEDU/SG-OGCI-COMIUNESCO
b) PROVEIDO N° D001031-2024-CONCYTEC-DPP-SDITT
Fecha Elaboración : San Borja, 19 de diciembre de 2024
Tengo el agrado de dirigirme a usted, en relación al asunto de la referencia, para informar lo siguiente:
I) Antecedentes
1.1. En la 42ª reunión, celebrada en noviembre de 2023, la Conferencia General de la Organización de las
Naciones Unidas para la Educación, la Ciencia y la Cultura (UNESCO) decidió preparar un instrumento
normativo internacional sobre la ética de la neuro tecnología en forma de recomendación. Desde la última
Conferencia General, la UNESCO ha trabajado activamente en esta cuestión, estableciendo un grupo de
expertos e iniciando amplias consultas a todos los niveles. Estos esfuerzos han dado como resultado el
presente Informe Preliminar y el proyecto de Recomendación que se adjuntan.
1.2. De conformidad con la Constitución de la UNESCO y con el Reglamento sobre las recomendaciones, se
invitó a los Estados Miembros a transmitir a la Secretaría de la UNESCO sus comentarios y observaciones
sobre este texto al menos diez meses antes de la apertura de la 43ª reunión de la Conferencia General.
1.3. Con fecha 09 de octubre de 2024, a través del Oficio de la referencia a), la Secretaria General de la
Comisión Nacional Peruana de Cooperación con la UNESCO remite al CONCYTEC el informe preliminar
y proyecto de recomendación sobre el instrumento normativo internacional en ética de la neuro tecnología,
indicando enviar comentarios y observaciones antes de la realización de la 43° Conferencia General.
1.4. Con fecha 17 de octubre de 2024, a través del proveído N°D001899-2024-CONCYTEC-DPP, la Dirección
de Políticas y Programas de CTI deriva a la Subdirección de Innovación y Transferencia Tecnológica
atender la solicitud.
1.5. Con fecha 18 de octubre de 2024, a través del proveído de referencia b), la Sub dirección de Innovación
y Transferencia Tecnológica deriva a la suscrita los documentos mencionados con el fin de atender la
solicitud.
438 Página 1 de 13
Consejo Nacional de Ciencia, Dirección de Políticas y
Tecnología e Innovación Programas de CTI
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
1.6. Para la elaboración del presente informe, se considera la siguiente base legal:
• Ley N° 31250 Ley del Sistema Nacional de Ciencia, Tecnología e Innovación (SINACTI).
• Ley N° 31374 Ley que promueve el uso de la inteligencia artificial en favor del desarrollo
económico y social.
II) Análisis
2.1. La UNESCO, siguiendo la Resolución 29 de su 42ª sesión, creó el Grupo Ad Hoc de Expertos (AHEG, por
sus siglas en ingles) para elaborar un borrador inicial de la Recomendación sobre Ética de la
Neurotecnología. El AHEG, compuesto por expertos de todas las regiones de la UNESCO con un balance
geográfico y de género, realizó su primera reunión del 22 al 26 de abril de 2024 en la sede de la UNESCO.
2.2. Posteriormente, el AHEG preparó una revisión preliminar del borrador, incorporando comentarios
relevantes y proponiendo mejoras en la estructura. Del 26 al 30 de agosto, el grupo se reunió nuevamente
en la sede de la UNESCO, finalizando el primer borrador de la Recomendación con secciones de
implementación y seguimiento. Este borrador fue enviado a los Estados Miembros, junto con un informe
preliminar, para recibir sus observaciones.
2.3. El informe preliminar consta de una introducción, un apartado de procesos, un apartado sobre el primer
borrador de la recomendación en ética de la neuroética y la última sección correspondiente a los próximos
pasos. El proyecto de recomendaciones en ética de la neuro tecnología contiene el alcance de las
aplicaciones definiciones, propósito y objetivo, valores y principios y áreas de medidas en políticas,
implementación y provisiones finales.
2.4. El presente informe se enfoca en el análisis y las recomendaciones sobre el borrador de la Recomendación
de Ética de la Neurotecnología, dado que constituye el núcleo del documento y el principal insumo para la
implementación práctica por parte de los Estados Miembros. Además, se incluyen comentarios sobre el
informe preliminar, con el objetivo de abordar aspectos relevantes que fortalecen el desarrollo del
documento, como se detalla en la tabla 1:
Tabla 1:
Sección Texto Original Comentarios y recomendaciones
Para reforzar la equidad en el
19. The AHEG delineated several areas of policy desarrollo y uso de la
action and proposed concrete courses of action by neurotecnología, se sugiere
domain, including those that are less regulated up recomendar la implementación de
to now such as educational settings, labour and mecanismos de colaboración
employment, and the direct-to-consumer and
Párrafo internacional que permitan a los
commercial domains. It calls on Member States to
19 países en desarrollo participar en
actively enforce policies that can protect human
rights against possible infringements related to igualdad de condiciones en este
neurotechnology development and use. desarrollo tecnológico. Esto
Furthermore, the Recommendation recognizes podría incluir, por ejemplo,
that data about the structure, activity and function programas específicos de
of the nervous system (neural data) should be transferencia tecnológica,
439 Página 2 de 13
Consejo Nacional de Ciencia, Dirección de Políticas y
Tecnología e Innovación Programas de CTI
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
Sección Texto Original Comentarios y recomendaciones
considered sensitive data, particularly when financiamiento equitativo para
collected outside of the medical context. This proyectos de investigación y el
element will likely have deep implications for establecimiento de plataformas
informed consent procedures and data processing multilaterales para el intercambio
in various settings, as only data collected within
de conocimientos y recursos.
the medical context is systematically recognized
Estas medidas son esenciales
sensitive in most jurisdictions today. A full list of
actions directed at neural and cognitive biometric para cerrar las brechas existentes
data policy, intellectual property, and cybersecurity y garantizar que los beneficios de
is provided. Attention is drawn to the end users of la neurotecnología lleguen a todas
neurotechnology that deserve special las regiones, especialmente a
consideration, such as children, older persons, aquellas con mayores limitaciones
persons with physical disabilities and persons with de recursos
mental health conditions. Provisions on gender
equality are also included. For each population,
the Recommendation provides a series of policy
actions.
19. El AHEG delineó varias áreas de acción
política y propuso cursos concretos de acción por
dominio, incluyendo aquellos que hasta ahora han
estado menos regulados, como los entornos
educativos, el trabajo y el empleo, y los dominios
comerciales directos al consumidor. Hace un
llamado a los Estados Miembros para que
apliquen activamente políticas que puedan
proteger los derechos humanos frente a posibles
infracciones relacionadas con el desarrollo y uso
de la neurotecnología. Además, la
Recomendación reconoce que los datos sobre la
estructura, actividad y función del sistema
nervioso (datos neuronales) deben considerarse
datos sensibles, particularmente cuando se
recopilan fuera del contexto médico. Este
elemento probablemente tendrá profundas
implicaciones para los procedimientos de
consentimiento informado y el procesamiento de
datos en diversos entornos, ya que solo los datos
recopilados dentro del contexto médico se
reconocen sistemáticamente como sensibles en la
mayoría de las jurisdicciones hoy en día. Se
proporciona una lista completa de acciones
dirigidas a la política de datos biométricos
neuronales y cognitivos, la propiedad intelectual y
la ciberseguridad. Se presta atención a los
usuarios finales de la neurotecnología que
merecen una consideración especial, como los
niños, las personas mayores, las personas con
discapacidades físicas y las personas con
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de Junín y Ayacucho"
Sección Texto Original Comentarios y recomendaciones
condiciones de salud mental. También se incluyen
disposiciones sobre igualdad de género. Para
cada población, la Recomendación ofrece una
serie de acciones políticas (traducción propia).
20. The inviolable and inherent dignity of every
human being is the foundation of universal human
rights and fundamental freedoms. Respect,
protection, and promotion of human dignity, as
established by international human right law, are
essential in the whole lifecycle of neurotechnology. La dignidad humana es un valor
Dignity encompasses the recognition of the central en las recomendaciones
intrinsic and equal worth of each person. de ética de la neurotecnología. El
Neurotechnology must never be used in ways that garantizar la dignidad significa
objectify, exploit individual vulnerabilities, or evitar prácticas que exploten a
undermine the dignity or rights of any individual, poblaciones vulnerables (por
including people living in vulnerable situations. ejemplo, comunidades rurales o
de bajos recursos) como sujetos
Párrafo 20. La dignidad inviolable e inherente a todo ser
20 humano es el fundamento de los derechos
de pruebas neurotecnológicas sin
humanos universales y de las libertades su consentimiento adecuado. Se
fundamentales. El respeto, la protección y la recomienda reforzar la
promoción de la dignidad humana, tal y como implementación de protocolos
establece el derecho internacional de los éticos específicos para asegurar
derechos humanos, son esenciales en todo el que las investigaciones en
ciclo de vida de la neurotecnología. La dignidad neurotecnología respeten la
abarca el reconocimiento del valor intrínseco e cultura y los derechos humanos
igual de cada persona. La neurotecnología nunca de los grupos indígenas y rurales.
debe utilizarse de forma que cosifique, explote las
vulnerabilidades individuales o socave la dignidad
o los derechos de cualquier individuo, incluidas las
personas que viven en situaciones vulnerables
(traducción propia).
25.Equitable access to neurotechnology should be
prioritized globally, ensuring that its benefits are
En un país con brechas
accessible to all, regardless of socioeconomics
status or geographical location. Special attention socioeconómicas significativas, la
must be given to low-and-middle-income neurotecnología podría
countries, resource-constrained settings, and profundizar desigualdades si solo
marginalized communities, including the specific beneficia a sectores privilegiados
needs of different groups, ages. Segments, o áreas centralizadas como la
Párrafo
25
cultural systems, languages, communities, and capital del país. La equidad en el
marginalized and vulnerable populations, people acceso a tecnologías
with disabilities, neurological disorders and mental neurocientíficas debería promover
health conditions. su aplicación por ejemplo en la
salud pública y la educación
25.El acceso equitativo a la neurotecnología debe
inclusiva, especialmente en áreas
ser prioritario a nivel mundial, garantizando que
sus beneficios sean accesibles para todos, rurales o con bajos recursos.
independientemente de la situación
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de Junín y Ayacucho"
Sección Texto Original Comentarios y recomendaciones
socioeconómica o la ubicación geográfica. Debe
prestarse especial atención a los países de
ingresos bajos y medios, a los entornos con
recursos limitados y a las comunidades
marginadas, incluidas las necesidades
específicas de los distintos grupos, edades.
segmentos, sistemas culturales, lenguas,
comunidades y poblaciones marginadas y
vulnerables, personas con discapacidad,
trastornos neurológicos y afecciones mentales
(traducción propia).
24. Given that widely recognized
neurotechnological innovation largely occurs in the
urban well-resourced sector, specific attention to
underserved and marginalized people is crucial to
prevent bias, ongoing disparities in healthcare,
stigma, neglect, and disrespect. Technological
assimilation, or using technology as a tool of Existen economías con presencia
colonization (a term the Recommendation refers to multicultural y diversa, en estos
as “technological colonialism”). Can threaten casos se deberían considerar las
cultural diversity and heritage, therefore must be particularidades de grupos
protected against. indígenas. Se recomienda
Párrafo garantizar que los valores de no
24. Dado que la innovación neurotecnológica
24
ampliamente reconocida se produce en gran
discriminación incluyan
medida en el sector urbano bien dotado de mecanismos para evitar sesgos
recursos, es crucial prestar una atención en neurotecnologías aplicadas
específica a las personas desatendidas y por ejemplo a salud o educación
marginadas para evitar los prejuicios, las (algoritmos que excluyan o sean
continuas disparidades en la atención sanitaria, la ineficaces en poblaciones
estigmatización, el abandono y la falta de respeto. específicas).
La asimilación tecnológica, o uso de la tecnología
como herramienta de colonización (término que la
Recomendación denomina «colonialismo
tecnológico»). Puede amenazar la diversidad
cultural y el patrimonio, por lo que debe protegerse
contra ella (traducción propia).
28. It is essential that any research and
development involving diverse groups and El respeto a la autonomía y al
communities is done with their permission and consentimiento es esencial. La
guidance, and conducted with their full prior and falta de información accesible en
informed consent and partnership in ways that lenguas indígenas podría limitar la
Párrafo
serve their interest and respect their traditional comprensión y el ejercicio pleno
28
knowledge end epistemic contributions. de este derecho. Se recomienda
implementar procedimientos de
28. Es esencial que toda investigación y desarrollo consentimiento informado
que implique a diversos grupos y comunidades se culturalmente apropiados y en
haga con su permiso y orientación, y se lleve a
lenguas nativas, en línea con el
cabo con su pleno consentimiento previo e
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de Junín y Ayacucho"
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informado y en colaboración, de forma que sirva a principio de respeto a la
sus intereses y respete sus conocimientos autonomía personal.
tradicionales y sus contribuciones epistémicas
(traducción propia).
35. Respect for indigenous rights, in accordance
with the United Nations Declaration on the Rights
of Indigenous People (UNDRIP). Requires that
neurotechnology, through its whole lifecycle, be
guided by a profound respect for indigenous rights, El uso de neurotecnología debe
ensuring that their lands (including during mining), considerar el bienestar común y la
knowledge, communal rights, and privacy are sostenibilidad, un principio clave
honored in all activities, including those related to en economías donde existen
resource extraction. problemas ambientales y
económicos. Se recomienda
Párrafo 35. Respeto de los derechos indígenas, de
promover tecnologías
35 acuerdo con la Declaración de las Naciones
Unidas sobre los Derechos de los Pueblos neurocientíficas que aborden
Indígenas (UNDRIP). Exige que la problemas locales, como salud
neurotecnología, a lo largo de todo su ciclo de vida mental en poblaciones afectadas
tenga un profundo respeto de los derechos por conflictos sociales,
indígenas, garantizando que sus tierras (incluso garantizando siempre el uso
durante la explotación minera), conocimientos, responsable de los recursos.
derechos comunales y privacidad sean honrados
en todas las actividades, incluidas las
relacionadas con la extracción de recursos
(traducción propia).
Se recomienda incluir la
78. Member States should establish necesidad de fortalecer
comprehensive incentive structures, such as tax capacidades locales mediante
incentives, grants, and awards, with a particular inversión en infraestructura
focus on encouraging the construction and
científica, formación de
development of manufacturing, computational
resources, and data analytics capabilities within especialistas y establecimiento de
public research institutions and small and medium programas de transferencia
enterprises (SMEs). Member States should also tecnológica. En el caso de
incentivize and support partnership that leverage economías en desarrollo, es
the computational resources and data analytics crucial promover la cooperación
Párrafo
78
capabilities of private firms to advance public internacional bajo un marco
research goals. These incentives should prioritize equitativo que asegure el
rewarding transparency, participatory intercambio justo de
development processes, and contributions to conocimientos y tecnologías,
societal benefits, aiming to foster an environment evitando la dependencia
where institutions and companies responsibly and
tecnológica de economías
align with human flourishing goals.
desarrolladas. Además, se
78. Los Estados miembros deberían establecer podrían incluir indicadores
estructuras de incentivos integrales, como específicos para medir el impacto
incentivos fiscales, subvenciones y premios, con de estas iniciativas en la
especial atención a fomentar la construcción y el reducción de brechas
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de Junín y Ayacucho"
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desarrollo de capacidades de fabricación, tecnológicas y en la mejora de
recursos computacionales y análisis de datos en capacidades locales.
las instituciones públicas de investigación y las
pequeñas y medianas empresas (PYME). Los .
Estados miembros también deberían incentivar y
apoyar las asociaciones que aprovechen los
recursos informáticos y las capacidades de
análisis de datos de las empresas privadas para
avanzar en los objetivos de la investigación
pública. Estos incentivos deben dar prioridad a
recompensar la transparencia, los procesos de
desarrollo participativos y las contribuciones a los
beneficios sociales, con el objetivo de fomentar un
entorno en el que las instituciones y las empresas
sean responsables y se alineen con los objetivos
de florecimiento humano (traducción propia).
82. Member States should develop a robust
El marco regulatorio para la
regulatory and legal framework to govern the
gobernanza de la recolección,
collection, processing, sharing, and all other uses
of neural and cognitive biometric data. This and procesamiento, distribución y
existing frameworks should recognize this data to otros usos de los datos
be both personal and sensitive data in medical and biométricos cognitivos y neurales
no- medical context. difieren entre los estados
Párrafo miembros de economías en
82 82. Los Estados miembros deben desarrollar un desarrollo y las desarrolladas por
marco normativo y jurídico sólido que regule la los pocos recursos y capacidades
recogida, el tratamiento, la puesta en común y propias de sus contextos. Se
todos los demás usos de los datos biométricos recomienda brindar estrategias
neurales y cognitivos. Este marco y los ya que puedan ser eficaces en estos
existentes deberían reconocer que estos datos
contextos específicos de las
son tanto personales como sensibles en el
contexto médico y no médico (traducción propia). economías en desarrollo.
Se recomienda incluir la
99. Member States should implement public and
organización de foros
community engagement processes that facilitate
genuine mutual learning and collaboration comunitarios y mesas de diálogo
throughout the whole lifecycle of neurotechnology. que involucren a científicos,
These processes should include regular and expertos en ética, gobiernos y
inclusive consultations with a wide array of actors. comunidades. Estos eventos
Párrafo The aim of these engagements should be to inform deben incluir explicaciones
99 policy development, shape. ethical guidelines, sencillas, material didáctico y
increase public awareness and understanding, ejemplos prácticos que ayuden a
align investment priorities, and ensure that la población a tomar decisiones
neurotechnology deployment aligns with public informadas para participar en el
interests and values. Special attention should be proceso del desarrollo del a
given to involving groups traditionally
underrepresented in technological policymaking,
neurotecnología en cada
segmento de su ciclo de vida.
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"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
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thereby fostering responsible innovation in the
field.
99. Los Estados miembros deben poner en marcha
procesos de participación pública y comunitaria
que faciliten un auténtico aprendizaje mutuo y la
colaboración a lo largo de todo el ciclo de vida de
la neurotecnología. Estos procesos deben incluir
consultas periódicas e inclusivas con una amplia
gama de actores. El objetivo de estos
compromisos debe ser informar sobre el
desarrollo de políticas, dar forma a las directrices
éticas, aumentar la concienciación y la
comprensión del público, alinear las prioridades
de inversión y garantizar que el despliegue de la
neurotecnología se alinea con los intereses y
valores públicos. Debe prestarse especial
atención a la participación de grupos
tradicionalmente infrarrepresentados en la
elaboración de políticas tecnológicas, fomentando
así la innovación responsable en este campo
(traducción propia).
114. Member States should adopt a range of
measures that prioritize ethical and equitable
research and innovation and support programs
that foster women’s and gender minorities’ Aunque se mencionan políticas
participation in neurotechnology. This includes inclusivas y programas de apoyo,
funding and other policies that prioritize ethical and sería útil incluir indicadores
equitable research and innovation, but also
medibles para evaluar el impacto
affirmative action initiatives to support the
participation of women and gender minorities in de estas iniciativas, como el
neurotechnology through targeted education porcentaje de participación de
programs, employment opportunities, mujeres y minorías de género en
entrepreneurship support, and leadership proyectos neurotecnológicos o el
development within the sector. Member States acceso a financiamiento
Párrafo
should also provide support systems such as específico.
114
mentorship programs, networking opportunities,
and resources to help women and gender Se recomienda, además, añadir la
minorities overcome barriers to participation and necesidad de campañas públicas
succeed in the neurotechnology field. que sensibilicen sobre la
importancia de la equidad de
114. Los Estados miembros deben adoptar una
serie de medidas que den prioridad a la género en la neurotecnología,
investigación y la innovación éticas y equitativas y incentivando la participación
apoyen programas que fomenten la participación desde etapas tempranas como la
de las mujeres y las minorías de género en la educación secundaria.
neurotecnología. Esto incluye la financiación y
otras políticas que den prioridad a la investigación
y la innovación éticas y equitativas, pero también
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de Junín y Ayacucho"
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iniciativas de acción afirmativa para apoyar la
participación de las mujeres y las minorías de
género en la neurotecnología a través de
programas de educación específicos,
oportunidades de empleo, apoyo a la iniciativa
empresarial y desarrollo del liderazgo dentro del
sector. Los Estados miembros también deben
proporcionar sistemas de apoyo, como programas
de tutoría, oportunidades de creación de redes y
recursos para ayudar a las mujeres y a las
minorías de género a superar las barreras a la
participación y a tener éxito en el campo de la
neurotecnología (traducción propia).
122. Member States should support the
development of health applications that prioritize
the unmet needs in the provision of neurological
and mental health. This should include
establishing research funding programs
specifically targeted at addressing identified gaps
in nervous system care. Se recomienda, incluir
mecanismos específicos para
122. Los Estados miembros deben apoyar el identificar brechas regionales y
Párrafo
122
desarrollo de aplicaciones sanitarias que den socioeconómicas en el acceso a
prioridad a las necesidades no cubiertas en la neurotecnologías para el
prestación de servicios de salud neurológica y diagnóstico y tratamiento en
mental. Esto debería incluir el establecimiento de países en desarrollo.
programas de financiación de la investigación
dirigidos específicamente a abordar las lagunas
identificadas en la atención del sistema nervioso
(traducción propia).
.
124. Member States should establish oversight
mechanisms to evaluate the physical and mental
health impacts of long-term use of
neurotechnological devices, with special attention
to invasiveness and reversibility of
neurotechnology interventions. This includes Se recomienda reforzar la
implementing regulatory measures requiring long- necesidad de estudios
term follow-up studies for approved multidisciplinarios y longitudinales
Párrafo
124
neurotechnology devices and establishing clear que evalúen los efectos físicos,
criteria for continued approval based on these mentales y sociales del uso
studies results. prolongado de neurotecnologías
en entornos vulnerables.
124. Los Estados miembros deben establecer
mecanismos de supervisión para evaluar los
impactos en la salud física y mental del uso a largo
plazo de dispositivos neurotecnológicos, con
especial atención a la invasividad y reversibilidad
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"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
Sección Texto Original Comentarios y recomendaciones
de las intervenciones neurotecnológicas. Esto
incluye la aplicación de medidas reguladoras que
exijan estudios de seguimiento a largo plazo para
los dispositivos neurotecnológicos aprobados y el
establecimiento de criterios claros para continuar
con la aprobación en función de los resultados de
estos estudios (traducción propia).
126. Member States should promote the
development of reliable and durable
neurotechnology for healthcare applications. This
includes encouraging the design of devices and
systems that require minimal maintenance,
ensuring they remain functional and effective
under everyday conditions. Regulatory bodies or
designated authorities should oversee the
enforcement of rigorous standards for quality,
safety, and longevity, thereby reducing the burden Se recomienda incluir el
on users and enhancing the dependability and establecer estándares rigurosos
sustainability of neurotechnological solutions. de diseño y mantenimiento que
Párrafo adapten dispositivos
126 126. Los Estados miembros deben promover el neurotecnológicos a condiciones
desarrollo de neurotecnología fiable y duradera locales, como climas extremos o
para aplicaciones sanitarias. Esto incluye falta de infraestructura
fomentar el diseño de dispositivos y sistemas que hospitalaria.
requieran un mantenimiento mínimo, garantizando
que sigan siendo funcionales y eficaces en
condiciones cotidianas. Los organismos
reguladores o las autoridades designadas
deberían supervisar la aplicación de normas
rigurosas de calidad, seguridad y longevidad,
reduciendo así la carga para los usuarios y
mejorando la fiabilidad y sostenibilidad de las
soluciones neurotecnológicas (traducción propia).
150. Member States should strengthen
comprehensive consumer protection laws to
include clear labelling on commercial
neurotechnology products, detailing their effects,
limitations, and risks to prevent misleading claims Se recomienda reforzar la
and ensure transparency. This also includes prohibición del uso de datos
prohibiting practices of "tying" or requiring the
neuronales en publicidad dirigida,
Párrafo disclosure of neural and cognitive biometric data
asegurando que el
150 as a condition to access goods or services, and
prohibition about third party data sharing or the consentimiento informado sea
uses of this data without affirmative opt-in option. claro, explícito y renovable en
cualquier momento.
150. Los Estados miembros deben reforzar las
leyes generales de protección de los
consumidores para incluir un etiquetado claro en
los productos comerciales de neurotecnología,
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de Junín y Ayacucho"
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detallando sus efectos, limitaciones y riesgos para
evitar afirmaciones engañosas y garantizar la
transparencia. Esto también incluye la prohibición
de prácticas de «vinculación» o de exigir la
revelación de datos biométricos neurales y
cognitivos como condición para acceder a bienes
o servicios, y la prohibición de compartir datos con
terceros o de utilizar estos datos sin una opción de
consentimiento afirmativo (traducción propia).
149. Member States should proactively establish a
regulatory framework that balances innovation in
the recreational and commercial domains with
protecting individual rights and well-being. This
framework should be dynamic, allowing for timely
updates as technology evolves and new insights
are gained about its impacts on society. This
includes providing adequate oversight to ensure
that neurotechnology does not cause harm, are
used consensually, and include robust Se observa la falta de inclusión de
mechanisms to protect users from potential mecanismos para garantizar que
psychological distress or manipulation. las aplicaciones comerciales de
Párrafo neurotecnología no se conviertan
149. Los Estados miembros deben establecer de
149 en productos elitistas,
forma proactiva un marco regulador que equilibre
la innovación en los ámbitos recreativo y comercial promoviendo políticas de acceso
con la protección de los derechos individuales y el equitativo y regulaciones de
bienestar. Este marco debe ser dinámico, precios en países en desarrollo.
permitiendo actualizaciones oportunas a medida
que la tecnología evoluciona y se obtienen nuevos
conocimientos sobre sus impactos en la sociedad.
Esto incluye proporcionar una supervisión
adecuada para garantizar que la neurotecnología
no cause daños, se utilice de forma consensuada
e incluya mecanismos sólidos para proteger a los
usuarios de una posible angustia psicológica o
manipulación (traducción propia).
160. Member States should develop capacities in Se recomienda que los Estados
governmental institutions and support government Miembros incluyan programas
officials to steer the technological development específicos de formación técnica y
ethically.
ética adaptados a contextos
Párrafo
locales, especialmente para
160 160. Los Estados miembros deben desarrollar las
capacidades de las instituciones gubernamentales países en desarrollo, donde las
y apoyar a los funcionarios para que dirijan el capacidades institucionales y de
desarrollo tecnológico de forma ética (traducción gobernanza requieren
propia). fortalecimiento.
165. Processes for monitoring and evaluation
Párrafo Se recomienda asegurar que los
should ensure broad participation of all actors,
165 procesos de monitoreo y
including, but not limited to, under-represented,
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de Junín y Ayacucho"
Sección Texto Original Comentarios y recomendaciones
vulnerable people or people in vulnerable evaluación incluyan datos
situations and ensuring social, cultural and gender desagregados sobre grupos
diversity. The monitoring and assessment of the vulnerables, garantizando
impact of neurotechnology and related ethics transparencia en los resultados y
policies and practices should be carried out
la generación de políticas públicas
continuously in a systematic way proportionate to
basadas en evidencia.
the relevant risks. This should be based on
internationally agreed frameworks and involve
evaluations of private and public institutions. Data
collection and processing should be conducted in
accordance with international law, national
legislation on data protection and data privacy,
and the values and principles outlined in this
Recommendation.
165. Los procesos de seguimiento y evaluación
deben garantizar una amplia participación de
todos los actores, incluidas, entre otras, las
personas infrarrepresentadas, vulnerables o en
situación de vulnerabilidad, y garantizar la
diversidad social, cultural y de género. El
seguimiento y la evaluación del impacto de la
neurotecnología y de las políticas y prácticas
éticas conexas deberían llevarse a cabo de forma
continua y sistemática, proporcional a los riesgos
pertinentes. Esto debería basarse en marcos
acordados internacionalmente e implicar
evaluaciones de instituciones privadas y públicas.
La recopilación y el tratamiento de datos deben
realizarse de conformidad con el Derecho
internacional, la legislación nacional sobre
protección de datos y privacidad de los datos, y los
valores y principios expuestos en la presente
Recomendación (traducción propia).
III) Conclusiones y recomendaciones
3.1. La neurotecnología representa una herramienta transformadora con un gran potencial en sectores como
la salud, la educación y la productividad. El borrador de Recomendación sobre Ética de la neurotecnología
constituye un insumo valioso para orientar el desarrollo de esta tecnología bajo principios éticos y
responsables. En este contexto, el presente informe incluye recomendaciones tanto sobre el informe
preliminar del primer borrador de la Recomendación como sobre la Recomendación en sí, con el fin de
garantizar que su implementación priorice la equidad y la ética. Esto resulta especialmente relevante en
países en desarrollo como Perú, donde las desigualdades socioeconómicas y regionales podrían
agravarse si no se toman medidas adecuadas para garantizar un acceso inclusivo y equitativo.
3.2. Asimismo, se enfatizó la importancia de la participación activa de comunidades vulnerables, incluidas las
rurales e indígenas, en los procesos de consulta, diseño y desarrollo de estas tecnologías, respetando sus
derechos, culturas y necesidades específicas. Finalmente, se subrayó la necesidad de establecer marcos
449 Página 12 de 13
Consejo Nacional de Ciencia, Dirección de Políticas y
Tecnología e Innovación Programas de CTI
"Decenio de la Igualdad de Oportunidades para Mujeres y Hombres"
"Año del Bicentenario, de la consolidación de nuestra Independencia, y de la conmemoración de las heroicas batallas
de Junín y Ayacucho"
normativos sólidos, participativos y culturalmente adecuados que fomenten un uso seguro, equitativo y
ético de la neurotecnología, abordando riesgos asociados a la explotación de datos, exclusión social y
violaciones de derechos humanos.
3.3. Se recomienda remitir el presente informe a la DPP para su derivación a la Secretaria General y continuar
con los trámites correspondientes.
Es cuanto tengo que informar para los fines que considere conveniente.
Atentamente
Documento firmado digitalmente
ZENIA JULIETA MEDINA CONTRERAS
SUB DIRECCIÓN DE INNOVACIÓN Y TRANSFERENCIA TECNOLÓGICA
ZMC
cc.:
450 Página 13 de 13
REPUBLIC OF KOREA/RÉPUBLIQUE DE CORÉE
PRELIMINARY REPORT ON THE FIRST DRAFT OF THE RECOMMENDATION ON THE
ETHICS OF NEUROTECHNOLOGY
This preliminary report on the draft Recommendation on the Ethics of Neurotechnology, was
prepared in accordance with Article 10.1 of the Rules of Procedure concerning recommendations to
Member States and international conventions covered by the terms of Article IV, paragraph 4, of the
Constitution.
INTRODUCTION
1. Within the general advancement of scientific knowledge and technology, the disciplines that
study the brain and mind have made significant progress. According to UNESCO, during the last
decades, neuroscience has been one of the most dynamic areas of research and innovation, with an
increasing number of patents (from less than 500 in 2000 to over 12,000 in 2020), scientific
publications (reaching 1.2 million in 2021) and investments (the neurotechnology devices market is
expected to reach USD24.2 billion by 2027) 1 . This progress has substantively advanced our
understanding of the nervous system, offering the possibility to intervene on the brain and address
many unmet medical needs, related especially to neurological disorders and mental health. It is also
a major source of ethical challenges deeply interconnected with human rights and human dignity, as
the nervous system is the coordinating centre of behaviour and mental processes enabling the
exercise of self-determination, the capacity to act as moral agents, to exert responsibility, cooperate
with others, deliberate about individual or collective decisions and develop one's own personality.
Considering the major impact of these developments and their significance for the human rights
framework, this debate falls clearly within the scope of UNESCO's mandate to advance the ethics of
science and technology.
2. Neurotechnology refers to devices, systems, and procedures that directly access, monitor,
analyse, predict or modulate the nervous system to understand, influence, restore, or anticipate its
structure, activity, function, or intentions. Historically, neurotechnology tools have been developed
for laboratory research, such as observing the brain activity of patients or healthy volunteers. These
tools have been used in the clinic for decades as diagnostic tools or to mitigate the impacts of
neurological and neurodegenerative disorders such as Parkinson's disease by stimulating targeted
brain areas and partially restoring brain functions. The convergence of neurotechnology with other
scientific and technological developments, particularly artificial intelligence, has opened the door to
more powerful, precise, and ready-to-use applications.
3. Consequently, neurotechnology is being mobilised in a growing number of settings and
situations, and it is expected to increase its footprint. Besides the medical field that keeps expanding,
new application domains emerge, including in education, the workplace, and the direct-to-consumer
market for entertainment or personal use.
4. In this context, the ethical challenges raised by neurotechnology go beyond those linked with
the medical or research field, that are usually well framed in many countries, bringing new challenges
for human rights. In some instances, neurotechnology may pose new threats to human dignity and
integrity, and challenge fundamental freedoms such as freedom of thought. With its power to modify
our nervous system, neurotechnology can shape the lives of persons, and the developments that
may bring positive impact could also be misused or have unintended negative consequences. Tools
interfering with the brain might challenge our ability to make free decisions. It raises also critical
concerns over issues of manipulation in the political domain, in marketing, in the recreational domain,
and in other areas outside the medical realm, as well as concerns over threats to democracy,
especially if one considers the convergence of neurotechnology with artificial intelligence. Data about
the structure, activity and function of the nervous system (neural data) can be processed to provide
information related to the health and mental states of the person. The right to privacy may be
Figures from the UNESCO report Unveiling the Neurotechnoloqy Landscape: Scientific Advancements, Innovations
and Maior trends, 2023
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threatened, as some aspects of inner life that are naturally concealed - private thoughts that relate
to us intimately and personally - might be disclosed when neural data is processed or combined with
other data. The global circulation of data, which is a hallmark of contemporary science, makes this
issue even more pressing and difficult to handle.
5. The risks to human rights, fundamental freedoms and human dignity are real, and concern
everyone, from patients with severe disabilities to a larger population of potential technology users
of different applications, such as children whose developing brains are very sensitive. In the context
of increasing healthcare inequalities, neurotechnology development and commercialisation can
challenge the principles of justice and solidarity. There are millions of patients with unmet medical
and the potential benefits of neurotechnology for healthcare are enormous. At the same time, there
are also prospects of healthy individuals who can access the latest technological developments to
enhance their cognitive functions (e.g., attention, memory) at the detriment of others such as in
educational settings or in the workplace. In this context, an international and coordinated effort is
required to steer an ethical development of neurotechnology for the benefit of humankind and
mitigate its impacts on human rights.
6. Under the leadership of UNESCO's Director-General, and parallel to other normative work of
UNESCO, the need to tackle the challenges imposed by neurotechnology was based on the research
conducted by the International Bioethics Committee (IBC) of UNESCO, whose experts prepared a
report on the Ethical Issues of Neurotechnologv in 2021, and the mandate for the elaboration of a
Recommendation on the Ethics of Neurotechnology as provided by the General Conference (42
C/Resolution 29).
7. The United Nations Secretary-General report on "Our Common Agenda" (2021) mentioned
neurotechnology as a frontier human rights issue, and Secretary General Antonio Guterres
established a working group at the Assistant Director-General level, co-led by UNESCO and the
Executive Office of the Secretary-General. The working group included other international
organizations, such as the Office of the United Nations High Commissioner of Human Rights and the
Organisation for Economic Co-operation and Development (OECD). The Working Group convened
two interdisciplinary expert consultation meetings in 2021 and 2022 to present key findings and
recommendations of the work done in the system (particularly the UNESCO- IBC reports) and to
advance a coordinated United Nations-wide system approach to the governance of neurotechnology.
Given its work in this field UNESCO was entrusted with the lead of this workstream.
8. UNESCO organised several events throughout this process, including a seminar for
Ambassadors and permanent delegates (April 2023) and an international conference in July 2023.
To inform the International Conference, UNESCO launched top notch research, based on machine
learning, mapping the technological developments, innovation and patents of neurotechnology,
(Unveiling the Neurotechnology Landscape: Scientific Advancements, Innovations and Major Trends,
2023) filling a gap in the understanding of the research, investments and innovation trends, as well
as the distribution and access to knowledge on neurotechnology all around the world. UNESCO also
prepared an overview of the risks and challenges of neurotechnologies for human rights.
9. At the same time, initiatives providing normative guidance for neurotechnology development
have been burgeoning at the international and national levels. Some countries have updated their
laws or are engaged in processes to do so. Soft law instruments and declarations at the international
level have been published recently, such as the Inter-American Declaration of Principles on
Neuroscience, Neurotechnoloqies. and Human Rights by the Inter-American Juridical Committee or
the EU Le6n Declaration on European Neurotechnoloqy at the EU inter-ministry level, both published
in 2023. Other initiatives include guidelines for stakeholders and producers of the technology, such
as the OECD Recommendation on Responsible Innovation in Neurotechnoloqy (2019) or the French
Charter for the responsible development of neurotechnology (2022). A European charter is now
under consideration by major scientific societies in this domain. The Council of Europe is also
currently leading a discussion on neurotechnology and human rights. UNESCO has been working
in close collaboration with the Office of the United Nations High Commissioner for Human Rights
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and the United Nations Human Rights Council. The latter has launched a consultation process
analysing the human rights implications of neurotechnology. The different initiatives were reflected in
UNESCO's Towards a draft text of a Recommendation on the Ethics of Neurotechnology: working
document, April 2024).
10. The frameworks mentioned above vary depending on their respective areas of application and
approaches. Given the increased activities in this domain, UNESCO has mapped these initiatives
and coordinated with them. The specific mandate on the ethics of science and technology as well as
its capacity to develop global standards with universal membership, position UNESCO well to
develop a global and pluralistic process, and to establish a platform for dialogue, bringing together
both developed and developing countries, different cultural perspectives, as well as various
stakeholders within the public and private sector. UNESCO has acted as a bridge between Member
States, civil society, the research community, academia, and the private sector, building on its record
of multi-stakeholder consultation and consensus building.
PROCESS
11. In line with 42 C/Resolution 29, on the basis of Member States proposals, and top experts
identified by the Secretariat of the Social and Human Sciences Sector (SHS) of UNESCO, an Ad
Hoc Expert Group (AHEG) was established by UNESCO's Director-General to prepare a first draft
text of a Recommendation on the Ethics of Neurotechnology. The AHEG is composed of 24
independent experts from all UNESCO regions, appointed on a geographical and gender balance
basis and bringing complementary disciplines. The first AHEG meeting was held at UNESCO's
Headquarters from 22 to 26 April 2024 and was opened and attended by the Assistant Director
General for SHS and supported by the Bioethics Section. The AHEG elected a Bureau with members
from all UNESCO regions, including two co-chairs (from the United States of America and France)
and a rapporteur (from Kenya). The AHEG drew on its own expertise and the work and reflection
already conducted at UNESCO to advance its work on the first draft of a Recommendation.
12. To collect feedback on the first version of the draft Recommendation, SHS, with the support of
field offices, conducted a multi-stakeholder consultation process on the first version of the draft
Recommendation from 6 June to 12 July 2024. The consultation process was based on three
components: (i) a global public online consultation, which collected over 7000 comments
demonstrating high interest in the topic despite its highly specialised nature; (ii) 25 regional, sub
regional and national online and in person consultations co-organised with host countries, institutions
and/or National Commissions for UNESCO in all of UNESCO's regions, involving some 800
participants from over 100 countries; and (iii) coordination with other international agencies, including
at the United Nations level, was conducted through the Inter-Agency Working Group on Artificial
Intelligence (IAWG-AI) as well as through the United Nations Inter-Agency Committee on Bioethics
(UNIACB).
13. The consultations generated a rich conversation that raised awareness and triggered regional
and sub-regional debates. The consultations have clearly shown the need and the strong appetite
to have an ethical framework on neurotechnology. Beyond the encouraging comments and positive
feedback collected during the regional and sub-regional debates, the consultation process provided
also concrete figures on the overall support to the document, with a majority of respondents
endorsing the choices made in the first draft. Many comments referred to the vocabulary and
language used in the draft, from fundamental concepts such as the definition of neurotechnology and
neural data to terms related to human rights and ethics of science. Thanks to the consultation, points
in need of clarification and passages requiring improvement were identified. Useful suggestions were
numerous, sometimes including concrete wording for some passages. The need to revise the
structure of the document to better reflect the articulation between values, ethical principles, human
rights, and policy actions, was also recognised. The consultation process fostered also global
discussions on the issue of consent and self-determination, the impact of neurotechnology on
children and the rising inequalities worldwide.
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14. The Bureau of the AHEG accompanied by the Secretariat prepared a preliminary revision of
the Recommendation draft taking into consideration the most relevant comments. A new structure
as well as many improvements in the text were suggested. The AHEG convened again during a
meeting week on 26-30 August at UNESCO Headquarters and finalised the first draft
Recommendation based on the feedback of the consultations and on its further discussions, and to
include the implementation and follow up section. As such, the first draft of the Recommendation is
transmitted to Member States, for their comments, together with this preliminary report.
THE FIRST DRAFT OF THE RECOMMENDATION
15. The AHEG decided to focus on the impacts of neurotechnology on humankind and human
rights. Given the spectrum of current and future applications of neurotechnology (from research and
clinic to education, workplace, entertainment) and the diversity of populations possibly affected by
these technological developments, the ambition was to produce a framework as comprehensive and
agile as possible. The discussion put the emphasis on recurring themes, such as the protection of
brain data collected by neurotechnology, the need to safeguard the self-determination of persons
while intervening on their brain, the respect for the principle of justice in neurotechnology
development and use, the need for techniques to work for the benefit of humanity as a whole, and
the desire to refuse any practice of discrimination, unconsented standardisation and alignment with
a dominant pattern.
16. One of the first tasks of the AHEG was the identification of critical ethical and human rights
challenges as well as deciding on the scope of the Recommendation and providing specific
definitions that could capture the complexity of the subject matter. During the first meeting, different
working groups were established to advance specific parts of the agenda, and to cover various
aspects and drafting chapters. During the second meeting week, the AHEG debated only in plenary
session while the Bureau worked on the integration of the outputs of the plenary discussion into draft
proposals.
17. Significant methodological choices were made with regard to definition and scope. Although
the definition of neurotechnology adopted in the draft Recommendation follows a classical distinction
between observational (those that collect and analyse data from the nervous system) and
interventional tools (modulation of brain and neural activity), defining neurotechnology is a delicate
exercise that has sparked many debates within the AHEG and elicited many comments in the
consultations. While the group wanted the definition to be as broad as possible so that it can apply
to a wide range of neurotechnology tools even in the future, the draft Recommendation provides also
some examples of current technologies for clarity. One notable aspect of the adopted definition by
AHEG is that attention should be put on the nervous system, beyond the brain (that is, consider the
peripheral nervous system along with the central nervous system). Indeed, neurotechnology can be
mobilised to restore function in cases of paralysis or motor disorders via stimulation of the spinal
cord. The AHEG was also aware of the fact that neurotechnology in a strict sense (recording of
signals or stimulation of neurons and nerves) is often combined with other tools and other data, such
as biometric data more generally (physiological measurements) and the processing of this data will
often involve artificial intelligence. The latter is crucial in many neurotechnology applications today.
This convergence of tools and data contributes increased power and efficacy when it comes to
observe, predict and modify mental states. As a consequence, it was decided that the
Recommendation should embrace a broad scope. It includes what the AHEG called "cognitive
biometric data", that is, data collected by non-neural biometric technologies that can be processed to
infer mental states: Consistent with this wide-ranging approach, it was decided that neurotechnology
ought to be considered in its whole lifecycle, from the early stages of mining for materials, prototyping,
research, design and development to deployment and use, including maintenance, operation, trade,
financing, monitoring and evaluation, validation, end-of-use, disassembly, termination, disposal and
recycling. It also considers the intersection with other converging technologies, such as artificial
intelligence.
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18. The draft Recommendation relies on an extensive list of values and ethical principles that are
detailed in a dedicated chapter. Given the success and the record of UNESCO's work on Artificial
Intelligence, the discussion among the experts started from the values already established in the
Recommendation on the Ethics of Artificial Intelligence, which were further discussed and refined to
fit the specificity of neurotechnology. The following values were put forward: the respect, protection
and promotion of fundamental human rights, fundamental freedoms and human dignity; promoting
human health and well-being; ensuring and respecting diversity and fairness; consideration for cross
cultural perspectives on human knowledge and its sharing; commitment to peace, fairness and justice
in society; global solidarity and international cooperation; sustainability; integrity and responsibility.
The values were developed into ethical principles and human rights at stake in neurotechnology:
beneficence, proportionality and do no harm; self-determination and freedom of thought; protection
of neural and cognitive biometric data for mental privacy; non-discrimination and inclusivity;
accountability; trustworthiness and transparency; epistemic justice, inclusive engagement and public
empowerment; best interests of the child and protection of future generations; global and social
justice, enjoying the benefits of scientific progress and its applications.
19. The AHEG delineated several areas of policy action and proposed concrete courses of action
by domain, including those that are less regulated up to now such as educational settings, labour
and employment, and the direct-to-consumer and commercial domains. It calls on Member States to
actively enforce policies that can protect human rights against possible infringements related to
neurotechnology development and use. Furthermore, the Recommendation recognises that data
about the structure, activity and function of the nervous system (neural data) should be considered
sensitive data, particularly when collected outside of the medical context. This element will likely have
deep implications for informed consent procedures and data processing in various settings, as only
data collected within the medical context is systematically recognised sensitive in most jurisdictions
today. A full list of actions directed at neural and cognitive biometric data policy, intellectual property,
and cybersecurity is provided. Attention is drawn to the end users of neurotechnology that deserve
special consideration, such as children, older persons, persons with physical disabilities and persons
with mental health conditions. Provisions on gender equality are also included. For each population,
the Recommendation provides a series of policy actions.
20. An implementation plan is included in the draft Recommendation. It proposes a UNESCO full
fledged program on the ethics of neurotechnology, based on the successful program established for
the implementation of the UNESCO's Recommendation on the Ethics of Artificial Intelligence (2021).
Such a program could include a Readiness Assessment Methodology to assist Member States in
identifying their status at specific moments of their readiness trajectory and a methodology for Ethical
Impact Assessment of neurotechnology based on rigorous scientific research and grounded in
international human rights law. These tools would be backed up by a research program on the ethics
of neurotechnology gathered in a UNESCO observatory with the aim of becoming a shared pool of
knowledge and awareness of good practices and innovations. Another key element would be the
creation of a collaborative platform fostering meaningful exchanges and facilitating collaboration
among Member States and among stakeholders to promote a global policy dialogue, including at
Ministerial level in the context of a Global Forum on the Ethics of Emerging Technologies, combining
the current Global Forum on the Ethics of Artificial Intelligence, and its annual edition, with this other
platform that would deal with developments in neurotechnology. A network of experts on the ethics
neurotechnology with balanced representation of all UNESCO's regional groups could be established
to support this effort.
NEXT STEPS
21. To be effective, the Recommendation needs to be accompanied by policy and support in
building national capacities for its implementation and transformation into concrete guidelines for
neurotechnology actors, legal and governance frameworks. As such, UNESCO will bring its 30 years
expertise in dealing with the ethics of emerging technologies, including bioethics and more recently
artificial intelligence, to assist Member States in fulfilling the provisions outlined in the
Recommendation once adopted. The comprehensive implementation programme mentioned above
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will be instrumental in that regard. The Recommendation will also provide a solid foundation for the
entire United Nations system in its collective response to the human rights challeng,es raised by
neurotechnology.
22. Member States are now invited to submit their comments and observations, in English or
French, on the first draft of the Recommendation annexed hereto, no later than 31 December 20242.
Responses should be addressed to Gabriela Ramos, Assistant Director-General for the Social and
Human Sciences, at the following email address: [email protected]. A final report containing
a draft text of the Recommendation will be prepared based on those comments and observations
and communicated to Member States by Spring 2025. The final report shall be submitted to the
intergovernmental meeting of a special committee (category 11 meeting) in Spring 2025 for finalization
and eventual adoption by UNESCO's General Conference at its 43rd session.
2 The first draft of the Recommendation is available in Arabic, Chinese, English, French, Russian and
Spanish on the following website:
https://www.unesco.org/en/ethics-neurotech/recommendation?hub=83294
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FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY
PREAMBLE
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health conditions,
along with the profound suffering they cause for individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better
preventive and therapeutic treatments for millions, benefitting humanity as a whole and providing
opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
self:-determination, privacy, personal identity, freedom of thought, risk of discrimination, inequality
and challenges to democracy, and that justice, trust and fairness must be upheld so that no country
and no one should be left behind, either by having fair access to neurotechnology and enjoying their
benefits or in the protection against their risks, while recognizing the different circumstances of
different countries and respecting the desire of some people not to take part in all technological
developments,
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security
by promoting collaboration among nations through education, the sciences, culture, and
communication and information, in order to further universal respect for justice, for the rule of law and
for the human rights and fundamental freedoms which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human rights,
as well as gender equality, social and global justice and development, physical and mental well
being and health, diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide neurotechnology in a
responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development and
policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General "to prepare a standard-
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setting instrument on the ethics of neurotechnology in the form of a recommendation", which is to be
submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration on
the Responsibilities of the Present Generations Towards Future Generations (1997); the Universal
Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on the Rights of
Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate Change (2017);
the Recommendation on Science and Scientific Researchers (2017); the Recommendation on the
Ethics of Artificial Intelligence (2021); the Recommendation on Open Science (2021); the Human
Rights Council's resolution on 'The right to privacy in the digital age" (NHRC/RES/42/15) (2019); the
Human Rights Council's resolution on "New and emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), and the UN Guiding Principles on Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to Al-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX
day of November 2025;
2. Recommends that Member States, with the support of UNESCO's Secretariat, apply
the provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other measures may be required, in conformity with the constitutional
practice and governing structures of each State, to give effect within their jurisdictions
to the principles and norms of the Recommendation in conformity with international law,
including international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound scientific research as well as
ethical analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
1.1 SCOPE
This Recommendation:
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1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on human health, human flourishing and on the enjoyment of human rights.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (OTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to animals
in research.
4. Approaches neurotechnology ethics as a systematic normative reflection based on a holistic,
multicultural, multidisciplinary, pluralistic and evolving framework of interdependent values,
principles, and actions that can guide societies in dealing responsibly with the impacts of
neurotechnology on human beings, societies, and the environment and ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the prevention of
harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from neuroscience,
medicine, engineering, psychology, ethics, human rights, law, sociology, anthropology
and other disciplines.
5. Covers the measurement, recording, and modification of the human nervous system, the
handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because the
highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to be
responsible for actions, cooperate with others, deliberate about collective decisions and develop
personality.
7. Further recognizes that humans develop and flourish in their interaction with other human
beings and a nurturing material and cultural environment, highlighting that autonomy is not just
individual but also relational, as it arises from and impacts one's interactions and belonging with
the community.
8. Addresses the ethical and human rights concerns that arise from the rapid developments
and the convergence of neurotechnology with other technologies such as spatial computing,
extended reality (XR), artificial intelligence (Al), sensors and semi-conductors. Notably, other
biometric data when processed to infer sensory, motor, and mental states raises similar ethical
concerns. Therefore, this Recommendation applies to both neurotechnology and the use of
cognitive biometric data, ensuring that ethical principles and practices are consistently applied
across these domains.
9. Further addresses the integration of Al with neurotechnology, which can enhance precision
and predictive capabilities, such as improving processing speed, reducing cost, optimizing
neurotechnology systems. However, it also magnifies ethical threats, including cybersecurity
concerns, lack of transparency, the potential for algorithmic bias, and risks to autonomy, mental
privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications of
neurotechnology. Calls on all concerned to act responsibly with regard to neurotechnology.
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1.2 DEFINITIONS
11. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include cognitive,
affective, and conative states), and supports consciousness, sleep and the experience of pain.
The nervous system activity and structure provide information inherent to all human beings and
the community, regardless of gender, ethnicity, language, or religion. The nervous system activity
is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, and procedures
encompassing both hardware and software-that directly access, monitor, analyze, .predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity,
function, or intentions (speech, motor). Neurotechnology combines elements of neuroscience,
engineering, and computing, among others.
13. Neurotechnology spans medical and non-medical applications and includes tools that
measure, infer, and influence nervous system activity, whether through direct interaction with the
nervous system or by interfacing it with devices and systems. It includes but is not limited to:
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical, optical,
magnetic and/or mechanical), chemical and biological signals associated with the
structure of and functional signals from the nervous system. These may be used to
identify, record, and/or monitor properties of nervous system activity, understand how
the nervous system works, diagnose pathological conditions, or control external
devices (brain machine interfaces (BMI), often referred to as brain computer interfaces
(BCI)). Of note, both open-loop (i.e., fixed-parameter brain stimulation) and closed
loop systems (i.e., state dependent stimulation) introduce complex ethical issues.
(i). Examples include but are not limited to Electroencephalography (EEG),
Magnetoencephalography (MEG), Magnetic resonance imaging (MRI),
Functional Magnetic resonance imaging (fMRI), Positron emission tomography
(PET), Functional Near-infrared spectroscopy (fNIRS), Implanted
microelectrodes, Optogenetics, Optical imaging, Diffusion weighted imaging,
Calcium imaging, Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for example,
to restore sensory input, such as hearing (i.e., cochlear implants) or Deep Brain
Stimulation (DBS) to treat tremors and other pathological conditions. They are meant
to either modulate the functions of the nervous system and/or send signals directly to
the nervous system by applying acoustic, electrical, magnetic or optical stimulation
and/or inhibition of the peripheral or central nervous system.
(i). Examples of this neurotechnology are implanted microelectrodes, BMI, DBS,
Optogenetic optical stimulation, Transcranial electrical stimulation (tES),
Transcranial Magnetic Stimulation (TMS) or Neuropharmacological infusion.
14. Of note, several sensor technologies collect data indirectly informing about neural activity.
Even if they are not neurotechnology per se, they raise similar ethical and human rights issues as
neurotechnology when used to infer mental states. They include but are not limited to eye-tracking,
Video Oculography, Typing dynamics, Voice recognition and analysis, Gait analysis, Skin
conductance, Heart rate variability, Sleep movement monitoring, Blood pressure measurement, or
facial- emotion recognition systems.
15. Neural data. Neural data are qualitative and quantitative data about the structure, activity
and function of the nervous system. They encompass data relating to a nervous system's activity,
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including both direct measurements of neuronal structure, activity and/or function (i.e., neuronal
firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e., blood flow
in fMRI and fNIRS). At the neurobiological level, neural data are the most direct correlates of
mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non-neural biometric
technologies can be processed to infer mental states, which this Recommendation refers to as
"cognitive biometric data".
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining for
materials, prototyping, research, design and development to deployment and use, including
maintenance, operation; trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology includes
its convergence with other technologies and the diversity of actors who are involved in every stage.
11. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the development and use
of neurotechnology in ways that are ethical, safe and effective for the good of humanity, individuals,
communities, societies, the environment and ecosystems, and to prevent harm in the present and
the future based on international law, in particular the Charter of the United Nations and
international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity and equality, including gender equality, and to respect
cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities, institutions,
private sector companies and every other relevant actor to ensure the embedding of
ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based, reliable and
reproducible;
(d) to provide a universal framework that not only articulates values and principles, but
also translates into concrete policy recommendations and effective implementation to
guide Member States in their engagement with neurotechnology in its whole lifecycle,
consistent with their obligations under international human rights law and other
international standards;
(e) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and consensus
building about ethical issues relating to neurotechnology;
(f) to promote justice and equitable access to developments and knowledge in the field
of neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among all actors to prevent misuse of
neurotechnology and to uphold human rights and ethical standards.
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111. VALUES AND PRINCIPLES
111.1 VALUES
111.1.1 Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
20. The inviolable and inherent dignity of every human being is the foundation of universal
human rights and fundamental freedoms. Respect, protection, and promotion of human dignity, as
established by international human rights law, are essential in the whole lifecycle of
neurotechnology. Dignity encompasses the recognition of the intrinsic and equal worth of each
person. Neurotechnology must never be used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any individual, including people living in
vulnerable situations.
111.1.2 Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical, mental,
and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the largest
number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
111.1.3 Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of neurotechnology.
Special consideration should be given to neurodiversity, minority groups, Indigenous Peoples, and
underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban well
resourced sector, specific attention to underserved and marginalised people is crucial to prevent
bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological assimilation,
or using technology as a tool of colonisation (a term the Recommendation refers to as
"technological colonialism"), can threaten cultural diversity and heritage, therefore must be
protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its benefits
are accessible to all, regardless of socioeconomic status or geographical location. Special
attention must be given to low- and middle-income countries, resource-constrained settings, and
marginalised communities, including the specific needs of different groups, ages, segments,
cultural systems, languages, communities, and marginalised and vulnerable populations, people
with disabilities, neurological disorders, and mental health conditions.
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided that
these choices are made in ways that respect the rights of others.
111.1.4 Consideration for cross-cultural perspectives on human knowledge and its sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
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28. It is essential that any research and development involving diverse groups and communities
is done with their permission and guidance, and conducted with their full prior and informed
consent and partnership in ways that serve their interests and respect their traditional knowledge
and epistemic contributions.
111.1.5 Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of thought
especially in situations where refusal to use the technology could lead to competitive disadvantage.
Such interferences include but are not limited to the use of force, threats, undisclosed access,
manipulation, or any scenario where consent is compromised, including as a result of power
imbalances.
30. The use of neurotechnology should be particularly scrutinized to avoid uses that segregate,
objectify or subordinate individuals or communities, reduce social cohesion by exacerbating pre
existing inequalities or generating novel inequalities that divide and antagonize individuals against
each other, and thereby threaten the coexistence between humans, other living beings and the
natural environment.
111.1.6 Global Solidarity and International Cooperation
31. The Recommendation should guide all actors in the development, deployment and use of
neurotechnology to act in solidarity and call for accountability in instances where neurotechnology
may be misused in ways that threaten human rights.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use to
prevent abuse and uphold global ethical standards.
111.1.7 Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used with a
deep respect for environmental stewardship, prioritizing the minimisation of ecological harm
throughout the lifecycle of the materials used, including, for mining extraction, data processing and
storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP), requires that neurotechnology, through its whole
lifecycle, be guided by a profound respect for Indigenous rights, ensuring that their lands (including
during mining), knowledge, communal rights, and privacy are honoured in all activities, including
those related to resource extraction.
111.1.8 Integrity and Responsibility
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with ethical
steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align with
both professional standards and societal values.
37. Integrity includes a commitment to taking responsibility for one's actions and being
accountable for their outcomes. This involves not only acknowledging successes but also owning
up to mistakes and taking corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-based,
objective and transparent research practices. It ensures that all scientific endeavours are
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conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant for
neurotechnology.
111.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred approach through fundamental ethical
principles including but not limited to self-determination, agency, freedom of thought, privacy,
cognitive liberty, personal and collective identity, trustworthiness, respect, reciprocity, and justice.
Furthermore, it incorporates the respect, promotion and protection of human rights.
111.2.1 Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and well-being, and empower individuals to make
informed decisions about their nervous system and mental health while fostering a better
understanding of themselves.
41. Neurotechnology should contribute to human flourishing without causing harm or
subordination, whether physically, economically, socially, politically, culturally, or mentally. The "do
no harm" principle must guide the whole lifecycle of neurotechnology, ensuring that the quality of
life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only unexpected
damage to the nervous system, but also to amplified inequalities within society.
43. Any restrictions to human rights must meet all applicable requirements under human rights
law, including the principles of legality, legitimate aim, necessity and proportionality.
44. The principles of proportionality, balance and legitimacy should govern the use of
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon the
foundational values of this document; (c) appropriate to the context and target user group; (d)
based on safety principles and rigorous scientific evidence.
111.2.2 Self-determination and Freedom of Thought
45. Throughout the whole lifecycle of neurotechnology, the protection and promotion of the rights
of freedom of thought, and self-determination must be secured.
46. Individuals have the right to make free, informed, and voluntary decisions about their
engagement with neurotechnology throughout the whole lifecycle, in accordance with international
human rights law and other international standards, including the right to refuse or withdraw from
its use, at any time, ensuring their autonomy and respect for their decision-making capacity is
upheld and where surrogate consent is used, the best interests of the affected.individual are
considered. Individuals who are enrolled in research should be informed of potential side effects
and given the opportunity to disclose if they have any contraindications for the procedures used.
Informed consent procedures should be affirmative, dynamic, and require opt-in, comprehensive
and transparent providing detailed information about the purposes, risks, benefits, alternatives,
and possible outcomes of the technology in all its application domains, ensuring that consent is
voluntary and that individuals fully understand the implications for their privacy, autonomy, and
well-being.
47. Neurotechnology should never be used to exert undue influence or manipulation, whether
through force, coercion, or other means that compromise self-determination and freedom of
thought. This protection covers both the internal processing of thoughts and their external
expression, ensuring freedom from any interference.
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111.2.3 Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct and indirect data about the nervous system
that is uniquely sensitive because they can be processed and analysed to provide deep insights
into the processes that underpin our mental states and behaviour, including self-awareness and
introspection. As it becomes increasingly difficult to anonymize data, there remains persistent risks
of misuse of this data by revealing neurobiological correlates of diseases, disorders, or general
mental states without the authorization of the person from whom data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural data must be conducted
with free and informed consent, in ways that respect the ethical and human rights principles
outlined in this Recommendation.
50. There should be clear safeguards against the misuse or unauthorised access of neural and
cognitive biometric data, including affirmative consent, data minimization and purpose
specification, data rights (such as rights to access, correct, and delete, and suspend processing of
data), and data security, particularly in contexts where such data might be aggregated with other Commented [오전1]: Adding the right to suspend data
sources. processing as one of the data rights
111.2.4 Non-Discrimination and lnclusivity
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface with
other technologies like Al, must commit to upholding ethical principles that prevent discrimination,
stigmatisation, targeting, or exploitation of any individuals or groups, particularly those in
vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or mental
characteristics, or other grounds protected under human rights law.
53. Non-inclusive technological development and standardisation may drive a trend toward
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural
and collective identity.
54. Garnering the trust and acceptance of communities in the whole lifecycle of neurotechnology
requires transparent engagement with the public, seeking their input and validation to align these
technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or discrimination
against older persons.
111.2.5 Accountability
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology requires all
actors to adhere to the highest ethical standards, remain open to feedback, be committed to
adjusting practices in response to new evidence or ethical concerns, and be held accountable for
their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and a duty
to anticipate and address potential harms-whether short-term, long-term or arising from unintended
use and impact.
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59. A commitment to accountability requires global, governmental, societal and collective action
to ensure those harmed by neurotechnology have access to justice, and that those responsible for
wrongdoing are required to take meaningful steps to identify, prevent, mitigate and account for how
they address and redress their adverse human rights impacts, including through corrective actions
and reparations.
111.2.6 Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection of human rights and fundamental
freedoms, all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international principles
of responsible conduct and scientific integrity. This includes preventing the replication or
amplification of biases, ensuring that neurotechnology is traceable and explainable, its capacities
and limitations are accurately portrayed, the conditions for accountability are clearly defined,
adhering to ethical guidelines in research and development, including the registration of trials, fair
participant selection, and approval by independent ethics committees.
111.2.7 Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about neurotechnology,
including recognizing diverse ways of knowing, and that all individuals and communities can
participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community engagement,
to ensure diverse populations can gain and exchange knowledge about nervous system
functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and
identity, to respect different ways of knowing and understanding. This respect for diversity ensures
that the knowledge and perspectives of diverse communities are valued and included in decision
making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may be
marginalized or excluded from knowledge production and dissemination.
65. All communities should have a voice in decisions that affect them, particularly when it comes
to the development and use of neurotechnology.
111.2.8 Best Interests of the Child and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right of
children and adolescents to participate in decisions that affect them. Technology should be
rigorously assessed to ensure it serves the best interests, well-being and healthy development of
children, as they grow into autonomous individuals and safeguard the rights of future generations
by ensuring that today's decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology for
early diagnosis, instruction, education, and continuous learning, it is equally important to make a
commitment to the holistic development of the child. This includes nurturing their social life,
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and
physical activity.
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111.2.9 Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must be
shared equitably among all contributors to that research and development, with a particular focus
on ensuring global distribution that promotes fairness and reduces disparities.
69. Neurotechnology developments should be leveraged to reduce global health inequities.
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings.
70. Research, development, and trials in neurotechnology must adhere to the highest ethical
standards, ensuring the non-exploitative participation of all individuals involved. This includes
safeguarding the rights and well-being of participants, and patients and their caregivers, as well
as ensuring the ethical collection and use of data. Special attention should be given to ensure that
those contributing to research and development have their fair share of the benefits and do not
bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never take
advantage of, the lack of necessary technological or medical infrastructure, education and skills,
as well as ethical-legal frameworks, particularly in LMICs, LDCs, LLDCs and SIDS, affecting
communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive recipients
of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing, and the use of which respects,
promotes and protects individual and collective human rights. This commitment should include
funding for interdisciplinary research that not only advances neurotechnological innovation but also
studies the ethical, legal, social, environmental and cultural implications of these technologies, and
supports the implementation and clinical translation of technological prototypes. Particular attention
should be given to the development and implementation of adequate technical, institutional,
procedural and other safeguards to ensure that they equitably benefit society and that human rights
are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology in
contexts that violate individual and collective human rights. Member States should conduct human
rights due diligence, including regular, comprehensive human rights impact assessments,
concerning neurotechnology that they develop, design, deploy, use, sell, operate or procure, in
order to prevent and mitigate their adverse human rights impacts. Specifically, neurotechnology
should not be used for purposes such as non-consensual interrogation in law enforcement, criminal
and civil justice, development or deployment of weapons targeted at the nervous system, social
control, attempts at coercive behavioural conformity based on personal beliefs or thoughts, political
or other opinion, gender identity or sexual orientation, or surveillance of mental states, among
others. Governments should adopt legislation that ensures neurotechnology is deployed
responsibly, and based on human rights, with robust oversight mechanisms to enforce adherence
to these restrictions and protect mental privacy and freedom of thought for all individuals. These
policies should be developed in consultation with diverse actors, including civil society, end-users,
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neurotechnology experts, ethicists, and human rights advocates, to ensure broad consensus and
respect for global human rights norms.
75. Member States should ensure transparency and accountability in their support, oversight,
and regulation of neurotechnology, particularly in publicly funded initiatives such as brain research
and development programs. While recognizing the limitations in disclosing certain sensitive
information, governments should require government sponsored neurotechnology projects to
publicly disclose the objectives, methodologies, intended uses, and societal impacts of their
neurotechnology initiatives wherever possible. This transparency is crucial for fostering public trust
and ensuring that neurotechnology advances are aligned with ethical standards and human rights.
76. Member States should apply a comprehensive approach to regulatory and policy measures
to protect against human rights harms related to neurotechnology developed, marketed, operated
or used by the private sector. This includes legislative and regulatory measures and accompanying
guidance, incentives, and transparency requirements. This comprehensive approach should also
require human rights due diligence, ensuring that businesses identify, prevent, mitigate, and
account for their adverse human rights impacts through context-dependent processes, including
human rights impact assessments, meaningful public and community engagement, and
transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, be
implemented ethically in accordance with human rights, and be aimed at promoting public safety
while protecting the rights and dignity of all those involved. This requires respect for fundamental
rights, such as human dignity, bodily integrity, confidentiality of personal data, due process and
fair trial rights, including the presumption of innocence, and the right against self-incrimination, as
well as freedom from torture and ill-treatment, the right to privacy, and the right to freedom of
thought.
78. Member States should establish comprehensive incentive structures, such as tax incentives,
grants, and awards, with a particular focus on encouraging the construction and development of
manufacturing, computational resources, and data analytics capabilities within public research
institutions and small and medium enterprises (SMEs). Member States should also incentivize and
support partnerships that leverage the computational resources and data analytics capabilities of
private firms to advance public research goals. These incentives should prioritize rewarding
transparency, participatory development processes, and contributions to societal benefits, aiming
to foster an environment where public institutions and companies innovate responsibly and align
with human flourishing goals.
79. Member States should establish a coordinated, cross-sectoral approach to assessing the
impacts of neurotechnology across the whole lifecycle. This approach should include, but is not
limited to:
(a) Economic Impact Assessments: Conducted by relevant national bodies responsible
for economic and labor policies to assess how neurotechnology impacts economic
growth, jobs, social justice, and environmental sustainability;
(b) Benefit-Risk Assessments: Managed by entities responsible for public health, medical
research, and consumer protections, these assessments should rigorously evaluate
the risks and benefits associated with the development, deployment, and use of
neurotechnology, including research, clinical applications, and consumer products.
The process should include thorough documentation, ethical oversight, and continuous
monitoring to ensure the safety, well-being, and equitable treatment of all individuals
involved;
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(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these assessments
should evaluate and mitigate risks to individuals' mental privacy posed by
neurotechnology. This includes ensuring that appropriate safeguards are in place to
protect neural and cognitive biometric data in compliance with national and
international privacy standards, and the data policy practices discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology. The process should ensure that
neurotechnology respects and promotes human rights, with particular attention to
vulnerable people and people living in vulnerable situations. HRIAs should involve
meaningful public and community engagement to incorporate diverse perspectives.
80. Member States should promote equitable access to neurotechnology worldwide. To achieve
such goals, efforts should be made to support the reduction of final costs for end users, pursue the
development, adoption and continuous support of non-proprietary software solutions, and explore
reimbursement strategies or subsidisation commensurate with conventions in local jurisdictions, in
sectors of crucial potential benefits.
81. Member States should adopt agile regulatory frameworks, including the use of regulatory
sandboxes-controlled environments for developing, testing, and evaluating neurotechnology-in
response to rapid advancements in neurotechnology and its convergence with other technologies
such as Al, spatial computing, and immersive technologies. These sandboxes should be used to
explore innovative applications, particularly in workplace settings, with appropriate ethical
oversight provided by regulatory bodies or national authorities. These frameworks should facilitate
innovation, ensure ethical data processing, and safeguard rights by incorporating mechanisms for
regular monitoring, evaluation, and dynamic policy adjustments in line with technological and
ethical developments.
IV.2 DATA POLICY
82. Member States should develop a robust regulatory and legal framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data. This and
existing frameworks should recognize this data to be both personal and sensitive data in medical
and non-medical contexts.
83. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals' neural and cognitive biometric data. If current policies do not
adequately address these areas, Member States should adopt targeted legislation or regulatory
frameworks to secure these protections. These safeguards should for example include affirmative
informed consent, data minimization and purpose limitation, data rights (including the right to
access, correct, and delete, and suspend processing of data), and stringent data security Commented [오전2]: Adding the right to suspend data
measures, such as advanced cybersecurity protocols to prevent unauthorized access and processing as one of the data rights
breaches. Such legislation or frameworks should prohibit the practice of tying access to goods or
services to the disclosure of neural and cognitive biometric data, require explicit opt-in for any data
sharing, and forbid the use of such data for targeted advertising without the individual's explicit,
affirmative informed consent.
84. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and computing
resources used for processing and storage of neural and cognitive biometric data. These policies
should emphasise data minimisation, ensuring that only the necessary amount of data is collected
and processed, and promote the proportional use of neurotechnology, aligning its deployment with
genuine needs and minimising unnecessary environmental impact. Measures should include
optimising energy efficiency, using renewable energy sources, promoting the recycling and
sustainable disposal of neurotechnology-related equipment, and ensuring the rehabilitation of
affected environments.
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85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, such· as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy and
ethics by design, requiring the incorporation of privacy-preserving technologies as default features
in their devices.
87. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories should
meet stringent cybersecurity, data privacy, and ethical use standards (including data minimisation
and purpose limitations), tiered access and other privacy-enhancing approaches. Appropriate
funding mechanisms should be established for the curation and maintenance of data and data
governance processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing in
neurotechnology research, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive biometric data, by establishing clear protocols for data
transfer that ensure secure and compliant data exchanges across borders, and standards for
interoperability of data, including governance frameworks for data sharing.
89. Member States should consider specific guidelines for the ethical use of neural and cognitive
biometric data in Al development and research, including consent procedures for uses of neural
and cognitive biometric data in training and application of Al models, ensuring transparency and
respecting individual and community rights.
IV.3 INTELLECTUAL PROPERTY (IP)
90. Member States should adopt policies to ensure that neural and cognitive biometric data, as
individual human activity derivatives, are not subject to proprietary rights. IP protection should only
apply to original data compilations (created through a process of aggregation, organization, or
selection, resulting in a new dataset) that meet strict and ethical criteria. Commented [오전3]: [DELETE] Limiting intellectual
property protection to ‘original data compilations’ is a
91. Member States should collaboratively establish clear, harmonised guidelines for IP rights sensitive topic that requires careful review and
discussion.
applicable to neurotechnology on an international scale. These guidelines should address the
patentability of Al-generated inventions and the ethical implications of IP laws, ensuring they Commented [오전4]: [DELETE] The patentability of AI-
promote global accessibility and innovation. generated inventions is a highly esoteric topic that
requires discussion at international organizations
dedicated to intellectual property, such as WIPO, and is
92. Member States should ensure that all actors adopt IP management strategies that currently under discussion.
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility.
93. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors. Commented [오전5]: [Further review is required] The
criteria for ‘all contributors’ are ambiguous, and the
94. Member States should adopt policies with respect to open science that balance the ‘policies and incentives for co-ownership and
preferential licensing agreements’ is also a sensitive
protection of IP with the promotion of immediate publication of results and data sharing. Particularly issue that requires thorough review and discussion.
with the convergence of digital technologies and the increasing concentration of those
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innovations in industry sectors, this balance is crucial to ensure that IP protection mechanisms do
not hinder scientific research, innovation, and the wide dissemination of knowledge and new
technologies. As a basic rule of equitable partnership, when Indigenous Peoples are involved in
neurotechnology research and development, open science processes, IP management strategy,
should be developed in collaboration with them from the beginning. Commented [오전6]: [Further review is required]
Discussion on intellectual property and collaboration
IV.4 CYBERSECURITY with indigenous peoples is needed at international
organizations specializing in intellectual property, such
as WIPO.
95. Member States should collaborate internationally to establish comprehensive standards for
cybersecurity across all neurotechnology domains. These standards should encompass hardware,
software, and data security measures to protect against potential cyber threats. By implementing
uniform cybersecurity standards, Member States should ensure the integrity, confidentiality,
security, and availability of neural data, as well as enhance user trust and confidence in
neurotechnology devices. Additionally, these standards should evolve in tandem with technological
advancements and emerging cyber threats to maintain robust protection against evolving risks.
96. Member States should employ red-teaming exercises-adversarial challenges to test the
efficacy of security systems-as a proactive measure to assess and enhance the safety, security,
and resilience of neurotechnology systems. By conducting regular red-teaming exercises, Member
States should proactively identify and address security gaps, test incident response procedures,
and strengthen the overall safety and cybersecurity posture of neurotechnology devices.
IV.5 COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
98. Member States should collaborate with international organizations, educational institutions,
and private and non-governmental entities to develop and disseminate accessible and engaging
educational materials tailored to diverse audiences to bridge knowledge gaps, particularly in
underserved regions about the nervous system and mental health functioning, as well as the
benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies' functionality, safety, efficacy, and societal impact, empowering
individuals to make informed decisions and to enable their ethical reflection about their use of
neurotechnology.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a wide
array of actors. The aim of these engagements should be to inform policy development, shape
ethical guidelines, increase public awareness and understanding, align investment priorities, and
ensure that neurotechnology deployment aligns with public interests and values. Special attention
should be given to involving groups traditionally underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation of accurate, precise, and accessible
language and terminology for discussing neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is inclusive, non-stigmatizing, and accurately
reflects the technologies' capabilities and limitations. Member States should establish regulatory
frameworks that require clear and ethical communication standards for neurotechnology. These
frameworks should require evidence-based reporting of capabilities, risks, and limitations across
all applications to avoid exaggeration of claims, including but not limited to applications in sleep,
attention, memory, and emotional regulation. Within these frameworks should be specific
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guidelines for ethical marketing and protocols for responsible communications about early-stage
research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user and
for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that evaluate
the impact of neurotechnology on children and adolescents.
104. Member States should safeguard children and adolescents from implicit and explicit coercion
to use neurotechnology. Member States should pay attention to the autonomy of children and
adolescents through informed consent and assent that is adapted to and respectful of age and
decision-making capacity.
105. Member States should fund research and development grants focused on creating user
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children, adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed to
teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
106. Member States should ensure research involves strict oversight and close follow-up of all
neurotechnology research involving children and adolescents. This oversight is crucial during the
developmental phases of childhood to address and mitigate any unforeseen long- term effects.
Such research must include comprehensive monitoring protocols and periodic evaluations to
ensure the ongoing safety and well-being of young participants, taking into account their unique
developmental needs and vulnerabilities. In the framework of research, involving children and
adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring units), special
attention will be given to consent and assent, particularly considering particular aspects of research
(time, iterations) to prevent any form of instrumentalization.
107. Member States should enact specific regulations that prohibit the use of marketing
techniques-such as neuromarketing, biometric emotional analytics, immersive advertising, and
virtual or augmented reality advertising-that rely on sensitive neural and cognitive biometric data
collected from children and adolescents. Recognizing the heightened vulnerability of children and
adolescents in digital environments, these regulations must explicitly forbid any practices that use
such data to influence or exploit children and adolescents.
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IV.7 OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by funding and
implementing evidence-based programs that integrate neurotechnology into routine care. These
programs should involve the entire support ecosystem, including family, caregivers, and medical
teams, to enhance quality of life. Priority should be given to developing and implementing tools
that prevent, delay, and treat age-related health conditions, impairments, and neurodegenerative
diseases. Member States should ensure that access to these neurotechnology programs is
equitable and does not exacerbate socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making for
older people using neurotechnology for sensorimotor and cognitive support. The consent process
should accommodate potential cognitive challenges faced by older adults, ensuring that consent
is informed, ongoing, and adaptable to changing health conditions. Policies should be in place to
ensure that assistive neurotechnology recognize changing cognitive capacities over time and
respect users' preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such as
robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8 WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive policies that promote and respect
gender equality and diversity in the whole lifecycle of neurotechnology. The policies should
prioritize inclusive research for addressing women and gender specific needs and differences,
require targeted data collection and analysis, include education and training programmes on
inclusive research practices, ensure public and community engagement with women and gender
health experts and advocacy groups and, incentivise gender responsive technology design, to
meet the needs and conditions specific to women and gender minorities. Affirmative action policies
are necessary to close gender gaps in these fields, increase representation, engagement and
leadership.
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women and gender minorities, and safeguard against
harassment and discrimination. This should include robust mechanisms for reporting and
addressing incidents of harassment and discrimination, ensuring accountability and support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women's and gender minorities'
participation in neurotechnology. This includes funding and other policies that prioritize ethical and
equitable research and innovation, but also affirmative action initiatives to support the participation
of women and gender minorities in neurotechnology through targeted education programs,
employment opportunities, entrepreneurship support, and leadership development within the
sector. Member States should also provide support systems such as mentorship programs,
networking opportunities, and resources to help women and gender minorities overcome barriers
to participation and succeed in the neurotechnology field.
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IV.9 PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support thereby
contributing to achieving equal enjoyment of human rights. They should implement regulatory
frameworks that require accessibility assessments for all new neurotechnology products to ensure
these products do not perpetuate existing disabilities or health disparities. These frameworks
should include protocols for testing with diverse groups of persons with disabilities to ensure
technology meets a wide range of needs and does not unintentionally exclude or disadvantage
any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their quality of life and functional
independence. These programs should include tax incentives for companies investing in assistive
neurotechnology research and development, grants for research institutions focusing on
neurotechnology for disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living assistance, and innovation
prizes for breakthroughs in affordable, accessible neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential neurotechnology
devices, such as neuroprosthetics, for persons with physical disabilities. They could encourage
public-private partnerships to make advanced neurotechnology affordable and integrate
neurotechnology coverage into national health insurance and other reimbursement schemes for
persons with physical disabilities. A national database of available neurotechnology resources and
support services should be developed to facilitate access and information sharing.
IV.10 PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to address
the increasing prevalence and special needs of people with mental health conditions, including
victims and survivors of trauma and violence, and the relevance of neurotechnology for these
communities.
119. Member States should allocate funding for long-term advocacy and efficacy studies, post
market oversight, and tiered scrutiny with special attention to invasiveness and reversibility of
neurotechnology interventions. It is important to ensure that people with mental health conditions
are well-informed and have reasonable expectations about the process.
120. Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
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123. Member States should build and maintain international solidarity to address global health
risks and uncertainties, and ensure that their implementation of healthcare for the nervous system
is consistent with international law and rigorous human rights obligations. This could involve
creating international forums for sharing best practices in the implementation of neurotechnology
in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and mental
health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results.
125. Member States should consider the significant cost and impact associated with pathologies
related to the nervous system, as well as the potential benefits of early diagnosis and access to
preventive and assistive neurotechnology. Public policies should prioritize the promotion of access
to these technologies and ensure health cost coverage for individuals in need.
126. Member States should promote the development of reliable and durable neurotechnology
for healthcare applications. This includes encouraging the design of devices and systems that
require minimal maintenance, ensuring they remain functional and effective under everyday
conditions. Regulatory bodies or designated authorities should oversee the enforcement of
rigorous standards for quality, safety, and longevity, thereby reducing the burden on users and
enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States should ensure the development or strengthening of existing comprehensive
neurotechnology medical device reporting systems that track and address adverse effects. In
contexts where such systems do not exist, Member States should establish them. Where systems
are already in place, they should be updated to specifically include neurotechnology. These
systems should be interoperable and contribute to a centralised, public, and transparent
international database, managed in collaboration with international organizations, to ensure that
global standards are met and accessible for public knowledge, international oversight and
research.
IV.12 RESEARCH ETHICS
128. Member States should reinforce the ethical frameworks governing neurotechnology research
to ensure robust protection of human participants. Member States should adopt clear guidelines
or policies that define the qualifications to ensure that research is conducted by professionals with
appropriate knowledge about the nervous system structure and function in addition to brain
disorders and is performed in adequate research settings. Furthermore, research protocols, public
or private, in the medical as well as the non-medical domain, should be carefully evaluated by
registered ethics boards (ethics committees) and specific attention dedicated to individuals with
special situations regarding vulnerability such as diminished capacity to consent or to make
decisions. Member States should ensure that all research institutions have mandatory ethics
training for researchers.
129. Member States should encourage multicentre international research that involves various
cultures and ethnic groups. Member States should promote international cooperation to develop
common reporting standards and protocols for interoperability, particularly for implantable
neurotechnology devices. This cooperation should aim to enhance the comparability and utility of
research globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered in
the design of a clinical trial, including policies to protect patients in case of cessation of activities
of the trial sponsor or promoter. Member States should establish requirements for clinical trials to
be included in relevant nationally or internationally approved registries, and encourage registration
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with community and patient registries. Also, clinical trials should report on appropriate medical
device reporting systems developed within Member States.
131. Technology developers should ensure that the validation of Al algorithms in neurotechnology
research include rigorous testing for biases, as well as measures to enhance explainability and
transparency, including the provenance of training datasets. Suitable techniques should be
employed to mitigate any biases present in Al models used in neurotechnology applications.
132. Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual's subjective
experience, agency and personal identity. Understanding how neurotechnology may impact
aspects of self-perception, consciousness, and identity is essential for addressing ethical concerns
and ensuring the well-being of individuals using these technologies. •
133. Member States should ensure those engaged in research implement regular auditing and
monitoring of research practices to ensure adherence to ethical standards. This should include
evaluating the adequacy of informed consent, particularly concerning data reuse and the potential
commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings to
participants. These protocols should ensure that such findings are conveyed promptly, respecting
participants' rights and autonomy. Additionally, Member States should mandate that researchers
provide the necessary support and coordination with healthcare providers to address any health
concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those_ with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants' right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13 EDUCATIONAL SETTINGS
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age
appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology's impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
137. Member States should adopt policies ensuring the voluntary deployment of neurotechnology
in education, grounded in fully informed consent. These policies must include clear, age
appropriate information about the technology's purpose, benefits, and risks, with adequate
consideration periods. Considering the increased complexity of obtaining voluntary consent in this
context, consent and assent procedures should involve children, adolescents, parents, guardians
and all actors necessary to obtain approval required for minors. Ethical oversight mechanisms
should be established, including regular consent renewal and immediate cessation of
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neurotechnology use upon withdrawal, and ensure anonymous feedback channels. Policies must
prohibit undue incentives or academic penalties for non-participation and take measures to avoid
creating or reinforcing inequalities among students. Additionally, Member States should support
student involvement in decision-making about neurotechnology integration and fund training
programs on its ethical use, empowering educators and students to critically assess its application.
138. Member States should establish a unified, robust oversight mechanism for neurotechnology
use in educational settings, incorporating regular audits, public and community feedback, culturally
appropriate and according to local conventions, and strict adherence to safety and ethical
standards, including an assessment of reversibility on the nervous system. Continuous research
should be funded to assess the long-term psychological and cognitive impacts of these
technologies. Oversight should involve periodic reviews based on empirical evidence to adjust
neurotechnology usage as needed, ensuring it serves student development and addresses risks
like dependency or de-skilling. This comprehensive approach will help maintain the safety,
effectiveness, and alignment of neurotechnology with best practices for student well-being and
learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations throughout
the neurotechnology whole lifecycle. This training should include ethical design, human rights law,
and societal impact assessment, preparing the next generation of technologists to critically
evaluate the implications of their work.
IV.14 LABOUR AND EMPLOYMENT
140. Member States should establish workplace policies and incentives that prioritize the health
and well-being of employees in the use of neurotechnology. These policies should ensure that any
deployment of neurotechnology is evidence-based, with a focus on applications that have been
scientifically validated to promote employee well-being, such as reducing stress or enhancing
workplace conditions (i.e., adaptive and responsive environments that adjust workloads based on
cognitive load). Deployment must be on a voluntary basis and employees must have the option to
opt out of using neurotechnology without facing any negative consequences or discrimination.
Under no circumstances should these technologies be used for punitive measures, mental
surveillance, or in ways that could compromise employee health.
141. Member States should require employers to clearly provide employees with comprehensive
information about how neurotechnology used in their workplace works, the benefits it offers,
transparency about what data are collected, how it is used, and who has access to it, and clearly
disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring fatigue
in commercial drivers or tracking attention in air traffic controllers). To respect employees' mental
privacy, employers should be prohibited from unauthorized access to neural and cognitive
biometric data that may be collected incidentally during routine workplace monitoring. Employers
should be prohibited from using neural and cognitive biometric data for any non-consented
purposes, particularly those that could negatively impact an employee's job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation and
secure storage of neural and cognitive biometric data, ensure that data is stored securely, with
access limited to authorised personnel only, is deleted once its intended purpose has been fulfilled.
Additionally, upon an employee's departure, all related records should be fully deleted or individual
data released to the employee, ensuring that no data is retained after the termination of
employment.
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144. Member States should ensure that when employees are issued multifunctional devices (i.e.,
earbuds or headphones that also include neural sensors) that can be used at work or at home,
employers should be prohibited from collecting neural and cognitive biometric data outside of
workplace settings and working hours and ensure that any data collected during work is used
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right of employees to obtain a
copy of any neural and cognitive biometric data collected about them, along with any
interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise create.
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for
purposes that demonstrably enhance workplace safety, employee well-being and dignity, and not
for enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should develop
stringent regulations against using neural and cognitive biometric data for profiling in the
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive
biometric data to discriminate against candidates, particularly neurodiverse individuals, ensuring
hiring practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or maintaining
employment, to limit such use where such neural and cognitive biometric data are directly relevant
to the specific requirements of the job.
IV.15 CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a regulatory framework that balances innovation
in the recreational and commercial domains with protecting individual rights and well-being. This
framework should be dynamic, allowing for timely updates as technology evolves and new insights
are gained about its impacts on society. This includes providing adequate oversight to ensure that
neurotechnology does not cause harm, are used consensually, and include robust mechanisms
to protect users from potential psychological distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include clear
labelling on commercial neurotechnology products, detailing their effects, limitations, and risks to
prevent misleading claims and ensure transparency. This also includes prohibiting practices of
"tying" or requiring the disclosure of neural and cognitive biometric data as a condition to access
goods or services, and prohibition about third party data sharing or the uses of this data without
affirmative opt-in option.
151. Member States should foster an environment that ensures all claims about consumer, non
medical technologies are supported by robust scientific evidence. They should, by regulation,
require that any products claiming to treat, prevent, or diagnose diseases or medical conditions be
validated through rigorous safety and efficacy testing, including clinical trials where necessary, and
be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and transparent
across all neurotechnological interventions, ensuring that participation is fully voluntary and
respects the privacy and autonomy of individuals. This principle should apply uniformly in various
domains such as sports, arts, where robust standards should safeguard against coercive use and
respect athletes' and artists' individual autonomy, community interests, and IP rights.
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153. Member States should steer the use and development of neurotechnology in the arts toward
ensuring the enhanced learning and cultural appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of consumer
technology, especially neurogaming and other devices that exploit the dopamine reward system
or seek to induce problematic and unhealthy use and overconsumption. Such regulations should
mandate clear labeling of risks, disclosures on their effects on the nervous system, enforce game
design standards and safety, privacy and age-appropriate design standards that prevent taking
advantage of a person's physical, mental and emotional vulnerability to lead to compulsive use or
addiction of gaming or digital recreational platforms combined with neurotechnology, to promote
healthy, balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that 'opt-out' features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding self-determination,
consent, privacy, and the potential for manipulation raised by neurotechnology that arise in the
contexts of recommender systems, priming and nudging, marketing during sleep and dream,
neuromarketing, and closed-loop environments by adopting comprehensive policies and
regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive biometric
data in recommender systems for manipulative or deceptive purposes, including in
political context. These regulations should require that any use of such data within
these systems be based on explicit, informed opt-in consent from users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging-subtly
influencing individuals' decisions or behaviours, often without their explicit awareness.
This is particularly critical in sensitive areas such as political messaging, commercial
advertisement, and healthcare. These frameworks should require explicit, informed
consent for any use of such data to influence decisions or behaviour, the right to opt
out of these systems, and transparency and clear disclosures at the point of data
collection, with strict limitations on using data for purposes beyond those explicitly
disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that influences
or manipulates individuals during sleep, such as marketing during sleep and dream.
Regulations should strictly prohibit commercial, marketing, or political applications that
target individuals during sleep, using neurotechnology or neural and cognitive
biometric data. Additionally, robust oversight mechanisms should be required to
ensure that any research or application of such technologies prioritizes the well-being,
privacy, and autonomy of individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in neuromarketing,
including by requiring comprehensive disclosures to ensure that all neuromarketing
activities are conducted transparently, with participants' explicit informed consent. This
includes ensuring that participants in neuromarketing research or campaigns are fully
aware of methods, risks, and intentions and affirmatively opt-in to participation. The
use, storage, and potential reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and use
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of closed-loop environments-such as immersive computing devices that adjust
experiences based on detected neural and cognitive biometric data. These policies
should require clear and accessible disclosure about how neural and cognitive
biometric data are used in these environments, prohibit real-time behavioral
modification or manipulation without explicit, informed consent, and implement
safeguards specifically designed to prevent abuses such as unauthorized surveillance,
manipulative interventions, and practices that could influence voting behavior, political
opinions, or exploit psychological and emotional vulnerabilities in real-time.
IV.16 ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human mental
performance outside of the medical context introduces complex ethical, social, and legal
challenges, which can create new kinds of disparities in the global world. When neurotechnology
is used in these contexts, it raises crucial questions about equity, consent, individual and
community autonomy, and the nature of enhancement of the nervous system itself. Member States
should ensure that any policies, law and regulatory frameworks that govern the use of
neurotechnology in these contexts do not exacerbate social inequalities or lead to discrimination,
address the potential risks (including to reversibility, invasiveness, and risks to self-determination)
and fully comply with human rights and dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in this Recommendation should respect,
promote and protect the ethical values, principles and standards related to this Recommendation,
and should take all feasible steps to give effect to its implementation.
159. Member States shall, according to their specific contexts, governing structures and
constitutional provisions, credibly and transparently advance the ethics of neurotechnology, in line
with the UNESCO Recommendation. Member States shall monitor and evaluate policies,
programmes and mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance
with national and international standards, and ensuring that data and insights from different
regulatory domains are shared effectively to inform decision-making and policy development.
These bodies should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions in respect of this
Recommendation, by cooperating with all relevant national and international governmental and
non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector's interests and therefore
UNESCO needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
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advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shall contribute by developing a full-fledged program with the following elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States in
identifying their status at specific moments of their readiness trajectory along a
continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of neurotechnology
based on rigorous scientific research and grounded in international human rights law,
along with specific guidance for its implementation in the whole neurotechnology
lifecycle, and capacity-building tools and materials to support Member States' efforts
to train government officials, policy-makers and other relevant actors on the
methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and the
efficiency of the policies for the ethics of neurotechnology and incentives against
defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of knowledge and awareness of good
practices and innovations available to all Member States and actors, in the form of
research reports, data, and statistics regarding policies for ethics of neurotechnology.
The research program should take into consideration the converging developments of
neurotechnology with other technologies such as artificial intelligence and quantum
technology, work to be conducted in collaboration with other relevant UNESCO
initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global policy
dialogue, including at Ministerial level in the context of a Global Forum on the ethics
of Emerging Technologies. Supporting this effort, UNESCO shall establish a network
of experts, with balanced representation of all UNESCO's regional groups, on the
neurotechnology.
165. Processes for monitoring and evaluation should ensure broad participation of all actors,
including, but not limited to, under-represented, vulnerable people or people in vulnerable
situations and ensuring social, cultural and gender diversity. The monitoring and assessment of
the impact of neurotechnology and related ethics policies and practices should be carried out
continuously in a systematic way proportionate to the relevant risks. This should be based on
internationally agreed frameworks and involve evaluations of private and public institutions. Data
collection and processing should be conducted in accordance with international law, national
legislation on data protection and data privacy, and the values and principles outlined in this
Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a whole, and the foundational values and
principles are to be understood as complementary and interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
481
prejudicing Member States' obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or perform
any act contrary to human rights, fundamental freedoms, human dignity and concern for the
environment and ecosystems.
482
RUSSIAN FEDERATION/FÉDÉRATION DE RUSSIE
Комментарии экспертов по тексту проекта
Рекомендации по этике нейротехнологий ЮНЕСКО
Под редакцией председателя Российского комитета по биоэтике
при Комиссии Российской Федерации по делам ЮНЕСКО
академика РАН, профессора А.Л. Хохлова
Текст Проекта Варианты коррекции текста Комментарии экспертов
ПРЕДВАРИТЕЛЬНЫЙ ПРОЕКТ
РЕКОМЕНДАЦИИ ОБ ЭТИЧЕСКИХ
АСПЕКТАХ НЕЙРОТЕХНОЛОГИЙ
ПРЕАМБУЛА
отмечая существенное и динамичное
воздействие нейротехнологий на сознание,
жизнь и благополучие людей, процветание
общества, природную среду и экосистемы,
принимая во внимание распространенность
во всем мире неврологических и
психических заболеваний, масштабы
которой продолжают расти, а также
глубокие страдания, которые они
причиняют людям и обществу, принимая во
внимание также потенциал
нейротехнологий, которые предлагают
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инновационные решения и более
эффективные профилактические и
терапевтические методы лечения для
миллионов людей, принося пользу всему
человечеству и предоставляя возможности
для усовершенствования охраны здоровья во
всех странах, учитывая, что применение
нейротехнологий поднимает
фундаментальные вопросы этического
порядка, касающиеся, в частности,
самоопределения, неприкосновенности
частной жизни, личностной идентичности,
свободы мысли, риска дискриминации,
неравенства и вызовов, возникающих перед
демократией, и что принципы
справедливости, доверия и равноправия
должны служить гарантией того, что ни
одна страна и ни один человек не окажутся в
проигрыше как с точки зрения равенства
доступа к нейротехнологиям и
использования их преимуществ, так и в
плане защиты от негативных последствий их
применения, и одновременно признавая
различие условий, существующих в разных
странах, а также нежелание некоторых
людей принимать непосредственное участие
в техническом прогрессе, напоминая, что в
соответствии с положениями своего Устава
ЮНЕСКО активно стремится содействовать
укреплению мира и безопасности путем
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расширения сотрудничества народов в
области образования, науки, культуры,
коммуникации и информации в интересах
поощрения всеобщего уважения
справедливости, законности и прав
человека, а также основных свобод,
провозглашенных для всех народов,
принимая во внимание далее ключевую роль
ЮНЕСКО, занимающей ведущие позиции в
вопросах международного диалога,
приращения знаний и установления
стандартов, касающихся этических аспектов
научной деятельности, технологического
прогресса и биологических исследований,
будучи убеждена в том, что представленная
ниже Рекомендация – нормативный
документ, разработанный на основе
целостного подхода и принципов
международного права с упором на
уважение человеческого достоинства и прав
человека, а также призванный поощрять
гендерное равенство, социальную и
глобальную справедливость и развитие,
физическое и психическое благополучие и
здоровье людей, личностное разнообразие,
взаимосвязанность, глобальную
солидарность, равноправие, недопущение
дискриминации, инклюзивность, защиту
окружающей среды и экосистем, сможет
направить процесс развития
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нейротехнологий в ответственное русло,
руководствуясь целями и принципами
Устава Организации Объединенных Наций,
подчеркивая необходимость уделения
особого внимания странам с низким и
средним уровнем дохода (СНСД), включая,
в частности, наименее развитые страны
(НРС), развивающиеся страны, не имеющие
выхода к морю (РСНВМ), и малые
островные развивающиеся государства
(МОСРГ), которые располагают
квалифицированными кадрами, но при этом
недостаточно представлены в сфере
разработки нейротехнологий и ограничены в
доступе к ним, особо отмечая, что
международное сотрудничество и
солидарность способствуют равноправному
доступу к нейротехнологиям и создают
условия для полного раскрытия их
потенциала, обеспечивая одновременно
решение актуальных этических проблем,
минимизацию потенциальных рисков
ненадлежащего использования и разработку
национальных стратегий развития
нейротехнологий на основе этических
принципов при полном соблюдении норм
международного права в области прав
человека, отмечая тот факт, что наличие
этических требований, рамочных принципов
деятельности и открытого доступа к
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научным знаниям стимулирует развитие
инноваций, наработок и стратегий,
согласующихся с международными нормами
в области прав человека, напоминая также,
что в ноябре 2023 года Генеральная
конференция ЮНЕСКО на своей 42-й
сессии приняла резолюцию 42 С/29, в
которой она уполномочила Генерального
директора «разработать нормативный
документ об этических аспектах
нейротехнологий в форме рекомендации»,
который должен быть представлен
Генеральной конференции на ее 43-й сессии
в 2025 году,
памятуя о положениях Всеобщей памятуя о положениях Нюрнбергского Следует добавить:
декларации прав человека 1948 года, кодекса 1947 года, Хельсинкской Нюрнбергский кодекс 1947 года,
положениях международных нормативно- декларации 1964 года в редакции 2024 г., Хельсинкская декларация 1964 года в
правовых документов в области прав Всеобщей декларации прав человека 1948 редакции 2024 г.
человека, в том числе года, положениях международных
нормативно-правовых документов в области
прав человека, в том числе
Конвенции 1951 года о статусе беженцев,
Конвенции 1958 года о дискриминации в
области труда и занятий, Международной
конвенции 1965 года о ликвидации всех
форм расовой дискриминации,
Международного пакта 1966 года о
гражданских и политических правах,
Международного пакта 1966 года об
экономических, социальных и культурных
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487
правах, Конвенции 1979 года о ликвидации
всех форм дискриминации в отношении
женщин, Конвенции 1989 года о правах
ребенка и Конвенции 2006 года о правах
инвалидов, о положениях Конвенции 1960
года о борьбе с дискриминацией в области
образования и Конвенции 2005 года об
охране и поощрении разнообразия форм
культурного самовыражения, а также любых
других имеющих отношение к этому
вопросу международно-правовых актов,
рекомендаций и деклараций, принимая во
внимание также положения Декларации
Организации Объединенных Наций 1986
года о праве на развитие, Декларации 1997
года об ответственности нынешних
поколений перед будущими поколениями,
Всеобщей декларации 2005 года о биоэтике
и правах человека, Декларации Организации
Объединенных Наций 2007 года о правах
коренных народов, Декларации этических
принципов в связи с изменением климата
2017 года, Рекомендации 2017 года в
отношении научной деятельности и научных
работников (исследователей), Рекомендации
2021 года об этических аспектах
искусственного интеллекта, Рекомендации
2021 года по открытой науке, а также
положения резолюции A/HRC/RES/42/15
Совета по правам человека «Право на
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неприкосновенность частной жизни в эпоху
цифровых технологий» 2019 года,
резолюции A/HRC/RES/41/11 Совета по
правам человека «Новые и появляющиеся
цифровые технологии и права человека»
2019 года и утвержденные ООН в 2011 году
«Руководящие принципы
предпринимательской деятельности в
аспекте прав человека», напоминая далее,
что в Рекомендации 2021 года об этических
аспектах искусственного интеллекта
отмечается важность этических вопросов,
связанных с использованием систем на
основе ИИ в области нейротехнологий и
нейрокомпьютерного интерфейса, памятуя
также об уже существующей экосистеме
национальных правил и стандартов и других
рамочных документах и инициативах,
разработанных соответствующими
структурами Организации Объединенных
Наций, межправительственными
организациями, такими как ОЭСР, в том
числе региональными организациями, а
также частными структурами,
профессиональными организациями, НПО и
научным сообществом, связанных с
этическими аспектами и регулированием
деятельности в сфере нейротехнологий,
1. принимает сегодня, ... ноября 2025 года,
настоящую
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489
Рекомендацию об этических аспектах
нейротехнологий; (3)
2. рекомендует государствам-членам при
поддержке Секретариата ЮНЕСКО
применять положения настоящей
Рекомендации с учетом конституционной
практики и особенностей структуры
управления каждого государства
посредством принятия надлежащих мер, в
том числе, при необходимости,
законодательного или иного характера,
направленных на претворение в жизнь в
пределах своих юрисдикций
сформулированных в Рекомендации
принципов и норм, в соответствии с
положениями международного права, в том
числе международного права в области прав
человека;
3. рекомендует также государствам-членам
обеспечить, чтобы все субъекты приняли на
себя обязательство по осуществлению
возложенных на них соответствующих
задач, связанных с выполнением настоящей
Рекомендации, а также довести положения
настоящей Рекомендации до сведения
международных, региональных и
национальных органов и учреждений,
научно-исследовательских и академических
организаций, государственных,
коммерческих и некоммерческих
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490
учреждений и организаций, занимающихся
вопросами нейротехнологий, с тем чтобы
разработка и применение нейротехнологий
осуществлялись с опорой на результаты
серьезных научных исследований и на
основе анализа и оценки этических
аспектов.
I. СФЕРА ПРИМЕНЕНИЯ И
ОПРЕДЕЛЕНИЯ
I.1 СФЕРА ПРИМЕНЕНИЯ
В настоящей Рекомендации:
1. Рассматриваются этические аспекты,
касающиеся нейротехнологий, учитывая,
что их применение может иметь
разнообразные позитивные и негативные
последствия для здоровья и благополучия
человека и для осуществления прав
человека.
2. Рассматриваются нейротехнологии, 2. Рассматриваются нейротехнологии, Предлагается детализировать описание сфер
применяемые для людей из разных слоев применимые людьми из разных слоев актуального и перспективного
общества и с разными возможностями, а общества и с разными возможностями; использования нейротехнологий, в связи со
также в различных областях, включая медицинские, исследовательские и спецификой этического регулирования
защиту здоровья и прямые продажи доступные нейротехнологии (доступные нейротехнологий при применении в
потребителям немедицинских товаров и через прямые продажи широкому кругу медицинских и немедицинских целях.
услуг (таких как устройства для потребителей немедицинских товаров и
поддержания красоты и здоровья, услуг), применимые в различных сферах
нейроигры ), и в разных контекстах общественной жизни, как в сфере
использования. здравоохранения в целях лечения и
поддержания здоровья, так и во
внемедицинских сферах - образования,
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491
спорта, досуга и развлечений поддержания
красоты; применимые в разных контекстах
использования. Немедицинское применение
нейротехнологий должно соответствовать
принципам гуманизма и милосердия, не
противоречить интересам общества и
отдельных социальных групп.
3. Речь идет только о людях, хотя в ней 3. Речь идет только о людях, хотя в ней
сформулированы важные соображения, сформулированы отдельные положения,
применимые также к исследованиям на применимые также к исследованиям на
животных. животных.
4. Под этичным подходом понимается 4. Под этичным подходом понимается
планомерное нормативное осмысление планомерное нормативное осмысление
этических аспектов нейротехнологий на аспектов применения нейротехнологий,
основе целостной, поликультурной, вызывающих беспокойство относительно
мультидисциплинарной, плюралистичной и медицинских, антропологических,
эволюционирующей системы социокультурных проблем и рисков,
взаимосвязанных ценностных установок, вызванных данным применением и его
принципов и процедур, способной последствиями. Осмысление с позиций
ориентировать общества в вопросах этичного подхода осуществляется на основе
ответственного учета долгосрочных целостной, поликультурной,
последствий, которые будет иметь мультидисциплинарной, плюралистической
применение нейротехнологий для людей, и эволюционирующей системы ценностных
обществ, природной среды и экосистем. установок (ценностей), принципов и
(a) Этические принципы при этом процедур, определяющей ответственное
рассматриваются в качестве основы для отношение общества к учёту долгосрочных,
нормативной оценки и методического значимых для человека, общества и
руководства в вопросах применения природы, последствий применения
нейротехнологий, использующей права нейротехнологий.
человека, человеческое достоинство,
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качество жизни и недопущение нанесения
вреда как целевой ориентир и базовое
условие.
(b) За основу при этом взят широкий спектр (b) За основу при этом взят широкий спектр
научных знаний, комментариев и мнений, научных знаний, комментариев и мнений,
почерпнутых в областях нейробиологии, почерпнутых в областях нейробиологии,
медицины, инженерной науки, психологии, медицины, инженерной науки,
этики, прав человека, юриспруденции, компьютерных наук, психологии, этики,
социологии, антропологии и других прав человека, юриспруденции, социологии,
научных дисциплин. антропологии и других научных дисциплин.
5. Рассматриваются вопросы оценки, Рассматриваются вопросы регистрации,
документирования и изменения состояния сбора, обработки, измерения,
нервной системы человека, сбора, анализа, документирования, анализа, оценки,
обработки, хранения, использования и интерпретации, хранения, использования и
повторного применения собранных данных, повторного применения данных,
а также другие социальные и экологические характеризующих состояние нервной
последствия, включая возникновение новых системы человека.
ментальных состояний. Кроме того, рассматриваются вопросы
нейротехнологического воздействия на
нервную систему человека, которое может
привести к изменению физических и
психических процессов человека, включая
возможность возникновения изменённых
ментальных состояний».
6. Признается, что вмешательства, 6. Признается, что вмешательства, Пункт 6 предлагается дополнить указанием
затрагивающие нервную систему, являются затрагивающие нервную систему человека, на важнейшие человеческие способности, в
весьма травматичными, поскольку особенно инвазивные, но также и том числе способность выступать агентом
сложнейшая нервная система человека неинвазивные, могут являться весьма морального действия и изложить в
является центром, координирующим его травматичными, поскольку сложнейшая расширенной редакции.
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поведение и психические процессы. Она нервная система человека является центром,
наделяет человека способностью координирующим его поведение и
осуществлять свободное волеизъявление, психические процессы. Работа нервной
выступать в качестве носителя морали, системы и психики связана с важнейшими
отвечать за свои действия, человеческими способностями,
взаимодействовать с другими людьми, определяющими его личность: со
обсуждать коллективные решения и способностью воспринимать окружающий
развивать личные качества. мир, взаимодействовать с природой и
обществом, общаться с другими людьми,
обсуждать коллективные решения,
обучаться и развивать личные качества,
ощущать и проявлять эмоции, осуществлять
свободное волеизъявление, отвечать за свои
действия, формировать идентичность и
обладать идентичностью, осознавать
собственную субъектность, быть агентом
морального действия.
7. Отмечается также, что человек
развивается и добивается успеха в процессе
взаимодействия с другими людьми и в
благоприятных с материальной и
культурной точек зрения условиях, а также
подчеркивается, что личная независимость
по своему характеру не только
индивидуальна, но и реляционна, поскольку
возникает в результате взаимодействий
человека и как следствие его
принадлежности к обществу.
8. Рассматриваются этические аспекты и 8. Рассматриваются этические аспекты и Пункт 8 предлагается изложить в редакции,
проблемы прав человека, возникающие в проблемы прав человека, возникающие в которая может обеспечить учет активного
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связи с быстрым развитием и конвергенциейсвязи с быстрым развитием и конвергенцией развития сферы, и не сужать область данных
нейротехнологий с другими технологиями, нейротехнологий с другими технологиями, рекомендаций перечислением отдельных
такими как пространственные вычисления, такими как иммерсивные технологии технологий.
расширенная реальность, ИИ-датчики и ИИ- (пространственные вычисления,
полупроводники. Примечательно, что
виртуальная реальность, дополненная
обработка других биометрических данных реальность, расширенная реальность, ИИ-
для целей определения сенсорных,
датчики и ИИ-полупроводники), технологии
моторных и ментальных состояний
искусственного интеллекта, иные
вызывает аналогичные вопросы этического технологии, регистрирующие психо-
порядка. В связи с этим сфера охвата физические состояния. Примечательно, что
настоящей Рекомендации распространяется обработка других биометрических данных
как на нейротехнологии, так и на для определения сенсорных, моторных и
использование когнитивныхментальных состояний вызывает вопросы
биометрических данных, обеспечивая
этического порядка аналогичные этическим
последовательное применение этических вопросам применения нейротехнологий. В
принципов и этически корректных методов связи с этим сфера охвата настоящей
работы в этих областях. Рекомендации распространяется как на
область применения нейротехнологии, так и
на область работы с биометрическими
данными или данными о психических
(когнитивных) процессах, полученными
способами, отличными от
нейротехнологических. Тем самым
обеспечивается последовательное
применение этических принципов и
этически корректных методов работы в
областях, связанных с отслеживанием
психофизиологических состояний человека.
9. Рассматривается также вопрос 9. Рассматривается также вопрос
комбинированного применения комбинированного применения
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нейротехнологий и искусственного нейротехнологий и искусственного
интеллекта, что позволяет повысить интеллекта, что позволяет повысить
точность и возможности прогнозирования, в точность и возможности прогнозирования, в
частности, увеличить скорость обработки частности, увеличить скорость обработки
данных, снизить издержки, оптимизировать данных, снизить издержки, оптимизировать
системы на основе нейротехнологий. В то системы на основе нейротехнологий. В то
же время комбинированное применение же время комбинированное применение
повышает угрозы этического характера, повышает угрозы этического характера,
включая проблемы кибербезопасности, включая проблемы кибербезопасности,
отсутствие прозрачности, возможность отсутствие прозрачности, возможность
алгоритмической предвзятости, алгоритмической предвзятости,
потенциальные угрозы личной потенциальные угрозы личной
независимости и психической независимости и психической
неприкосновенности, а также риски неприкосновенности, а также риски
незаконных действий. нецелевых и незаконных действий.
10. Поощряется мирное использование
нейротехнологий и ставится цель повысить
степень осведомленности о серьезных
этических проблемах и угрозах, связанных с
применением нейротехнологий в военной
сфере и в сфере безопасности. Содержится
призыв ко всем заинтересованным сторонам
проявить ответственный подход в
отношении нейротехнологий.
I.2 ОПРЕДЕЛЕНИЯ
11. Нервная система 11. Нервная система
Нервная система человека подразделяется на Нервная система – это организованная
центральную (головной и спинной мозг) и группа специализированных клеток,
периферическую нервную систему. участвующих в проведении
Результаты научных исследований электрохимических импульсов в организме
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496
показывают, что деятельность нервной человека и животных.
системы является основой сенсорных, Деятельность нервной системы
моторных и ментальных состояний человека обеспечивает внутреннее единство всех
(к которым относятся когнитивные, частей живого организма и связь организма
эмоциональные и волевые состояния), а с внешней средой.
также обеспечивает самоосознание, сон и Нервная система играет важнейшую роль в
восприятие человеком болевых ощущений. обнаружении стимулов из внутренней и
внешней среды и координации
соответствующих реакций на эти стимулы.
Деятельность нервной системы является
основой сенсорных, моторных и ментальных
состояний человека (к которым относятся
когнитивные, эмоциональные и волевые
состояния), а также обеспечивает
самоосознание, сон и восприятие человеком
болевых ощущений.
Нервная деятельность и структура нервной Структура и функции нервной системы Информация не может быть имманентно
системы обеспечивают получение обеспечивают специфические присуща, тем более, если она получается из
информации, имманентно присущей всем психофизические функции, присущие организма или из-вне.
людям и человеческому обществу в целом, каждому человеку как представителю
вне зависимости от пола, этнической биологического вида, вне зависимости от
принадлежности, языка или религии. пола, этнической принадлежности или
культурных особенностей.
Кроме того, нервная деятельность является Высшая нервная деятельность связана с
важным инструментом социокультурного формированием поведения человека,
взаимодействия. адекватного внешней среде, как природной,
так и социальной, что обеспечивает
возможность взаимодействия человека в
обществе
12. Нейротехнологии.
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Под нейротехнологиями понимаются
Под нейротехнологиями понимаются
устройства, системы и процедуры,
устройства, системы и процедуры,
охватывающие как аппаратное обеспечение,
охватывающие как аппаратное обеспечение,
так и программные средства, которые так и программные и инструментальные
напрямую получают доступ к нервной средства, которые напрямую получают
системе, отслеживают, анализируют,
доступ к нервной системе, отслеживают,
предсказывают или регулируют ее
анализируют, предсказывают или
состояние с целью понимания, оказания регулируют ее состояние с целью
воздействия, восстановления или
определения состояния, понимания,
прогнозирования состояния ее структуры,
оказания воздействия, восстановления или
активности, функциональности или
прогнозирования состояния ее структуры,
интенций (речь, моторика). активности, функциональности или
интенций (речь, моторика), как путем
прямого взаимодействия с ней, так и
посредством ее сопряжения с
устройствами и системами.
Нейротехнологии сочетают в себе, в Нейротехнологии сочетают в себе, в
частности, элементы нейронауки, частности, элементы нейронауки,
инженерного дела и компьютерной инженерного дела, наук о материалах, и
обработки данных. компьютерной обработки данных.
Примерами таких технологий могут служить
электроэнцефалография (ЭЭГ),
магнитоэнцефалография (МЭГ), магнитно-
резонансная томография (МРТ),
функциональная магнитно-резонансная
томография (фМРТ), позитронно-
эмиссионная томография (ПЭТ),
функциональная БИК-спектроскопия,
оптоакустика, вживленные микроэлектроды,
оптогенетика, термогенетика, хемогенетика,
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498
оптическая визуализация, диффузионно-
взвешенный метод визуализации,
кальциевая визуализация,
потенциалзависимые красители (ПЗК) или
микродиалитические исследования и т.д.
13. Нейротехнологии охватывают 13. Нейротехнологии охватывают Данный раздел п. 13 может быть включен в
медицинские и немедицинские области исследовательские, медицинские и п. 12.
применения и включают в себя немедицинские области применения и
инструментальные средства, позволяющие включают в себя инструментальные
производить измерения, определять средства, позволяющие производить
состояние и воздействовать на деятельность измерения, определять состояние и
нервной системы, как путем прямого воздействовать на деятельность нервной
взаимодействия с ней, так и посредством ее системы, как путем прямого взаимодействия
сопряжения с устройствами и системами. с ней (инвазивного или неинвазивного),
так и посредством ее сопряжения с
устройствами и системами.
Инвазивное взаимодействие предполагает Предлагается дополнить п. 13.
нарушение физической целостности
организма - временное или постоянное
погружение нейротехнологии внутрь
человеческого тела.
Неинвазивное взаимодействие производится
внешним образом. Однако неинвазивные
нейротехнологии, предполагающие
воздействие на мозг, по своим эффектам
могут быть сравнимы с инвазивными
технологиями, поскольку предполагают
прямое влияние на активность нейронов.
К ним, в частности, относятся: К нейротехнологиям, в частности,
относятся:
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(a) технические средства, позволяющие (а) Измерительные нейротехнологии - Данный параграф можно выделить в
измерять и анализировать физические нейротехнологии, позволяющие отдельный пункт и озаглавить:
(например акустические, электрические, непосредственно измерять и анализировать Измерительные нейротехнологии
оптические, магнитные и/или физические (например, акустические,
механические), химические и биологические электрические, оптические, магнитные
сигналы, связанные со структурными и и/или механические), химические и
функциональными элементами нервной биологические сигналы, связанные со
системы. Такие технические средства могут структурными и функциональными
использоваться для определения, элементами нервной системы. Такие
регистрации и/или мониторинга параметров технические средства могут использоваться
активности нервной системы, углубления для определения, регистрации и/или
понимания принципов ее мониторинга параметров активности
функционирования, диагностики нервной системы, углубления понимания
патологических состояний или управления принципов ее функционирования,
внешними устройствами (обеспечивающими диагностики патологических состояний или
взаимодействие человеческого мозга с управления внешними устройствами
компьютером и известными как (обеспечивающими взаимодействие
нейрокомпьютерный интерфейс (НКИ)). человеческого мозга с компьютером и
известными как нейрокомпьютерный
интерфейс (НКИ)).
Следует отметить, что как разомкнутые Следует отметить, что как разомкнутые
(например, стимуляция мозга с (например, стимуляция мозга с
фиксированными параметрами), так и фиксированными параметрами), так и
замкнутые системы (например, замкнутые системы (например,
нейростимуляция, зависящая от состояния нейростимуляция, зависящая от состояния
мозга) ставят перед нами сложные вопросы мозга) ставят перед нами сложные вопросы
этического порядка. этического порядка, поскольку влияют, как
на физические, так и на психические
процессы, а также могут иметь отложенные
эффекты.
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(i) примерами таких технологий могут
служить электроэнцефалография (ЭЭГ),
магнитоэнцефалография (МЭГ), магнитно-
резонансная томография (МРТ),
функциональная магнитно-резонансная
томография (фМРТ),
позитронноэмиссионная томография (ПЭТ),
функциональная БИК-спектроскопия,
вживленные микроэлектроды, оптогенетика,
оптическая визуализация, диффузионно-
взвешенный метод визуализации,
кальциевая визуализация, потенциал-
зависимые красители (ПЗК) или
микродиалитические исследования и т.д.;
(b) технические средства, которые (b) Воздействующие нейротехнологии - Параграф 13 (b) можно выделить в
взаимодействуют с нервной системой с нейротехнологии, которые отдельный пункт и озаглавить:
целью воздействия на ее активность, взаимодействуют с нервной системой с Воздействующие нейротехнологии
например, для восстановления работы целью воздействия на ее активность,
органов чувств, в частности слуха, такие как например, для восстановления работы
кохлеарные имплантаты, или глубинная органов чувств, в частности слуха, такие как
стимуляция головного мозга (ГСМ), кохлеарные имплантаты, или глубинная
используемая для лечения треморов и стимуляция головного мозга (ГСМ),
других патологий. используемая для лечения треморов и
других патологий.
Они используются для регулирования
функций нервной системы и/или
непосредственной передачи сигналов в
нервную систему с применением методики
акустической, электрической, магнитной
или оптической стимуляции и/или
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501
торможения периферической или
центральной нервной системы, (i)
примерами таких нейротехнологий являются
вживленные микроэлектроды,
нейрокомпьютерный интерфейс (НКИ),
глубинная стимуляция головного мозга
(ГСМ), оптогенетическая стимуляция,
транскраниальная электростимуляция (ТЭС-
терапия), транскраниальная магнитная
стимуляция (ТМС) или нейрофармакология.
14. Следует отметить, что некоторые 14. Сенсорные нейротехнологии – Пункт 14 предлагается назвать Сенсорные
сенсорные технологии собирают данные, нейротехнологии, позволяющие косвенно нейротехнологии
косвенно информирующие о нервной (без непосредственного воздействия на
активности. организм) измерять и анализировать
информацию, свидетельствующую о
нервной и психической активности.
Несмотря на то, что они не являются в
буквальном смысле нейротехнологиями,
использование их для определения
ментальных состояний поднимает те же, что
и нейротехнологии этические вопросы и
вопросы в области прав человека.
К сенсорным технологиям относятся, в К сенсорным нейротехнологиям относятся, в
частности, отслеживание движения глаз, частности, отслеживание движения глаз,
видеоокулография, идентификация личности видеоокулография, идентификация личности
по клавиатурному почерку, распознавание и по клавиатурному почерку, распознавание и
анализ голоса, анализ походки, регистрация анализ голоса, анализ походки, регистрация
электропроводности кожи и вариабельности электропроводности кожи и вариабельности
сердечного ритма, мониторинг движений во сердечного ритма, мониторинг движений во
сне, системы измерения кровяного давления сне, системы измерения кровяного давления
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или распознавания эмоций по выражению или распознавания эмоций по выражению
лица. лица и т.п.
15. Нейронные данные. Нейронные данные – 15. Нейронные данные – это качественные и
это качественные и количественные данные количественные данные о структуре,
о структуре, активности и активности и функциональности нервной
функциональности нервной системы. Они системы, полученные при использовании
охватывают данные, относящиеся к измерительных нейротехнологий. На
деятельности нервной системы, и включают нейробиологическом уровне нейронные
как прямые измерения структуры, данные являются прямым коррелятом
активности и/или функциональности ментальных состояний.
нейронов (например, нейронное
возбуждение или усредненные показатели
биоэлектрической активности, полученные с
помощью ЭЭГ), так и косвенные
функциональные показатели (например,
скорость кровотока при фМРТ и
функциональной БИК-спектроскопии). На
нейробиологическом уровне нейронные
данные являются прямым коррелятом
ментальных состояний.
16. Когнитивные биометрические данные. Когнитивные биометрические данные. В п. 16 раздела I.2 «Определения» Проекта
В настоящей Рекомендации под В настоящей Рекомендации под раскрывается термин «когнитивные
«когнитивными биометрическими данными» «когнитивными биометрическими данными» биометрические данные», который
понимаются нейронные данные вместе с понимаются нейронные данные вместе с встречается по всему тексту Проекта (п. 90,
данными, собранными при помощи данными, собранными при помощи 107, 142, 144 и пр.). Когнитивные
биометрических технологий, не связанных с биометрических технологий, не связанных с биометрические данные – это нейронные
нейронами, которые могут обрабатываться прямой регистрацией активности данные вместе с данными, собранными при
для определения ментальных состояний. церебральной ткани, но которые могут быть помощи биометрических технологий, не
применены для определения ментальных связанных с нейронами, которые могут
состояний. обрабатываться для определения
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ментальных состояний.
Введение данной конструкции, а также
общий подход Рекомендаций,
предполагающий возможность легального
обращения таких данных применительно к
различным сферам, вступает в противоречие
со статьей 12 Всеобщей декларации прав
человека 1948 года (неприкосновенность
личной жизни, защита чести и репутации),
статьей 17 Международного пакта о
гражданских и политических правах 1966
года (неприкосновенность личной жизни,
защита чести и репутации), статьи 16
Конвенции о правах ребенка 1989 года
(неприкосновенность личной жизни, защита
чести и репутации), статьями 8, 9, 11
Всеобщей декларации о биоэтике и правах
человека 2005 года (признание уязвимости
человека и уважение неприкосновенности
личности, неприкосновенность частной
жизни и конфиденциальность, недопущение
дискриминации и стигматизации) и иных
ключевых международных документов.
Обращение таких данных содержит
потенциал к расширению
дискриминационных практик, а также
предполагает высокие риски, связанные с их
обработкой, хранением и защитой, что
находит подтверждение по всему тексту
Проекта (п. 9, 10, 95, 96, 136 и пр.), при
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отсутствии четких механизмов защиты
таких данных.
17. Полный жизненный цикл. 17. Полный жизненный цикл.
Жизненный цикл нейротехнологии следует Жизненный цикл нейротехнологии - период
рассматривать, начиная с ранних этапов функционирования нейротехнологии,
добычи сырья и материалов, создания включая этап планирования, сбора
прототипа, исследовательской работы, информации, создания прототипа,
проектирования и создания и заканчивая исследовательской работы, проектирования
этапами развертывания и использования, к и создания, этап развертывания и
которым относятся техническое использования, к которым относятся
обслуживание, эксплуатация, сбыт, техническое обслуживание, эксплуатация,
финансирование, мониторинг и оценка сбыт, финансирование, мониторинг и оценка
эффективности, контроль эффективности, контроль
работоспособности, вывод из эксплуатации, работоспособности, этап вывода из
демонтаж и утилизация. Полный жизненный эксплуатации, демонтажа и утилизации.
цикл нейротехнологии включает в себя этап Полный жизненный цикл нейротехнологии
ее слияния с другими технологиями и включает в себя этап ее слияния с другими
подразумевает широкий круг участников на технологиями и подразумевает широкий
каждом из этапов. круг участников на каждом из этапов.
II. ЦЕЛИ И ЗАДАЧИ
18. Настоящая Рекомендация была
разработана с целью направить развитие и
использование нейротехнологий по
этичному, безопасному и эффективному
пути на благо человечества, отдельных
людей, общин, общества, окружающей
среды и экосистем, а также предотвратить
их использование во вред в настоящем и
будущем на основе международного права, в
частности Устава Организации
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Объединенных Наций и международного
права в области прав человека.
19. Задачи настоящей Рекомендации состоят
в:
(a) обеспечении защиты, поощрения и
уважения прав человека и основных свобод,
человеческого достоинства и равенства,
включая гендерное равенство, а также
уважения культурного разнообразия на
протяжении всего жизненного цикла
нейротехнологий;
(b) ориентировании деятельности
государств-членов, физических лиц, групп,
сообществ, государственных учреждений,
частных компаний и любых других
заинтересованных субъектов на обеспечение
учета этических аспектов на всех этапах
жизненного цикла нейротехнологий;
(c) обеспечении научного обоснования,
надежности и воспроизводимости
нейротехнологий на протяжении всего их
жизненного цикла;
(d) формировании универсальной основы,
которая будет не только определять
ценности и принципы, но и может быть
воплощена в конкретные политические
рекомендации и эффективные проекты, для
ориентирования государств-членов в их
взаимодействии с нейротехнологиями на
протяжении всего их жизненного цикла, в
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соответствии с их международно-правовыми
обязательствами в области прав человека и
другими международными стандартами; (7)
(e) содействии многостороннему,
междисциплинарному и плюралистическому
диалогу и достижению консенсуса в
отношении этических вопросов, касающихся
нейротехнологий;
(f) содействии справедливому и равному
доступу к разработкам и знаниям в области
нейротехнологий и совместному
использованию их преимуществ;
(g) обеспечении подотчетности и
солидарности всех субъектов в целях
предотвращения неправомерного
использования нейротехнологий и
соблюдения прав человека и этических
стандартов.
III. ЦЕННОСТИ И ПРИНЦИПЫ Раздел III Предварительного проекта
III.1 ЦЕННОСТИ «Ценности и принципы» включает два
III.1.1 Уважение, защита и поощрение прав подраздела – III.1 «Ценности» и III.2
человека, основных свобод и человеческого «Этические принципы и права человека».
достоинства Однако содержание данных подразделов не
20. Неприкосновенное и неотъемлемое позволяет уяснить разграничение между
достоинство каждого человека является ценностями и принципами.
основой универсальных прав человека и Такие категории как «устойчивость»,
основных свобод. Уважение, защита и «добросовестность», «ответственность»
поощрение человеческого достоинства, как традиционно рассматриваются в теории и
это установлено международным правом в практике международного права в качестве
области прав человека, имеют крайне принципов. Ввиду неочевидности деления
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важное значение при разработке и перечисленных в разделе категорий на
использовании нейротехнологий. ценности и принципы, целесообразно их
Человеческое достоинство включает в себя структурное объединение в раздел
признание неотъемлемой и равной ценности «Этические принципы».
каждого человека. Нейротехнологии С учетом актуальной структуры включение
никогда не должны использоваться для в наименование словосочетания «права
объективации, использования человека» является необоснованным, так как
индивидуальных факторов уязвимости, в рассматриваемом разделе речь идет о
ущемления достоинства или прав любого раскрытии содержания принципов.
человека, включая людей, находящихся в
уязвимом положении.
III.1.2 Содействие здоровью и благополучию
человека
21. Приоритетное внимание должно
уделяться разработке и применению
нейротехнологий, способствующих
всестороннему укреплению здоровья и
благополучия человека, при этом здоровье
рассматривается как комплексное состояние
физического, психического и социального
благополучия.
22. Ответственное распределение ресурсов 22. Ответственное распределение ресурсов Важно понимать, что именно коммерческое
на развитие нейротехнологий подразумевает на развитие нейротехнологий подразумевает применение нейротехнологий зачастую
их направление на профилактические, их направление на профилактические, является залогом их развития. В связи с этим
диагностические, терапевтические, диагностические, терапевтические, необходимо учитывать возможность
вспомогательные и реабилитационные цели, вспомогательные и реабилитационные цели, взаимовыгодного сотрудничества между
которые принесут пользу наибольшему которые принесут пользу наибольшему коммерческими структурами и
числу людей и тем, для кого они будут числу людей и тем, для кого они будут организациями, занимающимися
полезны наиболее всего, а не на полезны наиболее всего. использованием нейротехнологий в
потребительские или коммерческие виды гуманитарных целях.
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использования.
Ввиду того, что отдельные виды
нейротехнологий могут быть использованы
для улучшения эффективности обучения,
необходимо уделять внимание разработке
максимально доступных нейротехнологий в
образовании, чтобы не создавать ситуацию
дискриминации в зависимости от
доступности таких технологий.
III.1.3 Обеспечение и уважение Понятие «недопредставленные субъекты» не
разнообразия и непредвзятости раскрывается в международных актах.
23. Уважение к разнообразию и Содержание данного термина должно быть
непредвзятость должны обеспечиваться на определено в Проекте.
протяжении всего жизненного цикла
нейротехнологий. Особое внимание следует
уделить нейроразнообразию, группам
меньшинств, коренным народам и
недопредставленным субъектам.
24. Учитывая, что общепризнанные Пункт № 24. Данный пункт затрагивает
нейротехнологические инновации в важность предотвращения так называемого
основном происходят в городском секторе, «технологического колониализма». Однако в
хорошо обеспеченном ресурсами, решающее документе отсутствуют конкретные
значение для предотвращения предвзятости, рекомендации и методы, направленные на
продолжающегося неравенства в предупреждение этого явления. Сам концепт
медицинском обслуживании, социального технологического колониализма описан
отторжения, пренебрежения и неуважения поверхностно, без конкретных примеров его
имеет особое внимание к проявлений. Например, можно указать на
малообслуживаемым и изолированным случаи, когда развитые страны навязывают
группам населения. Технологическая свои технологии развивающимся странам,
ассимиляция, или использование технологии не учитывая их особенности и потребности,
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в качестве инструмента колонизации (в что приводит к зависимости от поставок и
Рекомендации это явление обозначается решений иностранных компаний. Между
термином «технологический колониализм»), тем, этот вопрос играет важную роль для
может угрожать культурному разнообразию предотвращения избыточного цифрового
и наследию, поэтому необходима влияния и создания неравенства в
соответствующая защита. развивающихся странах, а также в контексте
внедрения нейротехнологий.
Содержание терминов «технологическая
ассимиляция» и «технологический
колониализм» не раскрывается в
международных актах. Учитывая новизну
термина «технологический колониализм»
его значение должно быть раскрыто в
Проекте.
25. Равноправный доступ к Равноправный доступ к нейротехнологиям, в П. 25 может быть выделен в отдельный
нейротехнологиям должен быть особенности нейротехнологиям для раздел вне части III., раздел 1.3
приоритетной задачей глобального уровня в медицинских целей, оказывающих лечебное «Обеспечение и уважение разнообразия и
целях обеспечения доступности их или компенсирующее действие для непредвзятости».
преимуществ для всех, вне зависимости от повышения качества жизни человека,
социально-экономического статуса или должен быть приоритетной задачей
географического положения. глобального уровня в целях обеспечения
доступности их преимуществ для всех, вне
зависимости от социально-экономического
статуса или географического положения.
Особое внимание должно уделяться странам
с низким и средним уровнем дохода,
странам с ограниченными ресурсами и
находящимся в неблагоприятном положении
сообществам, включая особые потребности
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различных групп, поколений, категорий
населения, культурных систем, языковых
групп, сообществ, находящихся в
неблагоприятном и уязвимом положении
групп населения, инвалидов, людей с
неврологическими расстройствами и
психическими заболеваниями.
26. Отдельные лица и группы людей должны
иметь возможность выбирать образ жизни,
выражать свои убеждения и мнения,
делиться личным опытом и участвовать в
совместной разработке технологий при
условии, что этот выбор будет сделан с
соблюдением прав других людей.
III.1.4 Учет межкультурных перспектив
человеческих знаний и обмен ими
27. Уважительный обмен между
сообществами и культурами знаниями о
нервной системе человека и ее функциях
способствует доверию и укрепляет
сплоченность людей во всем мире в их
стремлении к здоровью и качеству жизни.
28. Крайне важно, чтобы любые
исследования и разработки с участием
разнообразных групп и сообществ
проводились с их разрешения и в
консультации с ними, а также с получением
их полного предварительного и осознанного
согласия и в партнерстве с ними, чтобы они
отвечали их интересам и уважали их
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традиционные знания и эпистемологический
вклад.
III.1.5 Приверженность миру,
непредвзятости и справедливости в
обществе
29. Использование нейротехнологий должно
способствовать развитию, а не подрывать
свободу мысли, особенно в ситуациях, когда
отказ от использования технологии может
привести к потере конкурентных
преимуществ. К таким вмешательствам
относятся, в частности, применение силы,
угрозы, несанкционированный доступ,
манипуляции или любые сценарии, когда
согласие получается недобровольно, в том
числе в результате нарушения баланса сил.
30. Использование нейротехнологий должно Формулировка пункта не уточняет, какой
изучаться особенно тщательным образом, с аспект использования нейротехнологий и
тем чтобы избежать их применения в какими специалистами «должен изучаться
ситуациях, которые могут привести к особенно тщательным образом» в контексте
сегрегации, объективации или подчинению данного раздела «Приверженность миру,
отдельных лиц или сообществ, снижению непредвзятости и справедливости в
социальной сплоченности, усугублению уже обществе». Очевидно, что, например, с
существующего неравенства или точки зрения медицины и когнитивных наук
возникновению новых форм неравенства, использование нейротехнологий должно
сеющих раскол и вражду между людьми и всесторонне и тщательно изучаться, но
тем самым ставящих под угрозу прежде всего для выявления возможных
сосуществование между людьми, с другими нежелательных эффектов для психического
живыми существами и окружающей их и физического здоровья.
природной средой.
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III.1.6 Глобальная солидарность и
международное сотрудничество
31. Рекомендация должна ориентировать
всех участников процесса разработки,
внедрения и использования
нейротехнологий на солидарные действия и
призывать к ответственности в случаях
неправомерного использования
нейротехнологий, ставящего под угрозу
права человека.
32. Международное сотрудничество крайне
важно для решения трансграничных
проблем, связанных с нейротехнологиями.
Особое внимание следует уделить
различным точкам зрения на приемлемое
использование нейротехнологий, с тем
чтобы предотвратить злоупотребления и
соблюсти глобальные этические стандарты.
(9)
III.1.7 Устойчивость На сегодняшний день не представляется
33. Учитывая, что устойчивое развитие возможным отследить очевидную прямую
требует разработки и использования связь между бесконтрольным развитием
нейротехнологий с глубоким уважением к нейротехнологий в немедицинских целях и
охране окружающей среды, с непропорциональным потреблением
первостепенным вниманием к минимизации ресурсов и энергии и образованием отходов,
экологического ущерба на протяжении всего на глобальном уровне. Именно это
жизненного цикла используемых основание, ограничения развития
материалов, включая добычу полезных нейротехнологий, представляется немного
ископаемых, обработку и хранение данных, надуманным. В тоже время создание
переработку и утилизацию. искусственных барьеров на пути прогресса
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данных технологий, под недостаточно
веским предлогом, может лишить
человечество тех позитивных вещей,
которые привнесут эти технологии
обществу. В лучшем случае призывы к
ограничениям под подобным предлогом
останутся просто декларативными.
Предлагается внедрить системы
мониторинга охраны окружающей среды,
связанные с жизненным циклом
нейротехнологий.
34. Нерегулируемое развитие
нейротехнологий, особенно в
немедицинских целях, может привести к
непропорциональному потреблению
ресурсов и энергии, а также к образованию
отходов.
35. Уважение прав коренных народов в П. 35 об уважении прав коренных народов
соответствии с Декларацией Организации напрямую не касается поднимаемого
Объединенных Наций о правах коренных «Рекомендациями» вопроса. Здесь он лишь
народов, требует, чтобы нейротехнологии на неоправданно расширяет пункт 34, ссылаясь
протяжении всего их жизненного цикла при этом на уже существующий документ, и
были ориентированы на глубокое уважение не носит специфического для
прав коренных народов, обеспечивая рассматриваемой проблемы характера.
бережное отношение к их землям (в том
числе во время добычи полезных
ископаемых), знаниям, общинным правам и
неприкосновенности частной жизни во всех
видах деятельности, включая добычу
ресурсов.
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III.1.8 Добросовестность и ответственность III.1.8 Добросовестность и ответственность
36. Добросовестность требует ото всех 36. Добросовестность требует от
участников полного жизненного цикла участников всех этапов полного
нейротехнологий непреклонного жизненного цикла нейротехнологий
соблюдения этических принципов. Она непреклонного соблюдения этических
включает в себя соблюдение этических принципов. Она включает в себя
рекомендаций и обеспечение соответствия соблюдение этических рекомендаций и
всех действий как профессиональным обеспечение соответствия всех действий как
стандартам, так и общественным ценностям. профессиональным стандартам, так и
общественным ценностям.
37. Добросовестность включает в себя
обязательство отвечать за свои действия и
отчитываться за их результаты. Это
подразумевает признание не только успехов,
но и ошибок и принятие корректирующих
мер в случае необходимости
38. Научная добросовестность – это
приверженность строгому поиску истины с
помощью научно обоснованных,
объективных и прозрачных
исследовательских методов. Она
обеспечивает проведение всех научных
исследований в имеющих отношение к
нейротехнологиям дисциплинах на основе
принципов честности, точности и уважения
к научному методу.
III.2 ЭТИЧЕСКИЕ ПРИНЦИПЫ И ПРАВА Раздел III.2 ЭТИЧЕСКИЕ ПРИНЦИПЫ И
ЧЕЛОВЕКА ПРАВА ЧЕЛОВЕКА
39. Настоящая Рекомендация использует Возникает необходимость уточнения
ориентированный на человека подход, понимания «когнитивных свобод», так как в
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515
основанный на базовых этических литературе понятие когнитивной свободы
принципах, включая самоопределение, приобретает многозначность. 1) Как свобода
субъектность, свободу мысли, от внешнего влияния, свобода от
неприкосновенность частной жизни, манипуляций психическим состоянием
когнитивную свободу, личную и внешними воздействиями (маркетинговых,
коллективную идентичность, надежность, технологических, цифровых). 2) Или как
уважение, взаимность и справедливость и свобода в выборе собственного
др. Кроме того, эти принципы включают когнитивного состояния, достигаемого как с
уважение, поощрение и защиту прав помощью физических и ментальных практик
человека. (обучение, молитва, медитация, спорт), так и
с помощью химических веществ (в том
числе и запрещённых психотропных).
III.2.1 Использование во благо, III.2.1 Использование во благо, Пункт 40 предлагается детализировать.
соразмерность и непричинение вреда соразмерность и непричинение вреда
40. Нейротехнологии должны 40. Нейротехнологии должны
способствовать укреплению здоровья и способствовать укреплению здоровья и
благополучия, а также предоставлять людям благополучия, а также предоставлять людям
возможность принимать осознанные возможность принимать осознанные
решения, касающиеся их нервной системы и решения, касающиеся их нервной системы и
психического здоровья, способствуя при психического здоровья, способствуя при
этом их лучшему пониманию самих себя. этом их лучшему пониманию самих себя.
Для формирования адекватных ожиданий
пользователей нейротехнологий и
информирования о возможных рисках и
оргрничениях применения нейротехнологии
производители нейротехнологий и
компании, оказывающие услуги с
применениям нейротехнологий, должны
обеспечивать исчерпывающее и понятное
объяснение функций нейротехнологий,
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целей ее применения, принципов действия и
эффективности с опорой на актуальные
научные источники, противопоказаний к
применению технологии, возможных
побочных от применения, эффектах
применения, указание на риски
специфичной индивидуальной
непереносимости (в случае воздействующих
технологий), инструкции по применению (в
том числе о способах
включения/выключения устройства,
продолжительности и условиях применения
нейротехнологии, утилизации
нейротехнологии).
41. Нейротехнологии должны
способствовать процветанию человека, не
причиняя ему вреда и не ставя его в
подчиненное положение, будь то с
физической, экономической, социальной,
политической, культурной или психической
точки зрения. Принцип непричинения вреда
должен лежать в основе всего жизненного
цикла нейротехнологий, обеспечивая защиту
и повышение качества жизни.
Необходимо обеспечение условий для Пункт 41 предлагается дополнить.
достаточного предварительного Это дополнение чрезвычайно актуально в
тестирования нейротехнологии и связи со складывающейся тенденцией отказа
наблюдения за последствиями применения от проверки безопасности на животных в
нейротехнологии в рамках клинических пользу проверки безопасности и
испытаний до того, как нейротехнология эффективности на людях-добровольцах при
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будет допущена к использованию как в получении ИДС.
сфере здравоохранения, так и в
немедицинских сферах.
42. Использование нейротехнологий для Следует подчеркнуть, в соответствии с
улучшения здоровья может привести не целью данных рекомендаций (целью
только к неожиданному повреждению является достижение благополучия
нервной системы, но и к усилению человека), приоритетным должно быть
неравенства в обществе. использование нейротехнологий по
медицинским показаниям. Так называемая
«терапия на улучшение» может нести риски
как самому пациенту, так и обществу.
Применение нейротехнологий должно быть
нацелено в первую очередь на
восстановление (приближение)
физиологической нормы у пациентов.
43. Любые ограничения прав человека
должны отвечать всем применимым
требованиям законодательства о правах
человека, включая принципы законности,
законной цели, необходимости и
соразмерности.
44. Принципы пропорциональности,
сбалансированности и законности должны
регулировать использование
нейротехнологий и данных, которые они
позволяют получить, с тем чтобы их
использование:
(a) было уместным и пропорциональным (a) было уместным и пропорциональным В пункте 44 важно выделить риски
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цели и ожидаемым выгодам, цели и ожидаемым выгодам как в избыточного и неоправданного применения
медицинской, так и в немедицинских высокорисковых нейротехнологий в
сферах, медицинской сфере, а в особенности
доступных технологий во внемедицинских
сферах.
Текст Проекта в настоящее время не
содержит указание на необходимость
урегулирования противоречий интересов
между исследовательскими амбициями и
запросами потенциальных пользователей
нейротехнологий, так как данная ситуация
касается этического вопроса о
распределении ограниченных ресурсов
(временных, научно-технических,
экономических)
Пример: большие временные и финансовые
затраты на разработку
многофункционального протеза НКИ при
запросе пользователей на быстрый доступ к
доступному и функциональному, но не
избыточному по своим функциям протезу.
Возможно это дополнение может быть
сделано к пункту 44.
(b) не противоречило основополагающим
ценностям, определенным в настоящем
документе,
(c) соответствовало контексту и целевой
группе пользователей,
(d) опиралось на принципы безопасности и
точные научные данные.
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III.2.2 Самоопределение и свобода мысли
45. На протяжении всего жизненного цикла
нейротехнологий необходимо обеспечивать
защиту и поощрение прав на свободу мысли
и самоопределение.
46. Люди имеют право принимать Пункт 46 содержит информацию о
свободные, осознанные и добровольные процедурах информированного согласия.
решения о своем взаимодействии с Целесообразно дополнить словами о
нейротехнологиями на протяжении всего их содержании и нормативном соответствии
жизненного цикла в соответствии с информированного добровольного согласия.
международным правом прав человека и
другими международными стандартами,
включая право отказаться или воздержаться
от их использования в любое время, при
этом должна быть гарантирована их
самостоятельность и уважение их
способности принимать решения, а в случае
использования согласия, которое дает
опекун недееспособного лица – учет
наилучших интересов этого лица.
Участвующие в исследованиях лица должны
быть проинформированы о возможных
побочных эффектах и иметь возможность
сообщить о наличии у них
противопоказаний к используемым
процедурам.
Процедуры информированного согласия В п. 46 Проекта содержится указание на то,
должны быть утвердительными, что процедуры информированного согласия
динамичными, рассчитанными на должны быть «утвердительными,
добровольное согласие, всеобъемлющими и динамичными». Не представляется
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прозрачными, содержащими подробную возможным определить содержание данной
информацию о целях, рисках, категории и каким образом предлагается
преимуществах, альтернативах и возможных достигать указанных свойств процедур
результатах использования технологии во информированного согласия. Содержание
всех областях ее применения, данных свойств должно быть раскрыто.
гарантирующими добровольность согласия
и полное понимание людьми последствий
для их частной жизни, самостоятельности и
благополучия.
47. Нейротехнологии никогда не должны
использоваться для оказания
неправомерного влияния или
манипулирования, будь то с помощью силы,
принуждения или других средств, которые
ставят под угрозу принципы
самоопределения и свободы мысли.
Эта защита распространяется как на Эта защита обеспечивает свободу внешнего В пункте 47 представляется важным дать
внутренний анализ мыслей, так и на их выражения мыслей от постороннего корректную трактовку выражения «свобода
внешнее выражение, обеспечивая свободу от вмешательства, также как и свободу мысли», так как в нынешней редакции
любого вмешательства. внутренней мыслительной жизни человека. неясна область распространения гарантий на
Недопустимо применение нейротехнологий свободу от любого вмешательства – на
для целенаправленной внешней внутренний анализ мыслей или на их
манипуляции психическими процессами внешнее выражение.
человека (эмоциями, физическими
потребностями, когнитивными процессами).
Кроме того, обеспечивается защита П. 47 можно дополнить, или отнести данное
результатов анализа психофизических дополнение к разделу III.2.3 Защита
процессов, которые могут свидетельствовать нейронных и когнитивных биометрических
о состояниях сознания, которые в обычной данных для обеспечения психической
ситуации вне применения нейротехнологии неприкосновенности.
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доступны лишь для субъективного
восприятия, или анализа психофизических
процессов, интерпретация которых может в
какой-либо мере свидетельствовать о
внутреннем содержании сознания
Не очевидны основания разделения пунктов
47 и 48.
III.2.3 Защита нейронных и когнитивных
биометрических данных для обеспечения
психической неприкосновенности
48. Нейротехнологии и когнитивные
биометрические технологии поднимают
вопросы, связанные с правом на
неприкосновенность частной жизни, в связи
с расширением их возможностей в области
сбора прямых и косвенных данных о
нервной системе, которые являются
уникальными и конфиденциальными,
поскольку могут быть обработаны и
проанализированы для получения глубокого
представления о процессах, лежащих в
основе нашего психического состояния и
поведения, включая самосознание и
самоанализ. Поскольку обеспечить
анонимность данных становится все
сложнее, сохраняется опасность их
неправомерного использования путем
выявления нейробиологических коррелятов
заболеваний, расстройств или общих
психических состояний без разрешения
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человека, у которого эти данные
собираются. (11)
49. Психическая неприкосновенность
является основополагающим фактором
защиты человеческого достоинства, личной
идентичности и субъектности.
Сбор, обработка, изменение и Для формирования адекватных ожиданий П. 49 предлагается уточнить с целью
распространение нейронных данных пользователей нейротехнологий сбор, корреляции с п. 40.
должны осуществляться на основе обработка, изменение и распространение
свободного и информированного согласия, с нейронных данных должны осуществляться
соблюдением этических принципов и прав на основе свободного и информированного
человека, изложенных в данной согласия, с соблюдением этических
Рекомендации. принципов и прав человека, изложенных в
данной Рекомендации.
50. Должны быть предусмотрены четкие
меры защиты от неправомерного
использования или несанкционированного
доступа к нейронным и когнитивным
биометрическим данным, включая
утвердительное согласие, минимизацию
данных и определение целей их
использования, права на данные (например,
права на доступ, исправление и удаление) и
безопасность данных, особенно в тех
случаях, когда такие данные могут
агрегироваться с данными из других
источников.
III.2.4 Отказ от дискриминации и
инклюзивность
51. Все субъекты, участвующие в
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жизненном цикле нейротехнологий,
особенно в их взаимодействии с другими
технологиями, такими как ИИ, должны
придерживаться этических принципов,
которые не допускают дискриминации,
травли, целенаправленного воздействия на
любых лиц или группы, особенно тех, кто
находится в уязвимом положении, а также
их эксплуатации.
52. Мы несем общую ответственность за то, Пункт 52 считаем целесообразным изложить
чтобы эти технологии не способствовали в логике изложения остального текста.
укоренению или расширению масштабов
существующего неравенства и не создавали
новых форм дискриминации по
неврологическим или психическим
характеристикам, а также по другим
признакам, защищенным в соответствии с
законодательством о правах человека.
53. Неинклюзивное технологическое
развитие и стандартизация могут
способствовать формированию тенденции к
унификации и доминированию
нейротипичности и способностей, которые
могут поставить под угрозу культурную и
коллективную идентичность.
54. Завоевание доверия и признания
сообществ на протяжении всего жизненного
цикла нейротехнологий требует прозрачного
взаимодействия с общественностью,
получения ее мнения и одобрения для
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приведения этих технологий в соответствие
с общественными ценностями и общим
благом.
55. Дискриминация по любым признакам, 55.1. Дискриминация по любым признакам, Пункт 55 предлагается разделить на два
включая интеллектуальные различия или включая интеллектуальные различия или отдельных смысловых пункта.
различия, связанные с нетипичностью, различия, связанные с нетипичностью,
подлежит осуждению. Нейротехнологии не подлежит осуждению. Нейротехнологии не
должны использоваться для обоснования, должны использоваться для обоснования,
оправдания или конкретизации такой оправдания или конкретизации такой
дискриминации. Следует с осторожностью дискриминации.
подходить к оценке нейротехнологических 51.2. Следует с осторожностью подходить к
инструментов, лоббируемых оценке нейротехнологических
правительствами для оказания таких важных инструментов, лоббируемых
услуг, как образование. правительствами для оказания таких важных
услуг, как образование.
56. Нейротехнологии не должны
использоваться для укоренения стереотипов,
социального отторжения или
дискриминации пожилых людей.
III.2.5 Подотчетность
57. Сохранение доверия и добросовестная
работа на протяжении всего жизненного
цикла нейротехнологий требуют от всех
участников соблюдения высочайших
этических стандартов, открытого
восприятия замечаний, готовности
корректировать методы работы в связи с
новыми данными или этическими
проблемами, а также нести ответственность
за свои действия.
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58. Подотчетность основана на Пункт 58 – представляется, что в этом
ответственности, четкой и прозрачной пункте должны быть определены субъекты,
коммуникации, а также на обязанности несущие ответственность за сохранность
прогнозировать и ликвидировать личных биометрических данных, а также
потенциальный ущерб в краткосрочном и механизмы установления данной
долгосрочном периоде, а также ущерб, ответственности в тех или иных контекстах
который может быть причинен в результате применения нейротехнологии. Также
непреднамеренного использования и необходим механизм установления субъекта
непредвиденного воздействия. ответственности за обслуживание и
изменение условий обслуживания
нейротехнологии.
Кроме того, необходим прозрачный
механизм сбора, анализа и представления
обратной связи от пользователей
нейротехнологии о качестве и реальных
эффектах примеряемой технологии, как
положительных, так и негативных; о
достижении заявленных разработчиком
целей с помощью нейротехнологии;
субъективной оценки ощущений
пользователя от применения
нейротехнологии; пожеланий к улучшению
работы технологии. Полученные данные
должны быть доступны.
59. Приверженность принципам Из рекомендаций неясно, какая инстанция /
подотчетности требует глобальных, лицо осуществляет контроль отчетности.
правительственных, общественных и Пункт 59 подразумевает, что
коллективных действий для обеспечения ответственными за выявление
доступа к правосудию для тех, кто правонарушений являются лица,
пострадал в результате применения совершившие эти правонарушения, что
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нейротехнологий, и для того, чтобы обязать звучит некорректно.
лица, ответственные за правонарушения,
принять конструктивные меры для их
выявления, предотвращения, смягчения и
представления отчетности о том, каким
образом эти лица будут устранять и
компенсировать негативное воздействие на
права человека, в том числе посредством
принятия корректирующих мер и
возмещения ущерба.
III.2.6 Надежность и прозрачность
60. Все субъекты на протяжении всего
жизненного цикла нейротехнологий должны
обеспечивать прозрачность своей
деятельности, ее опору на научные данные и
соответствие международным принципам
ответственного поведения и научной
добросовестности, с тем чтобы
гарантировать соблюдение, поощрение и
защиту прав человека и основных свобод.
Это включает в себя предотвращение
тиражирования предрассудков или их
усиления, обеспечение доступности
нейротехнологий для контроля и
объяснения, точное описание их
возможностей и ограничений, четкое
определение условий ответственности,
соблюдение этических норм при проведении
исследований и разработок, включая
регистрацию испытаний, честный отбор
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участников и одобрение независимыми
комитетами по этике.
III.2.7 Эпистемическая справедливость,
инклюзивное участие и расширение прав и
возможностей широкой общественности
61. Обеспечение справедливого и
равноправного распространения и
формирования знаний о нейротехнологиях,
включая признание различных способов
познания, а также возможностей участия в
их создании, распространении и применении
для всех людей и сообществ.
62. Содействие открытому и доступному 62. Содействие открытому и доступному
образованию, а также привлечение образованию, а также привлечение
общественности и сообществ, с тем чтобы общественности и сообществ, с тем чтобы
различные группы населения могли различные группы населения могли
получать знания о функционировании получать знания о функционировании
нервной системы, психическом здоровье, нервной системы, психическом здоровье,
медицинском и немедицинском применении медицинском и немедицинском применении
и инструментах нейротехнологий, а также и инструментах нейротехнологий,
обмениваться такими знаниями. биологических и социально-этических
рисках применения нейротехнологий,
степени исследованности принципов
действия и эффективности
нейротехнологий, а также обмениваться
такими знаниями
63. Эффективное взаимодействие с
общественностью и сообществами на
протяжении всего жизненного цикла
нейротехнологий требует уважения к
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разнообразию, включая языковое,
социальное и культурное разнообразие, а
также разнообразие наследия и видов
самоидентификации, что позволяет уважать
различные способы познания и понимания.
Такое уважение к разнообразию является
гарантией признания точек зрения и знаний
различных сообществ и их учета в процессах
принятия решений, а также уважения к
самоопределению.
64. Когда образование опирается на права
человека, это гарантирует соблюдение прав
всех людей при распространении и
производстве знаний и способствует
предотвращению эпистемической
несправедливости, когда определенные
группы могут оказаться в неблагоприятном
положении или будут исключены из
процесса производства и распространения
знаний.
65. Все сообщества должны иметь право
голоса при принятии решений, которые их
затрагивают, особенно когда речь идет о
разработке и использовании
нейротехнологий.
III.2.8 Наилучшее обеспечение интересов
ребенка и защита будущих поколений
66. Нервная система быстро развивается в
детстве и претерпевает радикальные
изменения в подростковом возрасте, что
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делает крайне важным соблюдение
принципов неприкосновенности частной
жизни, самоопределения и права детей и
подростков на участие в принятии решений,
которые их касаются.
Технологии должны подвергаться строгой Технологии должны подвергаться строгой
оценке, с тем чтобы гарантировать их оценке, с тем чтобы гарантировать их
соответствие наилучшим интересам, соответствие наилучшим интересам,
благополучию и здоровому развитию детей благополучию и здоровому развитию детей
по мере их взросления и превращения в по мере их взросления и превращения в
самостоятельных личностей, а также защиту самостоятельных личностей, а также защиту
прав будущих поколений путем обеспечения прав будущих поколений путем обеспечения
соответствия сегодняшних решений целям соответствия сегодняшних решений целям
их будущего благополучия. их будущего благополучия, соблюдения
принципов неприкосновенности частной
жизни, самоопределения и права детей и
подростков на участие в принятии решений,
которые их касаются.
67. С этической точки зрения, признавая
потенциальные преимущества
нейротехнологий для ранней диагностики,
воспитания, образования и непрерывного
обучения, не менее важно взять на себя
обязательства по всестороннему развитию
ребенка. Это включает воспитание детей как
членов общества, содействие формированию
конструктивных отношений и пропаганду
здорового образа жизни, включающего в
себя питание и физическую активность.
III.2.9 Глобальная и социальная
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справедливость, пользование результатами
научного прогресса и их практического
применения
68. Доступ к исследованиям и разработкам в
области нейротехнологий и выгоды от них
должны распределяться на справедливой
основе между всеми участниками этих
исследований и разработок, при этом особое
внимание должно уделяться организации
глобального распределения,
способствующего справедливости и
сокращению неравенства.
69. Развитие нейротехнологий необходимо
использовать для сокращения неравенства в
области здравоохранения во всем мире. Эти
технологии должны стать катализатором
повышения качества жизни, особенно в
условиях ограниченных ресурсов.
70. Исследования, разработки и испытания
нейротехнологий должны соответствовать
самым высоким этическим стандартам,
обеспечивая участие всех вовлеченных в
них лиц без какой бы то ни было
эксплуатации. Это включает в себя защиту
прав и благополучия участников, пациентов
и лиц, осуществляющих уход за ними, а
также соблюдение этических принципов при
сборе и использовании данных. Особое
внимание следует уделить тому, чтобы
участники исследований и разработок
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получали свою справедливую долю выгод и
не несли непропорционально большие
риски.
71. Необходимо предпринять усилия, в том
числе в области международного
сотрудничества, для устранения
сказывающегося на жизни сообществ
дефицита необходимой технической или
медицинской инфраструктуры,
образовательных возможностей и навыков, а
также этических принципов и нормативной
базы, в частности в странах с уровнем
дохода ниже среднего (СДНС), наименее
развитых странах (НРС), развивающихся
странах, не имеющих выхода к морю
(РСНВМ) и малых островных
развивающихся государствах (МОСРГ), и
недопущению использования этого
дефицита в чьих-либо интересах.
72. При разработке и оценке воздействия
инновационных нейротехнологий следует
рассмотреть возможность использования
ориентированной на человека парадигмы, в
которой конечные пользователи являются не
просто пассивными получателями
технологий, а активными участниками их
разработки на равных условиях.
IV. ОБЛАСТИ, ТРЕБУЮЩИЕ ПРИНЯТИЯ
СТРАТЕГИЧЕСКИХ МЕР
IV.1 ГОСУДАРСТВЕННЫЕ
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ИНВЕСТИЦИИ, ИСПОЛЬЗОВАНИЕ И
РЕГУЛИРОВАНИЕ НЕЙРОТЕХНОЛОГИЙ
73. Государствам-членам, частным
структурам и международным организациям
следует активно поддерживать
исследования, разработку и внедрение
нейротехнологий на благо общества. При
инвестировании приоритет должен
отдаваться тем видам их применения,
которые способствуют процветанию людей
и обеспечивают соблюдение, поощрение и
защиту индивидуальных и коллективных
прав человека. Это обязательство должно
включать (14) финансирование
междисциплинарных исследований, которые
способствуют не только развитию
нейротехнологических инноваций, но и
изучению этических, правовых, социальных,
экологических и культурных последствий
этих технологий, а также поддерживают
внедрение и клиническое использование
технологических прототипов. Особое
внимание следует уделять разработке и
внедрению надлежащих технических,
институциональных, процедурных и других
гарантий, с тем чтобы обеспечить
справедливое использование
нейротехнологий на благо общества и
соблюдение прав человека.
74. Государства-члены должны установить Гендерная идентичность не должна являться
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четкие запреты на использование основанием для так называемой
нейротехнологий в условиях, нарушающих «позитивной дискриминации» (термин
индивидуальные и коллективные права приводится в данном документе).
человека. Государствам-членам следует
реализовывать на практике должную
осмотрительность в вопросах прав человека,
включая регулярное проведение
комплексных оценок воздействия на права
человека в отношении нейротехнологий,
которые они разрабатывают, проектируют,
внедряют, используют, продают,
эксплуатируют или закупают, с целью
предотвращения и смягчения их негативного
воздействия на права человека. В частности,
нейротехнологии не должны использоваться
для таких целей, как допрос без согласия в
правоохранительных органах, уголовном и
гражданском правосудии, разработка или
развертывание оружия, нацеленного на
нервную систему, социальный контроль,
попытки принуждения к подчинению на
основе личных убеждений или мыслей,
политических или иных взглядов, гендерной
идентичности или сексуальной ориентации,
наблюдение за психическим состоянием и
т.д. Правительствам следует принять
законодательство, гарантирующее
ответственное применение нейротехнологий
и соблюдение прав человека, а также
создание надежных механизмов надзора для
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обеспечения соблюдения вышеупомянутых
ограничений и защиты психической
неприкосновенности и свободы мысли всех
людей. Такая политика должна
разрабатываться на основе консультаций с
различными субъектами, включая
представителей гражданского общества,
конечных пользователей, экспертов по
нейротехнологиям, специалистов по этике и
правозащитников, с тем чтобы обеспечить
широкий консенсус и соблюдение
глобальных стандартов в области прав
человека.
75. Государствам-членам следует
обеспечить прозрачность и подотчетность
осуществляемых ими поддержки, надзора и
регулирования нейротехнологий, особенно в
рамках финансируемых государством
инициатив, таких как программы
исследования и развития мозга. Признавая
ограничения в раскрытии определенной
конфиденциальной информации,
правительства должны требовать от
спонсируемых государством
нейротехнологических проектов публичного
раскрытия, когда это возможно, целей,
методологии, предполагаемого
использования и воздействия на общество
их нейротехнологических инициатив. Такая
прозрачность имеет решающее значение для
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укрепления общественного доверия и
обеспечения соответствия
нейротехнологических достижений
этическим нормам и правам человека.
76. Государствам-членам следует применять
комплексный подход к нормативно-
правовым и политическим мерам,
принимаемым для защиты от нанесения
ущерба правам человека, связанного с
нейротехнологиями, разрабатываемыми,
продаваемыми, эксплуатируемыми или
используемыми частным сектором. Это
включает в себя законодательные и
нормативные меры, а также сопутствующие
рекомендации, стимулирующие меры и
требования к обеспечению прозрачности.
Такой комплексный подход требует также
должной осмотрительности в отношении
прав человека и обеспечения того, чтобы
частные компании выявляли,
предотвращали и смягчали негативное
воздействие на права человека, а также
несли за него ответственность в рамках
адаптированных к соответствующим
условиям процедур, включая оценку
воздействия на права человека,
конструктивное взаимодействие с
общественностью и сообществами, а также
прозрачные коммуникации.
77. Государствам-членам следует
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обеспечить, чтобы любое использование
нейротехнологий в системе правосудия,
включая их рассмотрение судебными
органами, было основано на надежных
научных данных, осуществлялось с
соблюдением этических норм и прав
человека и было направлено на обеспечение
общественной безопасности при защите
прав и достоинства всех вовлеченных лиц.
Это требует соблюдения основных прав,
таких как (15) уважение человеческого
достоинства, телесной неприкосновенности,
конфиденциальности личных данных,
соблюдение процессуальных норм и прав на
справедливое судебное разбирательство,
включая презумпцию невиновности и право
на отказ от самообвинения, а также свободу
от пыток и жестокого обращения, право на
неприкосновенность частной жизни и право
на свободу мысли.
78. Государствам-членам следует создать
комплексные системы стимулов,
включающие налоговые льготы, субсидии и
премии, с особым акцентом на поощрение
создания и развития производства,
вычислительных ресурсов и возможностей
анализа данных в государственных научно-
исследовательских институтах и на малых и
средних предприятиях (МСП).
Государствам-членам следует также
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537
стимулировать и поддерживать партнерские
связи, которые используют вычислительные
ресурсы и возможности анализа данных
частных компаний для достижения целей
государственных исследований. Эти
стимулы должны в первую очередь
поощрять прозрачность, процессы
разработки на основе широкого участия и
вклад в создание общественных благ,
нацеливаясь на создание среды, в которой
государственные учреждения и компании
ответственно подходят к инновациям и
стремятся к достижению целей процветания
человечества.
79. Государствам-членам следует
разработать скоординированный
межсекторальный подход к оценке
воздействия нейротехнологий на
протяжении всего их жизненного цикла.
Такой подход может включать следующие
компоненты (список может быть дополнен):
(a) оценки экономического воздействия:
проводятся соответствующими
национальными органами, отвечающими за
экономическую и трудовую политику, для
оценки влияния нейротехнологий на
экономический рост, рабочие места,
социальную справедливость и
экологическую устойчивость;
(b) оценка выгод и рисков: такие оценки
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должны проводиться под руководством
организаций, отвечающих за общественное
здравоохранение, медицинские
исследования и защиту прав потребителей, и
содержать тщательно обоснованную оценку
рисков и выгод, связанных с разработкой,
внедрением и использованием
нейротехнологий, включая исследования,
клиническое применение и потребительские
товары. Этот процесс должен включать
тщательное документирование, этический
надзор и постоянный мониторинг для
обеспечения безопасности, благополучия и
справедливого отношения ко всем
участвующим в нем лицам;
(c) оценки воздействия на частную жизнь
(ОВЧ): такие оценки проводятся под
надзором соответствующих национальных
органов или учреждений, ответственных за
защиту данных и частной жизни и нацелены
на анализ и смягчение связанных с
нейротехнологиями рисков для психической
неприкосновенности людей. Это включает
предоставление соответствующих гарантий
для защиты нейронных и когнитивных
биометрических данных в соответствии с
национальными и международными
стандартами конфиденциальности и
практическими подходами к разработке
политики в отношении данных, о которых
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говорится в настоящей Рекомендации;
(d) оценка воздействия на права человека
(ОВПЧ): такие оценки проводятся под
надзором соответствующих национальных
правозащитных учреждений или
международных органов и нацелены на
выявление, предотвращение и устранение
потенциального негативного воздействия
нейротехнологий на права человека. Этот
процесс должен обеспечить соблюдение и
поощрение прав человека в области
нейротехнологий с особым вниманием к
уязвимым категориям населения и людям,
находящимся в уязвимом положении. ОВПЧ
должны предусматривать конструктивное
участие общественности и сообществ, с тем
чтобы обеспечить учет различных точек
зрения. (16)
80. Государствам-членам следует
содействовать равному доступу к
нейротехнологиям во всем мире. Для
достижения этих целей необходимо
поддерживать снижение итоговой стоимости
для конечных пользователей, продолжать
разработку, внедрение и постоянную
поддержку непатентованных программных
решений, а также изучить стратегии
возмещения или субсидирования,
сопоставимые с общепринятыми в местных
юрисдикциях нормами, в секторах, в
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которых возможно получение значительных
выгод.
81. Государствам-членам следует внедрять
адаптируемые нормативно-правовые базы, в
том числе с использованием нормативной
контролируемой среды для разработки,
тестирования и оценки нейротехнологий в
ответ на стремительное развитие
нейротехнологий и их сближение с другими
технологиями, такими как ИИ,
пространственные вычисления и
технологии, задействующие несколько
каналов восприятия. Такую
контролируемую среду следует
использовать для изучения инновационных
способов применения нейротехнологий,
особенно на рабочем месте, при
соответствующем этическом надзоре со
стороны регулирующих органов или
национальных властей. Нормативные рамки
должны способствовать инновациям,
гарантировать этичную обработку данных и
защищать права благодаря включению в них
механизмов регулярного мониторинга,
оценки и динамичной корректировки
политики в соответствии с развитием
технологий и этических норм.
IV.2 ПОЛИТИКА В ОТНОШЕНИИ
ДАННЫХ
82. Государствам-членам следует
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разработать надежную нормативно-
правовую базу, регулирующую сбор,
обработку, обмен и все другие виды
использования нейронных и когнитивных
биометрических данных. В такой
нормативно-правовой базе, как и в уже
существующих нормативных актах, должно
признаваться, что эти данные являются
персональными и конфиденциальными как в
медицинском, так и в немедицинском
контексте.
83. Государствам-членам следует
обеспечить комплексное включение в их
существующую политику защиты
неприкосновенности частной жизни строгих
гарантий в отношении нейронных и
когнитивных биометрических данных
человека. Если текущая политика не
предлагает надлежащего решения этих
проблем, государствам-членам следует
принять целенаправленные законы или
нормативно-правовые акты для обеспечения
такой защиты. Эти гарантии должны,
например, включать в себя утвердительное
информированное согласие, минимизацию
данных и ограничение целей использования,
права на данные (включая право на доступ,
исправление и удаление данных), а также
жесткие меры по обеспечению безопасности
данных, такие как передовые протоколы
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542
кибербезопасности для предотвращения
несанкционированного доступа и утечек.
Вышеупомянутые законы или нормативно-
правовые акты должны запрещать практику
привязки доступа к товарам или услугам к
раскрытию нейронных и когнитивных
биометрических данных, требовать явного
согласия на любой обмен данными и
запрещать использование таких данных для
целевой рекламы без явного,
утвердительного информированного
согласия человека.
84. Государствам-членам следует В контексте пункта необходимо указать на
разработать и внедрить конкретную строгое соблюдение принципа
политику по сокращению экологического конфиденциальности нейронных и
воздействия нейротехнологий, особенно в когнитивных биометрических данных.
отношении крупных центров обработки
данных и вычислительных ресурсов,
используемых для обработки и хранения
нейронных и когнитивных биометрических
данных. Такая политика должна быть
направлена на минимизацию данных,
обеспечивая сбор и обработку только
необходимого объема информации, и
способствовать пропорциональному
использованию нейротехнологий, при
котором их применение будет
ориентироваться на реальные потребности, а
ненужное воздействие на окружающую
среду будет сводиться к минимуму. Такие
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меры должны включать оптимизацию
энергоэффективности, использование
возобновляемых источников энергии,
содействие переработке и устойчивой
утилизации связанного с
нейротехнологиями оборудования и
восстановление пострадавшей среды.
85. Государствам-членам следует
поддерживать и стимулировать разработку и
внедрение технологических инноваций и
стандартов проектирования
нейротехнологий, в которых (17) приоритет
отдается защите психической
неприкосновенности, таких как современное
шифрование, защищенные базы данных с
многофакторной аутентификацией,
передовые методы анонимизации данных,
обработка и хранение данных на границе
сети (обработка и хранение данных как
можно ближе к месту их получения), что
позволит добиться более значительных и
ориентированных на принятие практических
мер результатов в области хранения
нейронных и когнитивных биометрических
данных в режиме реального времени.
86. Государствам-членам следует создавать
стимулы для производителей
нейротехнологий, с тем чтобы они уделяли
приоритетное внимание вопросам
конфиденциальности и этики при
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разработке, требуя включения в свои
устройства по умолчанию технологий,
обеспечивающих защиту
конфиденциальности.
87. Государствам-членам следует поощрять Проект закрепляет широкую дискрецию
этичный обмен данными путем создания государств-членов на трансграничный обмен
безопасных хранилищ данных для информацией и данными в области
используемых в научных исследованиях нейротехнологических исследований. При
нейронных и когнитивных биометрических этом отсутствуют необходимые стандарты и
данных. Эти хранилища должны отвечать протоколы защиты передачи таких данных,
строгим стандартам кибербезопасности, в том числе, от несанкционированного
конфиденциальности данных и этичного доступа третьих лиц. Данные положения
использования (включая минимизацию Проекта нарушают требования
данных и ограничение их назначения), иметь международных актов.
многоуровневый доступ и использовать Согласно п. 87 Проекта государства-членам
другие методы, направленные на укрепление следует поощрять этичный обмен данными
защиты конфиденциальности. Следует путем создания безопасных хранилищ
создать надлежащие механизмы данных для используемых в научных
финансирования для курирования и исследованиях нейронных и когнитивных
хранения данных, а также оптимизировать биометрических данных. В силу п. 88
процессы управления данными. Проекта государства-членам следует
уделять приоритетное внимание мерам по
сокращению препятствий для
трансграничного обмена данными в области
нейротехнологических исследований,
добиваясь более широкого согласования
стандартов защиты данных. В силу п. 94
Проекта государствам-членам следует
принять политику в отношении открытой
науки, которая обеспечивает баланс между
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защитой ИС и поощрением немедленной
публикации результатов исследований и
совместного использования данных.
Указанные положения Проекта нуждаются в
корректировке в части акцентуации
внимания на необходимости соблюдения
принципа безопасной передачи данных,
принципа уважения государственного
суверенитета при осуществлении передачи
данных, что находит свое отражение в таких
международных документах как:
Руководящие принципы ООН по
регламентации компьютеризированных
картотек, содержащих данные личного
характера 1990 года, Руководящие
принципы ОЭСР в области
неприкосновенности личной жизни 1980
года, Конвенция Совета Европы о защите
физических лиц при автоматизированной
обработке персональных данных 1981 года.
88. Государствам-членам следует уделять
приоритетное внимание мерам по
сокращению препятствий для
трансграничного обмена данными в области
нейротехнологических исследований,
добиваясь более широкого согласования
стандартов защиты данных, особенно в
отношении нейронных и когнитивных
биометрических данных, путем разработки
четких протоколов передачи данных,
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обеспечивающих безопасный и отвечающий
требованиям трансграничный обмен
данными, и стандартов функциональной
совместимости данных, включая системы
управления обменом данными.
89. Государствам-членам следует
рассмотреть возможность принятия
конкретных руководящих принципов
этичного использования нейронных и
когнитивных биометрических данных в
разработках и исследованиях в области ИИ,
включая процедуры получения согласия на
использование нейронных и когнитивных
биометрических данных при обучении и
применении моделей ИИ, обеспечивающие
прозрачность и соблюдение
индивидуальных и общинных прав.
IV.3 ИНТЕЛЛЕКТУАЛЬНАЯ Государствам-членам следует принять меры
СОБСТВЕННОСТЬ (ИС) для обеспечения того, чтобы нейронные и
90. Государствам-членам следует принять когнитивные биометрические данные,
меры для обеспечения того, чтобы являющиеся производными индивидуальной
нейронные и когнитивные биометрические деятельности человека, могли
данные, являющиеся производными быть объектом прав собственности только
индивидуальной деятельности человека, не со стороны государственных,
были объектом прав собственности. некоммерческих научных, образовательных,
медицинских организаций государств-
членов.
Использование нейронных и когнитивных
биометрических данных частными лицами
может привести к злоупотреблениям
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правами и свободами человека, что
необходимо контролировать
соответствующими структурами государств-
членов.
Защита ИС должна распространяться только
на оригинальные подборки данных
(созданные в процессе агрегирования,
организации или отбора, в результате
которых был получен новый набор данных),
отвечающие строгим этическим критериям.
91. Государствам-членам следует совместно Государствам-членам следует совместно
разработать четкие и унифицированные разработать четкие и унифицированные
руководящие принципы в отношении прав руководящие принципы в отношении прав
ИС, применимых к нейротехнологиям в ИС, применимых к нейротехнологиям в
международном масштабе. В этих международном масштабе. В этих
руководящих принципах должны быть руководящих принципах должны быть
учтены вопросы патентоспособности учтены вопросы патентоспособности
созданных ИИ изобретений и этические созданных изобретений и этические
последствия законов об ИС, а также последствия законов об ИС, а также
обеспечена их направленность на обеспечена их направленность на
расширение глобального доступа и расширение глобального доступа и
инновации. инновации, с учетом
государственных (национальных) интересов
государств-членов, отраженных в
соответствующих нормативных актах
государств-членов.
92. Государствам-членам следует Государствам-членам следует обеспечить
обеспечить принятие всеми субъектами принятие всеми субъектами стратегий
стратегий управления ИС, поощряющих управления ИС, поощряющих инновации, с
инновации и не допускающих чрезмерно учетом государственных (национальных)
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ограничительное использования патентов, интересов государств-членов, способствуя
способствуя тем самым созданию открытой тем самым созданию открытой экосистемы
экосистемы для инноваций. Такой подход для инноваций. Такой подход должен
должен постоянно адаптироваться к постоянно адаптироваться к меняющемуся
меняющемуся положению дел в сфере положению дел в сфере нейротехнологий.
нейротехнологий. Необходимо постоянно Необходимо постоянно отслеживать
отслеживать влияние политики в области влияние политики в области ИС на сектор
(18) ИС на сектор нейротехнологий, с тем нейротехнологий, с тем, чтобы она была
чтобы она была направлена на направлена на стимулирование инноваций,
стимулирование инноваций, обеспечивая обеспечивая при этом их этичное
при этом их этичное использование и использование и широкую доступность.
широкую доступность.
93. Государствам-членам следует
способствовать созданию среды для
совместной разработки в области
нейротехнологий, создавая условия для
принятия политики и стимулов в отношении
совместной ответственности и льготных
лицензионных соглашений, с тем чтобы
обеспечить справедливую компенсацию и
признание для всех участников.
94. Государствам-членам следует принять
политику в отношении открытой науки,
которая обеспечит баланс между защитой
ИС и поощрением немедленной публикации
результатов исследований и совместного
использования данных. В условиях
конвергенции цифровых технологий и
растущей концентрации этих инноваций в
промышленных секторах, этот баланс имеет
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особенное и решающее значение для
обеспечения того, чтобы механизмы охраны
ИС не препятствовали научным
исследованиям, инновациям и широкому
распространению знаний и новых
технологий. Основным правилом
равноправного партнерства при вовлечении
коренных народов в исследования и
разработки в области нейротехнологий
должна стать разработка в сотрудничестве с
ними с самого начала процедур открытой
науки и стратегии управления ИС.
IV.4 КИБЕРБЕЗОПАСНОСТЬ
95. Государствам-членам следует
сотрудничать на международном уровне для
установления всеобъемлющих стандартов
кибербезопасности во всех областях
нейротехнологий.
Эти стандарты должны охватывать Эти стандарты должны охватывать
аппаратное и программное обеспечение, а аппаратное и программное обеспечение, а
также меры по обеспечению безопасности также меры по обеспечению безопасности
данных для защиты от потенциальных данных и протоколов передачи информации
киберугроз. (регистрируемых и транслируемых данных,
управляющих команд и т.д.) для защиты от
потенциальных киберугроз.
Внедряя единые стандарты
кибербезопасности, государства-члены
должны обеспечивать целостность,
конфиденциальность, безопасность и
доступность нейронных данных, а также
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укреплять доверие пользователей к
нейротехнологическим устройствам. Кроме
того, эти стандарты должны развиваться в
одном ритме с технологическим прогрессом
и новыми киберугрозами, чтобы обеспечить
надежную защиту от меняющихся рисков.
96. Государствам-членам следует
организовать тестирование на угрозу извне –
состязательные испытания для проверки
эффективности систем безопасности,
которая будет использоваться в качестве
упреждающей меры для оценки и
повышения безопасности, надежности и
устойчивости нейротехнологических систем.
Проводя регулярное тестирование на угрозу
извне, государствам-членам следует
заблаговременно выявлять и устранять
пробелы в системе безопасности, проверять
процедуры реагирования на инциденты и
укреплять общую безопасность и
кибербезопасность нейротехнологических
устройств.
IV.5 КОММУНИКАЦИЯ, УЧАСТИЕ И
ИНФОРМАЦИЯ
97. Государствам-членам следует поощрять
коммуникацию и разрабатывать политику
взаимодействия в интересах развития
нейротехнологий, способствующую
информированному, инклюзивному и
уважительному диалогу между
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исследователями, разработчиками,
различными пользователями и широкой
общественностью в целях соблюдения
индивидуальных и общественных прав,
укрепления общественного доверия и
обращения к коллективному разуму и
разнообразию сообществ.
98. Государствам-членам следует
сотрудничать с международными
организациями, образовательными
учреждениями, частными и
неправительственными структурами в целях
разработки и распространения доступных и
увлекательных образовательных
материалов, адаптированных к интересам
различных аудиторий, с тем чтобы
восполнить пробелы в знаниях о нервной
системе и функционировании психического
здоровья, а также о преимуществах и рисках
нейротехнологий, особенно в регионах с
недостаточным уровнем обслуживания.
Такие программы должны быть направлены
на повышение уровня понимания
общественностью функциональности,
безопасности, эффективности и влияния
технологий на (19) общество, что позволит
людям принимать осознанные решения и
проводить этический анализ использования
ими нейротехнологий.
99. Государствам-членам следует внедрить
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процедуры взаимодействия с
общественностью и различными
сообществами, которые будут
способствовать подлинно взаимному
обучению и сотрудничеству на протяжении
всего жизненного цикла нейротехнологий.
Такие процедуры должны включать
регулярные и всесторонние консультации с
широким кругом субъектов. Целью такого
взаимодействия должно быть
информационное обеспечение разработки
политики, формирование этических
рекомендаций, повышение осведомленности
и понимания общественности, согласование
инвестиционных приоритетов и обеспечение
соответствия процессов внедрения
нейротехнологий общественным интересам
и ценностям. Особое внимание следует
уделить привлечению групп, традиционно
недопредставленных в процессе разработки
политики в сфере технологий, что будет
способствовать развитию ответственных
инноваций в этой области.
100. Государствам-членам следует вести
совместную работу над созданием точных,
четких и доступных определений и
терминологии для обсуждения
нейротехнологий с участием представителей
различных слоев общества, с тем чтобы
обеспечить в используемых формулировках
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инклюзивность, отсутствие предрассудков и
точное отражение возможностей и
ограничений технологий. Государствам-
членам следует создать нормативно-
правовую базу, содержащую требования по
четким и этичным стандартам
коммуникации в отношении
нейротехнологий. В эту нормативно-
правовую базу должны быть заложены
требования представления фактологически
обоснованной информации о возможностях,
рисках и ограничениях всех способов
применения нейротехнологий, включая, в
частности, их применение для
регулирования сна, внимания, памяти и
эмоций, с тем чтобы избежать чрезмерных и
необоснованных претензий. В рамках этой
базы должны быть разработаны конкретные
рекомендации по этичному маркетингу и
протоколы ответственного информирования
об исследованиях, находящихся на ранних
стадиях, и о новых технологиях.
101. Государствам-членам следует
разработать политику, способствующую
эффективному сотрудничеству между
конечными пользователями, учеными и
новаторами на протяжении всего
жизненного цикла разработки
нейротехнологической продукции, уделяя
особое внимание местам разработки
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нейротехнологий. Такая политика должна
предусматривать создание разнообразных
консультативных групп, включающих
представителей различных групп
пользователей и обеспечивающих уважение
к нейроразнообразию. Государствам-членам
следует также создавать платформы для
постоянного диалога и обратной связи
между пользователями, учеными и
разработчиками. Следует вовлекать
консультативные группы в процесс
разработки и тестирования новых
нейротехнологических продуктов в целях
оптимизации эффективности, обеспечения
удобства использования, долговечности и
экологичности соответствующих устройств.
Этот совместный подход нацелен на
обеспечение согласования инноваций в
области нейротехнологий с
соответствующими условиями и
потребностями различных групп
пользователей.
102. Государствам-членам следует
разработать соответствующие возрасту,
контексту, культуре и языку
образовательные программы по
нейротехнологиям. В них необходимо
включить обучающие модули для
поддержки вспомогательного использования
этих технологий в домашних условиях как
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для пользователя, так и для лиц,
осуществляющих уход, и членов семьи.
УЧЕТ ИНТЕРЕСОВ КОНКРЕТНЫХ
ПОЛЬЗОВАТЕЛЕЙ
IV.6 ДЕТИ И ПОДРОСТКИ
103. Государствам-членам следует
содействовать здоровому развитию мозга с
помощью политики, оценивающей
воздействие нейротехнологий на детей и
подростков. (20)
104. Государствам-членам необходимо
оградить детей и подростков от скрытого и
явного принуждения к использованию
нейротехнологий. Государствам-членам
следует уделять внимание
самостоятельности детей и подростков,
запрашивая их информированное согласие,
учитывающее их возраст и способность
принимать решения.
105. Государствам-членам следует
финансировать гранты на исследования и
разработки, направленные на создание
удобных в использовании вспомогательных
нейротехнологий, предназначенных для
детей и подростков с ограниченными
возможностями. В рамках таких проектов к
процессу разработки следует привлекать
детей, подростков, родителей и
воспитателей, с тем чтобы обеспечить
соответствие технологий их специфическим
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потребностям. Необходимо разработать
образовательные программы для обучения
детей и подростков, а также лиц,
осуществляющих уход за ними,
эффективному использованию и
обслуживанию этих технологий с
поддержкой на разных языках и без
дискриминации тех, кто не может или не
хочет работать с предлагаемыми
технологиями.
106. Государства-члены должны обеспечить
строгий надзор и тщательное наблюдение за
всеми исследованиями в области
нейротехнологий, в которых участвуют дети
и подростки. Такой надзор крайне важен на
этапах развития ребенка, с тем чтобы
устранить и смягчить любые
непредвиденные долгосрочные последствия.
Такие исследования должны включать в
себя комплексные протоколы мониторинга и
периодические оценки для постоянного
обеспечения безопасности и благополучия
юных участников с учетом их уникальных
потребностей в развитии и факторов
уязвимости.
В рамках исследований с участием детей и В рамках исследований с участием детей и
подростков, находящихся в уязвимом с подростков, находящихся в уязвимом с
медицинской точки зрения положении медицинской точки зрения положении
(например, детей, находящихся в отделениях (например, детей, находящихся в отделениях
мониторинга эпилепсии), особое внимание мониторинга эпилепсии), особое внимание
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следует уделять согласию и следует уделять согласию и
волеизъявлению, особенно с учетом волеизъявлению, с учетом мнения
конкретных аспектов исследования (время, законных представителей, принимая во
повторные циклы), с тем чтобы внимание конкретные аспекты
предотвратить инструментализацию в исследования (время, повторные циклы), с
любой ее форме. тем чтобы контролировать
инструментализацию в любой ее форме.
107. Государствам-членам следует принять Государствам-членам следует принять
конкретные правила, запрещающие конкретные правила, запрещающие
использование маркетинговых приемов, использование маркетинговых приемов,
таких как нейромаркетинг, биометрическая таких как нейромаркетинг, иммерсивная
эмоциональная аналитика, иммерсивная реклама, реклама на основе виртуальной или
реклама, реклама на основе виртуальной или дополненной реальности, а также принять
дополненной реальности, которые регламентированные правила для
используют конфиденциальные нейронные использования биометрической
и когнитивные биометрические данные, эмоциональной аналитики исключительно в
собранные у детей и подростков. Учитывая научных целях, которые используют
повышенную уязвимость детей и конфиденциальные нейронные и
подростков в цифровой среде, эти правила когнитивные биометрические данные,
должны прямо запрещать любые действия, собранные у детей и подростков. Учитывая
которые используют такие данные для повышенную уязвимость детей и
влияния на детей и подростков или их подростков в цифровой среде, эти правила
эксплуатации. должны строго регламентировать под
контролем ответственных лиц
государственных (некоммерческих)
научных, медицинских,
образовательных учреждений любые
действия, которые используют такие данные
для научной оценки влияния на детей и
подростков и не допускать использования
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данных действий для их эксплуатации.
IV.7 ПОЖИЛЫЕ ЛЮДИ
108. Государствам-членам необходимо 108. Государствам-членам необходимо
способствовать здоровому старению и способствовать здоровому старению и
поддерживать пожилых людей путем поддерживать людей пожилого, старческого
финансирования и осуществления научно возраста, а также долгожителей путем
обоснованных программ, включающих финансирования и осуществления научно
нейротехнологии в систему регулярного обоснованных программ, включающих
ухода. нейротехнологии в систему регулярного
ухода.
Эти программы должны охватывать всю
систему поддержки, включая семью, лиц,
обеспечивающих уход, и медицинские
группы, с тем чтобы повысить качество
жизни. Следует уделять приоритетное
внимание разработке и внедрению
инструментов для профилактики, отсрочки и
лечения возрастных заболеваний, проблем
со здоровьем и нейродегенеративных
заболеваний. Государствам-членам следует
обеспечить равный доступ к таким
нейротехнологическим программам и не
усугублять социально-экономическое
неравенство.
109. Государствам-членам следует
разработать руководящие принципы
проектирования нейротехнологий с учетом
потребностей пожилых людей, тщательно
продумывая необходимые для удобства
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использования компоненты панели
взаимодействия человека с компьютером
(например, шрифты, кнопки и цвет) и
возможности улучшения визуальных и
звуковых сигналов.
110. Государства-членам следует сохранять,
поддерживать и поощрять самостоятельное
принятие решений пожилыми людьми,
использующими нейротехнологии для
сенсомоторной и когнитивной поддержки.
Процесс получения согласия должен
учитывать (21) потенциальные когнитивные
проблемы, с которыми сталкиваются
пожилые люди, обеспечивая постоянное
наличие информированного и
адаптируемого к изменяющемуся состоянию
здоровья согласия. Необходимо принять
политику, обеспечивающую при
применении вспомогательных
нейротехнологий учет изменений
когнитивных способностей с течением
времени и уважение предпочтений
пользователей.
111. Государствам-членам следует
разработать этические рекомендации для
обеспечения того, чтобы такие
нейротехнологии как осуществляющие уход
роботы, улучшали, а не заменяли
взаимодействие с человеком, особенно при
уходе за людьми с нейродегенеративными
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заболеваниями. В таких рекомендациях
следует сделать акцент на необходимости
дополнения человеческого ухода, а не его
замены.
IV.8 ЖЕНЩИНЫ И ГЕНДЕРНОЕ Вызывает обоснованные сомнения указание
РАВЕНСТВО в п.п. 112-114 Проекта на необходимость
112. Государствам-членам следует принять защиты и обеспечения интересов
комплексную политику, направленную на «гендерных меньшинств».
поощрение и соблюдение гендерного Предложенные пункты устанавливают
равенства и разнообразия на протяжении необходимость защиты от притеснений и
всего жизненного цикла нейротехнологий, и дискриминаций «гендерных меньшинств» в
обеспечить ее выполнение. В соответствии с контексте обеспечения инклюзивности и
такой политикой приоритетное внимание комфортности рабочих мест и
должно уделяться инклюзивным исследовательской среды на протяжении
исследованиям, направленным на всего жизненного цикла нейротехнологий. С
удовлетворение потребностей женщин и учетом официальной позиции Российской
учет гендерных особенностей и различий. В Федерации к данной тематической повестке,
ней должны содержаться требования выраженной, в том числе отказом от
относительно целенаправленного сбора и подписания Декларации Организации
анализа данных, а также программы Объединённых Наций по вопросам
обучения и подготовки по инклюзивным сексуальной ориентации и гендерной
методам исследований. Политика должна идентичности 2008 года, обозначение
обеспечивать взаимодействие представленной категории лиц в тексте
общественности и различных сообществ с Рекомендаций не может быть поддержано.
экспертами по женскому и гендерному
здоровью и соответствующими группами
правозащитников, а также стимулировать
разработку учитывающих гендерный фактор
технологий с целью удовлетворения
потребностей женщин и гендерных
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меньшинств и создания для них
соответствующих условий. Для устранения
гендерного неравенства в этих областях,
расширения представительства и
взаимодействия и укрепления руководящей
роли необходима политика позитивной
дискриминации.
113. Государствам-членам следует
разработать четкие руководящие принципы
и нормативно-правовую базу для
обеспечения того, чтобы рабочие места и
исследовательская среда на протяжении
всего жизненного цикла нейротехнологий
были инклюзивными и комфортными,
особенно для женщин и гендерных
меньшинств, и обеспечивали защиту от
притеснений и дискриминации. Это должно
включать разработку надежных механизмов
информирования о случаях притеснений и
дискриминации и их устранения, а также
обеспечение подотчетности и поддержки.
114. Государствам-членам следует принять 114. Государствам-членам следует принять В п. 114. не указаны иные уязвимые группы
ряд мер, обеспечивающих приоритетное ряд мер, обеспечивающих приоритетное населения.
внимание к этичным и равноправным внимание к этичным и равноправным
исследованиям и инновациям, а также исследованиям и инновациям, а также В п. 114 Проекта указано на необходимость
поддержку программ, способствующих поддержку программ, способствующих инициативы в области «позитивной
участию женщин и гендерных меньшинств в участию женщин, а также уязвимых групп, дискриминации». Использование такого
сфере нейротехнологий. Они включают в в сфере нейротехнологий. Они включают в термина вызывает обоснованные сомнения,
себя финансирование и другие политические себя финансирование и другие политические учитывая, что в Преамбуле отмечено, что
меры, обеспечивающие приоритетное меры, обеспечивающие приоритетное данные Рекомендации – нормативный
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внимание к этичным и равноправным внимание к этичным и равноправным документ, разработанный на основе
исследованиям и инновациям, а также исследованиям и инновациям, а также принципов международного права,
инициативы в области позитивной инициативы в области позитивной призванный поощрять недопущение
дискриминации, направленные на дискриминации, направленные на дискриминации.
поддержку участия женщин и гендерных поддержку участия женщин в сфере В п. 114 Проекта также содержится термин
меньшинств в сфере нейротехнологий путем нейротехнологий путем разработки целевых «гендерные меньшинства», который
разработки целевых образовательных образовательных программ, предоставления воспроизводится еще в нескольких пунктах
программ, предоставления возможностей возможностей трудоустройства, поддержки (п. 112, 113 Проекта). При этом понятие
трудоустройства, поддержки предпринимательства и развития их «гендерные меньшинства» не раскрывается
предпринимательства и развития их руководящей роли в этом секторе. в международных актах. Содержание
руководящей роли в этом секторе. Государствам-членам также необходимо данного термина должно быть определено в
Государствам-членам также необходимо предоставить системы поддержки, такие как Проекте.
предоставить системы поддержки, такие как программы наставничества, возможности
программы наставничества, возможности сетевого взаимодействия и ресурсы, чтобы
сетевого взаимодействия и ресурсы, чтобы помочь женщинам преодолеть барьеры на
помочь женщинам и гендерным пути к участию и преуспеть в сфере
меньшинствам преодолеть барьеры на пути нейротехнологий.
к участию и преуспеть в сфере
нейроехнологий.
IV.9 ЛИЦА С ОГРАНИЧЕННЫМИ
ФИЗИЧЕСКИМИ ВОЗМОЖНОСТЯМИ
115. Государствам-членам следует принять
политику, направленную на использование
потенциала нейротехнологий для
ликвидации препятствий, с которыми
сталкиваются люди с ограниченными
физическими возможностями, и оказание им
поддержки, что будет (22) способствовать
равноправному пользованию правами
человека. Им следует принять нормативно-
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правовые акты, содержащие требование
проводить оценку доступности всех новых
нейротехнологических продуктов, с тем
чтобы эти продукты не способствовали
закреплению существующей инвалидности
или неравенства в состоянии здоровья.
Такие нормативно-правовые акты должны
включать протоколы тестирования с
участием различных групп людей с
ограниченными возможностями, с тем
чтобы обеспечить соответствие технологий
широкому спектру потребностей и не
допустить непреднамеренной изоляции или
ущемления прав какой-либо подгруппы.
116. Государствам-членам следует создать
программы стимулирования развития
нейротехнологий для людей с
ограниченными возможностями с целью
повышения качества их жизни и
функциональной независимости. Такие
программы должны включать налоговые
льготы для компаний, инвестирующих в
исследования и разработки в области
вспомогательных нейротехнологий, гранты
для исследовательских институтов,
занимающихся нейротехнологиями для
поддержки инвалидов, ускоренное
рассмотрение нормативных актов для
технологий, способных обеспечить
значительные достижения в области
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мобильности, коммуникации или помощи в
повседневной жизни, а также премии за
инновации, присуждаемые за прорывные
достижения в области разработки доступных
и приемлемых по стоимости
нейротехнологических решений.
117. Государствам-членам следует, по
возможности, субсидировать стоимость
основных нейротехнологических устройств,
таких как нейропротезы, для лиц с
ограниченными физическими
возможностями. Они могли бы поощрять
государственно-частные партнерства, чтобы
сделать передовые нейротехнологии
доступными, и включить покрытие
нейротехнологий в систему национального
медицинского страхования и другие схемы
возмещения расходов для лиц с
ограниченными физическими
возможностями. Для упрощения доступа и
обмена информацией следует создать
национальную базу данных по имеющимся
ресурсам и службам поддержки в области
нейротехнологий.
IV.10 ЛИЦА С ПСИХИЧЕСКИМИ В разделе IV.10 Проекта содержится
РАССТРОЙСТВАМИ указание на «лиц с психическими
118. Государствам-членам следует расстройствами». Конвенция о правах
содействовать проведению исследований и инвалидов 2006 года не содержит понятия
поощрять информационно-просветительские «лицо с психическими расстройствами».
инициативы, направленные на решение Учитывая использование данного термина,
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проблемы растущей распространенности его необходимо раскрыть.
психических расстройств и удовлетворение
потребностей лиц с такими расстройствами,
включая жертв и лиц, переживших травмы и
насилие, а также на рассмотрение
востребованности нейротехнологий для этих
сообществ.
119. Государствам-членам следует выделять
средства на долгосрочные исследования
эффективности нейротехнологий для сбора
аргументов в их поддержку, надзор после их
вывода на рынок и многоуровневые
проверки с особым вниманием к
инвазивности и обратимости
нейротехнологических вмешательств.
Важно, чтобы люди с психическими
расстройствами были хорошо
проинформированы об этом процессе и
связывали с ним обоснованные ожидания.
120. Государствам-членам следует уделять
приоритетное внимание финансированию
нейротехнологий, направленных на
улучшение качества жизни и повседневного
функционирования людей с психическими
заболеваниями. К ним относятся
технологии, помогающие справиться с
симптомами и улучшить когнитивные
функции, а также оказывающие
эмоциональную поддержку дома, на работе,
в их общинах и в обществе. Исследования и
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разработки должны проводиться с учетом
отзывов и взаимодействия с людьми с
психическими расстройствами и их
защитниками.
121. Государствам-членам следует
разработать политику, направленную на
расширение доступа к актуальным
достижениям в области нейротехнологий
для людей с психическими расстройствами,
с тем чтобы стоимость не была
препятствием для доступа к способным
изменить их качество жизни методам
лечения и поддержки. (23)
ЭТИЧЕСКИЕ АСПЕКТЫ
ЗДРАВООХРАНЕНИЯ И НАУЧНЫХ
ИССЛЕДОВАНИЙ
IV.11 ЗДРАВООХРАНЕНИЕ
122. Государствам-членам следует
поддерживать разработку прикладных
программ в области здравоохранения, в
которых приоритетными являются
неудовлетворенные потребности в охране
неврологического и психического здоровья.
Она должна включать создание программ
финансирования исследований,
направленных на устранение выявленных
недостатков в лечении нервной системы.
123. Государствам-членам следует
укреплять и поддерживать международную
солидарность противодействии глобальным
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угрозам и факторам неопределенности в
области здравоохранения, а также
обеспечивать соответствие их деятельности
по охране здоровья нервной системы
нормам международного права и строгим
обязательствам в области прав человека. Это
может включать создание международных
форумов для обмена передовым опытом
использования нейротехнологий в сфере
здравоохранения.
124. Государствам-членам следует создать
надзорные механизмы для оценки
воздействия на физическое и психическое
здоровье долгосрочного использования
нейротехнологических устройств, уделяя
особое внимание инвазивности и
обратимости нейротехнологических
вмешательств. Это включает в себя
принятие регуляторных мер, требующих
проведения долгосрочных последующих
исследований для одобренных
нейротехнологических устройств и
установления четких критериев для
дальнейшего одобрения на основании
результатов этих исследований.
125. Государствам-членам следует
учитывать значительные затраты и
последствия, связанные с патологиями
нервной системы, а также потенциальные
преимущества ранней диагностики и
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доступа к профилактическим и
вспомогательным нейротехнологиям.
Государственная политика должна уделять
приоритетное внимание расширению
доступа к этим технологиям и обеспечивать
покрытие расходов на здравоохранение для
нуждающихся.
126. Государствам-членам следует
содействовать разработке надежных и
долговечных нейротехнологий для
применения в здравоохранении. Это
включает в себя поощрение разработки
устройств и систем, которые требуют
минимального обслуживания при
сохранении их функциональности и
эффективности в повседневных условиях.
Регулирующие органы или уполномоченные
власти должны следить за соблюдением
строгих стандартов качества, безопасности и
долговечности, тем самым снижая нагрузку
на пользователей и способствуя повышению
надежности нейротехнологических решений
в эксплуатации и их экологичности.
127. Государствам-членам следует 127. Государствам-членам следует
обеспечить разработку или укрепление обеспечить разработку или укрепление
существующих комплексных систем существующих комплексных систем
отчетности по медицинским изделиям в отчетности по медицинским изделиям в
области нейротехнологий, которые области нейротехнологий, которые
отслеживают и устраняют побочные отслеживают и устраняют нежелательные
эффекты. В тех случаях, когда таких систем реакции. В тех случаях, когда таких систем
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не существует, государствам-членам следует не существует, государствам-членам следует
их создать. Когда такие системы уже их создать. Когда такие системы уже
существуют, их следует модернизировать, существуют, их следует модернизировать,
чтобы обеспечить в них конкретный учет чтобы обеспечить в них конкретный учет
нейротехнологий. Эти системы должны нейротехнологий. Эти системы должны
быть функционально совместимыми и иметь ресурс, быть функционально
вносить вклад в централизованную, совместимыми с системами государств-
публичную и прозрачную международную партнеров в случаях реализации программ
базу данных, управляемую в сотрудничестве сотрудничества. В случаях международного
с международными организациями в целях сотрудничества по конкретным проектам
обеспечения соблюдения глобальных научного, социального и медицинского
стандартов и доступа к ним в интересах назначения должны вносить вклад в
просвещения общественности, централизованную, публичную и
международного надзора и исследований. прозрачную международную базу данных,
управляемую в сотрудничестве с
международными организациями в целях
обеспечения соблюдения глобальных
стандартов и доступа к ним в интересах
просвещения общественности,
международного надзора и исследований.
IV.12 ЭТИЧЕСКИЕ АСПЕКТЫ НАУЧНЫХ В разделе IV.12 Проекта указана такая сфера
ИССЛЕДОВАНИЙ как «научные исследования», однако в
128. Государствам-членам следует укрепить Преамбуле отсутствует указание на базовые
этические рамки, регулирующие документы, затрагивающие проблему
исследования в области нейротехнологий, с участия человека в медицинских
тем чтобы обеспечить надежную защиту экспериментах - Нюрнбергский кодекс 1947
участвующих в них людей. Государствам- года, Хельсинкская декларация Всемирной
членам следует принять четкие руководящие медицинской ассоциации. Этические
принципы или (24) политику, определяющие принципы проведения медицинских
требования к квалификации, для исследований с участием человека в
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обеспечения того, чтобы исследования качестве субъекта 1964 года в редакции 2024
проводились в надлежащих условиях года.
специалистами, обладающими
соответствующими знаниями о структуре и В п. 128 Проекта имеется указание на «лиц
функционировании нервной системы, а со сниженными способностями выражения
также о расстройствах мозга. Кроме того, согласия или принятия решения». Не
протоколы государственных или частных представляется возможным определить
исследований как в медицинской, так и в содержание данной категории и кого именно
немедицинской сфере должны тщательно Проект относит к таким лицам. Содержание
оцениваться зарегистрированными советами данного термина должно быть раскрыто.
по этике (комитетами по этике), при этом
особое внимание должно уделяться людям,
оказавшимся в особых уязвимых ситуациях,
в частности людям со сниженными
способностями выражения согласия или
принятия решений. Государствам-членам
следует обеспечить наличие во всех научно-
исследовательских учреждениях
обязательного учебного курса по этическим
нормам для исследователей.
129. Государствам-членам следует поощрять
международные исследования на базе
многих центров с участием представителей
различных культур и этнических групп.
Государствам-членам следует содействовать
международному сотрудничеству в целях
разработки общих стандартов отчетности и
протоколов обеспечения функциональной
совместимости, особенно для
имплантируемых нейротехнологических
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устройств. Такое сотрудничество должно
быть направлено на повышение
сопоставимости данных и утилитарности
исследований в глобальном масштабе, что
будет способствовать большей
эффективности и этической
добросовестности исследований.
130. Государствам-членам следует
обеспечить рассмотрение всего жизненного
цикла нейротехнологий при разработке
клинического испытания, включая политику
защиты пациентов в случае прекращения
деятельности спонсора или организатора
испытания. Государствам-членам
необходимо установить требования к
включению результатов клинических
испытаний в соответствующие
национальные или утвержденные на
международном уровне реестры, а также
поощрять регистрацию в реестрах
сообществ и пациентов. Кроме того,
клинические испытания должны отражаться
в соответствующих системах отчетности о
медицинских изделиях, разработанных в
государствах-членах.
131. Разработчики технологий должны
обеспечить включение в проверку
алгоритмов ИИ в нейротехнологических
исследованиях тщательное тестирование на
предвзятость, а также принятие мер по
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повышению их объяснимости и
прозрачности, включая происхождение
наборов данных для обучения. Необходимо
использовать подходящие методы для
ликвидации любых предубеждений,
присутствующих в используемых в
нейротехнологиях моделях ИИ.
132. Государствам-членам следует
обеспечить нацеленность научно-
исследовательской деятельности на
изучение не только связанных с
нейротехнологиями биомедицинских
рисков, но и потенциального воздействия на
субъективный опыт человека, его
самосознание и личную
самоидентификацию. Понимание того, как
нейротехнологии могут влиять на различные
аспекты самовосприятия, сознания и
самоидентификации, необходимо для
решения этических проблем и обеспечения
благополучия людей, использующих эти
технологии.
133. Государствам-членам следует
гарантировать регулярное проведение
заинтересованными сторонами,
занимающимися научными исследованиями,
ревизий и мониторинга исследовательских
методов в целях обеспечения соблюдения
этических норм. Это должно включать
оценку информированного согласия на
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предмет соответствия требованиям,
особенно в отношении повторного
использования данных и потенциальной
коммерциализации нейронных данных.
134. Государствам-членам следует обязать 134. Государствам-членам следует обязать
исследователей в области нейротехнологий исследователей в области нейротехнологий
разработать четкие и прозрачные протоколы разработать четкие и прозрачные протоколы
для информирования участников о для информирования участников о
клинически значимых и имеющих клинически значимых и имеющих
практическую ценность случайных практическую ценность случайных
результатах. Такие протоколы должны результатах. Такие протоколы должны
обеспечивать оперативную передачу этих обеспечивать оперативную передачу этих
результатов при уважении к правам и результатов при уважении к правам и
самостоятельности участников. Кроме того, самостоятельности участников. Кроме того,
государствам-членам следует обязать государствам-членам следует обязать
исследователей обеспечить необходимую исследователей обеспечить необходимую
поддержку и координацию с медицинскими поддержку и координацию с научными,
работниками для решения любых проблем медицинскими работниками для решения
со здоровьем, возникающих в связи с этими любых проблем со здоровьем, возникающих
результатами. в связи с этими результатами.
135. Государствам-членам следует
обеспечить надлежащее информирование
лиц, участвующих в нейротехнологических
исследованиях или лиц, с которыми
проводятся нейротехнологические
манипуляции, о возможности случайных
открытий, особенно тех, которые имеют
значительные последствия для здоровья.
Процесс получения информированного
согласия должен четко описывать
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последствия, связанные с этими
результатами, право участников выбирать,
хотят ли они получать информацию о таких
результатах, и гарантировать уважение к их
решениям в этом отношении на протяжении
всего исследования или лечения.
КОНКРЕТНЫЕ ОБЛАСТИ ПРИМЕНЕНИЯ
ЗА ПРЕДЕЛАМИ ЗДРАВООХРАНЕНИЯ
IV.13 ОБРАЗОВАТЕЛЬНАЯ СРЕДА
136. Государствам-членам следует с 136. Государствам-членам следует с Раздел IV.13 Проекта допускает
осторожностью подходить к интеграции осторожностью подходить к интеграции возможность применения нейротехнологий
нейротехнологий в образование, нейротехнологий в образование, в образовательной среде. В п. 136 Проекта
обеспечивая, чтобы их использование было обеспечивая, чтобы их использование было содержится указание, что «государствам-
основано на фактических данных, основано на фактических данных, членам следует с осторожностью подходить
соответствовало целям образования и соответствовало целям образования и к интеграции нейротехнологий в
дополняло традиционные методы обучения. дополняло традиционные методы обучения. образование». Документ признает, что
Особое внимание следует уделять Особое внимание следует уделять современное общество не обладает
целостному развитию учащихся, т.е. не целостному развитию учащихся, т.е. не достаточными знаниями о пользе
только успеваемости, но и психическому только успеваемости, но и психическому технологий, поэтому указывает, что
здоровью, благополучию и общим здоровью, благополучию и общим «необходимо регулярно проводить оценку
интересам. Государствам членам следует интересам. С учетом высокой опасности влияния нейротехнологий на развитие
разработать соответствующие возрасту нарушения основных прав и свобод учащихся, включая психическое здоровье, а
рекомендации по использованию человека и гражданина, учитывая открытый также разработать процессы этической
нейротехнологий на разных этапах характер перечня немедицинских сфер экспертизы для контроля за их внедрением».
образования и в разных форматах обучения использования нейротехнологий, Экспериментальный подход к применению
в целях обеспечения инклюзивности. рекомендовано следовать ограничительному нейротехнологий в образовательной сфере
Необходимо регулярно проводить оценку подходу до того момента, пока не будут вызывает разумные опасения, принимая во
влияния нейротехнологий на развитие получены достоверные данные о влиянии внимание потенциальное влияние
учащихся, включая психическое здоровье, а нейротехнологий на психическое здоровье нейротехнологий на психическое здоровье
также разработать процессы этической лиц, если таковые применяются не в обучающихся. Данное положение также
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экспертизы для контроля за их внедрением. медицинских целях. вступает в противоречие с положениями п. 7
Основное внимание должно быть Нюрнбергского кодекса 1947 года
направлено на развитие критического (предусматривающего, что эксперименту
мышления, творческих способностей и должна предшествовать соответствующая
эмоционального интеллекта, а не только на подготовка, и его проведение должно быть
повышение успеваемости. обеспечено оборудованием, необходимым
для защиты испытуемого от малейшей
возможности ранения, инвалидности или
смерти), а также Хельсинкской декларации
Всемирной медицинской ассоциации.
Этические принципы проведения
медицинских исследований с участием
человека в качестве субъекта 1964 года (в
частности, п.п. 19-20, предусматривающим
особую защиту уязвимых лиц и групп лиц).
Таким образом, разделяя общий посыл к
продвижению использования
нейротехнологий в сфере здравоохранения,
видится недоказуемым, что следует отразить
в международных актах о правах человека.
137. Государствам-членам следует принять
политику, обеспечивающую добровольное
внедрение нейротехнологий в образование
на основе всесторонне информированного
согласия. Такая политика должна содержать
четкую, соответствующую возрасту
информацию о назначении, преимуществах
и рисках технологий с указанием
соответствующих сроков рассмотрения этой
информации. Учитывая повышенную
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сложность получения добровольного
согласия в данном контексте, в процедурах
получения согласия и разрешения должны
участвовать дети, подростки, родители,
опекуны и все субъекты, необходимые для
получения согласия, запрашиваемого у
несовершеннолетних. Необходимо создать
механизмы этического надзора, включая
регулярное продление согласия и
немедленное прекращение использования
нейротехнологий при отказе от них, а также
обеспечить анонимные каналы обратной
связи. Политика должна запрещать
неоправданные стимулы или академические
наказания за неучастие и принимать меры,
чтобы избежать создания или усиления
неравенства среди учащихся. Кроме того,
государствам-членам следует поддерживать
участие учащихся в принятии решений об
интеграции нейротехнологий и
финансировать программы обучения по их
этичному использованию, что позволит
педагогам и учащимся критически
оценивать их применение.
138. Государствам-членам следует создать
единый и надежный механизм надзора за
использованием нейротехнологий в
образовательных учреждениях,
включающий регулярные проверки и
обратную связь с общественностью и
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населением, учитывающий культурные
особенности и местные традиции, а также
обеспечивающий строгое соблюдение
стандартов безопасности и этики, включая
проведение оценки обратимости
воздействия на нервную систему.
Необходимо финансировать постоянные
исследования для оценки долгосрочного
психологического и когнитивного
воздействия этих технологий. Надзор
должен включать в себя основанные на
эмпирических данных периодические
обзоры для корректировки использования
нейротехнологий по мере необходимости, с
тем чтобы обеспечить развитие учащихся и
устранить риски, такие как зависимость или
деквалификация. Такой (22) комплексный
подход поможет обеспечить безопасность,
эффективность и соответствие
нейротехнологий передовым методам
обеспечения благополучия учащихся и
повышения успеваемости.
139. Государствам-членам следует
инвестировать в образовательные
программы и программы повышения
квалификации, в целях развития у новаторов
и бизнес-лидеров навыков учета этических
соображений на протяжении всего
жизненного цикла нейротехнологий. Такое
обучение должно включать в себя этическое
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проектирование, законодательство в области
прав человека и оценку воздействия на
общество, подготавливая следующее
поколение технических специалистов к
критической оценке последствий их работы.
IV.14 ТРУД И ЗАНЯТОСТЬ В Проекте содержатся положения,
140. Государствам-членам следует касающиеся учета интересов конкретных
разработать применяемые на рабочих местах пользователей, а также конкретных областей
политику и стимулы, которые будут уделять применения за пределами здравоохранения,
приоритетное внимание здоровью и однако отсутствует указание на ключевые
благополучию сотрудников при документы в области защиты
использовании нейротехнологий. Такая соответствующих пользователей или
политика должна обеспечивать опору всех регулирования указанных областей.
процессов развертывания нейротехнологий В разделе IV.14 Проекта указана такая сфера
на фактические данные, с акцентом на виды как «труд и занятость», однако в Преамбуле
их практического применения, отсутствует указание на Декларацию
направленность которых на улучшение Международной организации труда «Об
благосостояния сотрудников, в частности на основополагающих принципах и правах в
снижение стресса или улучшение условий сфере труда» 1998 года.
труда (например, адаптивная и быстро
реагирующая среда, которая регулирует
рабочую нагрузку в зависимости от
когнитивной) была научно подтверждена.
Внедрение нейротехнологий должно быть
добровольным, а сотрудники должны иметь
возможность отказаться от использования
нейротехнологий без каких-либо негативных
последствий или дискриминации. Ни при
каких обстоятельствах эти технологии не
должны использоваться для карательных
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мер или психической слежки и не должны
ставить под угрозу здоровье сотрудников.
141. Государствам-членам следует обязать
работодателей предоставлять сотрудникам
четкую и исчерпывающую информацию о
том, как работают нейротехнологии,
используемые на их рабочем месте, какие
преимущества они дают, обеспечивать
прозрачность в отношении того, какие
данные собираются, как они используются и
кто имеет к ним доступ, а также наглядно
демонстрировать любые потенциальные
риски, связанные с их использованием.
142. Государствам-членам следует требовать В Проекте введено понятие «когнитивные
от работодателей, использующих биометрические данные», а также
нейротехнологии на рабочем месте, содержится ряд положений, касающихся
принятия прозрачной политики, защиты информации и персональных
раскрывающей цель их использования, данных (раздел III.2.3 «защита нейронных и
ограничивающей сферу их применения когнитивных биометрических данных для
законными целями в интересах работника и обеспечения психической
третьих сторон (например, безопасность, неприкосновенности», раздел IV.2
контроль усталости водителей «политика в отношении данных», раздел IV
коммерческого транспорта или контроль «кибербезопасность», раздел IV.14, пункт
внимания авиадиспетчеров). Для 142 - нейронные и когнитивные
соблюдения неприкосновенности частной биометрические данные работников и пр.),
жизни сотрудников работодателям следует однако отсутствует указание на ключевые
запретить несанкционированный доступ к документы в области защиты персональных
нейронным и когнитивным биометрическим данных, такие как Руководящие принципы
данным, которые могут быть случайно ООН по регламентации
собраны в ходе обычной проверки на компьютеризированных картотек,
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рабочем месте. Работодателям следует содержащих данные личного характера 1990
также запретить использовать нейронные и года, Международная декларация ЮНЕСКО
когнитивные биометрические данные для о генетических данных человека 2003 года.
любых целей, на которые они не получали
согласия, особенно для целей, которые
могут негативно повлиять на гарантии
занятости сотрудника или на его частную
жизнь.
143. Государства-члены должны обязать 143. Государства-члены должны обязать
работодателей внедрять передовые методы работодателей внедрять передовые методы
минимизации данных и безопасного минимизации данных и безопасного
хранения нейронных и когнитивных хранения нейронных и когнитивных
биометрических данных, обеспечить биометрических данных, обеспечить
надежное хранение данных, ограничить надежное хранение данных, ограничить
доступ к ним только для уполномоченного доступ к ним только для уполномоченного
персонала и удалять их сразу после персонала и удалять их сразу после
выполнения поставленной задачи. Кроме выполнения поставленной задачи, кроме
того, при увольнении сотрудника все тех, что имеют научно-исследовательское
связанные с ним записи должны быть значение и могут использоваться в
полностью удалены или индивидуальные деперсонифицированном виде на основе
данные должны быть переданы сотруднику, информированного согласия участников
чтобы после прекращения трудовых научного исследования. Кроме того, при
отношений у работодателя не оставалось увольнении сотрудника все связанные с ним
никаких данных. записи должны быть полностью удалены
или индивидуальные данные должны быть
переданы сотруднику, чтобы после
прекращения трудовых отношений у
работодателя не оставалось никаких данных,
кроме тех, что имеют научно-
исследовательское значение и могут
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использоваться в деперсонифицированном
виде на основе информированного согласия
участников научного исследования.
144. Государствам-членам следует 144. Государствам-членам следует
обеспечить, чтобы при выдаче сотрудникам обеспечить, чтобы при выдаче сотрудникам
многофункциональных устройств многофункциональных устройств
(например, наушников-вкладышей или (например, наушников-вкладышей или
накладных наушников с встроенными накладных наушников с встроенными
нейронными датчиками), которые можно нейронными датчиками), которые можно
использовать на работе или дома, использовать на работе или дома
работодателям было запрещено собирать работодателям было строго
нейронные и когнитивные биометрические регламентировано в интересах здоровья и в
данные вне рабочего места и рабочего научно-исследовательских целях собирать
времени, при этом любые данные, нейронные и когнитивные биометрические
собранные в рабочее время, должны данные вне рабочего места и рабочего
использоваться исключительно в времени, при этом любые данные,
оговоренных целях. Работодателям следует собранные в рабочее время, должны
внедрить технические средства защиты, использоваться исключительно в
чтобы автоматически отключать сбор оговоренных целях. Работодателям следует
данных в нерабочее время. внедрить технические средства защиты,
чтобы была возможность автоматически
отключать сбор данных в нерабочее время.
145. Государства-члены должны обеспечить
соблюдение работодателями права
работников на получение копии всех
собранных о них нейронных и когнитивных
биометрических данных, а также любых
интерпретаций, сделанных на их основе, в
доступной и понятной форме. Применение
этих инструментов без согласия является
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должностным преступлением и
компрометирует их полезное использование
в других случаях.
146. Государствам-членам следует требовать Государствам-членам следует требовать
запрашивания однозначного согласия запрашивания однозначного согласия
работника на любое использование работника на любое использование
нейротехнологий на рабочем месте, при нейротехнологий, в том числе на рабочем
этом они должны использоваться только в месте, при этом они должны использоваться
целях, которые очевидно способствуют только в целях, которые очевидно
повышению безопасности труда, способствуют повышению безопасности
благосостояния и достоинства работника, а труда, улучшения качества восстановления
не для повышения производительности за здоровья после трудового периода,
счет здоровья работника. благосостояния и достоинства работника, а
не для повышения производительности за
счет здоровья работника.
147. Государства-члены должны защищать Не раскрыто содержание термина
работников от эксплуатации, а также «нейроотличное лицо». Данный термин
разработать строгие правила, запрещающие отсутствует в международных документах.
использовать нейронные и когнитивные Учитывая новизну данной категории важно
биометрические данные для составления раскрыть её содержание.
характеристики на рабочем месте, в том
числе при приеме на работу. Эти правила
должны запрещать использование
нейронных и когнитивных биометрических
данных для дискриминации кандидатов,
особенно нейроотличных лиц, обеспечивая
применение справедливых и инклюзивных
методик найма на работу.
148. Государствам-членам следует строго
регулировать использование
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нейротехнологий при приеме на работу или
принятии решений о сохранении рабочего
места, ограничивая такое использование
теми случаями, когда нейронные и
когнитивные биометрические данные имеют
прямое отношение к конкретным рабочим
требованиям.
IV.15 ПОТРЕБИТЕЛЬСКАЯ И
КОММЕРЧЕСКАЯ СФЕРЫ
149. Государствам-членам следует
проявлять инициативу и формировать
нормативноправовую базу, которая
обеспечит баланс между инновациями в
рекреационной и коммерческой сферах и
защитой прав и благополучия отдельных
лиц. Такая нормативно-правовая база
должна быть динамичной и
предусматривать возможности для
своевременного обновления по мере
развития технологий и получения новых
знаний о их влиянии на общество. Это
включает в себя надлежащий надзор с целью
обеспечения того, чтобы нейротехнологии
не причиняли вреда, использовались по
обоюдному согласию и включали надежные
механизмы защиты пользователей от
потенциального психологического стресса
или манипуляций.
150. Государствам-членам следует усилить Не раскрыто содержание термина
комплексные законы о защите прав «коммерческие нейротехнологические
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потребителей, включив в них четкую продукты». Данный термин отсутствует в
маркировку коммерческих международных документах. Учитывая
нейротехнологических продуктов с новизну данной категории важно раскрыть
подробным описанием их действия, её содержание.
ограничений и рисков, чтобы предотвратить
распространение вводящих в заблуждение
заявлений и обеспечить прозрачность. Это
также включает запрет на практику
«привязки» или требование раскрытия
нейронных и когнитивных биометрических
данных в качестве условия доступа к
товарам или услугам, а также запрет на
обмен данными с третьими сторонами или
использование этих данных без
положительного согласия.
151. Государствам-членам следует создать
условия, в которых все заявления о
потребительских немедицинских
технологиях будут подкреплены надежными
научными данными. Они должны в
законодательном порядке требовать, чтобы
любые продукты, которые предполагается
использовать для лечения, профилактики
или диагностики заболеваний или состояния
здоровья, были подтверждены путем
тщательного тестирования безопасности и
(28) эффективности, включая клинические
испытания, если это необходимо, и
использовались под надлежащим
медицинским наблюдением.
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152. Государства-члены должны обеспечить
внедрение подробных и прозрачных
процедур получения информированного
согласия на любые нейротехнологические
вмешательства, гарантируя полную
добровольность участия и уважение частной
жизни и автономии людей. Этот принцип
должен применяться единообразно в
различных сферах, таких как спорт или
искусство, где надежные стандарты должны
защищать от принудительного
использования нейротехнологий и
обеспечить уважение к индивидуальной
независимости спортсменов и творческих
работников, интересам сообщества и правам
ИС.
153. Государствам-членам следует
направлять использование и развитие
нейротехнологий в искусстве на
обеспечение более эффективного обучения и
развитие культурного восприятия без
ущерба для индивидуальной независимости
и без риска унификации культур.
154. Государствам-членам следует принять
меры по предотвращению неправомерного
использования нейротехнологий в
потребительских технологиях, особенно
нейроигр и других устройств, которые
используют дофаминовую систему
поощрения или стремятся побудить к
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586
проблематичному и нездоровому
использованию и чрезмерному
потреблению. Такие правила должны
предусматривать четкую маркировку
рисков, раскрытие информации о
воздействии технологий на нервную
систему, соблюдение стандартов дизайна
игр, а также стандартов безопасности,
конфиденциальности и возрастного
соответствия, которые не позволяют
использовать физическую, умственную и
эмоциональную уязвимость человека в
целях его побуждения к компульсивному
использованию или формирования
зависимости от игровых или цифровых
развлекательных платформ в сочетании с
нейротехнологиями, с тем чтобы
способствовать их здоровому,
сбалансированному использованию,
особенно среди детей.
155. Государствам-членам следует
обеспечить, чтобы устройства, способные
выполнять несколько функций, такие как
очки с расширенной реальностью или умные
наушники с нейронными датчиками,
включали аппаратные средства управления,
позволяющие пользователям выборочно
отключать нейротехнологические функции,
сохраняя при этом базовую
функциональность. Нормативные акты
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587
должны обеспечивать доступность и
простоту функций «отказа», способствуя
здоровому, сбалансированному
использованию таких устройств, особенно
среди детей и уязвимых групп населения.
156. Государствам-членам следует
рассмотреть серьезные этические вопросы,
касающиеся самоопределения, согласия,
неприкосновенности частной жизни и
возможностей для манипулирования и
возникающие в связи с нейротехнологиями в
контексте рекомендательных систем,
фиксированных установок и теории
подталкивания, маркетинга во время сна и
сновидения, нейромаркетинга и замкнутой
среды, путем принятия комплексной
политики и нормативных актов.
(a) Рекомендательные системы: следует
однозначно запретить использование
нейронных и когнитивных биометрических
данных в рекомендательных системах для
манипулятивных или обманных целей, в том
числе в политическом контексте. В
соответствии с этими правилами любое
использование таких данных в этих
системах должно основываться на
однозначном и информированном согласии
пользователей.
(b) Подталкивание: следует регулировать
использование нейронных и когнитивных
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биометрических данных для подталкивания
– скрытого влияния на решения или
поведение людей, часто без их явного
осознания. Это особенно важно в таких
деликатных областях, как распространение
политических идей, коммерческая реклама и
здравоохранение. Соответствующие
нормативные акты должны требовать
запрашивания явного, информированного
согласия на любое (29) использование таких
данных для влияния на решения или
поведение, закрепления права отказаться от
использования этих систем, а также
прозрачности и четкого раскрытия
информации в момент сбора данных, со
строгими ограничениями на использование
данных в целях, выходящих за рамки
раскрытых.
(c) Маркетинг во время сна и сновидений:
следует запретить использование
нейротехнологий, которые влияют на
человека или манипулируют им во время
сна, например, маркетинг во время сна и
сновидений. Нормативные акты должны
строго запрещать воздействие на людей во
время сна в коммерческих, маркетинговых
или политических целях с использованием
нейротехнологий или нейронных и
когнитивных биометрических данных.
Кроме того, необходимо создать надежные
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механизмы надзора, гарантирующие, что
любые исследования или виды применения
таких технологий будут в первую очередь
направлены на обеспечение благополучия,
защиту неприкосновенности частной жизни
и автономии людей и будут уделять особое
внимание потенциальным долгосрочным
психологическим и когнитивным
последствиям манипуляций с различными
фазами сна.
(d) Нейромаркетинг: необходима защита от
использования нейромаркетинга в не
соответствующих этическим принципам
целях и от его неэтичных методов,
включающая, в частности, требование
всеобъемлющего раскрытия информации
для обеспечения прозрачности всех
нейромаркетинговых мер, осуществляемых с
однозначного и информированного согласия
участников. Она включает в себя также
обеспечение полной осведомленности
участников нейромаркетинговых
исследований или кампаний о методах,
рисках и намерениях и запрашивание их
четкого согласия на участие. Использование,
хранение и возможное повторное
применение собранных данных должно быть
строго регламентировано.
(e) Среда с замкнутым циклом: необходимы
четкие нормативные рекомендации по
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разработке и использованию различных
видов среды с замкнутым циклом, таких как
создающие эффект присутствия
компьютерные устройства, которые
корректируют восприятие на основе
обнаруженных нейронных и когнитивных
биометрических данных. Политика в этой
области должна требовать четкого и
доступного раскрытия информации об
использовании нейронных и когнитивных
биометрических данных в такой среде,
запрещать изменение поведения или
манипуляции им в режиме реального
времени без однозначного
информированного согласия и включать
гарантии, специально разработанные для
предотвращения таких злоупотреблений, как
несанкционированное наблюдение,
манипулятивные вмешательства и методы,
которые могут повлиять на поведение
избирателей, политические взгляды или
использовать психологические и
эмоциональные факторы уязвимости в
режиме реального времени.
IV.16 РАСШИРЕНИЕ ВОЗМОЖНОСТЕЙ 157. Государствам-членам следует Применение нейротехнологий для
ЧЕЛОВЕКА обеспечить, чтобы любые стратегии, законы расширения когнитивных возможностей
157. Использование нейротехнологий для и нормативно-правовые акты, человека связано с рисками для здоровья
улучшения памяти, внимания или других регулирующие использование человека, гармоничного развития всех его
аспектов умственной деятельности человека нейротехнологий в этих ситуациях, не психических функций, должны применяться
вне медицинского контекста ставит перед приводили к усугублению социального в случае когнтивных расстройств и в
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нами сложные этические, социальные и неравенства и к дискриминации, учитывали соответствии с медицинскими показаниями.
правовые вопросы, поскольку в нашем потенциальные риски» - возможно, стоить Этичный подход предполагает
глобальном мире они могут привести к усилить, например: «использование предварительную оценку соотношения
появлению новых видов неравенства. Когда нейротехнологий в этих ситуациях [для возможных рисков для здоровья человека и
нейротехнологии используются в таких улучшения памяти, внимания или других предполагаемых положительных эффектов
ситуациях, они затрагивают важнейшие аспектов умственной деятельности человека от применения нейротехнологий.
вопросы, касающиеся справедливости, вне медицинского контекста] должно Возможность применения нейротехнологии
согласия, автономии личности и общества, а регулироваться законами и нормативно- во внемедицинских целях для расширения
также характера усовершенствования правовыми актами с учетом потенциальных возможностей человека должна быть
нервной системы. Государствам-членам рисков, в том числе, во избежание рассмотрена с учетом того, что принцип
следует обеспечить, чтобы любые стратегии, усугубления социального неравенства и действия технологий может быть
законы и нормативно-правовые акты, дискриминации. недостаточно изучен на данный момент;
регулирующие использование может отсутствовать доказательная база об
нейротехнологий в этих ситуациях, не эффективности и отсутствии нежелательных
приводили к усугублению социального реакций применения нейротехнологий;
неравенства и к дискриминации, учитывали возможно возникновение непредсказуемых
потенциальные риски (включая индивидуальных реакций на применение
обратимость, инвазивность и риски для нейротехнологии конкретным
самоопределения) и полностью пользователем; возможны отложенные
соответствовали принципу уважения прав и эффекты применения нейротехнологии;
достоинства человека. (30) возможно формирование зависимости от
применения нейротехнологии, двойное
использование.
Применение нейротехнологий для
расширения когнитивных способностей
человека сопряжено с возможностью
возникновения у пользователя проблем
экзистенциального характера: размытия
идентичности вследствие слияния с
технологией и зависимостью от неё, потерей
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самостоятельности в формировании
внутреннего действия и поведения,
замыкания на применении нейротехнологии
как самоцели деятельности пользователя.
Расширение способностей человека с
помощью нейротехнологий должно служить
высоким созидательным гуманистическим
целям, не нарушающим традиционные
человеческие ценности; необходимо
ограждать развитие нейротехнологий ради
целей, способствовующих деятельности,
разрушающей личность человека и
подрывающей общественные устои.
V. ВЫПОЛНЕНИЕ РЕКОМЕНДАЦИИ
158. Государствам-членам и всем
упомянутым в настоящей Рекомендации
субъектам следует соблюдать,
распространять и отстаивать упомянутые в
ней этические ценности, принципы и
стандарты, а также принимать все
возможные меры для ее практического
выполнения.
159. Государствам-членам следует с учетом
конкретных условий, структур управления и
конституционных положений отстаивать
прозрачным и заслуживающим доверия
образом этические принципы использования
нейротехнологий в соответствии с
Рекомендацией ЮНЕСКО. Государства-
члены осуществляют мониторинг и оценку
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политики, программ и механизмов,
связанных с нейротехнологиями и их
этическими аспектами. Мониторинг
прогресса может основываться на
совмещении количественных и
качественных методов.
160. Государствам-членам следует развивать 160. Государствам-членам следует развивать
потенциал правительственных учреждений и потенциал правительственных учреждений и
поддерживать государственных чиновников, поддерживать государственных чиновников,
с тем чтобы они могли направлять развитие с тем чтобы они могли с учетом мнения
технологий с учетом этических принципов. экспертов в области науки, здравоохранения
и образования направлять развитие
технологий с учетом этических принципов.
161. Государствам-членам следует создать
или назначить национальные организации,
отвечающие за контроль и координацию
регулирования, тщательного мониторинга и
надзора за нейротехнологиями в
соответствующих государственных
учреждениях. На эти координирующие
органы следует возложить задачу
обеспечения последовательного применения
законов нормативных актов, защиты
здоровья и безопасности населения, а также
поддержки соблюдения этических норм и
прав человека на протяжении всего
жизненного цикла нейротехнологий. Это
включает в себя содействие
межведомственному сотрудничеству,
контроль за соблюдением национальных и
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международных стандартов, а также
организацию эффективного обмена данными
и информацией из различных областей
регулирования для принятия решений и
разработки политики. Эти органы также
должны помогать координировать
взаимодействие с общественностью и
сообществами.
162. Государствам-членам следует
стремиться расширять и дополнять
собственные меры в отношении настоящей
Рекомендации путем сотрудничества со
всеми соответствующими национальными и
международными правительственными и
неправительственными организациями, а
также транснациональными корпорациями и
научными организациями, чья деятельность
подпадает под действие положений и
соответствует целям настоящей
Рекомендации. Гражданское общество
призвано сыграть важную роль в
отстаивании интересов общественного
сектора, в связи с чем ЮНЕСКО
необходимо будет обеспечить и
поддерживать его легитимность.
163. ЮНЕСКО следует обеспечить
популяризацию и широкое распространение
текста настоящей Рекомендации с
использованием всех имеющихся
возможностей и довести ее до сведения
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595
государств-членов, национальных комиссий
по делам ЮНЕСКО, соответствующих
международных и региональных партнеров
и правозащитных организаций, а также
консультативных органов ЮНЕСКО по
вопросам этики для распространения на всех
уровнях и среди всех субъектов в этой
сфере.
164. Для оказания поддержки государствам-
членам в выполнении настоящей
Рекомендации путем разработки конкретных
программ и политики и развития
институционального потенциала в области
этики нейротехнологий ЮНЕСКО внесет
свой вклад, подготовив полномасштабную
программу, включающую следующие
элементы:
(a) методологию ЮНЕСКО для оценки
готовности, которая поможет
государствамчленам в определении статуса
своей готовности по целому ряду аспектов
на конкретном этапе; (31)
(b) методологию ЮНЕСКО для оценки
этического воздействия (ОЭВ)
нейротехнологий, разработанную на основе
углубленных научных исследований и
международного права прав человека, а
также конкретное руководство по ее
применению на всех этапах жизненного
цикла нейротехнологий и учебные средства
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и материалы для поддержки работы
государств-членов по подготовке
государственных служащих, лиц,
ответственных за принятие решений, и
других соответствующих субъектов к
применению методологии;
(c) методологию ЮНЕСКО по оценке
ожидаемой и фактической результативности
и эффективности стратегии этичного
применения нейротехнологий и
соответствующие меры стимулирования с
учетом поставленных задач;
(d) программу исследований ЮНЕСКО,
которая будет сосредоточена на этических
аспектах нейротехнологий, подготовлена на
основе анализа современного состояния
технологических разработок и
предназначена для оценки текущего и
будущего воздействия нейротехнологий на
общество и окружающую среду. Результаты
основанного на фактах анализа будут
собраны в отдельном информационном
центре ЮНЕСКО, который станет общей
платформой для распространения знаний и
повышения осведомленности о передовом
опыте и инновациях. Эту информацию все
государства-члены и участники смогут
получать в форме докладов о результатах
исследований, данных и статических
материалов, касающихся политики в
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области этики нейротехнологий. Программа
исследований должна учитывать сближение
нейротехнологий с другими технологиями,
такими как искусственный интеллект и
квантовые технологии, и проводиться в
сотрудничестве с другими
соответствующими инициативами
ЮНЕСКО.
(e) платформу ЮНЕСКО для совместной
работы, на которой будут созданы условия
для конструктивных обменов и
сотрудничества между государствами-
членами и всеми субъектами в целях
развития глобального диалога по вопросам
политики, в том числе на уровне министров
в рамках Глобального форума по этическим
аспектам новых технологий. ЮНЕСКО
создаст в поддержку этих усилий сеть
экспертов по нейротехнологиям, в которой
будут представлены на сбалансированной
основе все региональные группы ЮНЕСКО.
165. Процедуры мониторинга и оценки
должны обеспечивать широкое участие всех
субъектов, в том числе недопредставленных
и уязвимых групп или лиц, оказавшихся в
уязвимом положении, а также социальное,
культурное и гендерное разнообразие.
Мониторинг и оценка воздействия
нейротехнологий и соответствующих
стратегий и подходов, касающихся их
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этичного применения, должны
осуществляться на постоянной и системной
основе пропорционально соответствующим
рискам. Эта работа должна проводиться на
основе согласованных на международном
уровне рамочных принципов и
предусматривать проведение оценки
деятельности как частных, так и
государственных учреждений. Сбор и
обработка данных должны осуществляться в
соответствии с международным правом,
национальным законодательством о защите
информации от несанкционированного
доступа и о защите персональных данных, а
также ценностными установками и
принципами, изложенными в настоящей
Рекомендации.
VI. ЗАКЛЮЧИТЕЛЬНЫЕ ПОЛОЖЕНИЯ
166. Настоящую Рекомендацию необходимо
воспринимать как единое целое, а
сформулированные в ней базовые
ценностные установки и принципы
деятельности – как взаимодополняющие и
взаимосвязанные.
167. Ничто в настоящей Рекомендации не
может быть истолковано как замена,
изменение или иное негативное следствие
для обязательств или прав государств-
членов в соответствии с международным
правом и как дающее тому или иному
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государству, другому (32) – социальному
субъекту, группе или отдельному лицу
какие-либо основания заниматься любой
деятельностью или совершать любые
действия в нарушение прав человека,
основных свобод, человеческого
достоинства и принципа уважительного
отношения к окружающей среде и
экосистемам.
ДОПОЛНИТЕЛЬНЫЕ
ЗАМЕЧАНИЯ
Этические аспекты нейросетей
• Поскольку нейросети все больше
интегрируются в общество, крайне
важно сформировать перечень
возможных этических последствий,
которые они влекут за собой.
• Справедливость, прозрачность,
подотчетность, конфиденциальность
и экономическое воздействие — вот
лишь некоторые этические аспекты,
требующие тщательного
рассмотрения. Ответственная
разработка и использование
нейросетей требует сотрудничества
между технологами, политиками,
этиками и обществом.
• Одной из самых важных этических
проблем в области ИИ и МО является
справедливость и предвзятость.
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600
Алгоритмы машинного обучения
обучаются на исторических данных,
и если эти данные содержат
предвзятость, алгоритмы могут
увековечить и даже усугубить эту
предвзятость. Например, было
обнаружено, что системы
распознавания лиц имеют более
высокий уровень ошибок для людей с
более темным тоном кожи, что может
привести к несправедливому
обращению, дискриминации и
нарушению конфиденциальности.
• Для устранения предвзятости в
нейросетях требуются разнообразные
и репрезентативные наборы данных,
тщательное тестирование и
разработка алгоритмов, призванных
смягчить предвзятость. Это также
подразумевает постоянный
мониторинг и корректировку, чтобы
гарантировать, что предвзятость не
проникнет в систему с течением
времени.
• Огромный объем данных,
необходимых для обучения
нейросетей, вызывает опасения по
поводу конфиденциальности и
безопасности данных. Сбор и
хранение персональных данных
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влечет за собой значительную
ответственность.
Несанкционированный доступ,
утечки данных или неправильное
использование конфиденциальной
информации могут иметь серьезные
последствия для отдельных лиц и
организаций.
• Чтобы решить эти этические
проблемы, разработчики и
организации должны уделять
первостепенное внимание защите
данных, внедрять надежное
шифрование и соблюдать правила
конфиденциальности (например,
такие как Общий регламент по
защите данных (GDPR) и Закон
Калифорнии о защите прав
потребителей (CCPA)). Прозрачные
политики использования данных и
надежные механизмы согласия
имеют важное значение для
обеспечения того, чтобы люди
сохраняли контроль над своей личной
информацией.
• В тексте проекта Рекомендаций речь
идет о получении, использовании,
охране «нейронных и когнитивных
биометрических данных».
Необходимо уточнить к какой
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категории данные относятся: к
персональным данным, к
медицинской тайне или
самостоятельному виду тайны. От
этого будет зависеть режим их
правовой режим, связанный со
сбором, сохранением,
распространением, уничтожением и
пр., а также ответ на вопрос «должны
ли государства в целом определять
правовой режим этих данных?».
• Нейросети часто работают как
«черные ящики», что затрудняет
понимание того, как они приходят к
своим решениям. Такое отсутствие
прозрачности может быть
проблематичным, когда системы
нейросетей используются в
критически важных приложениях,
таких как здравоохранение или
финансы, где понимание обоснования
решения имеет решающее значение.
• Чтобы решить эту проблему,
исследователи работают над
разработкой более интерпретируемых
моделей ИИ и созданием методов
объяснения решений ИИ.
Прозрачность и объяснимость не
только создают доверие у
пользователей, но и позволяют
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выявлять и исправлять
потенциальные предубеждения или
ошибки.
• Поскольку системы нейросетей
становятся все более автономными,
возникают вопросы относительно
подотчетности и ответственности.
Кто несет ответственность, если
нейросеть принимает вредоносное
решение? Разработчик, организация,
внедряющая систему, или сама
нейросеть?
• Установление четких границ
ответственности и подотчетности
имеет важное значение для решения
этих этических проблем. Необходимо
разработать правовые рамки и
правила для определения
ответственности и обеспечения того,
чтобы разработчики и организации
принимали соответствующие меры
для предотвращения вреда,
причиняемого нейросетями.
• Широкое внедрение технологий ИИ и
автоматизации может привести к
сокращению рабочих мест в
различных отраслях. Хотя ИИ может
создавать новые возможности и
повышать производительность, он
также может привести к потере
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рабочих мест и экономическому сбою
для определенных групп. Этические
соображения в данном случае
включают в себя решение проблемы
влияния автоматизации на общество
путем инвестирования в программы
переподготовки и повышения
квалификации затронутых
работников, разработку политик,
способствующих смене работы, и
обеспечение справедливого
распределения преимуществ ИИ.
• Технологии нейросетей предлагают
огромный потенциал для инноваций
и прогресса в различных областях.
Однако, чтобы использовать их
преимущества и при этом
минимизировать вред, важно
учитывать этические аспекты,
связанные с их разработкой и
внедрением. Справедливость,
прозрачность, подотчетность,
конфиденциальность и
экономическое воздействие — вот
лишь некоторые из этических
аспектов, которые требуют
тщательного рассмотрения.
• Ответственная разработка и
использование нейросетей требует
сотрудничества между технологами,
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политиками, специалистами по этике
и обществом. Отдавая приоритет
этическим соображениям, появится
возможность гарантии, что нейросети
улучшат благосостояние людей и
внесут позитивный вклад в наше
будущее. Поскольку эти технологии
продолжают развиваться, постоянная
приверженность этике будет
оставаться решающим фактором в
руководстве их разработкой и
применением.
• При составлении и последующей
ратификации данного проекта
следует учитывать уже принятые
ООН этические кодексы, такие как
декларация по генному человека
(1997)1, генетическим данным
человека (2003) , биоэтике и правам
2
человека (2005)3, по искусственному
интеллекту (2021)4, а также
резолюция ГА ООН о праве на
неприкосновенность частной жизни в
эпоху цифровых технологий от 17
1 https://www.un.org/ru/documents/decl_conv/declarations/human_genome.shtml
2 https://www.un.org/ru/documents/decl_conv/declarations/genome_dec.shtml
3 https://www.un.org/ru/documents/decl_conv/declarations/bioethics_and_hr.shtml
4 https://news.un.org/ru/story/2021/11/1414592
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декабря 2018 г. № 73/179
(A/HRC/RES/42/15) .5
Важно
стремиться к созданию
преемственности и расширению
принципов этики ООН, в том числе в
контексте использования
нейротехнологий. К примеру, для
правового и этического
урегулирования внедрения
нейротехнологий можно
использовать концепцию
«нейроэтики». Это направление
позволит выявить ценностные
позиции и создать систему правил,
защищающих личность от
дискриминации в эпоху
нейросетевых технологий, учитывая
интересы граждан стран-участниц.
• Считаем целесообразным добавить
дополнительный пункт, где должны
быть представлена система
биоэтического регулирования, если
их применение предполагается
здоровыми людьми.
• Преамбула Проекта содержит
указание на ряд международных
актов, которые были приняты во
внимание при его составлении:
5 https://documents.un.org/doc/undoc/gen/n18/450/00/pdf/n1845000.pdf
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Всеобщая декларация прав человека
1948 года, Конвенция 1951 года о
статусе беженцев и пр. Несмотря на
то, что перечень документов
сформулирован как открытый, в нем
не перечислены ключевые
документы, регламентирующие
аспекты, затронутые в Проекте.
• Текст Проекта содержит некоторые
внутренние противоречия с
принципами, указанными в
Преамбуле, а также с ключевыми
международными актами о правах
человека. В Преамбуле проекта
указано, что Рекомендация – это
нормативный документ,
разработанный на основе принципов
международного права с упором на
уважение человеческого достоинства
и прав человека, а также призванный
(помимо прочего) поощрять
гендерное равенство, равноправие,
недопущение дискриминации.
• По смыслу Проекта перечень
немедицинских областей носит
открытый характер. Применение
нейротехнологий в немедицинской
области с учетом непредвиденности
результатов и высокой степени
опасности последствий применения
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608
видится непредсказуемым, что
следует отразить в международных
актах о правах человека.
• Отдельные сферы немедицинского
применения вызывают наиболее
серьезные опасения. В п. 39 раздела
III.2 Проекта указано, что
«Рекомендация использует
ориентированный на человека
подход, основанный на базовых
этических принципах, включая
самоопределение, субъектность,
свободу мысли, неприкосновенность
частной жизни, личную
идентичность, надежность,
уважение…».
• В то же время в разделе IV.8 п. 112
Проекта указано, что приоритетное
внимание должно уделяться
инклюзивным исследованиям,
направленным на удовлетворение
потребностей женщин и учет
гендерных особенностей и различий.
• В п. 114 отмечено, что государствам-
членам следует принять ряд мер,
обеспечивающих приоритетное
внимание к инициативам в области
позитивной дискриминации,
направленные на поддержку участия
женщин и гендерных меньшинств в
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609
сфере нейротехнологий.
• В п. 116 Проекта отмечено, что
программы стимулирования развития
нейротехнологий для людей с
ограниченными возможностями с
целью повышения качества их жизни
и функциональной независимости
должны включать налоговые льготы
для компаний, инвестирующих в
исследования и разработки в области
вспомогательных нейротехнологий.
• Таким образом, в тексте Проекта
обнаруживается дискриминация,
устанавливающая приоритетные
направления исследований –
потребности женщин и гендерных
меньшинств, а также повышенные
льготы для исследований в
определенной области. В тексте
Проекта используется термин
«позитивная дискриминация».
• В указанной части Проект
противоречит ст. 7 Всеобщей
декларации прав человека 1948 года,
согласно которой все люди имеют
право на равную защиту от какой бы
то ни было дискриминации, и от
какого бы то ни было
подстрекательства к такой
дискриминации.
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610
• В п. 39 раздел III.2 Проекта указано,
что Рекомендация основана на
базовых этических принципах,
включая самоопределение,
субъектность, свободу мысли,
неприкосновенность частной жизни,
когнитивную свободу, личную и
коллективную идентичность и пр. Но
далее по всему тексту Проекта
наблюдается посягательство на
обозначенные категории при
отсутствии надежных механизмов
правовой защиты. В п. 42 Проекта
отмечено, что применение
нейротехнологий может привести к
неравенству; п. 47 Проекта отмечено,
что нейротехнологии могут быть
использованы для манипулирования
или оказания неправомерного
влияния; в п. 48 Проекта указано, что
сохраняется опасность
неправомерного использования
данных, полученных при применении
нейротехологий; в п. 52 Проекта
отмечено, что нейротехнологии
могут привести к укоренению или
расширению неравенства; в п. 55
Проекта отмечено, что необходимо с
осторожностью подходить к оценке
нейротехнологических инструментов.
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Отдельные разделы посвящены
применению нейротехнологий в
немедицинских целях, при этом
результат их применения крайне
непредсказуем (образование, научные
исследования, труд и занятость,
расширение возможностей человека и
пр.).
• Таким образом, базовые этические
принципы, отмеченные в Проекте,
могут не соблюдаться в случае его
применения при отсутствии
надежных механизмов правовой
защиты пострадавших.
• Соблюдение когнитивных свобод
требует сохранения принципа
конфиденциальности при сборе,
анализе и интерпретации
нейроданных и когнитивных данных,
строгое соблюдение принципов
биоэтики применительно к
информационным системам и
системам искусственного интеллекта.
• В Проекте введено понятие
«когнитивные биометрические
данные», а также содержится ряд
положений, касающихся защиты
информации и персональных данных
(раздел III.2.3 «защита нейронных и
когнитивных биометрических данных
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612
для обеспечения психической
неприкосновенности», раздел IV.2
«политика в отношении данных»,
раздел IV «кибербезопасность»,
раздел IV.14, пункт 142 - нейронные
и когнитивные биометрические
данные работников и пр.), однако
отсутствует указание на ключевые
документы в области защиты
персональных данных, такие как
Руководящие принципы ООН по
регламентации
компьютеризированных картотек,
содержащих данные личного
характера 1990 года, Международная
декларация ЮНЕСКО о генетических
данных человека 2003 года.
• Проект содержит противоречащее
требованиям международных актов
решение в части допустимости
возникновения интеллектуальных
прав в отношении оригинальных
подборок нейронных и когнитивных
биометрических данных, созданных в
процессе агрегирования, организации
или отбора, в результате которых
получен новый набор данных. В п. 90
Проекта указано, что государствам-
членам следует принять меры для
обеспечения того, чтобы нейронные и
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когнитивные биометрические
данные, являющиеся производными
индивидуальной деятельности
человека, не были объектом права
собственности. Защита ИС должна
распространяться только на
оригинальные подборки данных
(созданные в процессе агрегирования,
организации или отбора, в результате
которых был получен новый набор
данных).
• В Проекте содержатся положения,
касающиеся интеллектуальных прав,
которые могут возникнуть на
результаты такой деятельности
(раздел IV. 3), однако отсутствует
указание на Всемирную декларацию
по интеллектуальной собственности
2000 года.
• В Проекте Рекомендаций учтены
ключевые этические аспекты
разработки и применения
нейротехнологий в интересах
человека, общества и природной
среды, предложены этические
принципы, обеспечивающие
устойчивое развитие
нейротехнологий в долгосрочной
перспективе.
• Есть проблемы, связанные с
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интересами пациентов в случае
прекращения поддержки и
обслуживания устройств
компаниями, которое ориентированы
только на коммерческие интересы
(уже есть несколько таких примеров
в мире), но скорее всего авторы
Рекомендаций считают эту проблему
локальной, т.е. регулировать это надо
на уровне национального
законодательства.
• Рекомендации должны включать:
а) рекомендацию для возможного
обеспечения автономности используемых
вне клиники медицинских
нейротехнологических устройств от
подключения к интернету и другим сетям
передачи данных, что повысит их
защищенность и помехоустойчивость в
средах, перегруженных электромагнитным
излучением, либо в зонах отсутствия
возможности подключения к сетям передачи
данных.
б) законодательное ограничение
возможности «биохакинга» инвазивными
нейротехнологическими системами, т.е.
самовольную, вне клиники, самостоятельно
или с привлечением посторонней помощи,
имплантацию нейротехнологических
устройств в организм для лечения или
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улучшения функций человека.
Наряду с упомянутыми выше пунктами полагаем целесообразным учитывать следующее:
- принимая во внимание, что документ является рекомендацией, необходимо исключить терминологию и конструкции, свойственные
договорным инструментам, в частности, слова «commitments», «commit», «must», «shall»;
- необходимо исключить неконсенсусные термины «gender identity», «gender minorities», «women and gender»;
- увязка вопросов этики нейротехнологий с их техническим производством, добычей для них ресурсов и их влиянием на экологию,
экосистемы или окружающую среду ведет к дискриминации стран по политическим мотивам и является категорически неприемлемым;
- использование понятийного аппарата, который имеет универсальный характер, («нервная система», «нейротехнологии» и т.д.) необходимо
использовать с оговоркой «для целей данной Рекомендации»;
- в п. 21 предлагаем заменить «health as holistic state of physical, mental and social well-being» на определение, используемое в Конституции
ВОЗ – «health as a state of complete physical, mental and social well-being»;
- п. 23 особое внимание при разработке нейротехнологий «нейрообразованию, нацменьшинствам, коренному населению и
непредставленным голосам» не требуется;
- п. 106 термин «medically vulnerable situations» не является консенсусной;
- п. 167 перечисление «уязвимых» и «маргинализированных групп населения, требующих «особого отношения» в контексте
нейротехнологий должно быть выдержано в более сжатой и строгой форме.
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SLOVAKIA/SLOVAQUIE
Comments on the first draft of the Recommendation on the Ethics of
Neurotechnology
Slovak Bioethics Committee Slovak Commission for UNESCO
General comments:
Thoughts and formulations are repeated, it lengthens the text and reduces attention.
More specific recommendation for implementation of the document by member
states should be included.
Specific comments:
Comment on Preamble: “trust and fairness must be upheld so that no country and no
one should be left behind” - While in an ideal world, this would be reasonable aim, in
the current situation this idea is practically impossible. Some countries are
inaccessible or difficult to democratically discuss with, whether because of their non-
democratic regimes or because of an ongoing war.
Comment on 3.: Exclusive focus on humans is something worth rethinking. Testing
these technologies on animals is an ethical concern on its own right. In addition,
there are also other categories of entities worth ethical consideration, such as future
generations and other group entities, but also entities like states and corporation. In
fact, this document takes into consideration most of these, so it’s not correct to say
that humans are the exclusive focus of ethical considerations.
Comment on 10.: The phrase “Calls on all concerned to act responsibly with regard
to neurotechnology” is too abstract to be informative. It’s not clear what “acting
responsibly” means here.
Comment on 11.: “regardless of gender, ethnicity, language, or religion” should
include “sexual orientation”. At least in Slovakia the latter is a source of great
inequality and discrimination.
Comment on 22.: Is it realistic to expect that consumer-driven or commercial
application will not be a major drive in research and development in this area? On
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another note, “benefiting the largest number of people” and “benefiting those who
stand to gain the most” can well conflict (as the moral dilemmas witness). It cannot
be presupposed that the two will lead to the same class of people.
Comment on 23.: The collection of “special consideration” categories appears
unsystematic. Indigenous People are a minority, but are listed separately, along with
more generic category of minority. Neurodivergent people are a minority as well.
Apart from that, other forms of mental disorders and mental illnesses are not taken
into consideration here. Underrepresented voices again includes various minorities
so it is not clear why is it listed separately. A more systematic list would be surely
more helpful. Also, this list should perhaps be the same as the list of parties
deserving special consideration listed later in the document.
Comment on 25.: Equitable access, while laudable, does not seem entirely realistic.
In Slovakia people are already lacking standard medication, and if the healthcare
continues to be underfunded, it would be surprising if we had cutting-edge
neurotechnology. Healthcare funding is not equal in various countries, so how it can
be expected that cutting-edge technology will be equitably accessible?
Comment on 28. and Consideration for specific users: Full informed consent might
be problematic in many cases. For instance, dementia progresses. For each patient
there is a time interval when it is tragically unclear whether they can give informed
consent.
Comment on 30. and Enhancement: Enhancement will most likely exacerbate
existing inequalities and generate novel inequalities. It is not clear whether it can be
prevented or if it can, how that can be achieved. To give an example, someone with
financial resources will pay for enhancing their memory and attention. This in turn will
increase their capacities to generate more resources, and thus creating even larger
distance between this person and those worse off.
Comment on 36.: Alignment with societal values is surely desirable, but it is not clear
how to deal with the fact that these values often conflict.
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Comment on 38: There is a clear distinction between “knowing” and “understanding.”
While most neurotechnology applications rely on identifying input-output
relationships, their safe implementation demands a thorough understanding of the
mechanisms linking specific inputs to corresponding outputs. Therefore,
interdisciplinary research that bridges knowledge gaps, ensuring the development of
neurotechnologies is both effective and safe, should be fostered.
Comment on 46.: In combination with AI, is it really possible to foresee side effects?
Comment on 52.: Whose shared responsibility there is? All stakeholders’?
Comment on 58.: It is doubtful whether there will always be a responsible party for
each wrongdoing, especially for neurotechnologies combined with AI (cf.
responsibility gaps problem frequently discussed in AI ethics).
Comment on 60.: Traceability and explainability of neurotechnology might not be
always possible to ensure, especially if combined with AI.
Comment on 61.: Similarly as with access to neurotechnology, access to knowledge
about it seems to be unlikely equitable. Research is often behind the paywall and
while there are open science initiatives they still fail to make access of someone at
a good UK university, for instance, the same as access of someone at a Slovak
scientific institution.
Comment on 68.: See comment on 25.
Comment on 94.: See comment on 61.
Comment on 106.: Shouldn’t strict oversight and close follow-up be something
generally desirable, not just in the case of children and adolescents?
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Comment on IV.8: It is surprising that women, who are perfectly non-disabled and
nowadays often even positively discriminated are listed as a category deserving
special consideration while other categories (like sexual minorities and ethnic
minorities) who are very often discriminated are not. As a woman I find it slightly
offensive but what bothers me more is the omission of those more often
discriminated categories.
Comment on 119.: Like the reasonable person standard, reasonable expectations of
mentally impaired people are something worth more consideration. What if the
person in question is not, at that time, reasonable (because of their current mental
state)?
Comment on Enhancement: See comment on 30.
Comment on 157.: Once enhancement is a standard practice, how do we know that
it would exist outside of the medical context? We might see poorer memory or
attention then as a disability deserving treatment, rather than as a normal difference
in talent and capacities of various people.
Bratislava, December 16th 2024.
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SPAIN/ESPAGNE
Comment received from Mr Alberto Gago Fernandez, Director of the Office for a Digital Spain 2030 and International Relations, Ministry for Digital Transformation
and Civil Service of Spain:
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SWEDEN/SUÈDE
COUNTRY: Sweden
Contact person: Eva Lundgren
GENERAL COMMENTS
Thank you for this opportunity to contribute with comments from Sweden on the first draft of UNESCO’s Recommendation concerning the Ethics
of Neurotechnology.
This document addresses a field with immense potential and equally substantial risks. The pace of progress in neurotechnology, particularly when
coupled with AI, promises transformative applications. These developments introduce complex ethical challenges that demand careful
consideration concerning globally coordinated oversight, mutually agreed policies, and frameworks.
Accordingly, a global recommendation from UNESCO could play an important role in supporting and urging Member States and relevant actors to
take necessary measures to ensure that the neurotechnological development is carried out in line with universal principles of human rights,
established research and medical ethics standards/laws. At the same time, the effects of this development on the planet and the environment
must be considered.
Experts who we have consulted welcome UNESCO’s initiative to act proactively. However, it is a challenging task to design a normative
instrument in an area as novel as neurotechnology, whose development, direction, impact, and scope are difficult to predict at this stage.
We hope that our amendments can be of assistance in the preparation for the second draft to be negotiated at the forthcoming Intergovernmental
meeting at UNESCO. Please see our initial remarks on a first reading below, but we reserve the right to give further remarks on a second revised
draft text.
We begin with providing some overall comments.
AIMS, OBJECTIVES, CONTENT AND SCOPE
The primary and most important purpose of the recommendation must be to work towards safeguarding and promoting that neurotechnology is
developed and applied with respect for, protection and promotion of human rights, fundamental freedoms, human dignity and with the best interest
for the environment.
One main task for this recommendation is to promote equitable access, alongside clear guidelines that ensure safety for medical patients and
other users. As for other areas, particularly the commercial sector and for enhancement, we believe that the main merit of the recommendation is
to urge for caution. In other words, we identify a need for the recommendation to address different issues depending on the area of policy action.
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We welcome that the draft takes a clear stance in favour of “allocation of resources for neurotechnology […] directed toward preventative,
diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the largest number of people and those who stand to gain the most,
rather than consumer-driven or commercial applications.” (III. 1 Values, §22) This position must be consistently reflected throughout the entire
text, which sometimes echoes ideas that resemble transhumanist perspectives (human enhancement). On occasion, the text ascribes an almost
unreasonable potential to neurotechnology to benefit humanity in general, for instance in phrases about “human flourishing”. Since future
scenarios within these areas (in particular the commercialised wellness and health industries) are hard to predict, we believe it is better for the
recommendation to take a cautious stance towards such formulations.
At the same time, it is within these yet unexplored areas that regulations and guidelines are lacking and we identify the greatest risks of abuse and
where this Recommendation accordingly could be most useful. For the medical field, there are already established research ethics guidelines,
which this recommendation needs to align with and demonstrate awareness of. As for processing of personal data and the use of AI, this
recommendation should not differ from existing international regulations which are binding for many of UNESCO’s Member States, for example
the EU-legislation. In general, there should be more attention to existing policies and regulations, and we welcome an addition of “if current
policies do not adequately address these areas” when relevant.
Due to an extensive scope, the text is very long and would benefit from being significantly streamlined, a topic that will be revisited further down.
One way to streamline the text is to begin sections/chapter with general recommendations that are applicable/relevant to all areas/sections (for
instance in the chapter on Areas of policy actions).
FEASIBILITY, IMPLEMENTATION AND RELEVANCE
The excessive level of details risks reducing the relevance of the Recommendation, make it vulnerable to societal, environmental, and technical
changes, and obstruct implementation rather than facilitating it. The different needs, conditions and situations of the Member States must also be
considered.
We welcome the approach that all engaged actors in this field are responsible “[…] to ensure the embedding of ethics in all stages of the
neurotechnology lifecycle”, which is acknowledged in II Aims and Objectives, §19 (b). To clarify and emphasize that this is a shared
responsibility, the recommendation should more explicitly underline the responsibility of each actor involved in this field, even if the Member States
of course can never abdicate their ultimate responsibility.
SCOPE, DEFINITIONS AND PERSPECTIVES
The broad definition of neurotechnology (I.2 Definitions, §§12-14) has both strengths and weaknesses. A broad definition means that almost all
technologies that can predict neural states can fall under this scope - even tools like questionnaires. This broad inclusion might benefit from
clearer boundaries or examples to distinguish neurotechnology from other general diagnostic or inferential tools.
On the other hand, there might be good reasons for keeping a broad definition for the purpose of future relevance. However, the broader the
definition, the greater the scope. For clarification and avoiding misinterpretation, not at least since this is a very complex field, we believe it would
be worthwhile to explain the rationale behind excluding certain medical applications, for instance pharmacological treatment with influence on the
nervous system, with the exception for neuropharmacological infusion (§13 b.i).
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In addition, we ask for improved clarifications of distinctions between neurotechnology for enhancement and for medical applications (with the
purpose of improving the lives for people with medical needs).
The importance of science-based evidence/methods/applications/integrity etc. must be stronger emphasized. We also ask for better consistency in
the use of the terms evidence based, scientific evidence and robust scientific evidence, or clarification of their significance in relation to each
other.
It is also a bit difficult to understand whether research is omitted consciously in some of the paragraphs when only development and deployment
of neurotechnology is mentioned. Hence, how the recommendations articulated in this text differentiate between different stages are sometimes
unclear (see detailed comments further down).
Neurotechnology is a subject still very much limited to experts. To make the recommendation more accessible to an audience without expert
knowledge in this subject, it is of great importance that the text is as pedagogically written as possible, but without losing clarity. In addition,
experts with deep knowledge in neurotechnology have commented that sentences often are too long and sometimes difficult to follow.
To be relevant and fulfil its objectives, it is crucial that a normative instrument such as this Recommendation demonstrates how it relates to
established concepts, perspectives, policy recommendations and legally binding writings in other relevant normative instruments. Especially those
from the UN system, but also from other relevant organizations. Sometimes the text deviates from the normative UN language, which needs to be
adjusted. When established concepts are used, they should be consistent with recognised meanings and applications. If deviations are justified,
they should be followed by clarifications. Generally, we see no reason for this Recommendation to establish its own concepts that are
synonymous with established concepts.
Sweden relies on UNESCO’s Secretariat to adjust the terminology to better reflect normative UN language.
Furthermore, references to relevant international and global policies/laws are of course crucial. For instance, we miss the inclusion of the World
Medical Association (WMA) Declaration of Helsinki regarding ethical principles for medical research involving human participants, which is the
basis for national laws and regulations in many countries, including Sweden,1 the ISO 14155:2020 Clinical Investigation of medical devices for
human subjects and regulations and directives from the European Union such as the European Union Medical Device Regulation (MDR) etc.2
There may be other documents that are under consideration, like the European Charter for the Responsible Development of Neurotechnologies –
European Brain Council (EBC)3.
National experts have also requested that the Recommendation must demonstrate better awareness of the discussion in the medical ethics
literature regarding the need to redirect the neuroethical discussion towards the practically most important issues. Clinical neurologists consider
that neuroethicists “ignore issues of public health and social justice, such as the effects of lifelong exposure to toxins on our brains. Also ignored
1 WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants – WMA – The World Medical Association
2 ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice; Regulation - 2017/745 - EN - Medical Device
Regulation - EUR-Lex
3 European Brain Council, under public consultation – European Charter for the Responsible Development of Neurotechnologies.
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are the ethical challenges posed by traumatic brain injuries that are incurred in warfare.” 4 The current draft also sometimes deviates from well-
established medical ethics and medical research ethics in ways that would result in less protection for patients and research subjects. Concrete
examples are given in the amendments further down (paragraphs 27, 29, 40-42, 46, 75, 106, 128, and 130).
AREAS OF POLICY ACTIONS
Although the Member States are ultimately responsible for promoting and ensuring an ethical neurotechnology, the Recommendation should
clarify that no actors involved in this field can be exempt from responsibility.
As previously mentioned, many of the paragraphs and calls for action are very detailed, with risk of being counterproductive. Especially important
is to remove those that fall outside the mandate of an UNESCO recommendation, which is not legally binding.
We further suggest moving the section Consideration for specific users, §§103-121, to its own chapter.
Enhancement, which is an area predicted to grow tremendously and with substantial risks, must be further explored.
SUSTAINABLE DEVELOPMENT
Sweden welcomes that the Recommendation addresses sustainability but identify a need for this area to be further explored, both in a broad
sense and with specific emphasis on the environmental dimension. The latter is of particular importance since the Recommendation addresses
the whole lifecycle of neurotechnology, including mining for materials and AI. Likewise, the social and economic aspects of sustainability are of
great importance and should be given a more prominent role. The Recommendation must clearly demonstrate its support for the Sustainable
Development Goals as expressed in Agenda 2030 and awareness of the interdependent relationship between the three pillars of sustainability
(the ecological, the social and the economic).
DISPOSITION AND STRUCTURE
We ask you to consider this proposed new disposition:
PREAMBLE
I DEFINITIONS
II AIMS
III SCOPE OF APPLICATIONS AND DEFINITIONS
IV AIMS AND OBJECTIVES OBJECTIVES
V VALUES AND PRINCIPLES
4Whitehouse PJ, George DR. Book review: Ethical issues in neurology. New England Journal of Medicine 2008; 359: 2737–8. On this debate, see also:
Gilbert F, Goddard E. Thinking ahead too much: Speculative ethics and implantable brain devices. AJOB Neuroscience 2014;5(1):49–51
Berger F. Pour un renouvellement de l’encadrement éthique des neurotechnologies. In: Hirsch E, Hirsch F, eds. Traité de Bioéthique IV. Les Nouveaux
Territoires de la Bioéthique. Toulouse, France: Éditions érès; 2018: 387–403.
Sven Ove Hansson “Neuroethics for Fantasyland or for the clinic? The limitations of speculative ethics”, Cambridge Quarterly of Healthcare Ethics 29: 630-
641 (2020).
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VI CONSIDERATION FOR SPECIFIC USERS (could also fit after Areas of Policy Actions)
VI AREAS OF POLICY ACTIONS ACTION
VII IMPLEMENTATION
VIII FINAL PROVISIONS
You will find our amendments under each section further down.
ORIGINAL TEXT NEW PROPOSED TEXT EXPLANATIONS TO NEW PROPOSED
TEXT, QUESTIONS, COMMENTS etc.
PREAMBLE PREAMBLE PREAMBLE
Paragraph 1 Paragraph 1 Paragraph 1
Recognizing the profound and dynamic impacts of Recognizing the profound and dynamic
neurtechnology on human mind lives and flourishing, impacts of neurotechnology on human mind
and societies, environment, and ecosystems, humankind lives and flourishing, and
societies, environments, and ecosystems,
Paragraph 2
Considering the major and growing global prevalence
of neurological and mental health conditions, along with
the profound suffering they cause for individuals and
societies worldwide,
Paragraph 3
Acknowledging the potential of neurotechnology to Acknowledging the potential of This paragraph should favour those that
offer innovative solutions and deliver better preventive neurotechnology to offer innovative solutions benefits most from neurotechnological
and therapeutic treatments for millions, benefitting and deliver better preventive and therapeutic and neuro-scientific innovations, namely
humanity as a whole and providing opportunities for treatments for people/the humankind people in need of medical care due to
health improvements in all countries, millions, benefitting humanity as a whole and severe illnesses.
providing opportunities for health
improvements in all countries, Is medical more correct than therapeutic?
Paragraph 4
Also considering that neurotechnology raises Also considering underscoring Our advice is to use a language that
fundamental ethical issues for instance regarding self- that neurotechnology must never be used in much stronger promotes a human based
determination, privacy, personal identity, freedom of a way raises fundamental ethical issues that approach.
thought, risk of discrimination, inequality and challenges stands in conflict with the universal human
to democracy, and that justice, trust and fairness must rights and the rights of the child, for instance Split this paragraph in three paragraphs.
be upheld so that no country and no one should be left regarding self-determination, privacy, See suggestion below.
behind, either by having fair access to neurotechnology personal identity, freedom of thought, and
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and enjoying their benefits or in the protection against risk of discrimination, inequality and See comment in §13 as regards the
their risks, while recognizing the different circumstances challenges to democracy, and that justice, suggested addition of “and the rights of
of different countries and respecting the desire of same trust and fairness must be upheld so that no the child”.
people not to take part in all technological country and no one should be left behind,
developments, either by having fair access to
neurotechnology and enjoying their benefits
or in the protection against their risks, while
recognizing the different circumstances of
different countries and respecting the desire
of same people not to take part in all
technological developments,
Recognizing that neurotechnology raises Even if the added examples may be
fundamental ethical issues regarding extensive, we believe it is important to
commercialization of neural data, risk include these crucial points.
concerning security and data protection,
long-term safety, inequality and challenges
to democracy
Underlines and that justice, trust and See §9 and §10 in the Preamble, that
fairness must be upheld so that no country also address geographical matters.
and no one should be left behind, either by Consider collecting all paragraphs on this
having fair access to neurotechnology and topic so they follow each other.
enjoying their benefits or in the protection
against their risks, while recognizing the
different circumstances of different countries
and respecting the desire of same people
not to take part in all technological
developments,
Paragraph 5
Recalling that, by the terms of its Constitution,
UNESCO seeks to contribute to peace and security by
promoting collaboration among nations through
education, the sciences, culture, and communication
and information, in order to further universal respect for
justice, for the rule of law and for the human rights and
fundamental freedoms which are affirmed for the
peoples of the world,
Paragraph 6
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Given the leading role of UNESCO, at the forefront of Incomplete sentence.
the international dialogue, knowledge production and
standard setting on the ethics of science and
technology and bioethics,
Paragraph 7
Convinced that the Recommendation presented here, This sentence is very exhaustive and
as a standard-setting instrument developed through a should preferably be split.
global approach, based on international law, focusing on
human dignity and human rights, as well as gender
equality, social and global justice and development,
physical and mental well- being and health, diversity,
interconnectedness, global solidarity, fairness, non-
discrimination, inclusiveness, and environmental and
ecosystem protection, can guide neurotechnology in a
responsible direction,
Paragraph 8
Guided by the purposes and principles of the Charter of This paragraph should be moved up,
the United Nations, maybe begin the Preamble.
Paragraph 9
Emphasizing that specific attention must be paid to
low- and middle-income countries (LMICs), including
but not limited to least developed countries (LDCs),
landlocked developing countries (LLDCs) and small
island developing States (SIDS), as they have their
capacity but have been underrepresented in the
development and access to neurotechnology,
Paragraph 10
Underscoring that global cooperation and solidarity Underscoring that global cooperation and
facilitates fair access to neurotechnology and enables solidarity is crucial to facilitates fair access to
the realization of the full potential of neurotechnology, neurotechnology and to realize enables the
while addressing the ethical challenges, mitigating realizeation of the full potential of
against potential misuse, and ensuring that national neurotechnology, while addressing the
neurotechnology strategies are guided by ethical ethical challenges, mitigating against
potential misuse, and ensuring that national
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principles in full respect of international human rights neurotechnology strategies are guided by
law, ethical principles in full respect of
international human rights law,
Paragraph 11
Noting that ethical guidelines, frameworks and open
science promote innovation, development and policies
aligned with international human rights law,
Paragraph 12
Also recalling that in November 2023, the General
Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated
the Director-General "to prepare a standard- setting
instrument on the ethics of neurotechnology in the
form of a recommendation", which is to be submitted
to the General Conference at its 43rd session in
2025,
Paragraph 13
Bearing in mind the Universal Declaration of Human This paragraph should be placed in
Rights (1948), the instruments of the international conjunction with paragraph 4, in which
human rights framework, including the Convention case the addition of considering “the
Relating to the Status of Refugees (1951), the rights of the child” does not need to be
Discrimination (Employment and Occupation) specified.
Convention (1958), the lnternational Convention on the
Elimination of All Forms of Racial Discrimination (1965),
the lnternational Covenant on Civil and Political Rights
(1966), the lnternational Covenant on Economic, Social
and Cultural Rights (1966), the Convention on the
Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the
Child (1989), and the Convention on the Rights of
Persons with Disabilities (2006), the Convention against
Discrimination in Education (1960), the Convention on
the Protection and Promotion of the Diversity of Cultural
Expressions (2005), as well as any other relevant
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international instruments, recommendations and
declarations,
Paragraph 14
Also noting the United Nations Declaration on the Right
to Development (1986); the Declaration on the
Responsibilities of the Present Generations Towards
Future Generations (1997); the Universal Declaration
on Bioethics and Human Rights (2005); the United
Nations Declaration on the Rights of lndigenous
Peoples (2007); the Declaration of Ethical Principles in
relation to Climate Change (2017); the Recommendation
on Science and Scientific Researchers (2017); the
Recommendation on the Ethics of Artificial lntelligence
(2021); the Recommendation on Open Science (2021);
the Human Rights Council's resolution on 'The right to
privacy in the digital age" (NHRC/RES/42/15) (2019);
the Human Rights Council's resolution on "New and
emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), and the UN Guiding
Principles on Business and Human Rights (2011),
Paragraph 15
Recalling that the 2021 Recommendation on the Ethics
of Artificial lntelligence, recognizes ethical questions
related to Al-powered systems for neurotechnology and
brain-computer interfaces,
Paragraph 16
Also conscious of the existing ecosystem of national We suggest removing the OECD since
policies, and other frameworks and initiatives elaborated other organizations might be equally
by relevant United Nations entities, intergovernmental relevant to acknowledge, and the
organizations such as OECD, including regional recommendation will then end up with a
organizations, as well as those by the private sector, long list.
professional organizations, non-governmental
organizations, and the scientific community, related to
the ethics and regulation of neurotechnology,
630
16.1
Adopts the present Recommendation on the Ethics of
neurotechnology on this XXX day of November 2025;
16.2
Recommends that Member States, with the support of
UNESCO's Secretariat, apply the provisions of this
Recommendation by taking appropriate steps, including
whatever legislative or other measures may be
required, in conformity with the constitutional practice
and governing structures of each State, to give effect
within their jurisdictions to the principles and norms of
the Recommendation in conformity with international
law, including international human rights law;
16.3
Also recommends that Member States engage all
actors, to ensure that they play their respective roles in
the implementation of this Recommendation; and bring
the Recommendation to the attention of international,
regional and national authorities and bodies, research
and academic organizations, institutions and
organizations in public, private and civil society sectors
involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound
scientific research as well as ethical analysis and
evaluation.
I. SCOPE OF APPLICATIONS AND DEFINITIONS I. SCOPE OF APPLICATIONS AND I. SCOPE OF APPLICATIONS AND
DEFINITIONS DEFINITIONS
I.1 SCOPE We suggest that SCOPE comes after
DEFINITIONS and AIMS AND
OBJECTIVES
This section is also very extensive. Try to
condense.
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See paragraph 3 in SCOPE OF
APPLICATION in the Recommendation
on the Ethics of AI (2021), which
highlights prioritized domains for the
recommendation. Something similar
should be done in this recommendation
for clarification.
Also see paragraph 4 in SCOPE OF
APPLICATION in the Recommendation
on the Ethics of AI (2021), which clarifies
addressed target groups (“This
Recommendation is addressed to
Member States, both as AI actors and as
authorities responsible for developing
legal and regulatory frameworks
throughout the entire AI system life cycle,
and for promoting business responsibility.
It also provides ethical guidance to all AI
actors, including the public and private
sectors, by providing a basis for an ethical
impact assessment of AI systems
throughout their life cycle.”)
This Recommendation: This recommendation applies an ethical,
Human Rights based approach to all stages
of the life cycles of neurotechnology, and, as
such:
1. Addresses ethical issues related to Acknowledges the positive impacts that The positive impacts of neurotechnology
neurotechnology, as it can have many positive and neurotechnology can have on human health, on human flourishing and the enjoyment
adverse impacts on human health, human flourishing and, at the same time, addresses the of human rights need clarification.
and on the enjoyment of human rights. adverse impact of the technology on human
health, human flourishing and the enjoyment
of human rights….
2. Considers neurotechnology for people of diverse 2. Considers neurotechnology for all people
backgrounds and abilities, and various fields, including of diverse backgrounds and abilities, and
health, non-medical direct-to-consumer (DTC), such as various fields, including health, non-medical
wellness devices, neurogaming), addressing various direct-to-consumer (DTC), such as wellness
settings where neurotechnology may be utilised. devices, (neurogaming), addressing various
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settings where neurotechnology may be
utilised.
3. Focuses on humans only but acknowledges Where in this draft are animals
important considerations that apply to animals in considered besides in this paragraph?
research.
4. Approaches neurotechnology ethics as a systematic 4. Approaches neurotechnology ethics as a What is the meaning of normative
normative reflection based on a holistic, multicultural, systematic normative reflection based on a reflection in this context?
multidisciplinary, pluralistic and evolving framework of holistic, multicultural, multidisciplinary,
interdependent values, principles, and actions that can pluralistic and evolving framework of
guide societies in dealing responsibly with the impacts interdependent Human Rights based values,
of neurotechnology on human beings, societies, and the principles, and actions that can guide aiming
environment and ecosystems. at guiding societies in dealing responsibly
with the impacts of neurotechnology on
human beings, societies, and the
environment and ecosystems.
a) It considers ethics as a basis for the normative
evaluation and guidance of neurotechnology,
with human rights, human dignity, well-being,
and the prevention of harm as a compass and
foundation.
b) It draws upon a full range of scholarship, It draws upon a full range of scholarship,
commentary and views from neuroscience, including commentary and views from
medicine, engineering, psychology, ethics, neuroscience, medicine, engineering,
human rights, law, sociology, anthropology and psychology, ethics, human rights, law,
other disciplines. sociology, anthropology and other
disciplines.
5. Covers the measurement, recording, and 5. Covers the measurement, recording, and The difference between measurement
modification of the human nervous system, the modification of the human nervous system, and recording is not clear. Consider
handling, analysis, treatment, storage, use and reuse of the handling, analysis, treatment, storage, removing recording.
the data collected, along with other societal and use and reuse of the data collected, along
environmental impacts, including the emergence of new with other societal and environmental
cognitive states. impacts, including the emergence of new
cognitive states.
6. Recognizes that interventions involving the nervous
system are very sensitive because the highly complex
human nervous system is the coordinating centre of
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behaviour and mental processes. It enables the
exercise of self-determination, the capacity to act as
moral agents, to be responsible for actions, cooperate
with others, deliberate about collective decisions and
develop personality.
7. Further recognizes that humans develop and flourish This paragraph needs clarification. It
in their interaction with other human beings and a starts with acknowledging that interaction
nurturing material and cultural environment, highlighting with other humans and the material and
that autonomy is not just individual but also relational, cultural environment is fundamental for
as it arises from and impacts one's interactions and our human development, and then
belonging with the community. addresses autonomy as a state that is
both individual and relational. The
message and the essence are very
unclear.
The established definition of autonomy,
especially in medical law, is the right of
adults with capacity to make informed
decisions about their own medical care
(and concerning non-medical applications
of neurotechnology affecting an
individual)
The autonomy principle is a main guiding
principle in medical ethics.
A respect for competent decisions by
adult patients is also a cornerstone of
medical law.
The vague definition of autonomy in this
paragraph is poorly aligned with the
general understanding of this important
concept
8. Addresses the ethical and human rights concerns Many of the definitions in this paragraph
that arise from the rapid developments and the are unfamiliar to the public and readers
convergence of neurotechnology with other without expert knowledge in the field of
technologies such as spatial computing, extended neurotechnology. Consider adding them
reality (XR), artificial intelligence (Al), sensors and semi-
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conductors. Notably, other biometric data when to the section of Definitions, that
processed to infer sensory, motor, and mental states preferably should come before Scope.
raises similar ethical concerns. Therefore, this
Recommendation applies to both neurotechnology and The paragraph needs to be re-worded.
the use of cognitive biometric data, ensuring that ethical
principles and practices are consistently applied across
these domains.
9. Further addresses the integration of Al with
neurotechnology, which can enhance precision and
predictive capabilities, such as improving processing
speed, reducing cost, optimizing neurotechnology
systems. However, it also magnifies ethical threats,
including cybersecurity concerns, lack of transparency,
the potential for algorithmic bias, and risks to autonomy,
mental privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and […] Galls on Urges all concerned to act Regarding the paragraph as a whole:
seeks to raise awareness on the profound ethical responsibly with regard to neurotechnology. should it be moved to AIMS?
challenges and threats that come with the military and
security applications of neurotechnology. Galls on all
concerned to act responsibly with regard to
neurotechnology.
I.2 DEFINITIONS For pedagogical reasons, the section
about DEFINITIONS should preferably
come right after the PREAMBLE. There
might also be good reasons for adding
concepts that need to be explained for the
reader.
For the purpose of this Recommendation:
11. Nervous system. The nervous system includes the 11. Nervous system. The nervous system The terms cerebellum and brainstem
central (brain, spinal cord) and peripheral (somatic, includes the central (brain, cerebellum, should be added in order to be fully
autonomic, enteric) nervous system. Scientific evidence brainstem, spinal cord) and peripheral correct.
demonstrates that nervous system activity is the basis (somatic, autonomic, enteric) nervous
of sensory, motor, and mental states (which include system. Scientific evidence demonstrates While the term 'brain' is commonly used
cognitive, affective, and conative states), and supports that nervous system activity is the basis of in everyday language and general
consciousness, sleep and the experience of pain. The sensory, motor, and mental states (which contexts to refer to the entire structure,
nervous system activity and structure provide include cognitive, affective, and conative the terms brain, cerebellum, and
information inherent to all human beings and the states), and supports consciousness, sleep brainstem are more coherent with
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community, regardless of gender, ethnicity, language, and the experience of pain. The nervous established scientific and medical
or religion. The nervous system activity is also system activity and structure provide language, and accordingly more
instrumental in social and cultural interactions. information inherent to all human beings and appropriate in this context.
the community, regardless of gender,
ethnicity, language, or religion. The nervous
system activity is also instrumental in social
and cultural interactions.
12. Neurotechnology. Neurotechnology refers to Neurotechnology refers to devices, systems, or indirectly measure should be added to
devices, systems, and procedures- encompassing both and procedures- encompassing both cover so called non-touch and remote
hardware and software-that directly access, monitor, hardware and software- that directly or methods that may influence the nervous
analyze, predict or modulate the nervous system to indirectly measure, access, monitor, system.
understand, influence, restore, or anticipate its structure, analyze, predict or modulate the nervous
activity, function, or intentions (speech, motor). system to understand, influence, restore, or The text in the parenthesis (speech,
Neurotechnology combines elements of neuroscience, anticipate its structure, activity, function, or motor) is unclear, suggested additions
engineering, and computing, among others intentions (speech, motor, auditory, visual or contributes to clarification.
tactile sensations). Neurotechnology
combines elements of neuroscience, It is unclear what doesn’t qualify as
engineering, and computing, among others neurotechnology in this definition. Since it
includes technologies that can predict
neural states, almost anything could fall
under this scope – even tools like
questionnaires. This broad inclusion
might benefit from clearer boundaries or
examples to distinguish neurotechnology
from other general diagnostic or
inferential tools.
13. Neurotechnology spans medical and non-medical
applications and includes tools that measure, infer, and
influence nervous system activity, whether through
direct interaction with the nervous system or by
interfacing it with devices and systems. It includes but is
not limited to:
a) Technical tools that measure and analyse b) Technical tools that measure and Consider adding cell therapy.
physical (i.e., acoustic, electrical, optical, analyse physical (i.e., acoustic, And cells that can be conditionally altered
magnetic and/or mechanical), chemical and electrical, optical, magnetic and/or by opto- or chemogenetics. The cell’s
biological signals associated with the structure mechanical), chemical and function can be altered and therefore also
of and functional signals from the nervous biological signals associated with change the human feeling and behaviour.
system. These may be used to identify, record, the structure of and functional
and/or monitor properties of nervous system signals from the nervous system
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636
activity, understand how the nervous system (including cell therapy). These may
works, diagnose pathological conditions, or be used to identify, record, and/or
central external devices (brain machine monitor properties of nervous
interfaces (BMI), often referred to as brain system activity, understand how the
computer interfaces (BCI)). Of note, both open- nervous system works, diagnose
loop (i.e., fixed-parameter brain stimulation) pathological conditions, or central
and closed- loop systems (i.e., state dependent external devices (brain machine
stimulation) introduce complex ethical issues. interfaces (BMI), often referred to as
brain computer interfaces (BCI). Of
note, both open-loop (i.e., fixed-
parameter brain stimulation) and
closed- loop systems (i.e., state
dependent stimulation) introduce
complex ethical issues.
a) (i). Examples include but are not limited to (i). Examples of measurement methods Please clarify that this section refers to
Electroencephalography (EEG), include but are not limited to examples: “of measurement methods“
Magnetoencephalography (MEG), Magnetic Electroencephalography (EEG), fMRI is one type of MRI method/protocol.
resonance imaging (MRI), Functional Magnetic Magnetoencephalography (MEG), Magnetic Several other exists e.g. diffusion
resonance imaging (fMRI), Positron emission resonance imaging (MRI), Functional weighted imaging. It is also suggested to
tomography (PET), Functional Near-infrared Magnetic resonance imaging (fMRI), add: and other MRI methods
spectroscopy (fNIRS), lmplanted Diffusion weighted imaging, and other MRI
microelectrodes, Optogenetics, Optical methods, Positron emission tomography Computed Tomography (CT) is a
imaging, Diffusion weighted imaging, Calcium (PET), Computed Tomography (CT), common imaging method and has been
imaging, Voltage dye sensors, or Microdialysis. Neuronavigation systems, Functional Near- added.
infrared spectroscopy (fNIRS), lmplanted
microelectrodes, Optogenetics, Optical Neuronavigation systems are used
imaging and monitoring, Calcium imaging, together with brain images to calculate
Voltage dye sensors, or Microdialysis. anatomical position e.g. during brain
surgery and has therefore been added.
Since optical monitoring is common, and
monitoring was added.
Even if the scope is very broad, maybe an
explanation of what is excluded should be
considered.
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b) Technical tools that interact with the nervous Technical tools that interact with the nervous DBS and other simulation methods
system to change its activity, for example, to system to change its activity, for example, to doesn’t remove or treat the disorder.
restore sensory input, such as hearing (i.e., restore sensory input, such as hearing (i.e., More examples of common use have
cochlear implants) or Deep Brain Stimulation cochlear implants) or Deep Brain Stimulation been added.
(DBS) to treat tremors and other pathological (DBS) to treat reduce symptoms of tremor,
conditions. They are meant to either modulate movement disorders and other pathological Vagus nerve stimulation can also be
the functions of the nervous system and/or send symptoms. They are meant to either added as an example of method.
signals directly to the nervous system by modulate the functions of the nervous
applying acoustic, electrical, magnetic or optical system and/or send signals directly to the The last parts have been deleted since
stimulation and/or inhibition of the peripheral or nervous system by applying acoustic, modulate includes inhibition.
central nervous system. electrical, magnetic or optical stimulation
and/or inhibition of the peripheral or central
nervous system.
(b). (i). Examples of this neurotechnology are implanted Examples of this neurotechnology are Optogenetic is one method and optical
microelectrodes, BMI, DBS, Optogenetic optical implanted microelectrodes, BMI, DBS, stimulation without genetic modification is
stimulation, Transcranial electrical stimulation (tES), Optogenetic or optical stimulation, Ablation another method, and these should be
Transcranial Magnetic Stimulation (TMS) or (by ultrasound or other mechanical waves, separated.
Neuropharmacological infusion. radiofrequency heating or cryo),
Transcranial electrical stimulation (tES), Ablative methods are not mentioned:
Transcranial Magnetic Stimulation (TMS) or They destruct nervous tissue in a
Neuropharmacological infusion. controlled way.
14. Of note, several sensor technologies collect data Of note, several sensor technologies collect It is perhaps important to emphasize that
indirectly informing about neural activity. Even if they data indirectly informing about neural detailed monitoring of human behaviour
are not neurotechnology per se, they raise similar activity. Even if they are not neurotechnology (eye-tracking, tracking of gestures and
ethical and human rights issues as neurotechnology per se, they already raise similar ethical and facial expressions, voice/speech
when used to infer mental states. They include but are human rights issues as neurotechnology characteristics, language use etc.) is
not limited to eye-tracking, Video Oculography, Typing when used to infer mental states. They currently a much more effective method
dynamics, Voice recognition and analysis, Gait include but are not limited to eye-tracking, to reveal hidden internal states,
analysis, Skin conductance, Heart rate variability, Sleep Video Oculography, Typing dynamics, Voice intentions, responses to external stimuli
movement monitoring, Blood pressure measurement, or recognition and analysis, Gait analysis, Skin relating to inner goals, preferences etc.
facial- emotion recognition systems. conductance, Heart rate variability, Sleep than any existing neurotechnological
movement monitoring, Blood pressure technique.
measurement, or facial- emotion recognition
systems. Thus, a recommendation of such
applications could become a blueprint for
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future neurotechnological applications
(relates to §16 below)
15. Neural data. Neural data are qualitative and The implications of direct correlates in this
quantitative data about the structure, activity and context needs to be clarified or left out.
function of the nervous system. They encompass data
relating to a nervous system's activity, including both
direct measurements of neuronal structure, activity
and/or function (i.e., neuronal firing or averaged
bioelectric signals from EEG) and indirect functional
indicators (i.e., blood flow in fMRI and fNIRS). At the
neurobiological level, neural data are the most direct
correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with It could be mentioned here or in another
data collected by non-neural biometric technologies can suitable place in the document that non-
be processed to infer mental states, which this neural parameters can be GPS positions.
Recommendation refers to as "cognitive biometric
data".
17. Whole lifecycle. Neurotechnology should be
considered from the early stages of mining for materials,
prototyping, research, design and development to
deployment and use, including maintenance, operation;
trade, financing, monitoring and evaluation, validation,
end-of-use, disassembly, termination, disposal and
recycling. The whole lifecycle of neurotechnology
includes its convergence with other technologies and the
diversity of actors who are involved in every stage.
II. AIMS AND OBJECTIVES A paragraph that specifically addresses
environmental sustainability should be
added. None of the paragraphs
addresses this fundamental aspect.
18. This Recommendation has been created with the Consider leaving out this paragraph since
aim of guiding the development and use of it appears to be redundant.
neurotechnology in ways that are ethical, safe and
effective for the good of humanity, individuals,
communities, societies, the environment and
ecosystems, and to prevent harm in the present and the
future based on international law, in particular the
Charter of the United Nations and international human
rights law.
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19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect
of human rights and fundamental freedoms,
human dignity and equality, including gender
equality, and to respect cultural diversity during
the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, All actors addressed here, besides
individuals, groups, communities, institutions, Member States, i.e. individuals, groups,
private sector companies and every other communities, institutions, private sector
relevant actor to ensure the embedding of companies and every other relevant
ethics in all stages of the neurotechnology actor, should consequently be addressed
lifecycle; in the recommendation, when
appropriate.
(c) to ensure that neurotechnology in its whole to ensure that neurotechnology in its whole The term evidence-based has a specific
lifecycle is evidence-based, reliable and lifecycle is evidence-based science based, meaning in medical usage, i.e. does not
reproducible; reliable and reproducible; mean “based on evidence” but rather
based on evidence collected and
interpreted in a specific manner that
includes striving for randomized clinical
trials as the gold standard.
Science based is more accurate in this
context.
Also se §100 and §136.
(d) to provide a universal framework that not only
articulates values and principles, but also It should be specified what is meant by
translates into concrete policy “international human rights law”
recommendations and effective implementation
to guide Member States in their engagement
with neurotechnology in its whole lifecycle,
consistent with their obligations under
international human rights law and other
international standards;
(e) to foster multi-stakeholder, multidisciplinary and to foster a multi-stakeholder,
pluralistic dialogue and consensus building multidisciplinary and pluralistic dialogue and
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about ethical issues relating to consensus building about ethical issues
neurotechnology; relating to neurotechnology;
(f) to promote justice and equitable access to What is the message here? Is this
developments and knowledge in the field of referring to neurotechnology for all kind of
neurotechnology and the sharing of benefits; purposes, including enhancement? This
paragraph needs to be adjusted to not
give that impression.
(g) to ensure accountability and solidarity among
all actors to prevent misuse of neurotechnology
and to uphold human rights and ethical
standards.
III. VALUES AND PRINCIPLES Suggestion: Consider beginning this
chapter with common statements that are
applicable to all areas/dimensions in
order to avoid repetitions and
duplications.
Some of the paragraphs also overlap with
IV AREAS OF POLICY ACTION.
III.1 VALUES The difference between VALUES and
ETHICAL PRINCIPLES AND HUMAN
RIGHTS is unclear and must be refined.
III.1.1 Respect, protection and promotion of human Human rights return in III.2. Ethical
rights, fundamental freedoms and human dignity Principles and Human Rights.
20. The inviolable and inherent dignity of every human
being is the foundation of universal human rights and
fundamental freedoms. Respect, protection, and
promotion of human dignity, as established by
international human rights law, are essential in the
whole lifecycle of neurotechnology. Dignity
encompasses the recognition of the intrinsic and equal
worth of each person. Neurotechnology must never be
used in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of any
individual, including people living in vulnerable
situations.
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III.1.2 Promoting human health and well-being
21. Prioritizing the development and application of Proritizing research, the and a Maybe move highlighted text to
neurotechnology that promotes comprehensive development and application of DEFINITIONS?
human health and well-being, viewing health as a neurotechnology that promotes
holistic state of physical, mental, and social well- comprehensive human health and well-
being. being, viewing health as a holistic state
of physical, mental, and social well-
being.
22. The responsible allocation of resources for The responsible allocation of resources for This is very important. Neurotechnology
neurotechnology should be directed toward neurotechnology should be directed towards for the benefit of those who benefit most
preventative, diagnostic, therapeutic, assistive, and preventative, diagnostic, therapeutic, from the technology must be in the centre
rehabilitative purposes that benefit the largest number of assistive, and rehabilitative purposes that of this recommendation.
people and those who stand to gain the most, rather benefit the largest number of people and
than consumer-driven or commercial applications. those who stand to gain the most, rather Compare §25 where neurotechnology in a
than consumer-driven or commercial general sense is promoted as something
applications. that unconditionally benefits humanity.
III.1.3 Ensuring and respecting diversity and
fairness
23. Respect for diversity and fairness, must be upheld in 23. Respect for diversity and fairness, must
the whole lifecycle of neurotechnology. Special be upheld in the whole lifecycle of
consideration should be given to neurodiversity, minority neurotechnology. Special consideration
groups, lndigenous Peoples, and underrepresented should be given to neurodiversity, minority
voices. groups, lndigenous Peoples, persons with
disabilities and other underrepresented
voices.groups of peoples.
24. Given that widely recognized neurotechnological Given that widely recognized Move the explanation of “technological
innovation largely occurs in the urban well- resourced neurotechnological innovation largely occurs colonisation” to DEFINITIONS.
sector, specific attention to underserved and in the urban well- resourced sector, specific
marginalised people is crucial to prevent bias, ongoing attention to underserved and marginalised
disparities in healthcare, stigma, neglect, and people is crucial to prevent bias, ongoing
disrespect. Technological assimilation, or using disparities in healthcare, stigma, neglect,
technology as a tool of colonisation (a term the and disrespect. Technological assimilation,
Recommendation refers to as "technological or using technology as a tool of colonisation
colonialism"), can threaten cultural diversity and (a term the Recommendation refers to as
heritage, therefore must be protected against. "technological colonialism"), can threaten
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cultural diversity and heritage, therefore
must be protected against.
25. Equitable access to neurotechnology should be 25. Equitable access to neurotechnology The requirement of equitable access to
prioritized globally, ensuring that its benefits are should be prioritized globally, ensuring that neurotechnology needs to be specified.
accessible to all, regardless of socioeconomic status or its benefits are accessible to all, regardless Equitable access to medical treatment is
geographical location. Special attention must be given of socioeconomic status or geographical certainly to be desired, but not all
to low- and middle-income countries, resource- location. Special attention must be given to potential uses of neurotechnology may be
constrained settings, and marginalised communities, low- and middle-income countries, resource- desirable.
including the specific needs of different groups, ages, constrained settings, and marginalised
segments, cultural systems, languages, communities, communities, including the specific needs of “marginalised” appears twice in the same
and marginalised and vulnerable populations, people different groups, ages, segments, cultural sentence and the second appearance
with disabilities, neurological disorders, and mental systems, languages, communities, and should be removed.
health conditions. marginalised andpopulations living in
vulnerable situations such aspopulations,
personsople with disabilities, neurological
disorders, and mental health conditions.
26. lndividuals and groups should be allowed to make 26. lndividuals and groups of peoples should What is the purpose of this paragraph?
lifestyle choices, express beliefs and opinions, share be allowed to make lifestyle choices, As it is worded now, it gives the
personal experiences, and participate in co-designing express beliefs and opinions, share personal impression that UNESCO promotes non-
technologies, provided that these choices are made in experiences, and participate in co-designing scientifically based experiments as long
ways that respect the rights of others. technologies, provided that these choices as those involved respect the rights of
are made in ways that respect the rights of others.
others.
III.1.4 Consideration for cross-cultural perspectives This section (§§27-28) can be removed.
on human knowledge and its sharing The essence can be communicated in
other paragraphs/sections.
27. Respectful knowledge sharing on the human Important to clarify that respectful
nervous system and its functions across communities knowledge sharing must follow the
and cultures fosters trust and strengthens global principles of open science in accordance
cohesion in the pursuit of health and quality of life. with UNESCOs recommendation on
Open Science (2021).
28. It is essential that any research and This paragraph could also fit under III.1.8
development involving diverse groups and lntegrity and Responsibility and
communities is done with their permission and should include medical applications or
guidance, and conducted with their full prior and equivalent.
informed consent and partnership in ways that
serve their interests and respect their traditional
knowledge and epistemic contributions.
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III.1.5 Commitment to peace, fairness and justice in
society
29. The use of neurotechnology should be used to The text refers to the need for “consent”
promote, not undermine freedom of thought especially where established medical ethics would
in situations where refusal to use the technology could require something more, namely
lead to competitive disadvantage. Such interferences “informed consent”.
include but are not limited to the use of force, threats,
undisclosed access, manipulation, or any scenario See §28 where informed consent it used.
where consent is compromised, including as a result of
power imbalances.
30. The use of neurotechnology should be particularly
scrutinized to avoid uses that segregate, objectify or
subordinate individuals or communities, reduce social
cohesion by exacerbating pre- existing inequalities or
generating novel inequalities that divide and antagonize
individuals against each other, and thereby threaten the
coexistence between humans, other living beings and
the natural environment.
III.1.6 Global Solidarity and International
Cooperation
31. The Recommendation should guide all actors in the Is research exempted here?
development, deployment and use of neurotechnology It would be good to clarify.
to act in solidarity and call for accountability in instances
where neurotechnology may be misused in ways that
threaten human rights.
32. lnternational cooperation is essential to addressing lnternational cooperation is essential to Yellow marked sentence needs
cross-border issues related to neurotechnology. addressing cross-border issues related to clarification. How and why must particular
Particular attention must be given to differing neurotechnology. Particular attention must attention be given to differing
perspectives on acceptable use to prevent abuse and be given to differing perspectives on perspectives on acceptable use in order
uphold global ethical standards. acceptable use to prevent abuse and uphold to prevent abuse and uphold global
global ethical standards. ethical standards? What kind of differing
perspectives are referred to?
III.1.7 Sustainability
33. Considering that sustainability requires that 33. Neurotechnology must Considering that
neurotechnology be developed and used with a deep sustainability requires that neurotechnology
respect for environmental stewardship, prioritizing the be developed and used with a deep respect
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minimisation of ecological harm throughout the lifecycle for environmental stewardship,
of the materials used, including, for mining extraction, ensuring/safeguarding that prioritizing the
data processing and storage, recycling and disposal minimisation of ecological harm is
practices. minimized/avoided throughout the lifecycle of
the materials used, including, for . That
includes mining extraction, data processing
and storage, recycling and disposal
practices.
34. The unregulated development of neurotechnology, This paragraph must be reworded into an
especially for non-medical purposes, might lead to aspiration or position.
disproportionate consumption of resources and energy
and waste production.
35. Respect for lndigenous rights, in accordance with 35. Respect for lndigenous rights, in
the United Nations Declaration on the Rights of accordance with the United Nations
lndigenous Peoples (UNDRIP), requires that Declaration on the Rights of lndigenous
neurotechnology, through its whole lifecycle, be guided Peoples (UNDRIP), requires that
by a profound respect for lndigenous rights, ensuring neurotechnology, through its whole lifecycle,
that their lands (including during mining), knowledge, be is guided by a profound respect for
communal rights, and privacy are honoured in all lndigenous rights, ensuring that their lands
activities, including those related to resource extraction. (including during mining), knowledge,
communal rights, and privacy are honoured
in all activities, including those related to
resource extraction.
III.1.8 lntegrity and Responsibility
36. lntegrity requires that all actors in the whole lifecycle Is this VALUE or POLICY?
of neurotechnology field act with ethical steadfastness. It
includes adhering to ethical guidelines and ensuring
that all actions align with both professional standards
and societal values.
37. lntegrity includes a commitment to taking
responsibility for one's actions and being accountable
for their outcomes. This involves not only acknowledging
successes but also owning up to mistakes and taking
corrective actions when necessary.
38. Scientific integrity is the commitment to the rigorous 38. Scientific integrity is the commitment to
pursuit of truth through evidence-based, objective and the rigorous pursuit of truth through science
transparent research practices. It ensures that all based/established evidence-based,
scientific endeavours are conducted with honesty, objective and transparent research
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accuracy, and respect for the scientific method of practices. It ensures that all scientific
disciplines relevant for neurotechnology. endeavours are conducted with honesty,
accuracy, and respect for the scientific
method of disciplines relevant for
neurotechnology.
III.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
39. This Recommendation embraces a human-centred
approach through fundamental ethical principles
including but not limited to self-determination, agency,
freedom of thought, privacy, cognitive liberty, personal
and collective identity, trustworthiness, respect,
reciprocity, and justice. Furthermore, it incorporates the
respect, promotion and protection of human rights.
III.2.1 Beneficence, Proportionality and Do No Harm
40. Neurotechnology should promote health and §§40-42 The text about enhancement
well-being, and empower individuals to make (medical interventions that provide
informed decisions about their nervous system and functionality beyond normal human
mental health while fostering a better functionality) is unclear. The phrase in
understanding of themselves. §40 that neurotechnology should
“empower individuals to make informed
decisions about their nervous system and
mental health” gives the impression of
allowing for enhancements. The text in
§42 mentions that enhancement may
involve medical risks but does not
exclude such risk-taking, whereas §41
says that neurotechnology should not
cause harms. From the viewpoint of
established medical ethics, the principle
of non-maleficence excludes the
performance of enhancing interventions
with significant medical risks. It is
surprising that this standpoint not clearly
supported in the document.
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41. Neurotechnology should contribute to human See comments above.
flourishing without causing harm or subordination,
whether physically, economically, socially, politically,
culturally, or mentally. The "do no harm" principle must
guide the whole lifecycle of neurotechnology, ensuring
that the quality of life is protected and promoted.
42. Embracing neurotechnology for enhancement may This paragraph must be reworded and
lead to the risk of not only unexpected damage to the much clearer distance itself from
nervous system, but also to amplified inequalities within enhancement and its risks (see
society. comments in §40). In addition, the
paragraph, at least partly, overlaps with
the IV.16 Enhancement.
43. Any restrictions to human rights must meet all This paragraph is redundant and should
applicable requirements under human rights law, be left out.
including the principles of legality, legitimate aim,
necessity and proportionality.
44. The principles of proportionality, balance and Is this VALUE or POLICY?
legitimacy should govern the use of neurotechnology
and the data it enables, to ensure their use is: (a)
appropriate and proportional to the objective and
expected benefits that are aimed to be achieved; (b) do
not infringe upon the foundational values of this
document; (c) appropriate to the context and target user
group; (d) based on safety principles and rigorous
scientific evidence.
III.2.2 Self-determination and the Freedom of
Thought
45. Throughout the whole lifecycle of neurotechnology,
the protection and promotion of the rights of freedom of
thought, and self-determination must be secured.
46. lndividuals have the right to make free, informed, This description appears to be closer to
and voluntary decisions about their engagement with the medical ethical concept of autonomy.
neurotechnology throughout the whole lifecycle, in
accordance with international human rights law and ‘Self-determination’ is for most people in
other international standards, including the right to medicine and psychology probably more
refuse or withdraw from its use, at any time, ensuring related to explaining the driving forces
their autonomy and respect for their decision-making behind motivation (SDT theory)
capacity is upheld and where surrogate consent is
used, the best interests of the affected individual are See comment §7 above.
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considered. lndividuals who are enrolled in research
should be informed of potential side effects and given The part about the right of individuals who
the opportunity to disclose if they have any take part in a clinical trial does not
contraindications for the procedures used. lnformed mention their right to retain a medically
consent procedures should be affirmative, dynamic, and useful treatment that they received in a
require opt-in, comprehensive and transparent trial if they so wish. In several trials with
providing detailed information about the purposes, risks, implanted neurotechnological devices,
benefits, alternatives, and possible outcomes of the participants who could not themselves
technology in all its application domains, ensuring that pay for continued treatment were forced
consent is voluntary and that individuals fully to have a well-functioning device
understand the implications for their privacy, autonomy, surgically removed at the end of the trial.5
and well-being. The rights of trial patients to continued
treatment should be supported in the
document.
47. Neurotechnology should never be used to exert
undue influence or manipulation, whether through
force, coercion, or other means that compromise self-
determination and freedom of thought. This protection
covers both the internal processing of thoughts and
their externa! expression, ensuring freedom from any
interference.
III.2.3 Protection of Neural and Cognitive Biometric
Data for Mental Privacy
48. Neurotechnology and cognitive biometric Very long sentence and difficult to grasp.
technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct This is correct, but mainly for cognitive
and indirect data about the nervous system that is biometric technologies (see comment §14
uniquely sensitive because they can be processed and above).
analysed to provide deep insights in the processes that
underpin our mental states and behaviour, including
self-awareness and introspection. As it becomes
increasingly difficult to anonymize data, there remains
persistent risks of misuse of this data by revealing
neurobiological correlates of diseases, disorders, or
general mental states without the authorization of the
person from whom data are collected.
5 Sven Ove Hansson, “The ethics of explantation”, BMC Medical Ethics, 22:121, 2021. Link: https://rdcu.be/cxqdJ
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49. Mental privacy is fundamental for the protection of 49. Mental privacy is fundamental for the Crossed out sentence is important but
human dignity, personal identity, and agency. The protection of human dignity, personal could be moved to an introductory part of
collection, processing, modification, and sharing of identity, and agency. In order to protect VALUES AND PRINCIPLES, if such a
neural data must be conducted with free and informed mental privacy, The the collection, section is added. Mental privacy is
consent, in ways that respect the ethical and human processing, modification, and sharing of fundamental for the protection of human
rights principles outlined in this Recommendation. neural data must be conducted with free and dignity, personal identity, and agency.
informed consent, in ways that safeguards
and respect the ethical and human rights
principles outlined in this Recommendation.
50. There should be clear safeguards against the
misuse or unauthorised access of neural and cognitive
biometric data, including affirmative consent, data
minimization and purpose specification, data rights
(such as rights to access, correct and delete), and data
security, particularly in contexts where such data might
be aggregated with other sources.
III.2.4 Non-Discrimination and Inclusivity
51. All actors involved in the whole lifecycle of
neurotechnology, particularly in its interface with other
technologies like Al, must commit to upholding ethical
principles that prevent discrimination, stigmatisation,
targeting, or exploitation of any individuals or groups,
particularly those in vulnerable situations.
52. There is a shared responsibility to ensure that
these technologies do not perpetuate or amplify
existing inequalities or create new forms of
discrimination based on neurological or mental
characteristics, or other grounds protected under
human rights law.
53. Non-inclusive technological development and Shouldn’t this statement be followed by a
standardisation may drive a trend toward recommendation?
homogenisation and the dominance of neurotypicality
and capacities that may threaten cultural and collective
identity.
54. Garnering the trust and acceptance of communities This is very vague. Who is in favour of the
in the whole lifecycle of neurotechnology requires public’s trust?
transparent engagement with the public, seeking their
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input and validation to align these technologies with
societal values and the common good.
55. Discrimination on any grounds, including intellectual 55. Discrimination on any grounds, including Yellow marked sentence is difficult to
differences or those related to atypicality, should be intellectual differences or those related to understand. Is it neurotechnological
condemned. Neurotechnology should not be used to atypicality, should be condemned. solutions or evaluations of
inform, justify, or reify such discrimination. Care should Neurotechnology should must not be used to neurotechnological solutions that should
be taken to evaluate neurotechnology solutions inform, justify, or reify such discrimination. be carefully conducted? If the latter,
promoted through governments for essential services Care should be taken to evaluate explain why.
such as education. neurotechnology solutions promoted through
governments for essential services such as §67 and §§136-138: Here the use of
education. neurotechnology in education is
discussed without any mention of the
specific neurotechnologies that could be
used for education. In §138 it is proposed
that “neurotechnology in educational
settings” could include technologies that
need “an assessment of reversibility on
the nervous system” and could give rise
to “dependency or de-skilling”. Nothing is
said about which these technologies are.
56. Neurotechnology should not be used to perpetuate 56. Neurotechnology should not be used to This should apply to everyone.
stereotypes, stigma, or discrimination against older perpetuate stereotypes, stigma, or
persons. discrimination against older any persons or
groups of people.
III.2.5 Accountability
57. Maintaining trust and integrity throughout the whole 57. Maintaining trust and integrity throughout Very important to underline that design,
lifecycle of neurotechnology requires all actors to the whole lifecycle of neurotechnology adjustments etc. must be scientifically
adhere to the highest ethical standards, remain open to requires all actors to adhere to the highest based. “Evidence” is too vague in this
feedback, be committed to adjusting practices in ethical standards, remain open to feedback, context, since it is quite often used
response to new evidence or ethical concerns, and be be committed to adjusting practices in carelessly to give the appearance of a
held accountable for their actions. response to new evidence or ethical scientific approach.
concerns, and be held accountable for their
actions.
58. Accountability is grounded in responsibility, clear Remove or re-word? This is a general
and transparent communication, and a duty to description of accountability.
anticipate and address potential harms-whether short-
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term, long-term or arising from unintended use and
impact.
59. A commitment to accountability requires global, How should accountability be addressed
governmental, societal and collective action to ensure within different stages of development?
those harmed by neurotechnology have access to I.e. research, development, deployment?
justice, and that those responsible for wrongdoing are A differentiation is missing.
required to take meaningful steps to identify, prevent,
mitigate and account for how they address and redress
their adverse human rights impacts, including through
corrective actions and reparations.
III.2.6 Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection The message here is also applicable on
of human rights and fundamental freedoms, all actors other areas, such as for instance
throughout the whole lifecycle of neurotechnology must Accountability, Non-Discrimination
ensure that their activities are transparent, grounded in and Inclusivity, Integrity and
scientific evidence, and aligned with international Responsibility.
principles of responsible conduct and scientific integrity.
This includes preventing the replication or amplification
of biases, ensuring that neurotechnology is traceable
and explainable, its capacities and limitations are
accurately portrayed, the conditions for accountability
are clearly defined, adhering to ethical guidelines in
research and development, including the registration of
trials, fair participant selection, and approval by
independent ethics committees.
III.2.7 Epistemic Justice, Inclusive Engagement and
Public Empowerment
61. Ensuring fair and equitable distribution and creation 61. Ensuring fair and equitable distribution Delete diverse ways of knowing since
of knowledge about neurotechnology, including and creation of knowledge about knowledge should be science based.
recognizing diverse ways of knowing, and that all neurotechnology, including recognizing
individuals and communities can participate in its diverse ways of knowing, and that all
creation, sharing, and applications. individuals and communities can participate
in its creation, sharing, and applications.
62. Promoting open and accessible education, along Here it is very important to underline that
with public and community engagement, to ensure knowledge must be scientifically based
diverse populations can gain and exchange knowledge and with a non-profit, public good interest.
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about nervous system functioning, mental health, and
medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement 63. Effective public and community Again, “respect different ways of knowing
throughout the whole lifecycle of neurotechnology engagement throughout the whole lifecycle and understanding” is promoted. What’s
requires respect for diversity, including linguistic, social, of neurotechnology requires respect for the purpose and implications in this
cultural, heritage, and identity, to respect different ways diversity, including linguistic, social, cultural, context? Does it also include non-science
of knowing and understanding. This respect for diversity heritage, and identity, to respect different based ways of knowing and
ensures that the knowledge and perspectives of diverse ways of knowing and understanding. This understanding?
communities are valued and included in decision- respect for diversity ensures that the
making processes, and respects self-determination. knowledge and perspectives of diverse Respect for diversity is generally
communities are valued and included in important but cannot be promoted when it
decision- making processes, and respects comes to knowledge in neurotechnology,
self-determination. that must be science based.
64. Grounding education in human rights ensures that This claim is quite far-fetched; education
the knowledge shared and produced respects the in human rights do not necessarily
rights of all individuals, preventing epistemic injustice ensures that knowledge sharing and
where certain groups may be marginalized or excluded production respects the rights of all
from knowledge production and dissemination. individuals etc.
65. All communities should have a voice in decisions that This is vague. Does this refer to all kinds
affect them, particularly when it comes to the of neurotechnology and all kinds of
development and use of neurotechnology. communities, including those that want to
develop and use neurotechnology for
enhancement and/or for commercial
purpose?
III.2.8 Best Interest of the Child and Protection of Consider merging this part to IV.6, where
future generations CHILDREN AND ADOLESCNETS also is
addressed.
66. The nervous system is rapidly evolving during
childhood and critically changing during adolescence,
which makes it crucial to preserve the privacy, self-
determination and the right of children and adolescents
to participate in decisions that affect them. Technology
should be rigorously assessed to ensure it serves the
best interests, well-being and healthy development of
children, as they grow into autonomous individuals and
safeguard the rights of future generations by ensuring
that today's decisions promote their future wellbeing.
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67. From an ethical perspective, while recognizing the From an ethical perspective, while The text felt incomplete. According to
potential benefits of neurotechnology for early recognizing the potential benefits of brain research, a healthy lifestyle should
diagnosis, instruction, education, and continuous neurotechnology for early diagnosis, also take sleep and access to nature into
learning, it is equally important to make a commitment instruction, education, and continuous account.
to the holistic development of the child. This includes learning, it is equally important to make a
nurturing their social lite, fostering meaningful commitment to the holistic development of It is important to state risk factors as well
relationships, and promoting a healthy lifestyle the child. This includes nurturing their social as factors fostering wellbeing, in line with
encompassing nutrition and physical activity. lite, fostering meaningful relationships, and the CRC.
promoting a healthy lifestyle encompassing
nutrition, sleep, and physical activity and
access to nature. This also includes the
prevention and protection of any kinds of
violations of the child´s rights.
III.2.9 Global and social justice, enjoying the
benefits of scientific progress and its application
68. Access to and benefits arising from research and 68. Access to and benefits arising from Important to underline that research and
development in neurotechnology must be shared science based research and development in development must be science based.
equitably among all contributors to that research and neurotechnology must be shared equitably This paragraph could also go under IV
development, with a particular focus on ensuring global among all contributors to ensure that research AREAS OF POLICY ACTION.
distribution that promotes fairness and reduces and development, with a particular focus on
disparities. ensuring global distribution that promotes
fairness and reduces disparities.
69. Neurotechnology developments should be This paragraph is based on the
leveraged to reduce global health inequities. These assumption that neurotechnology can
technologies should serve as catalysts for improving the contribute to reducing global health
quality of lite, particularly in resource-limited settings. inequalities. For this to be credible, it
would have to be shown that access to
neurotechnology is a priority for
healthcare in low- and middle-income
countries. The claim that
neurotechnologies can “serve as
catalysts” would need an explanation of
how this could happen.
70. Research, development, and trials in What is meant by fair share of the
neurotechnology must adhere to the highest ethical benefits?
standards, ensuring the non-exploitative participation of
all individuals involved. This includes safeguarding the Are there any risks of using
rights and well-being of participants, and patients and disproportionately in this context, i.e. is
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their caregivers, as well as ensuring the ethical this a word open for interpretations that
collection and use of data. Special attention should be can counteract the objectives of this
given to ensure that those contributing to research and recommendation in general and of this
development have their fair share of the benefits and do paragraph in particular?
not bear disproportionately the risks.
71. Efforts, including international cooperation, should
be made to overcome, and never take advantage of,
the lack of necessary technological or medical
infrastructure, education and skills, as well as ethical-
legal frameworks, particularly in LMICs, LDCs, LLDCs
and SIDS, affecting communities.
72. The development and impact assessment of novel What are the implications of this
neurotechnology should consider the implementation of paragraph? The text should be simplified.
human-centred paradigms in which end-users are not
merely passive recipients of the technologies but active End-users should be clarified, maybe in
co-shapers on an equal footing. DEFINITIONS.
IV. AREAS OF POLICY ACTIONS In order to avoid repetition and to
condense the text, this chapter could
preferably begin with paragraphs that
address issues that are applicable to and
relevant for all areas, for instance cross
country collaboration, multi stakeholder
perspective.
Many of the recommendations are also
too detailed and some of them are
outside the mandate of an UNESCO
recommendation which is not legally
binding.
Throughout this chapter, it is the Member
States that are held responsible. In some
cases, this is correct. In other cases,
other actors should (also) be addressed
(for instance employers in section IV.14
Labour and Employment).
Finally, try to avoid repeating values and
ethical principles etc. that already have
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been addressed. This chapter should
instead focus on how these values and
principles should be applied into policies
and actions.
IV.1 GOVERNMENT INVESTMENT, USE AND
REGULATION
73. Member States, private actors and international Member States, private actors and Until today, medical applications are by
institutions should actively support the research, international institutions should actively far the most important use of these
development, and deployment of neurotechnology for support the research of high quality, technologies. The deployment of
the public good. Investments should prioritize development, and deployment of neurotechnology for the public good
applications that foster human flourishing, and the use neurotechnology for the public good. therefore needs to have a strong medical
of which respects, promotes and protects individual and Investments should prioritize applications focus, including access to these new
collective human rights. This commitment should that foster human health and well-being treatment approaches for everyone in
include funding for interdisciplinary research that not flourishing, and the use of which respects, society – based on the individual’s
only advances neurotechnological innovation but also promotes and protects individual and medical needs.
studies the ethical, legal, social, environmental and collective human rights. This commitment
cultural implications of these technologies, and supportsshould include funding for interdisciplinary The requirement that member states
the implementation and clinical translation of research that not only advances should support the development of
technological prototypes. Particular attention should be neurotechnological innovation but also neurotechnology that fosters “human
given to the development and implementation of studies the ethical, legal, social, flourishing” is too vague to be meaningful.
adequate technical, institutional, procedural and other environmental and cultural implications of Also, is this within the mandate of an
safeguards to ensure that they equitably benefit society these technologies, and supports the UNESCO recommendation? The obvious
and that human rights are upheld. implementation and clinical translation of priority for governments should be
technological prototypes. Particular attention medical uses of neurotechnology (and
should be given to the development and other medical applications of
implementation of adequate technical, neuroscience).
institutional, procedural and other safeguards
to ensure that they equitably benefit society
and that human rights are upheld.
74. Member States should establish clear prohibitions Member States should establish clear The paragraph is very long. Maybe split
against the use of neurotechnology in contexts that prohibitions against the use of into three paragraphs as suggested?
violate individual and collective human rights. Member neurotechnology in contexts that violate
States should conduct human rights due diligence, individual and collective human rights.
including regular, comprehensive human rights impact Member States should conduct human rights
assessments, concerning neurotechnology that they due diligence, including regular,
develop, design, deploy, use, sell, operate or procure, comprehensive human rights impact
in order to prevent and mitigate their adverse human assessments, concerning neurotechnology They in this context is confusing. Does
rights impacts. Specifically, neurotechnology should not that they develop, design, deploy, use, sell, They refer to the Member States (i.e.
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be used for purposes such as non-consensual operate or procure, in order to prevent and governments/the state) or to actors
interrogation in law enforcement, criminal and civil mitigate their adverse human rights impacts. operating within a state? Preferably,
justice, development or deployment of weapons actors operating within a state should be
targeted at the nervous system, social control, attempts --- included.
at coercive behavioural conformity based on personal Specifically, neurotechnology should not be
beliefs or thoughts, political or other opinion, gender used for purposes such as non-consensual
identity or sexual orientation, or surveillance of mental interrogation in law enforcement, criminal
states, among others. Governments should adopt and civil justice, development or deployment
legislation that ensures neurotechnology is deployed of weapons targeted at the nervous system,
responsibly, and based on human rights, with robust social control, attempts at coercive
oversight mechanisms to enforce adherence to these behavioural conformity based on personal
restrictions and protect mental privacy and freedom of beliefs or thoughts, political or other opinion,
thought for all individuals. These policies should be gender identity or sexual orientation, or
developed in consultation with diverse actors, including surveillance of mental states, among others.
civil society, end-users, neurotechnology experts,
ethicists, and human rights advocates, to ensure broad ---
consensus and respect for global human rights norms. Governments should adopt legislation that
ensures neurotechnology is deployed
responsibly, and based on human rights,
with robust oversight mechanisms to enforce
adherence to these restrictions and protect
mental privacy and freedom of thought for all
individuals. These policies should be
developed in consultation with diverse
actors, including civil society, end-users,
neurotechnology experts, ethicists, and
human rights advocates, to ensure broad
consensus and respect for global human
rights norms.
75. Member States should ensure transparency and This paragraph is problematic. According
accountability in their support, oversight, and regulation to the UNESCO recommendation on
of neurotechnology, particularly in publicly funded Open Science (2022), §12, "the public
initiatives such as brain research and development sector has a leading role to play in
programs. While recognizing the limitations in disclosing the implementation of open science.
certain sensitive information, governments should Nevertheless, open science principles
require government sponsored neurotechnology should also guide the research funded by
projects to publicly disclose the objectives, the private sector.” Also §20e is
methodologies, intended uses, and societal impacts of promoting that funders (etc) should “adopt
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their neurotechnology initiatives wherever possible. This policies that require and reward open
transparency is crucial for fostering public trust and access to scientific knowledge, including
ensuring that neurotechnology advances are aligned scientific publications, open research
with ethical standards and human rights. data, open software, source code and
open hardware […]”
Hence, it is very unfortunate if this
recommendation promotes strong
distinctions regarding transparency and
accountability based on funding (public or
private).
The phrase “[…] recognizing the
limitations in disclosing certain sensitive
information […]” is problematic from an
Open Science perspective, since it gives
companies mandate to prevent
researchers from publishing material/data
that may be sensitive to the company.
Sensitive information and limitations need
to be clarified.
76. Member States should apply a comprehensive Consider modifying this paragraph so it
approach to regulatory and policy measures to protect applies to all actors – private as well as
against human rights harms related to neurotechnology public. A lot of research and medical care
developed, marketed, operated or used by the private is taken place in public institutions
sector. This includes legislative and regulatory (hospitals and universities). Otherwise,
measures and accompanying guidance, incentives, and clearly underline that this specific
transparency requirements. This comprehensive paragraph is addressed to the private
approach should also require human rights due sector.
diligence, ensuring that businesses identify, prevent,
mitigate, and account for their adverse human rights
impacts through context-dependent processes,
including human rights impact assessments, meaningful
public and community engagement, and transparent
communications.
77. Member States should ensure that any use of 77. Member States should ensure that any This is the first time that robust scientific
neurotechnology in the justice system, including its use of neurotechnology in the justice evidence is used. Shouldn’t this apply to
consideration by the judiciary should be grounded in system, including its consideration by the all areas, and especially to the medical
robust scientific evidence, be implemented ethically in judiciary, should be grounded in robust field? Are there any deliberate reasons
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accordance with human rights, and be aimed at scientific evidence, be implemented ethically for making a distinction between “robust
promoting public safety while protecting the rights and in accordance with human rights, and be scientific evidence” and “scientific
dignity of all those involved. This requires respect for aimed at promoting public safety while evidence”?
fundamental rights, such as human dignity, bodily protecting the rights and dignity of all those
integrity, confidentiality of personal data, due process involved. This requires respect for The paragraph is also very long, it would
and fair trial rights, including the presumption of fundamental rights, such as human dignity, benefit from being shortened.
innocence, and the right against self-incrimination, as bodily integrity, confidentiality of personal
well as freedom from torture and ill-treatment, the right data, due process, and fair trial rights, In addition, informed consent should be
to privacy, and the right to freedom of thought. including the presumption of innocence, and included.
the right against self-incrimination, as well as
freedom from torture and ill-treatment, the
right to privacy, and the right to freedom of
thought.
78. Member States should establish comprehensive This paragraph demands that all Member
incentive structures, such as tax incentives, grants, and States should have “incentive structures,
awards, with a particular focus on encouraging the such as tax incentives, grants, and
construction and development of manufacturing, awards” that support “computational
computational resources, and data analytics capabilities resources” and certain other capabilities.
within public research institutions and small and medium This may not be an appropriate demand
enterprises (SMEs). Member States should also on all Member States, since their
incentivize and support partnerships that leverage the industrial and fiscal policies may have to
computational resources and data analytics capabilities take other issues into account, such as
of private firms to advance public research goals. These resource limitations.
incentives should prioritize rewarding transparency,
participatory development processes, and contributions The benefits of such a detailed request in
to societal benefits, aiming to foster an environment an UNESCO recommendation are also
where public institutions and companies innovate questionable.
responsibly and align with human flourishing goals.
79. Member States should establish a coordinated, The sustainability/the environmental
cross-sectoral approach to assessing the impacts of aspects of neurotechnology should be
neurotechnology across the whole lifecycle. This highlighted in a separate paragraph.
approach should include, but is not limited to:
a) Economic lmpact Assessments: Conducted by
relevant national bodies responsible for
economic and labor policies to assess how
neurotechnology impacts economic growth,
jobs, social justice, and environmental
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sustainability;
b) Benefit-Risk Assessments: Managed by entities
responsible for public health, medical research,
and consumer protections, these assessments
should rigorously evaluate the risks and
benefits associated with the development,
deployment, and use of neurotechnology,
including research, clinical applications, and
consumer products. The process should
include thorough documentation, ethical
oversight, and continuous monitoring to ensure
the safety, well-being, and equitable treatment
of all individuals involved;
c) Privacy lmpact Assessments (PIAs): under the
oversight of relevant national authorities or
agencies responsible for data protection and
privacy, these assessments should evaluate
and mitigate risks to individuals' mental privacy
posed by neurotechnology. This includes
ensuring that appropriate safeguards are in
place to protect neural and cognitive biometric
data in compliance with national and
international privacy standards, and the data
policy practices discussed herein;
d) Human Rights lmpact Assessments (HRIAs):
with oversight from relevant national human
rights institutions or international bodies,
identify, prevent, and address potential human
rights impacts of neurotechnology. The process
should ensure that neurotechnology respects
and promotes human rights, with particular
attention to vulnerable people and people living
in vulnerable situations. HRIAs should involve
meaningful public and community engagement
to incorporate diverse perspectives.
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80. Member States should promote equitable access to This paragraph requires that Member
neurotechnology worldwide. To achieve such goals, States should “support the reduction of
efforts should be made to support the reduction of final final costs for end users” of
costs for end users, pursue the development, adoption neurotechnology. This requirement has
and continuous support of non-proprietary software no restriction to specific types of
solutions, and explore reimbursement strategies or neurotechnology. It is reasonable to
subsidisation commensurate with conventions in local demand such government support for
jurisdictions, in sectors of crucial potential benefits. medical uses, but not beyond that and
especially not for enhancement or
entertainment. It’s a huge difference
between neurotechnology for medical
purpose that can save lives or facilitate
the lives of severely ill individuals,
compared to treatments on healthy
persons based on their desire to boost
their health.
In addition, the definition of end-users
should be explained earlier in the text,
maybe in Definitions.
81. Member States should adopt agile regulatory It is questionable whether Member States
frameworks, including the use of regulatory sandboxes- could and should be held responsible for
controlled environments for developing, testing, and using sandbox environments to develop
evaluating neurotechnology-in response to rapid all types of neurotechnology. Member
advancements in neurotechnology and its convergence States can/should be urged to introduce
with other technologies such as Al, spatial computing, laws and other incentives that ensure
and immersive technologies. These sandboxes should ethical, safe, and sustainable
be used to explore innovative applications, particularly neurotechnology, but this does not
in workplace settings, with appropriate ethical oversight necessarily mean that it is the Member
provided by regulatory bodies or national authorities. States themselves who should be
These frameworks should facilitate innovation, ensure responsible for implementing the
ethical data processing, and safeguard rights by sandboxes. In the case of the private
incorporating mechanisms for regular monitoring, sector, including the entertainment and
evaluation, and dynamic policy adjustments in line with wellness industries, that responsibility
technological and ethical developments. should lie with the companies.
This paragraph should consider the
existing EU Regulation 2024/1689 on
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artificial intelligence (particularly §§57-
63).
IV.2 DATA POLICY
82. Member States should develop a robust regulatory 82. Member States should develop, if this It is important to emphasize that the
and legal framework to govern the collection, does not already exist, a robust regulatory sharing of data in a scientific context is
processing, sharing, and all other uses of neural and and legal framework to govern the collection, extremely important for medical science.
cognitive biometric data. This and existing frameworks processing, sharing, and all other uses of In the EU personal data processing in
should recognize this data to be both personal and neural and cognitive biometric data. This medical science and other areas is
sensitive data in medical and non-medical contexts. and existing frameworks should recognize already regulated through the General
this data to be both personal and sensitive Data Protection Regulation (GDPR).
data in medical and non-medical contexts. Regulations need to balance the potential
gains for humanity against the right to
personal integrity. This relates to §85 and
§87 below.
It is also questionable whether this
request is within the mandate of an
UNESCO recommendation.
83. Member States should ensure that their existing This paragraph is very long, detailed, and
privacy policies comprehensively cover stringent difficult to grasp.
safeguards for individuals' neural and cognitive
biometric data. lf current policies do not adequately
address these areas, Member States should adopt
targeted legislation or regulatory frameworks to secure
these protections. These safeguards should for example
include affirmative informed consent, data minimization
and purpose !imitation, data rights (including the right to
access, correct, and delete data), and stringent data
security measures, such as advanced cybersecurity
protocols to prevent unauthorized access and
breaches. Such legislation or frameworks should
prohibit the practice of tying access to goods or
services to the disclosure of neural and cognitive
biometric data, require explicit opt-in for any data
sharing, and forbid the use of such data for targeted
advertising without the individual's explicit, affirmative
informed consent.
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84. Member States should develop and implement 84. Member States should develop and Environmental sustainability must be
specific policies to reduce the ecological footprint of implement specific policies to reduce that better asserted.
neurotechnology, particularly in relation to large-scale ensure that the ecological footprints of
data centers and computing resources used for neurotechnology are sustainable, particularly
processing and storage of neural and cognitive in relation to large-scale data centers and
biometric data. These policies should emphasise data computing resources used for processing
minimisation, ensuring that only the necessary amount and storage of neural and cognitive biometric
of data is collected and processed, and promote the data. These policies should emphasise data
proportional use of neurotechnology, aligning its minimisation, ensuring that only the
deployment with genuine needs and minimising necessary amount of data is collected and
unnecessary environmental impact. Measures should processed, and promote the proportional use
include optimising energy efficiency, using renewable of neurotechnology, aligning its deployment
energy sources, promoting the recycling and with genuine needs and minimising
sustainable disposal of neurotechnology-related unnecessary environmental impact.
equipment, and ensuring the rehabilitation of affected Measures These policies should include
environments. optimising energy efficiency, using
renewable energy sources, promoting the
recycling and sustainable disposal of
neurotechnology-related equipment, and
ensuring the rehabilitation of affected
environments.
85. Member States should support and incentivise the What is the definition of cutting-edge
development and implementation of technological anonymization techniques in this context?
innovations and design standards for neurotechnology Needs to be clarified.
that prioritize the protection of mental privacy, such as
state-of-the-art encryption, secure databases with multi-
factor authentication, cutting-edge anonymization
techniques, and edge-processing and storage
(processing and storing data closer to where it is being
generated), leading to greater action-led results in real
time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology
manufacturers to prioritize privacy and ethics by design,
requiring the incorporation of privacy-preserving
technologies as default features in their devices.
87. Member States should encourage ethical data Between which parties should the data be
sharing by establishing secure, data repositories for shared? Who should have access to the
neural and cognitive biometric data used in research. data? Needs to be clarified.
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These repositories should meet stringent cybersecurity,
data privacy, and ethical use standards (including data Consider adding “lf current policies do not
minimisation and purpose limitations), tiered access adequately address these areas”. For
and other privacy-enhancing approaches. Appropriate instance, within the EU the GDPR is
funding mechanisms should be established for the applicable.
curation and maintenance of data and data governance
processes streamlined.
88. Member States should prioritize efforts to reduce How will this paragraph align with
obstacles to cross-border data sharing in regulatory frameworks like GDPR?
neurotechnology research, working towards greater
alignment of data protection standards, particularly
concerning neural and cognitive biometric data, by
establishing clear protocols for data transfer that ensure
secure and compliant data exchanges across borders,
and standards for interoperability of data, including
governance frameworks for data sharing.
89. Member States should consider specific guidelines should consider is rather weak. Consider
for the ethical use of neural and cognitive biometric data adding “lf current policies do not
in Al development and research, including consent adequately address these areas”. For
procedures for uses of neural and cognitive biometric instance, see §10 in EU Regulation
data in training and application of Al models, ensuring 2024/1689 on artificial intelligence.
transparency and respecting individual and community
rights.
IV.3 INTELLECTUAL PROPERTY (IP) This section is problematic for mainly two
reasons:
1) a recommendation from UNESCO isn't
legally binding, and
2) Intellectual property rights are already
legislated on a national, European and
international level. It is questionable if all
of the suggested paragraphs are
compatible with The WTO Agreement on
Trade-Related Aspects of Intellectual
Property Rights (TRIPS).
Hence this section should be reworded
with reference to already exiting
agreements and legislations.
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90. Member States should adopt policies to ensure that 90. Member States should adopt policies to This paragraph should be deleted. Can
neural and cognitive biometric data, as individual human ensure that neural and cognitive biometric neural and cognitive biometric data be the
activity derivatives, are not subject to proprietary rights. data, as individual human activity derivatives, property of the individuals whose data
IP protection should only apply to original data are not subject to proprietary rights. IP have been collected? If yes, why should it
compilations (created through a process of aggregation, protection should only apply to original data not remain that way? The last sentence
organization, or selection, resulting in a new dataset) compilations (created through a process of needs to be deleted since what is
that meet strict and ethical criteria. aggregation, organization, or selection, protected by intellectual property rights is
resulting in a new dataset) that meet strict regulated in other international
and ethical criteria. agreements (see comment above).
91. Member States should collaboratively establish 91. Member States should collaboratively
clear, harmonised guidelines for IP rights applicable to establish clear, harmonised guidelines for IP
neurotechnology on an international scale. These rights applicable to neurotechnology on an
guidelines should address the patentability of Al- international scale. These guidelines should
generated inventions and the ethical implications of IP address the patentability of Al-generated
laws, ensuring they promote global accessibility and inventions and the ethical implications of IP
innovation. laws, ensuring they promote global
accessibility and innovation.
92. Member States should ensure that all actors adopt Member States should ensure that all actors Difficult to understand the essence and
IP management strategies that encourage innovation adopt IP management strategies that implication of marked text. Is it in conflict
and avoid overly restrictive patent use, fostering an encourage innovation and avoid overly with norms/laws regarding patent
open innovation ecosystem. This approach should restrictive patent use, fostering an open protection and copyright?
continuously adapt to the evolving landscape of innovation ecosystem. This approach should The last part of the sentence should be
neurotechnology. The impact of IP policies on the continuously adapt to the evolving deleted. Intellectual Property Rights
neurotechnology sector should be continuously landscape of neurotechnology. The impact should not be viewed as being a
monitored to ensure they stimulate innovation while of IP policies on the neurotechnology sector hindrance to research or innovation.
ensuring ethical use and broad accessibility. should be continuously monitored to ensure
they stimulate innovation while ensuring
ethical use and broad accessibility.
93. Member States should foster an environment of co- 93. Member States should foster an This paragraph should be deleted. Also,
creation in neurotechnology, by facilitating policies and environment of co-creation in who benefits from this?
incentives for co-ownership and preferential licensing neurotechnology, by facilitating policies and
agreements to ensure equitable compensation and incentives for co-ownership and preferential
recognition for all contributors. licensing agreements to ensure equitable
compensation and recognition for all
contributors.
94.Member States should adopt policies with respect to 94. Member States should adopt policies This paragraph should be deleted. It is
open science that balance the protection of IP with the with respect to open science that balance badly phrased and it is very difficult to
promotion of immediate publication of results and data the protection of IP with the promotion of grasp the scope and intention. In addition,
sharing. Particularly with the convergence of digital immediate publication of results and data Open Science needs to interact with
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technologies and the increasing concentration of those sharing. Particularly with the convergence of Intellectual Property Rights (IPR) and IPR
innovations in industry sectors, this balance is crucial to digital technologies and the increasing should not be viewed as being a
ensure that IP protection mechanisms do not hinder concentration of those innovations in hindrance to research or innovation.
scientific research, innovation, and the wide industry sectors, this balance is crucial to
dissemination of knowledge and new technologies. As a ensure that IP protection mechanisms do not
basic rule of equitable partnership, when lndigenous hinder scientific research, innovation, and
Peoples are involved in neurotechnology research and the wide dissemination of knowledge and
development, open science processes, IP management new technologies. As a basic rule of
strategy, should be developed in collaboration with equitable partnership, when lndigenous
them from the beginning. Peoples are involved in neurotechnology
research and development, open science
processes, IP management strategy, should
be developed in collaboration with the
indigenous communities from the beginning.
IV.4 CYBERSECURITY
95. Member States should collaborate internationally to
establish comprehensive standards for cybersecurity
across all neurotechnology domains. These standards
should encompass hardware, software, and data
security measures to protect against potential cyber
threats. By implementing uniform cybersecurity
standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data,
as well as enhance user trust and confidence in
neurotechnology devices. Additionally, these standards
should evolve in tandem with technological
advancements and emerging cyber threats to maintain
robust protection against evolving risks.
96. Member States should employ red-teaming
exercises-adversarial challenges to test the efficacy of
security systems-as a proactive measure to assess and
enhance the safety, security, and resilience of
neurotechnology systems. By conducting regular red-
teaming exercises, Member States should proactively
identify and address security gaps, test incident
response procedures, and strengthen the overall safety
and cybersecurity posture of neurotechnology devices.
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IV.5 COMMUNICATION, PARTICIPATION, AND This section can be condensed. Seems
INFORMATION like many paragraphs address the
same/similar topics, for instance §§97-99,
and §101.
In addition, factors regarding open and
accessible education, public and
community engagement are already
addressed in III.2.7 Epistemic Justice,
Inclusive Engagement and Public
Empowerment (§§61-65).
In the UNESCO Recommendation on the
Ethics of AI (2021), public participation,
awareness and understanding of AI
technologies etc., is addressed under
Awareness and literacy (§§44-45), while
Communication and Information is
addressed as Policy Area 9 (§§112-115).
Consider making a similar distinction.
97. Member States should promote communication and
develop engagement policies for neurotechnology that
foster informed, inclusive, and respectful dialogue
between researchers, developers, diverse users, and
the broader public to respect individual and community
rights, promote public trust, and harness the collective
intelligence and diversity of communities.
98. Member States should collaborate with international
organizations, educational institutions, and private and
non-governmental entities to develop and disseminate
accessible and engaging educational materials tailored
to diverse audiences to bridge knowledge gaps,
particularly in underserved regions about the nervous
system and mental health functioning, as well as the
benefits and risks of neurotechnology. These programs
should aim to increase public understanding of the
technologies' functionality, safety, efficacy, and societal
impact, empowering individuals to make informed
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decisions and to enable their ethical reflection about
their use of neurotechnology.
99. Member States should implement public and
community engagement processes that facilitate
genuine mutual learning and collaboration throughout
the whole lifecycle of neurotechnology. These
processes should include regular and inclusive
consultations with a wide array of actors. The aim of
these engagements should be to inform policy
development, shape ethical guidelines, increase public
awareness and understanding, align investment
priorities, and ensure that neurotechnology deployment
aligns with public interests and values. Special attention
should be given to involving groups traditionally
underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co- The term “evidence-based” has a specific
creation of accurate, precise, and accessible language meaning in medical usage, i.e. does not
and terminology for discussing neurotechnology that mean “based on evidence” but rather
involves actors from diverse backgrounds to ensure that based on evidence collected and
the language used is inclusive, non-stigmatizing, and interpreted in a specific manner that
accurately reflects the technologies' capabilities and includes striving for randomized clinical
limitations. Member States should establish regulatory trials as the gold standard.
frameworks that require clear and ethical
communication standards for neurotechnology. These Science-based is more accurate in this
frameworks should require evidence-based reporting of context.
capabilities, risks, and limitations across all applications
to avoid exaggeration of claims, including but not limited Also see §19c and §136
to applications in sleep, attention, memory, and
emotional regulation. Within these frameworks
should be specific guidelines for ethical marketing and
protocols for responsible communications about early-
stage research and emerging technologies.
101. Member States should develop policies that foster This paragraph can be condensed. It
effective collaboration between end- users, researchers seems like the same message is
and innovators throughout the whole lifecycle of repeated, but with different wordings.
neurotechnology product development, with special
focus given to the places where the neurotechnology is
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being developed. These policies should mandate the
creation of diverse advisory panels, including
representatives from various user groups and
respecting neurodiversity. Member States should also
establish platforms for ongoing dialogue and feedback
between users, researchers and developers. Advisory
panels should be involved in the process of developing
and testing new neurotechnology products to optimize
device efficacy, usability, longevity, and sustainability.
This collaborative approach aims to ensure that
innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, Member States should consider developing Should develop is too strong. Medical
contextually-appropriate, culturally- appropriate, and age-appropriate, contextually-appropriate, technologies or technologies in general?
linguistically-appropriate education about culturally- appropriate, and linguistically- Can Member States be held responsible
neurotechnology. This should include training modules appropriate science based education about for educating and supporting healthy
to aid in the supportive use of these technologies at neurotechnology that is age-, contextually, individuals to use neurotechnological
home, both for the user and for caregivers and family culturally and linguistically appropriate. This tools for boosting their health, ability etc?
members. can include training modules to aid in the
supportive use of these technologies at Add that education must be scientifically
home, both for the user and for caregivers based and arranged by established
and family members. actors, preferably acknowledged science
or medical institutions/centres or
universities.
CONSIDERATION FOR SPECIFIC USERS We suggest that this section begins with
recommendations that are applicable to
all, and then address issues that are
unique for selected users.
Also consider moving this section to a
separate chapter.
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain Member States should promote ensure should promote is too vague. Also see
development through policies that evaluate the impact healthy brain development through policies comment on §106.
of neurotechnology on children and adolescents. that evaluate the impact of neurotechnology
on children and adolescents.
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104. Member States should safeguard children and Member States should must safeguard should pay attention is too vague. We
adolescents from implicit and explicit coercion to use children and adolescents from implicit and recommend that the Recommendation
neurotechnology. Member States should pay attention to explicit coercion to use neurotechnology. does not introduce its own principles
the autonomy of children and adolescents through Member States should pay attention to the within medical ethics, but instead refers to
informed consent and assent that is adapted to and autonomy of children and adolescents established codes like the Declaration of
respectful of age and decision-making capacity. through informed consent and assent that is Helsinki.
adapted to and respectful of age and
decision-making capacity.
105. Member States should fund research and We welcome strong support to children
development grants focused on creating user- friendly and adolescents with disabilities (incl.
assistive neurotechnology tailored for children and their families and caregivers) regarding
adolescents with disabilities. These projects should user-friendly assistive neurotechnology.
involve children, adolescents, parents and caregivers in
the design process to ensure the technologies meet However, we are not sure that this
their specific needs. Educational programs should be paragraph should pinpoint methods and
developed to teach children and adolescents and their efforts such as educational programs. If
caregivers how to effectively use and maintain these retained, educational programs should be
technologies, with support available in multiple defined.
languages and accessible without discriminating
against those who either cannot or choose not to
engage with the proposed technology.
106. Member States should ensure research involves This paragraph about research on
strict oversight and close follow-up of all children omits the most basic requirement
neurotechnology research involving children and that established medical research ethics
adolescents. This oversight is crucial during the has on research on children (and all
developmental phases of childhood to address and individuals who have reduced ability to
mitigate any unforeseen long- term effects. Such provide their informed consent), namely
research must include comprehensive monitoring that research that can be performed on
protocols and periodic evaluations to ensure the adult subjects should not be performed on
ongoing safety and well-being of young participants, children or vulnerable subjects. On the
taking into account their unique developmental needs other hand, there is a need for more
and vulnerabilities. In the framework of research, clinical research on e.g. children.
involving children and adolescents in medically Important that the recommendation
vulnerable situations (i.e., children in epilepsy shows awareness of this dilemma/tension
monitoring units), special attention will be given to
consent and assent, particularly considering particular
aspects of research (time, iterations) to prevent any
form of instrumentalization.
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107. Member States should enact specific regulations Member States should enact specific We suggest expanding this paragraph
that prohibit the use of marketing techniques-such as regulations that prohibit the use of marketing with this extra text to incorporate
neuromarketing, biometric emotional analytics, techniques-such as neuromarketing, additional neuroscientific and ethical
immersive advertising, and virtual or augmented reality biometric emotional analytics, immersive considerations. This expansion would
advertising-that rely on sensitive neural and cognitive advertising, and virtual or augmented reality provide a more comprehensive
biometric data collected from children and adolescents. advertising-that rely on sensitive neural and understanding of the risks associated with
Recognizing the heightened vulnerability of children and cognitive biometric data collected from these marketing techniques and
adolescents in digital environments, these regulations children and adolescents. strengthen the rationale for their
must explicitly forbid any practices that use such data to prohibition when targeting children and
influence or exploit children and adolescents. ------ adolescents.
Recognizing the heightened vulnerability of
children and adolescents in digital Maybe split into two paragraphs as
environments, and with regards to children's suggested.
and adolescents' developing brains,
especially in areas related to decision-
making, these regulations should explicitly
forbid any practices that use such data to
influence or exploit children and
adolescents.
---
To effectively implement and support this
prohibition, it is strongly recommended to
foster collaboration among neuroscientists,
psychologists, ethicists, and policymakers to
ensure the prohibition is comprehensive and
effectively enforced across all relevant digital
platforms and technologies.
IV.7 OLDER PERSONS
108. Member States should promote healthy aging and Member States should promote healthy Important point. But may be hard to
support elderly individuals by funding and implementing aging and support elderly individuals by implement in Member States without a
evidence-based programs that integrate funding and implementing science based publicly funded/weak health system.
neurotechnology into routine care. These programs evidence-based programs that integrate
should involve the entire support ecosystem, including neurotechnology into routine care. These
family, caregivers, and medical teams, to enhance programs should involve the entire support The term equitable in this context requires
quality of life. Priority should be given to developing and ecosystem, including family, caregivers, and further clarification. It is unclear whether it
implementing tools that prevent, delay, and treat age- medical teams, to enhance quality of life. solely addresses socioeconomic equity or
related health conditions, impairments, and Priority should be given to developing and encompasses a broader scope of
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neurodegenerative diseases. Member States should implementing tools that prevent, delay, and equality, including geographical, cultural,
ensure that access to these neurotechnology programs treat age-related health conditions, and other relevant factors. A more precise
is equitable and does not exacerbate socioeconomic impairments, and neurodegenerative definition would enhance the
inequalities. diseases. Member States should ensure that understanding and implementation of this
access to these neurotechnology programs recommendation.
is equitable and does not exacerbate
socioeconomic inequalities. It should be clarified that Member States’
Member States should strive to provide responsibility to “promote healthy aging
uniform access to these neurotechnology and support elderly individuals by funding
programs across all regions within their and implementing evidence-based
territories, including rural and remote areas, programs that integrate neurotechnology
to ensure equal availability and prevent into routine care” must be restricted
geographical disparities in care quality and to/focused on programs that are the best
outcomes. means to achieve the goals of geriatric
and nursing care. It cannot be Member
States’ responsibility to promote healthy
aging, delay or prevent age-related health
conditions to “stay fit and young”.
109. Member States should establish guidelines for The section seems incomplete. Consider
neurotechnology design sensitive to the needs of older adding hardware design and functionality
adults, carefully considering human-computer interface in order to include the physical/material
factors for usability (such as fonts, buttons, and colour) aspects.
and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and
promote autonomous decision-making for older people
using neurotechnology for sensorimotor and cognitive
support. The consent process should accommodate
potential cognitive challenges faced by older adults,
ensuring that consent is informed, ongoing, and
adaptable to changing health conditions. Policies should
be in place to ensure that assistive neurotechnology
recognize changing cognitive capacities over time and
respect users' preferences.
111. Member States should develop ethical guidelines 111. Member States should develop ethical When designing policies related to the
to ensure that neurotechnology such as robotic guidelines to ensure that neurotechnology care of older persons, the focus should be
caregivers enhance rather than replace human such as robotic caregivers enhance rather on the care needs, rather than on the
interaction, particularly in the care of individuals with than replace human interaction, particularly traditional design of care. Otherwise,
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neurodegeneration. These guidelines should in the care of individuals with there is a risk that older persons will not
emphasize the augmentation of human care, not its neurodegeneration. These guidelines should be able to take advantage of the
replacement. emphasize the augmentation of human care, opportunities offered by new technologies
not its replacement. The guidelines should because caregivers do not want to use
address the needs of the older person for them. The proposed wording could be
good care and participation and human one such inhibiting effect.
contact.
IV.8 WOMEN AND GENDER IV.8 WOMEN AND GENDER GENDER Replace the title and reformulate §§112-
EQUALITY 114
We find the section with the title Women
and gender problematic. The current text
risks framing women as inherently
vulnerable and in need of protection and
help, which may unintentionally reinforce
gender stereotypes. Instead, the text
would benefit from a more general
approach that focuses on gender equality
in the development and introduction of
new technologies. This shift would allow
for a more neutral narrative that
accurately represents the various social,
economic, and health-related factors
contributing to inequality among
individuals of different genders, and thus,
would align better with contemporary
perspectives on equality and human
rights. In line with this, the section should
be re-titled ‘Gender equality’.
112. Member States should adopt and enforce 112. Member States should adopt and
comprehensive policies that promote and respect enforce comprehensive policies that promote
gender equality and diversity in the whole lifecycle of and respect gender equality and diversity in
neurotechnology. The policies should prioritize inclusive the whole lifecycle of neurotechnology. The
research for addressing women and gender specific policies should prioritize inclusive research
needs and differences, require targeted data collection for addressing women and gender specific
and analysis, include education and training needs and differences, require targeted data
programmes an inclusive research practices, ensure collection and analysis, include education
public and community engagement with women and and training programmes and inclusive
gender health experts and advocacy groups and, research practices that ensure gender
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incentivise gender responsive technology design, to equality, ensure public and community
meet the needs and conditions specific to women and engagement with women and gender health
gender minorities. Affirmative action policies are experts and advocacy groups and,
necessary to close gender gaps in these fields, incentivise gender responsive technology
increase representation, engagement and leadership. design, to meet the needs and conditions
specific to women, persons with disabilities
and gender minorities LBTQI persons.
Affirmative action policies are necessary to
close gender gaps in these fields, increase
representation, engagement and leadership.
113. Member States should establish clear guidelines If the sections regarding Consideration for
and legal frameworks to ensure that workplaces and specific users will be left out to a separate
research environment, throughout the whole lifecycle of chapter, this paragraph could be rewritten
neurotechnology, are inclusive and supportive, so it applies to all “specific users”
particularly for women and gender minorities, and addressed and moved to the beginning of
safeguard against harassment and discrimination. This this section.
should include robust mechanisms for reporting and
addressing incidents of harassment and discrimination,
ensuring accountability and support.
114. Member States should adopt a range of measures
that prioritize ethical and equitable research and
innovation and support programs that foster women's
and gender minorities' participation in neurotechnology.
This includes funding and other policies that prioritize
ethical and equitable research and innovation, but also
affirmative action initiatives to support the participation of
women and gender minorities in neurotechnology
through targeted education programs, employment
opportunities, entrepreneurship support, and leadership
development within the sector. Member States should
also provide support systems such as mentorship
programs, networking opportunities, and resources to
help women and gender minorities overcome barriers to
participation and succeed in the neurotechnology field.
IV.9 PERSONS WITH PHYSICAL DISABILITIES
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115. Member States should adopt policies that harness
the potential of neurotechnology by removing barriers
experienced by persons with physical disabilities and
providing support thereby contributing to achieving
equal enjoyment of human rights. They should
implement regulatory frameworks that require
accessibility assessments for all new neurotechnology
products to ensure these products do not perpetuate
existing disabilities or health disparities. These
frameworks should include protocols for testing with
diverse groups of persons with disabilities to ensure
technology meets a wide range of needs and does not
unintentionally exclude or disadvantage any subgroup.
116. Member States should create incentive programs Member States should create incentive Important to clarify that not only assistive
to promote the development of neurotechnology for programs to promote the development of neurotechnology should be covered.
people with disabilities to promote their quality of life neurotechnology for people persons with
and functional independence. These programs should disabilities to promote their quality of life and Is it within the mandate of this
include tax incentives for companies investing in functional independence. These programs Recommendation and UNESCO to
assistive neurotechnology research and development, should include tax incentives for companies propose tax incentives for certain types of
grants for research institutions focusing on investing in assistive and/or rehabilitative industries?
neurotechnology for disability support, expedited neurotechnology research and development,
regulatory reviews for technologies offering significant grants for research institutions focusing on
advancements in mobility, communication, or daily neurotechnology for disability support and
living assistance, and innovation prizes for rehabilitation, expedited regulatory reviews
breakthroughs in affordable, accessible for technologies offering significant
neurotechnology solutions. advancements in mobility, communication,
or daily living assistance, and innovation
prizes for breakthroughs in affordable,
accessible neurotechnology solutions.
117. Member States should, whenever possible, Member States should, whenever possible, The added text in red ensures that
subsidise the cost of essential neurotechnology devices, subsidise the cost of essential language accessibility is presented as an
such as neuroprosthetics, for persons with physical neurotechnology devices, such as integral part of making neurotechnology
disabilities. They could encourage public-private neuroprosthetics, for persons with physical resources truly accessible to all potential
partnerships to make advanced neurotechnology disabilities. They could encourage public- users, regardless of their linguistic
affordable and integrate neurotechnology coverage into private partnerships to make advanced background.
national health insurance and other reimbursement neurotechnology affordable and integrate
schemes for persons with physical disabilities. A national neurotechnology coverage into national Yellow-marked section is too detailed and
database of available neurotechnology resources and health insurance and other reimbursement could be left out.
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support services should be developed to facilitate schemes for persons with physical
access and information sharing. disabilities. A national database of available
neurotechnology resources and support
services should be developed to facilitate
access and information sharing. To ensure
accessibility and understanding for all users,
this database and related information should
be available in multiple languages, fulfilling
accessibility requirements allowing
individuals to access critical information in
their preferred language.
IV.10 PERSONS WITH MENTAL HEALTH
CONDITIONS
118. Member States should foster research and promote 118. Member States should foster research Is communities the correct word here?
awareness-raising initiatives to address the increasing and promote awareness-raising initiatives to Would groups of peoples be more correct
prevalence and special needs of people with mental address the increasing prevalence and or individuals suffering from these health
health conditions, including victims and survivors of special needs of people with mental health conditions or something similar, be more
trauma and violence, and the relevance of conditions, including victims and survivors of appropriate?
neurotechnology for these communities. trauma and violence, and the relevance of
neurotechnology for these communities.
119. Member States should allocate funding for long- Member States should allocate funding for What is the essence of long-term
term advocacy and efficacy studies, post- market long-term advocacy and efficacy studies, advocacy in this context? “Defence” or
oversight, and tiered scrutiny with special attention to post- market oversight, and tiered scrutiny “opinion/policy impact”?
invasiveness and reversibility of neurotechnology with special attention to invasiveness and
interventions. It is important to ensure that people with reversibility of neurotechnology This paragraph is very difficult to
mental health conditions are well-informed and have interventions. It is important to ensure that understand and needs to be reworded.
reasonable expectations about the process. people People with mental health conditions
are should be well-informed and have
reasonable expectations about the process.
120. Member States should prioritize funding for State based funding in this context must
neurotechnology that is designed to improve quality of be science based and should (as far as
life and daily functioning of individuals with mental possible) be safeguarded from pro-profit
health conditions. This includes technologies that assist interests.
in managing symptoms, improving cognitive functions,
and providing emotional support at home, in the
workplace, in their communities, and in society.
Research and development should be guided by
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feedback and engagement with persons with mental
health conditions and their advocates.
121. Member States should establish policies that A good vision. But hard to see how it will
improve access to timely advances in neurotechnology be implemented in practice
for those with mental health conditions to ensure that (neuromodulation treatment is as today
cost is not a barrier to accessing potentially life-altering very costly).
treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
122. Member States should support the development of 122. Member States should support the The yellow-marked text may not be
health applications that prioritize the unmet needs in the development of health applications that required, as it may be too specific and
provision of neurological and mental health. This should prioritize the unmet medical needs in the detailed.
include establishing research funding programs provision of neurological and mental health.
specifically targeted at addressing identified gaps in This should include establishing research
nervous system care. funding programs specifically targeted at
addressing identified gaps in nervous
system care.
123. Member States should build and maintain 123. Member States should build and Consider leaving out the last sentence,
international solidarity to address global health risks maintain international solidarity to address since it might be redundant.
and uncertainties, and ensure that their implementation global health risks and uncertainties, and
of healthcare for the nervous system is consistent with ensure that their implementation of
international law and rigorous human rights obligations. healthcare for the nervous system is
This could involve creating international forums for consistent with international law, medical
sharing best practices in the implementation of and scientific standards, and rigorous
neurotechnology in healthcare. human rights obligations. This could involve
creating international forums for sharing best
practices in the implementation of
neurotechnology in healthcare.
124. Member States should establish oversight
mechanisms to evaluate the physical and mental health
impacts of long-term use of neurotechnological devices,
with special attention to invasiveness and reversibility of
neurotechnology interventions. This includes
implementing regulatory measures requiring long-term
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follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval
based on these studies results.
125. Member States should consider the significant costMember States should consider the Important to add rehabilitative
and impact associated with pathologies related to the significant cost and impact associated with neurotechnology.
nervous system, as well as the potential benefits of pathologies related to the nervous system,
early diagnosis and access to preventive and assistive as well as the potential benefits of early The implication and meaning of “[…]
neurotechnology. Public policies should prioritize the diagnosis and access to preventive, and consider the significant cost and impact
promotion of access to these technologies and ensure assistive and rehabilitative neurotechnology. […]” is unclear.
health cost coverage for individuals in need. Public policies should prioritize the promotion
of access to these technologies and ensure
health cost coverage for individuals in need.
126. Member States should promote the development 126. Member States should promote the
of reliable and durable neurotechnology for healthcare development of reliable, safe and durable
applications. This includes encouraging the design of neurotechnology for healthcare applications.
devices and systems that require minimal maintenance, This includes encouraging the design of
ensuring they remain functional and effective under devices and systems that require minimal
everyday conditions. Regulatory bodies or designated maintenance, ensuring they remain safe,
authorities should oversee the enforcement of rigorous functional and effective under everyday
standards for quality, safety, and longevity, thereby conditions. Regulatory bodies or designated
reducing the burden on users and enhancing the authorities should oversee the enforcement
dependability and sustainability of neurotechnological of rigorous standards for quality, safety, and
solutions. longevity, thereby reducing the burden on
users and enhancing the dependability and
sustainability of neurotechnological
solutions.
127. Member States should ensure the development or
strengthening of existing comprehensive
neurotechnology medical device reporting systems that
track and address adverse effects. In contexts where
such systems do not exist, Member States should
establish them. Where systems are already in place,
they should be updated to specifically include
neurotechnology. These systems should be
interoperable and contribute to a centralised, public,
and transparent international database, managed in
collaboration with international organizations, to ensure
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that global standards are met and accessible for public
knowledge, international oversight and research.
IV.12 RESEARCH ETHICS
128. Member States should reinforce the ethical […] Furthermore, research protocols, public The requirements of “[…] specific
frameworks governing neurotechnology research to or private, in the medical as well as the non- attention dedicated to individuals with
ensure robust protection of human participants. medical domain, should be carefully special situations regarding vulnerability
Member States should adopt clear guidelines or policies evaluated by registered ethics boards (ethics such as diminished capacity to consent or
that define the qualifications to ensure that research is committees) and specific attention dedicated to make decisions […]” is vague in
conducted by professionals with appropriate knowledge to individuals with special situations comparison to established medical ethics,
about the nervous system structure and function in regarding vulnerability such as diminished which require that research is not
addition to brain disorders and is performed in adequate capacity to consent or to make decisions. performed on people with diminished
research settings. Furthermore, research protocols, […] capacity to consent/dissent if it can be
public or private, in the medical as well as the non- performed on people with full capacity to
medical domain, should be carefully evaluated by do so.
registered ethics boards (ethics committees) and
specific attention dedicated to individuals with special Consequently, the text must be reworded
situations regarding vulnerability such as diminished to stay in line with established medical
capacity to consent or to make decisions. Member and research ethical standards.
States should ensure that all research institutions have
mandatory ethics training for researchers.
129. Member States should encourage multicentre Member States should encourage
international research that involves various cultures and multicentre international research that
ethnic groups. Member States should promote involves various cultures and ethnic groups.
international cooperation to develop common reporting Member States should promote international
standards and protocols for interoperability, particularly cooperation to develop common reporting
for implantable neurotechnology devices. This standards and protocols for interoperability,
cooperation should aim to enhance the comparability particularly for implantable neurotechnology
and utility of research globally, improving both the devices. This cooperation should aim to
efficacy and ethical integrity of research. enhance the comparability and utility of
research globally, improving both the
efficacy and ethical integrity of research.
130. Member States should ensure that the whole As in §46, the document fails to support
lifecycle of neurotechnology is considered in the design the rights of trial patients to continued
of a clinical trial, including policies to protect patients in treatment after the end of the trial.
case of cessation of activities of the trial sponsor or
promoter. Member States should establish
requirements for clinical trials to be included in relevant
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nationally or internationally approved registries and
encourage registration with community and patient
registries. Also, clinical trials should report on
appropriate medical device reporting systems
developed within Member States.
131. Technology developers should ensure that the Maybe it would it be more feasible to
validation of Al algorithms in neurotechnology research address AI in a separate section/chapter?
include rigorous testing for biases, as well as measures This paragraph is applicable for other
to enhance explainability and transparency, including the areas besides health.
provenance of training datasets. Suitable techniques
should be employed to mitigate any biases present in Al This paragraph should consider the
models used in neurotechnology applications. existing EU Regulation 2024/1689 on
artificial intelligence (particularly §§10, 53
and 55).
132. Member States should ensure that research efforts This paragraph presumes that issues
not only focus on biomedical risks associated with concerning the patient’s “[…] subjective
neurotechnology but also investigate potential effects on experience, agency and personal identity”
an individual's subjective experience, agency and are not part of “biomedical” assessments.
personal identity. Understanding how neurotechnology These issues are essential parts of any
may impact aspects of self-perception, consciousness, competent clinical assessment of a
and identity is essential for addressing ethical concerns patient’s health and well-being.
and ensuring the well-being of individuals using these
technologies.
133. Member States should ensure those engaged in
research implement regular auditing and monitoring of
research practices to ensure adherence to ethical
standards. This should include evaluating the adequacy
of informed consent, particularly concerning data reuse
and the potential commercialisation of neural data.
134. Member States should require researchers in
neurotechnology to establish clear and transparent
protocols for communicating clinically significant and
actionable incidental findings to participants. These
protocols should ensure that such findings are conveyed
promptly, respecting participants' rights and autonomy.
Additionally, Member States should mandate that
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researchers provide the necessary support and
coordination with healthcare providers to address any
health concerns that arise from these findings.
135. Member States should ensure that individuals
involved in neurotechnology research or receiving
neurotechnological interventions are adequately
informed about the potential for incidental findings,
particularly those with significant health implications.
The informed consent process should clearly outline
what these findings might entail, the participants' right to
choose whether they wish to be informed about such
findings, and guarantee that their decisions in this
regard will be respected throughout the study or
treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF
HEALTH
IV.13 EDUCATIONAL SETTINGS Are the recommendations applicable to all
educational settings or would references
to specific educational settings improve
the feasibility?
136. Member States should approach with caution the Member States should approach with Regarding science-based, also see §19c
integration of neurotechnology in education, ensuring caution the integration of neurotechnology in and §100.
that its use is evidence-based and aligned with the education, ensuring that its use is science-
education goals and complements traditional learning and evidence-based and aligned with the What is the meaning of and overall
methods. Emphasis should be placed on promoting the education goals and complements traditional interests in this context?
holistic development of students, focusing not just on learning methods. If neurotechnology is
academic performance but also on mental health, well- integrated in education, emphasis should be In order to improve the readability, we
being, and overall interests. To ensure inclusivity, placed on promoting the holistic suggest splitting this paragraph.
Member States should develop age- appropriate development of students, focusing not just
guidelines for neurotechnology use across different on academic performance but also on The term learning styles has been
educational stages and learning styles. Regular mental health, well-being, and overall removed from the text due to its ambiguity
assessments of neurotechnology's impact on student interests. and potential for misinterpretation. The
development, including mental health, should be concept of distinct learning styles (e.g.,
conducted, with ethical review processes established to ---- visual, auditory, kinesthetic) is indeed a
oversee deployment. The primary focus should be on To ensure inclusivity, Member States should well-known neuromyth (myth about how
fostering critical thinking, creativity, and emotional develop age- appropriate guidelines for the brain functions) that lacks solid
neurotechnology use across different scientific evidence. It is crucial to avoid
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intelligence rather than solely enhancing academic educational stages, taking into account perpetuating this misconception in
performance. individual differences in cognitive educational policy recommendations.
development and learning needs and To address this issue, we have replaced
learning styles. Regular assessments of the reference to learning styles with
neurotechnology's impact on student language that more accurately reflects
development, including mental health, current scientific understanding. The
should be conducted, with ethical review revised text emphasizes the importance
processes established to oversee of recognizing individual differences in
deployment. The primary focus should be on cognitive development and learning
fostering critical thinking, creativity, and needs, while promoting diverse,
social-emotional skills emotional intelligence evidence-based learning strategies. This
rather than solely enhancing academic approach aligns with contemporary
performance. neuroeducational research and supports
the development of inclusive, effective
educational practices.
The term emotional intelligence has been
replaced with social-emotional skills,
which is more adequate and aligns better
with evidence-based educational
practices. This term encompasses the
important interpersonal and intrapersonal
abilities we want to develop in students,
without relying on the controversial
concept of emotional intelligence that lack
robust scientific evidence and suggests a
distinct type of intelligence, which is not
supported by current psychological
research.
137. Member States should adopt policies ensuring the Member States should adopt policies Long paragraph, should be split.
voluntary deployment of neurotechnology in education, ensuring that the voluntary deployment of
grounded in fully informed consent. These policies must neurotechnology in education are grounded
include clear, age- appropriate information about the in fully informed consent. These policies
technology's purpose, benefits, and risks, with adequate must include clear, age- appropriate
consideration periods. Considering the increased information about the technology's purpose,
complexity of obtaining voluntary consent in this context, benefits, and risks, with adequate
consent and assent procedures should involve children, consideration periods. Considering the
adolescents, parents, guardians and all actors increased complexity of obtaining voluntary
necessary to obtain approval required for minors. consent in this context, consent and assent
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Ethical oversight mechanisms should be established, procedures should involve children,
including regular consent renewal and immediate adolescents, parents, guardians and all
cessation of neurotechnology use upon withdrawal, actors necessary to obtain approval required
and ensure anonymous feedback channels. Policies for minors.
must prohibit undue incentives or academic penalties ---
for non-participation and take measures to avoid Ethical oversight mechanisms should be
creating or reinforcing inequalities among students. established, including regular consent
Additionally, Member States should support student renewal and immediate cessation of
involvement in decision-making about neurotechnology neurotechnology use upon withdrawal, and
integration and fund training programs on its ethical use, ensure anonymous feedback channels.
empowering educators and students to critically assess Policies must prohibit undue incentives or
its application. academic penalties for non-participation and
take measures to avoid creating or
reinforcing inequalities among students.
---
Additionally, Member States should support
student involvement in decision-making
about neurotechnology integration and fund
training programs on its ethical use,
empowering educators and students to
critically assess its application.
138. Member States should establish a unified, robust Member States should establish a unified, Long paragraph, should be split.
oversight mechanism for neurotechnology use in robust oversight mechanism for
educational settings, incorporating regular audits, public neurotechnology use in educational settings Consider giving examples of these
and community feedback, culturally appropriate and at all levels of education, incorporating technologies. Also see §55.
according to local conventions, and strict adherence to regular audits, public and community
safety and ethical standards, including an assessment feedback, culturally appropriate and
of reversibility on the nervous system. Continuous according to local conventions, and strict
research should be funded to assess the long-term adherence to safety and ethical standards,
psychological and cognitive impacts of these including an assessment of reversibility on
technologies. Oversight should involve periodic reviews the nervous system.
based on empirical evidence to adjust neurotechnology
usage as needed, ensuring it serves student ----
development and addresses risks like dependency or Continuous research should be funded to
de-skilling. This comprehensive approach will help assess the short- and long-term
maintain the safety, effectiveness, and alignment of psychological and cognitive impacts of these
neurotechnology with best practices for student well- technologies. Oversight should involve
being and learning outcomes. periodic reviews based on empirical
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evidence to adjust neurotechnology usage
as needed, ensuring it serves student
development and addresses risks like
dependency or de-skilling. This
comprehensive approach will help maintain
the safety, effectiveness, and alignment of
neurotechnology with best practices for
student well-being and learning outcomes.
139. Member States should invest in educational and Questionable to make the state
professional development programs to equip innovators responsible for this type of capacity
and business leaders with the skills to integrate ethical development for the business sector.
considerations throughout the neurotechnology whole If this paragraph will remain, also
lifecycle. This training should include ethical design, consider moving it. Capacity building in
human rights law, and societal impact assessment, the private sector could also be under
preparing the next generation of technologists to IV.14 LABOUR AND EMPLOYMENT.
critically evaluate the implications of their work.
IV.14 LABOUR AND EMPLOYMENT The responsibilities of the employers
should be emphasized.
This section is very long and detailed,
should benefit from being shortened.
140. Member States should establish workplace 140. Member States should establish
policies and incentives that prioritize the health and policies and laws, with regard to existing
well-being of employees in the use of neurotechnology. policies and laws, regarding the use of
These policies should ensure that any deployment of neurotechnology in the workplace to
neurotechnology is evidence-based, with a focus on safeguard the privacy and safety of the
applications that have been scientifically validated to employees. workplace policies and
promote employee well-being, such as reducing stress incentives that prioritize the health and well-
or enhancing workplace conditions (i.e., adaptive and being of employees in the use of
responsive environments that adjust workloads based neurotechnology. These policies should Examples are given below on eye-
on cognitive load). Deployment must be on a voluntary ensure that any The deployment of tracking for safety reasons in commercial
basis and employees must have the option to opt out of neurotechnology should be is evidence- traffic etc. The purposes stated here
using neurotechnology without facing any negative based, with a focus on applications that should therefore not appear to be
consequences or discrimination. Under no have been scientifically validated to achieve exhaustive.
circumstances should these technologies be used for the legitimate purpose for which it is used,
punitive measures, mental surveillance, or in ways that for example promote employee well-being,
could compromise employee health. such as reducing stress or enhancing
workplace conditions (i.e., adaptive and
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responsive environments that adjust
workloads based on cognitive load). Consider splitting the paragraph here.
---- How will this paragraph, especially in
Deployment must be on a voluntary basis regard to the employees’ consent, align
and employees must have the option to opt with regulatory frameworks like GDPR?
out of using neurotechnology without facing See for example page 7 in Article 29
any negative consequences or Working Party Guidelines on consent
discrimination. Under no circumstances under Regulation 2016/679.
should these technologies be used for
punitive measures, mental surveillance, or
in ways that could compromise employee
health.
141. Member States should require employers to clearly Member States should, if neurotechnology is Some forms of biometric data and AI
provide employees with comprehensive information used, require employers to clearly provide systems within the workplace can be
about how neurotechnology used in their workplace employees with comprehensive information, classified as high risk, in which case the
works, the benefits it offers, transparency about what for example about… existing EU Regulation 2024/1689 on
data are collected, how it is used, and who has access artificial intelligence must be observed.
to it, and clearly disclose any potential risks of their use.
As regards transparency in this paragraph
and the next, consider the §50 in the
existing EU Regulation 2024/1689 on
artificial intelligence.
142. Member States should require employers who use Is there an overlap with §141?
neurotechnology in the workplace to adopt transparent
policies that disclose the purpose of the use, limit the How will this paragraph, especially in
scope of its use to legitimate purposes in the interest of regard to the employees’ consent, align
the employee and third parties (i.e., safety, monitoring with regulatory frameworks like GDPR?
fatigue in commercial drivers or tracking attention in air
traffic controllers). To respect employees' mental What is the scope of the last sentence? Is
privacy, employers should be prohibited from it only for routine workplace monitoring?
unauthorized access to neural and cognitive biometric
data that may be collected incidentally during routine
workplace monitoring. Employers should be prohibited
from using neural and cognitive biometric data for any
non-consented purposes, particularly those that could
negatively impact an employee's job security or privacy.
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143. Member States should require employers to adopt First priority should be that
best practices for data minimisation and secure storage employers/companies follow laws and
of neural and cognitive biometric data, ensure that data regulations.The paragraph should rather
is stored securely, with access limited to authorised state that Member States should
personnel only, is deleted once its intended purpose has encourage employers to adopt best
been fulfilled. Additionally, upon an employee's practices.
departure, all related records should be fully deleted or
individual data released to the employee, ensuring that Can there never be any legitimate
no data is retained after the termination of employment. purpose for an employer to retain data
after the termination of an employment?
144. Member States should ensure that when Member States should ensure require that Re-write this paragraph in order to make
employees are issued multifunctional devices (i.e., when employees are issued multifunctional this recommendation applicable also for
earbuds or headphones that also include neural devices (i.e., earbuds or headphones that other types of devices, unless it is
sensors) that can be used at work or at home, also include neural sensors) that can be relevant to highlight these devices
employers should be prohibited from collecting neural used at work or at home, employers should specifically.
and cognitive biometric data outside of workplace be prohibited from do not collect collecting
settings and working hours and ensure that any data neural and cognitive biometric data outside How will this paragraph, especially in
collected during work is used exclusively for agreed- of workplace settings and working hours and regard to the employees’ consent, align
upon purposes. Employers should implement ensure that any data collected during work is with regulatory frameworks like GDPR?
technological safeguards to automatically disable data used in accordance with applicable laws and The paragraph should rather state that
collection during non-work hours. regulations. exclusively for agreed-upon data should be used in accordance to
purposes. Employers should implement laws and regulations.
technological safeguards to automatically
disable data collection during non-work
hours.
145. Members States should ensure that employers Is this in line with established laws and
respect the right of employees to obtain a copy of any regulations, i.e. that the employers own
neural and cognitive biometric data collected about the employees’ neural and cognitive
them, along with any interpretations drawn from it in an biometric data?
accessible and comprehensible manner. To use these
tools without consent constitutes a breach of trust, How will this paragraph align with
undermining the value they would otherwise create. regulatory frameworks like GDPR?
146. Member States should require, through stringent There seems to be and overlap with other
regulations, that any use of neurotechnology in the paragraphs, for example §140.
workplace require explicit employee consent, and be
used only for purposes that demonstrably enhance How will this paragraph, especially in
workplace safety, employee well-being and dignity, and regard to the employees’ consent, align
with regulatory frameworks like GDPR?
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not for enhancing productivity at the expense of
employee health. The purposes stated should not be
exhaustive since it risks reducing the
relevance. The purposes stated should
therefore be put as examples. Earlier
paragraphs refer to third parties’ interests.
147. Member States should guard against the How will this paragraph align with
exploitation of employees, and they should develop regulatory frameworks like GDPR?
stringent regulations against using neural and cognitive
biometric data for profiling in the workplace, including in
hiring. These regulations should prohibit the use of
neural and cognitive biometric data to discriminate
against candidates, particularly neurodiverse
individuals, ensuring hiring practices are fair and
inclusive.
148. Member States should strictly regulate the use of How does this paragraph relate to §142
neurotechnology for hiring or maintaining employment, stating that “Employers should be
to limit such use where such neural and cognitive prohibited from using neural and cognitive
biometric data are directly relevant to the specific biometric data for any non-consented
requirements of the job. purposes, particularly those that could
negatively impact an employee's job
security [...]”?
IV. 15 CONSUMER AND COMMERCIAL DOMAINS
149. Member States should proactively establish a We see a risk that this phrasing is too
regulatory framework that balances innovation in the vague to ensure that the recreational and
recreational and commercial domains with protecting commercial industries respect individual
individual rights and well-being. This framework should rights etc. since their whole business idea
be dynamic, allowing for timely updates as technology is to profit on people’s desire to boost
evolves and new insights are gained about its impacts their health and well-being.
on society. This includes providing adequate oversight
to ensure that neurotechnology does not cause harm,
are used consensually, and include robust mechanisms
to protect users from potential psychological distress or
manipulation.
150. Member States should strengthen comprehensive
consumer protection laws to include clear labelling on
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commercial neurotechnology products, detailing their
effects, limitations, and risks to prevent misleading
claims and ensure transparency. This also includes
prohibiting practices of "tying" or requiring the
disclosure of neural and cognitive biometric data as a
condition to access goods or services, and prohibition
about third party data sharing or the uses of this data
without affirmative opt-in option.
151. Member States should foster an environment that
ensures all claims about consumer, non- medical
technologies are supported by robust scientific
evidence. They should, by regulation, require that any
products claiming to treat, prevent, or diagnose
diseases or medical conditions be validated through
rigorous safety and efficacy testing, including clinical
trials where necessary, and be used under appropriate
medical supervision.
152. Member States must enforce informed consent Member States must enforce informed Or are there good reasons for addressing
processes that are thorough and transparent across all consent processes that are thorough and sports and arts specifically?
neurotechnological interventions, ensuring that transparent across all neurotechnological
participation is fully voluntary and respects the privacy interventions, ensuring that participation is
and autonomy of individuals. This principle should apply fully voluntary and respects the privacy and
uniformly in various domains such as sports, arts, where autonomy of individuals. This principle
robust standards should safeguard against coercive use should apply uniformly in various all domains
and respect athletes' and artists' individual autonomy, such as sports, arts, where robust standards
community interests, and IP rights. should safeguard against coercive use and
respect athletes' and artists' individual
autonomy, community interests, and IP
rights.
153. Member States should steer the use and The message here is unclear. Does
development of neurotechnology in the arts toward neurotechnology have the potential to
ensuring the enhanced learning and cultural enhance cultural appreciation? Member
appreciation without compromising individual autonomy States should not intervene on people’s
or leading to cultural homogenisation. cultural experiences.
154. Member States should adopt policies to prevent the adopt policies too vague? And what are
misuse of neurotechnology of consumer technology, the Tech companies’ responsibilities?
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especially neurogaming and other devices that exploit
the dopamine reward system or seek to induce
problematic and unhealthy use and overconsumption.
Such regulations should mandate clear labeling of risks,
disclosures on their effects on the nervous system,
enforce game design standards and safety, privacy and
age-appropriate design standards that prevent taking
advantage of a person's physical, mental and emotional
vulnerability to lead to compulsive use or addiction of
gaming or digital recreational platforms combined with
neurotechnology, to promote healthy, balanced use,
especially among children.
155. Member States should ensure that devices Should management and ownership over
capable of multiple functions, such as XR glasses or data generated through the use of these
smart earbuds with neural sensors, include hardware- devices be mentioned? Or is this taken
based controls that allow users to selectively disable care of in the section of Data Policy? If
neurotechnology features while maintaining basic yes, maybe a good idea to refer to that
functionality. Regulations should ensure that 'opt-out' section?
features are accessible and straightforward, promoting
healthy, balanced use especially among children and
vulnerable populations.
156. Member States should address the profound
ethical questions regarding self-determination, consent,
privacy, and the potential for manipulation raised by
neurotechnology that arise in the contexts of
recommender systems, priming and nudging, marketing
during sleep and dream, neuromarketing, and closed-
loop environments by adopting comprehensive policies
and regulations that:
(a) Recommender systems: explicitly
prohibit the use of neural and
cognitive biometric data in
recommender systems for
manipulative or deceptive
purposes, including in political
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context. These regulations should
require that any use of such data
within these systems be based on
explicit, informed opt-in consent
from users.
(b) Nudging: govern the use of neural
and cognitive biometric data for
nudging-subtly influencing
individuals' decisions or
behaviours, often without their
explicit awareness. This is
particularly critical in sensitive
areas such as political messaging,
commercial advertisement, and
healthcare. These frameworks
should require explicit, informed
consent for any use of such data to
influence decisions or behaviour,
the right to opt out of these
systems, and transparency and
clear disclosures at the point of
data collection, with strict
limitations on using data for
purposes beyond those explicitly
disclosed.
[…] such as marketing during sleep and The marked text needs to be checked
(c) Marketing during sleep and dream: dream. Regulations should strictly prohibit with experts. According to established
prohibit the use of neurotechnology commercial, marketing, or political research, the brain can neither register
that influences or manipulates applications that target individuals during nor process information through hearing
individuals during sleep, such as sleep, using neurotechnology or neural and during sleep.
marketing during sleep and dream. cognitive biometric data […]
Regulations should strictly prohibit
commercial, marketing, or political
applications that target individuals
during sleep, using
neurotechnology or neural and
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cognitive biometric data.
Additionally, robust oversight
mechanisms should be required to
ensure that any research or
application of such technologies
prioritizes the well-being, privacy,
and autonomy of individuals, with
particular attention to the potential
long-term psychological and
cognitive impacts of manipulating
sleep states.
(d) Neuromarketing: safeguard against
unethical aims and practices in
neuromarketing, including by
requiring comprehensive
disclosures to ensure that all
neuromarketing activities are
conducted transparently, with
participants' explicit informed
consent. This includes ensuring
that participants in neuromarketing
research or campaigns are fully
aware of methods, risks, and
intentions and affirmatively opt-in
to participation. The use, storage,
and potential reuse of the collected
data should be strictly regulated.
(e) Closed Loop Environments: provide
clear regulatory guidelines on the
design and use of closed-loop
environments-such as immersive
computing devices that adjust
experiences based on detected
neural and cognitive biometric data.
These policies should require clear
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and accessible disclosure about
how neural and cognitive biometric
data are used in these
environments, prohibit real-time
behavioral modification or
manipulation without explicit,
informed consent, and implement
safeguards specifically designed to
prevent abuses such as
unauthorized surveillance,
manipulative interventions, and
practices that could influence voting
behavior, political opinions, or
exploit psychological and emotional
vulnerabilities in real-time.
IV.16 ENHANCEMENT This section should be given more
attention.
The implications of neurotechnological
enhancement, especially when
innovations extend beyond therapeutic
applications within healthcare and move
into areas of human enhancement,
require particular attention. As new
neurotechnological innovation emerge,
there is a growing potential for their
application in enhancing human cognition
and abilities outside traditional medical
contexts, raising important ethical and
social considerations. In reviewing the
draft of this Recommendation, we note
that while the document addresses
various ethical aspects of
neurotechnology, there is limited
exploration of enhancement applications
of new neurotechnological innovations.
Considering the profound implications of
such applications, we would encourage a
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more comprehensive analysis of this topic
within the recommendations. It is crucial
that the risks and responsibilities
associated with human enhancement
technologies are further considered to
ensure that ethical principles and
appropriate legislation are robustly
applied in this emerging area.
157. The use of neurotechnology to improve memory, The use of neurotechnology to improve The phrase outside of the medical context
attention, or other aspects of human mental performance memory, attention, or other aspects of human is difficult to interpret, particularly since
outside of the medical context introduces complex mental performance outside of the medical enhancement of the nervous system itself
ethical, social, and legal challenges, which can create context introduces complex ethical, social, is included. The principle of non-
new kinds of disparities in the global world. When and legal challenges […] When maleficence in medical ethics should be
neurotechnology is used in these contexts, it raises neurotechnology is used in these contexts, it an important part of the ethics of
crucial questions about equity, consent, individual and raises crucial questions about equity, neurotechnology and other applied
community autonomy, and the nature of enhancement of consent, individual and community neuroscience.
the nervous system itself. Member States should ensure autonomy, and the nature of enhancement of
that any policies, law and regulatory frameworks that the nervous system itself.[…]
govern the use of neurotechnology in these contexts do
not exacerbate social inequalities or lead to
discrimination, address the potential risks (including to
reversibility, invasiveness, and risks to self-
determination) and fully comply with human rights and
dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in
this Recommendation should respect, promote and
protect the ethical values, principles and standards
related to this Recommendation, and should take all
feasible steps to give effect to its implementation.
159. Member States shall, according to their specific
contexts, governing structures and constitutional
provisions, credibly and transparently advance the
ethics of neurotechnology, in line with the UNESCO
Recommendation. Member States shall monitor and
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evaluate policies, programmes and mechanisms related
to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and
qualitative approaches.
160. Member States should develop capacities in
governmental institutions and support government
officials to steer the technological development
ethically.
161. Member States should establish or designate
national organizations responsible for overseeing and
coordinating the regulation, vigilance, and oversight of
neurotechnology across relevant government agencies.
These coordinating bodies should be tasked with
ensuring that legal and regulatory frameworks are
consistently applied, that public health and safety are
protected, and that ethical standards and human rights
are upheld throughout the whole lifecycle of
neurotechnology. This includes facilitating inter-agency
collaboration, monitoring compliance with national and
international standards, and ensuring that data and
insights from different regulatory domains are shared
effectively to inform decision-making and policy
development. These bodies should also help coordinate
public and community engagement.
162. Member States should strive to extend and
complement their own actions in respect of this
Recommendation, by cooperating with all relevant
national and international governmental and non-
governmental organizations, as well as transnational
corporations and scientific organizations, whose
activities fall within the scope and objectives of this
Recommendation. Civil society will be an important
actor to advocate for the public sector's interests and
therefore UNESCO needs to ensure and promote its
legitimacy.
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163. UNESCO should publicize and disseminate this
Recommendation widely through all available means,
and share it with Member States, National Commissions
for UNESCO, relevant international and regional
partners, human rights institutions as well as with
UNESCO ethics advisory bodies for dissemination to
all levels and actors in this field.
164. To support Member States implementing this Compare VII. Promotion of
Recommendation by developing concrete programs the present Recommendation, §§137-
and policies and developing institutional capacities in 139 in the Recommendation on the Ethics
the ethics of neurotechnology, UNESCO shall of Artificial lntelligence (2021). For this
contribute by developing a full-fledged program with the Recommendation to be relevant for many
following elements: years to come, it might be a good idea to
outline guidelines rather than a list of
concrete initiatives.
(a) UNESCO Readiness Assessment Methodology
(RAM) to assist Member States in identifying their
status at specific moments of their readiness trajectory
along a continuum of dimensions;
(b) UNESCO methodology for Ethical lmpact
Assessment (EIA) of neurotechnology based on
rigorous scientific research and grounded in
international human rights law, along with specific
guidance for its implementation in the whole
neurotechnology lifecycle, and capacity-building tools
and materials to support Member States' efforts to train
government officials, policy-makers and other relevant
actors on the methodology;
( c) UNESCO methodology to evaluate ex ante and ex
post the effectiveness and the efficiency of the policies
for the ethics of neurotechnology and incentives against
defined objectives;
(d) UNESCO research program that will focus an the
ethics of neurotechnology, grounded on an appraisal
that is informed by the current state of technological
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developments, to assess the current and future impact
of neurotechnology an societies and the environment.
This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of
knowledge and awareness of good practices and
innovations available to all Member States and actors,
in the form of research reports, data, and statistics
regarding policies for ethics of neurotechnology. The
research program should take into consideration the
converging developments of neurotechnology with other
technologies such as artificial intelligence and quantum
technology, work to be conducted in collaboration with
other relevant UNESCO initiatives.
( e) UNESCO collaborative platform fostering
meaningful exchanges and facilitating collaboration
among Member States and among all actors to promote
a global policy dialogue, including at Ministerial level in
the context of a Global Forum an the ethics of Emerging
Technologies. Supporting this effort, UNESCO shall
establish a network of experts, with balanced
representation of all UNESCO's regional groups, on the
neurotechnology.
165. Processes for monitoring and evaluation should
ensure broad participation of all actors, including, but
not limited to, under-represented, vulnerable people or
people in vulnerable situations and ensuring social,
cultural and gender diversity. The monitoring and
assessment of the impact of neurotechnology and
related ethics policies and practices should be carried
out continuously in a systematic way proportionate to
the relevant risks. This should be based on
internationally agreed frameworks and involve
evaluations of private and public institutions. Data
collection and processing should be conducted in
accordance with international law, national legislation
on data protection and data privacy, and the values and
principles outlined in this Recommendation.
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VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a
whole, and the foundational values and principles are to
be understood as complementary and interrelated.
167. Nothing in this Recommendation may be
interpreted as replacing, altering or otherwise
prejudicing Member States' obligations or rights under
international law, or as approval for any State, other
political, economic or social actor, group or person to
engage in any activity or perform any act contrary to
human rights, fundamental freedoms, human dignity
and concern for the environment and ecosystems.
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SWITZERLAND/SUISSE
Commentaire général de la Suisse sur l’avant-projet de
Recommandation sur l’éthique des neurotechnologies
L’avant-projet de Recommandation sur l’éthique des neurotechnologies de l’UNESCO
représente une contribution importante pour encadrer les enjeux éthiques posés par les
neurotechnologies. La Suisse salue la clarté de sa structure, qui aide à naviguer dans un
texte dense, ainsi que son approche équilibrée visant à répondre aux défis éthiques des
neurotechnologies, tout en proposant des orientations concrètes pour y répondre.
La Suisse est d’avis qu’en privilégiant l’application des droits actuels à ces nouveaux défis
éthiques, la recommandation doit éviter l’introduction et la création de nouveaux droits dans
le domaine du droit international, notamment dans le domaine des droits de l’homme et celui
du droit international humanitaire. Ce choix pragmatique maintient une continuité avec les
cadres normatifs internationaux.
La flexibilité laissée aux États est primordiale pour la mise en œuvre de la Recommandation.
Elle leur permet d’ajuster les orientations aux spécificités de leurs contextes nationaux, tout
en respectant des lignes directrices claires.
Cependant, nous souhaitons souligner plusieurs points d’amélioration :
• Un document plus concis, recentré sur les priorités essentielles, renforcerait son
efficacité et faciliterait le consensus international. Une réduction des redondances et
une meilleure focalisation sur certains enjeux critiques permettraient d’augmenter
l’adhésion des parties prenantes.
• Le texte gagnerait à être davantage aligné avec les instruments existants, tels que la
Déclaration universelle des droits de l’homme, le Pacte international relatif aux droits
civils et politiques (Pacte II), la Convention relative aux droits des personnes
handicapées (CIDPH) ou encore les Principes directeurs des Nations Unies sur les
entreprises et les droits de l’homme. Des références explicites au droit humanitaire
international renforceraient également sa pertinence face aux défis juridiques et
éthiques spécifiques. Il serait également pertinent de faire écho aux discussions en
cours au sein du Conseil des droits de l’homme et de prendre en compte les
recommandations de son Comité consultatif, notamment en vue de l’élaboration de
principes directeurs spécifiques pour les neurotechnologies.
• En ce qui concerne la propriété intellectuelle, une révision ou une suppression de
cette section allégerait le texte sans en diminuer la pertinence. Les accords
internationaux existants, notamment l’Accord sur les aspects des droits de propriété
intellectuelle qui touchent au commerce ADPIC (TRIPS), offrent déjà un cadre clair et
technologiquement neutre. Celui-ci s’applique donc également au domaine de la
neurotechnologie. Parmi les aspects déjà réglés au niveau international, on peut citer
par exemple la protection des compilations de données ou encore les critères de
brevetabilité des inventions. Une résolution touchant ces aspects nous semble inutile.
• Des références explicites aux conventions de l’Organisation internationale du travail
(OIT) permettraient de mieux refléter les implications des neurotechnologies sur les
droits des travailleurs. De même, des orientations spécifiques pour protéger les droits
des enfants, conformément à la Convention relative aux droits de l’enfant (CIDE),
pourraient être intégrées, notamment face aux risques psychologiques et aux défis
liés à leur capacité de consentement.
• Le document devrait inclure des mécanismes clairs pour garantir une répartition
équitable des bénéfices des neurotechnologies, conformément à l’article 12 du Pacte
international relatif aux droits économiques, sociaux et culturels (PIDESC).
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• Il est également important de prendre en compte les travaux fait dans le contexte
régional, par exemple de prendre en compte la Convention sur les droits de l’homme
et la biomédecine du Conseil de l’Europe (dite Convention d’Oviedo). En effet, c’est
le seul instrument juridique contraignant au niveau international sur ce sujet. Il s’agit
également de tenir compte des développements pertinents issus de la jurisprudence
de la Cour européenne des droits de l’homme.
• Nous considérons positivement un soutien de l’UNESCO aux États membres pour
l’application de la Recommandation sur l’éthique des neurotechnologies. Toutefois,
nous estimons que le développement d’un programme à part entière tel que
mentionné au paragraphe 164 devrait être discuté de manière approfondie en lien au
processus de planification stratégique actuel, notamment dans le cadre de
l’élaboration en cours des prochains programmes et budgets (43 C/5). Il convient de
souligner que, jusqu’à présent, le projet de document C/5 soumis à la consultation
des États membres ne fait pas mention du développement d’un tel programme. Ces
discussions permettront de garantir une prise en compte équilibrée des ambitions
programmatiques, des préoccupations budgétaires et des priorités stratégiques
globales de l’Organisation, tout en répondant aux besoins et capacités disponibles
des États membres.
En conclusion, cet avant-projet constitue une base solide, mais des ajustements ciblés
pourraient renforcer son efficacité, sa lisibilité et son alignement avec les cadres juridiques
internationaux.
Vous trouverez les propositions détaillées de la Suisse dans le document intitulé
« 20241224_Ethics Neurotech_Specific Comments Switzerland ». Nous espérons que ces
éléments apporteront une contribution utile à l’élaboration de la prochaine version de ce
document important.
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SWITZERLAND’S COMMENTS ON THE
FIRST DRAFT OF THE RECOMMENDATION ON THE ETHICS OF NEUROTECHNOLOGY
1. Modifications in TC 2. Comments
PREAMBLE
Recognizing the profound and dynamic impacts of
neurotechnology on human mind, lives and flourishing, and
societies, environment, and ecosystems,
Considering the major and growing global prevalence of
neurological and mental health conditions, along with the
profound suffering they cause for individuals and societies
worldwide,
Acknowledging the potential of neurotechnology to offer Replace “innovative” by “new” as
innovative new solutions and deliver better preventive and “innovative” may bias the reader.
therapeutic treatments for millions, benefitting humanity as
a whole and providing opportunities for health
improvements in all countries,
Also considering that neurotechnology raises fundamental The issues are not only ethical, but
legal and ethical issues for instance regarding self- also legal and political, especially
determination, privacy, personal identity, freedom of with regard to fundamental human
thought, risk of discrimination, inequality and challenges to rights, human dignity and the rule of
democracy, and that justice, trust and fairness must be law.
upheld so that no country and no one should be left behind,
either by having fair access to neurotechnology and
enjoying their benefits or in the protection against their “…different circumstances…”: This
risks, while recognizing the different circumstances of should not to be understood as a
different countries and respecting the desire of some relativisation of the binding human
people not to take part in all technological developments, rights guarantees.
Recalling that, by the terms of its Constitution, UNESCO
seeks to contribute to peace and security by promoting
collaboration among nations through education, the
sciences, culture, and communication and information, in
order to further universal respect for justice, for the rule of
law and for the human rights and fundamental freedoms
which are affirmed for the peoples of the world,
Given the leading role of UNESCO, at the forefront of the
international dialogue, knowledge production and standard
setting on the ethics of science and technology and
bioethics,
Convinced that the Recommendation presented here, as a
standard-setting instrument developed through a global
approach, based on international law, focusing on human
dignity and human rights, as well as gender equality, social
and global justice and development, physical and mental
well-being and health, diversity, interconnectedness, global
solidarity, fairness, non-discrimination, inclusiveness, and
environmental and ecosystem protection, can guide
neurotechnology in a responsible direction,
Guided by the purposes and principles of the Charter of the
United Nations,
Underscoring that global cooperation and solidarity Not only IHRL but also International
facilitates fair access to neurotechnology and enables the Law in general should be mentioned
realization of the full potential of neurotechnology, while as well as IHL.
addressing the legal and ethical challenges, mitigating
against potential misuse, and ensuring that national
neurotechnology strategies are guided by ethical principles
in full respect of international law, including international
human rights law and international humanitarian law,
Noting that ethical guidelines, frameworks and open Innovation, development and policies
science promote innovation, development and policies should not only align with human
aligned and conform with international human rights law, rights but respect them.
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Also recalling that in November 2023, the General
Conference of UNESCO, at its 42nd session, adopted 42
C/Resolution 29, by which it mandated the Director-General
“to prepare a standard-setting instrument on the ethics of
neurotechnology in the form of a recommendation”, which is
to be submitted to the General Conference at its 43rd
session in 2025,
Bearing in mind the Universal Declaration of Human The Convention against Torture
Rights (1948), the instruments of the international human (CAT) is also relevant.
rights framework, including the International Covenant on
Civil and Political Rights (1966), the International Covenant Where applicable, international
on Economic, Social and Cultural Rights (1966), the humanitarian law should also be
Convention Relating to the Status of Refugees (1951), the mentioned here, for instance, the
Discrimination (Employment and Occupation) Convention Geneva Conventions (1949) and
(1958), the International Convention on the Elimination of their Additional Protocols (1977).
All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the Suggest to move the “the
International Covenant on Economic, Social and Cultural International Covenant on Civil and
Rights (1966), the Convention on the Elimination of All Political Rights (1966), the
Forms of Discrimination against Women (1979), the International Covenant on Economic,
Convention against Torture and Other Cruel, Inhuman or Social and Cultural Rights (1966)” up
Degrading Treatment or Punishment (1984), the and mention them right after
Convention on the Rights of the Child (1989), and the “international human rights
Convention on the Rights of Persons with Disabilities framework” as they are key
(2006), the Convention against Discrimination in Education instruments, composing together with
(1960), the Convention on the Protection and Promotion of the UDHR the International Bill of
the Diversity of Cultural Expressions (2005), as well as any Human Rights
other relevant international instruments, recommendations Suggest also to add the additional
and declarations, protocols of the different
conventions.
Also noting the United Nations Declaration on the Right to
Development (1986); the Declaration on the
Responsibilities of the Present Generations Towards Future
Generations (1997); the Universal Declaration on Bioethics
and Human Rights (2005); the United Nations Declaration
on the Rights of Indigenous Peoples (2007); the Declaration
of Ethical Principles in relation to Climate Change (2017);
the Recommendation on Science and Scientific
Researchers (2017); the Recommendation on the Ethics of
Artificial Intelligence (2021); the Recommendation on Open
Science (2021); the Human Rights Council’s resolution on Replace by the latest Human Rights
“Neurotechnology and human rights” (A/HRC/RES/51/3) Council Resolutions and add other
(2022); the Human Rights Council’s resolution on “New and HRC relevant resolutions.
emerging digital technologies and human rights”
(A/HRC/RES/53/29) (2023); the Human Rights Council’s
resolution on “The right to privacy in the digital age”
(A/HRC/RES/5442/2115) (202319); the Human Rights
Council’s resolution on “New and emerging digital
technologies and human rights” (A/HRC/RES/41/11)
(2019), and the UN Guiding Principles on Business and
Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of
Artificial Intelligence, recognizes ethical questions related to
AI-powered systems for neurotechnology and brain-
computer interfaces,
Also conscious of the existing ecosystem of national
policies, and other frameworks and initiatives elaborated by
relevant United Nations entities, intergovernmental
organizations such as OECD, including regional
organizations, as well as those by the private sector,
professional organizations, non-governmental
organizations, and the scientific community, related to the
ethics and regulation of neurotechnology,
1. Adopts the present Recommendation on the Ethics of
neurotechnology on this XXX day of November 2025;
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2. Recommends that Member States, with the support of What seems to be missing is a
UNESCO’s Secretariat, apply the provisions of this Chapeau-Statement that all activities
Recommendation by taking appropriate steps, including need to be in compliance with
whatever legislative or other measures may be required, international law, there are only
in conformity with the constitutional practice and implicit references (based on IL /
governing structures of each State, to give effect within references to instruments that need
their jurisdictions to the principles and norms of the to be considered).
Recommendation in conformity with international law,
including international human rights law and Something like:
international humanitarian law; “Affirms that Neurotechnology must
be in accordance with international
law, including [the UN Charter,]
international humanitarian law,
international human rights law; and,
as appropriate, other relevant legal
frameworks, including regional
instruments]”
3. Also recommends that Member States engage all Very important. Keep.
actors, to ensure that they play their respective roles in
the implementation of this Recommendation; and bring
the Recommendation to the attention of international,
regional and national authorities and bodies, research
and academic organizations, institutions and
organizations in public, private and civil society sectors
involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound
scientific research as well as ethical analysis and
evaluation.
I. SCOPE OF APPLICATION AND
DEFINITIONS
I.1. SCOPE
This Recommendation:
1. Addresses ethical issues related to The impacts/risks will not only impair
neurotechnology, as it can have many specific the enjoyment of human rights but
positive and adverse impacts on human health, can also violate them, it is therefore
important to mention their respect.
human flourishing and on the enjoyment and
respect of human rights. As a justification for this
recommendation, include “many
specific positive and adverse
impacts…”.
2. Considers neurotechnology for people of diverse
backgrounds and abilities, and various fields,
including health, non-medical direct-to-consumer
(DTC), such as wellness devices, neurogaming),
addressing various settings where neurotechnology
may be utilised.
3. Focuses on humans only but acknowledges
important considerations that apply to animals in
research.
4. Approaches neurotechnology ethics as a systematic
normative reflection based on a holistic,
multicultural, multidisciplinary, pluralistic and
evolving framework of interdependent values,
principles, and actions that can guide societies in
dealing responsibly with the impacts of
neurotechnology on human beings, societies, and
the environment and ecosystems.
(a) It considers ethics as a framework basis for This phrase can be misunderstood if
the normative evaluatingon and guidingance the reader assumes a simplistic or
norms of in neurotechnology, with human static view of ethics. See suggestion.
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rights, human dignity, well-being, and the
prevention of harm as a compass and
foundation.
(b) It draws upon a full range of scholarship,
commentary and views from neuroscience,
medicine, engineering, psychology, ethics,
human rights, law, sociology, anthropology
and other disciplines.
5. Covers the measurement, recording, and
modification of the human nervous system, the
handling, analysis, treatment, storage, use and
reuse of the data collected, along with other societal
and environmental impacts, including the
emergence of new cognitive states.
6. Recognizes that interventions involving the nervous Suggestion: add to the list that the
system are very sensitive because the highly (central) nervous system is a key
complex human nervous system is the coordinating condition for our notion of “humanity”,
what makes up humans as humans
centre of behaviour and mental processes. It
(e.g., rationality, freedom, self-
enables the exercise of self-determination, the consciousness, etc.). So the nervous
capacity to act as moral agents, to be responsible system does not only have
for actions, cooperate with others, deliberate about importance for the individual or for
collective decisions and develop personality. society, but for humanity as a whole.
7. Further recognizes that humans develop and
flourish in their interaction with other human beings
and a nurturing material and cultural environment,
highlighting that autonomy is not just individual but
also relational, as it arises from and impacts one’s
interactions and belonging with the community.
8. Addresses the ethical and human rights concerns
that arise from the rapid developments and the
convergence of neurotechnology with other
technologies such as spatial computing, extended
reality (XR), artificial intelligence (AI), sensors and
semi-conductors. Notably, other biometric data
when processed to infer sensory, motor, and mental
states raises similar ethical concerns. Therefore,
this Recommendation applies to both
The term “cognitive biometric data”
neurotechnology and the use of cognitive biometric
could benefit from clarification to
data, ensuring that ethical principles and practices avoid confusion with conventional
are consistently applied across these domains. biometrics.
9. Further addresses the integration of AI with
neurotechnology, which can enhance precision and
predictive capabilities, such as improving
processing speed, reducing cost, optimizing
neurotechnology systems. However, it also
magnifies ethical threats, including cybersecurity
concerns, lack of transparency, the potential for
algorithmic bias, and risks to autonomy, mental
privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and This presents an excessively one-
seeks to raise awareness on the profound ethical sided focus on risks and threats.
challenges and threats that come with the military Moreover, UNESCO is not the
appropriate forum for discussions on
and security applications of neurotechnology. cCalls
security policy or military matters,
on all concerned to act responsibly with regard to including the regulation or prohibition
neurotechnology and to respect international law. of military applications. Please
delete.
702
Add “and to respect international
law”.
I.2. DEFINITIONS
11. Nervous system. The nervous system includes the “Supports consciousness” is an
central (brain, spinal cord) and peripheral (somatic, awkward wording. Replace by
autonomic, enteric) nervous system. Scientific “shapes” or “enables”
consciousness.
evidence demonstrates that nervous system activity
is the basis of sensory, motor, and mental states “Sleep-wake cycles” instead of
(which include cognitive, affective, and conative “sleep” and you might also mention
states), and supports shapes consciousness, sleep- the “awareness” as an important
wake cycles and the experience of pain. The emerging phenomenon.
nervous system activity and structure provide
information inherent to all human beings and the Consider mentioning “language /
communication” - a key basis of
community, regardless of gender, ethnicity, culture all around the globe.
language, or religion. The nervous system activity is
also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to
devices, systems, and procedures—encompassing
both hardware and software—that directly access,
monitor, analyze, predict or modulate the nervous
system to understand, influence, restore, or
anticipate its structure, activity, function, or
intentions (speech, motor). Neurotechnology
combines elements of neuroscience, engineering,
and computing, among others.
13. Neurotechnology spans medical and non-medical
applications and includes tools that measure, infer,
and influence nervous system activity, whether
through direct interaction with the nervous system or
by interfacing it with devices and systems. It
includes but is not limited to:
(a) Technical tools that measure and analyse
physical (i.e., acoustic, electrical, optical,
magnetic and/or mechanical), chemical and
biological signals associated with the structure
of and functional signals from the nervous
system. These may be used to identify, record,
and/or monitor properties of nervous system
activity, understand how the nervous system
works, diagnose pathological conditions, or
control external devices (brain machine
interfaces (BMI), often referred to as brain
computer interfaces (BCI)). Of note, both open-
loop (i.e., fixed-parameter brain stimulation)
and closed-loop systems (i.e., state dependent
stimulation) introduce complex ethical issues.
(i). Examples include but are not limited to
Electroencephalography (EEG),
Magnetoencephalography (MEG),
Magnetic resonance imaging (MRI),
Functional Magnetic resonance imaging
(fMRI), Positron emission tomography
(PET), Functional Near-infrared
spectroscopy (fNIRS), Implanted
microelectrodes, Optogenetics, Optical
imaging, Diffusion weighted imaging,
Calcium imaging, Voltage dye sensors, or
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Microdialysis.
(b) Technical tools that interact with the nervous Is brain surgery and psychosurgery
system to change its activity, for example, to included or excluded from this list of
restore sensory input, such as hearing (i.e., technologies?
cochlear implants) or Deep Brain Stimulation
(DBS) to treat tremors and other pathological
conditions. They are meant to either modulate
the functions of the nervous system and/or
send signals directly to the nervous system by
applying acoustic, electrical, magnetic or
optical stimulation and/or inhibition of the
peripheral or central nervous system.
(i). Examples of this neurotechnology include You may add transcranial direct
but are not limited to are implanted current stimulation (tDCS)
microelectrodes, BMI, DBS, Optogenetic In general: emphasize that this is a
non-exhaustive list of examples,
optical stimulation, Transcranial electrical
especially since new technologies
stimulation (tES), Transcranial Magnetic may be developed in the future and
Stimulation (TMS) or you still want this document to
Neuropharmacological infusion. remain valid then.
14. Of note, several sensor technologies collect data Where exactly is the line drawn? A
indirectly informing about neural activity. Even if simple camera is also a technology
they are not neurotechnology per se, they raise that detects sensory data that can be
used to infer mental states, for
similar ethical and human rights issues as
example whether someone is sad or
neurotechnology when used to infer mental states. happy or angry…
They include but are not limited to eye-tracking,
Video Oculography, Typing dynamics, Voice
recognition and analysis, Gait analysis, Skin
conductance, Heart rate variability, Sleep movement
monitoring, Blood pressure measurement, or facial-
emotion recognition systems.
15. Neural data. Neural data are qualitative and
quantitative data about the structure, activity and
function of the nervous system. They encompass
data relating to a nervous system’s activity,
including both direct measurements of neuronal
structure, activity and/or function (i.e., neuronal
firing or averaged bioelectric signals from EEG) and
indirect functional indicators (i.e., blood flow in fMRI
and fNIRS). At the neurobiological level, neural data
are the most direct correlates of mental states.
16. Cognitive Biometric Data. Neural data, along with See comment above (para 8): this
data collected by non-neural biometric technologies point is vague (please provide
can be processed to infer mental states, which this examples).
Recommendation refers to as “cognitive biometric
data”.
17. Whole lifecycle. Neurotechnology should be
considered from the early stages of mining for
materials, prototyping, research, design and
development to deployment and use, including
maintenance, operation, trade, financing, monitoring
and evaluation, validation, end-of-use, disassembly,
termination, disposal and recycling. The whole
lifecycle of neurotechnology includes its
convergence with other technologies and the
diversity of actors who are involved in every stage.
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II. AIMS AND OBJECTIVES
18. This Recommendation has been created with the Caution against using the word
aim of guiding the development and use of “ethical”, which is usually employed
neurotechnology in ways that are ethically in a neutral way, to denote “ethically
responsible / good”, at least say
responsible, safe and effective for the good of
“ethically justifiable / responsible” or
humanity, individuals, communities, societies, the else.
environment and ecosystems, and to prevent harm
in the present and the future based on in full respect Replace “based on” by “in full respect
of States obligations under international law, in of States obligations under”.
particular the Charter of the United Nations and
international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and
respect of human rights and fundamental
freedoms, human dignity and equality,
including gender equality, and to respect
cultural diversity during the whole
neurotechnology lifecycle;
(b) to guide the actions of Member States,
individuals, groups, communities, institutions,
private sector companies and every other
relevant actor to ensure the embedding of
ethics in all stages of the neurotechnology
lifecycle;
(c) to ensure that neurotechnology in its whole
lifecycle is evidence-based, reliable and
reproducible;
(d) to provide a universal framework that not only
articulates values and principles, but also
translates into concrete policy
recommendations and effective
implementation to guide Member States in
their engagement with neurotechnology in its
whole lifecycle, consistent with their
obligations under international human rights
law and other international obligations and Add “obligations”.
standards;
(e) to foster multi-stakeholder, multidisciplinary
and pluralistic dialogue and consensus
building about ethical issues relating to
neurotechnology;
(f) to promote justice and equitable access to
developments and knowledge in the field of
neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among
all actors to prevent misuse of
neurotechnology and to uphold human rights
and ethical standards.
III. VALUES AND PRINCIPLES
III.1. VALUES
III.1.1. Respect, protection and promotion of See comment above (para 2 of
Preamble). The title suggests a
human rights, fundamental freedoms and statement regarding respect of HR,
human dignity but deals exclusively with human
dignity.
20. The inviolable and inherent dignity of every human The core of the argument in favour of
being is the foundation of universal human rights the universal validity of human
705
and fundamental freedoms and has universal rights is human dignity.
validity. Respect, protection, and promotion of
human dignity, as established by international
human rights law, are essential in the whole
lifecycle of neurotechnology. Dignity encompasses
the recognition of the intrinsic and equal worth of
each person. Neurotechnology must never be used
in ways that objectify, exploit individual
vulnerabilities, or undermine the dignity or rights of
any individual, including people living in vulnerable What is the definition of vulnerable
situations?
situations.
III.1.2. Promoting human health and well-being Concern: While the recommendation
emphasizes well-being, it does not
sufficiently address the equitable
distribution of neurotechnological
health benefits, especially in low-
resource settings, nor does it
guarantee safe and effective
applications. ICESCR Article 12
stresses the right to health, requiring
equitable access to health benefits,
yet the current text offers no clear
mechanisms for prioritizing public
health applications over
commercial interests.
Improvement suggestion: Prioritize
research and applications that meet
public health needs, especially in
underserved areas, and establish
guidelines for the ethical deployment
of neurotechnology in healthcare.
Incorporate CRPD Article 25
provisions, emphasizing accessible
and non-discriminatory access to
neurotechnology for persons with
disabilities.
21. Prioritizing the development and application of
neurotechnology that promotes comprehensive
human health and well-being, viewing health as a
holistic state of physical, mental, and social well-
being.
22. The responsible allocation of resources for See comment above (III.1.2).
neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and
Are only “health-related benefit”
rehabilitative purposes that benefit the largest
meant here or some other kinds of
number of people and those who stand to gain the benefits as well?
most, rather than consumer-driven or commercial
applications.
III.1.3. Ensuring and respecting diversity and
fairness
23. Respect for diversity and fairness, must be upheld Delete comma.
in the whole lifecycle of neurotechnology. Special
consideration should be given to neurodiversity,
minority groups, Indigenous Peoples, and
underrepresented voices.
24. Given that widely recognized neurotechnological
innovation largely occurs in the urban well-
resourced sector, specific attention to underserved
and marginalised people is crucial to prevent bias,
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ongoing disparities in healthcare, stigma, neglect,
and disrespect. Technological assimilation, or using
technology as a tool of colonisation (a term the
Recommendation refers to as “technological
colonialism”), can threaten cultural diversity and
heritage, therefore must be protected against.
25. Equitable access to neurotechnology, free from Suggestion to add a minima “or other
discrimination, should be prioritized globally, factors” after “geographical location”.
ensuring that its benefits are accessible to all, It would be best to directly cite and
refer to all grounds of
regardless of socioeconomic status or geographical
discrimination mentioned in art. 26
location. Special attention must should be given to of the ICCPR. Mentioning only
low- and middle-income countries, resource- socioeconomic status and
constrained settings, and marginalised geographical location risks leaving
communities, including the specific needs of aside situation in which access to
different groups, ages, segments, cultural systems, neurotech may be rendered
languages, communities, and marginalised and accessible in a discriminatory way,
based on race, gender, religion, etc.
vulnerable populations, people with disabilities, This also applies to the bottom part
neurological disorders, and mental health of the paragraph, the listing should
conditions. be comprehensive (why is gender,
for instance, not mentioned?).
Replace “must” by “should”, as this is
a recommendation (see also in
paragraphs below).
26. Individuals and groups should be allowed to make
lifestyle choices, express beliefs and opinions,
share personal experiences, and participate in co-
designing technologies, provided that these choices
are made in ways that respect the rights of others.
III.1.4. Consideration for cross-cultural
perspectives on human knowledge and its
sharing
27. Respectful knowledge sharing on the human
nervous system and its functions across
communities and cultures fosters trust and
strengthens global cohesion in the pursuit of health
and quality of life.
28. It is essential that any research and development Add “free” to “informed consent”.
involving diverse groups and communities is done
with their permission and guidance, and conducted Concern about the diversity of
wording for well-established
with their full prior and free informed consent and
principle, namely free and informed
partnership in ways that serve their interests and consent (see also in this respect art.
respect their traditional knowledge and epistemic 6 of the Universal Declaration on
contributions. human rights and biomedicine):
Different qualification throughout the
text “free informed”, only “informed
consent”, “fully informed consent”,
“affirmative consent”, “voluntary
consent”, “free, informed and
voluntary consent”: Consider
harmonising.
III.1.5. Commitment to peace, fairness and The title doesn’t seem to fit well to
para 29 and 30. What about peace?
justice in society
29. The use of neurotechnology should be used to See comment on para. 28.
promote, not undermine freedom of thought
especially in situations where refusal to use the
technology could lead to competitive disadvantage.
Such interferences include but are not limited to the
707
use of force, threats, undisclosed access,
manipulation, or any scenario where consent is
compromised, including as a result of power
imbalances.
30. The use of neurotechnology should be particularly Art. 26 ICCPR notably.
scrutinized to avoid uses that segregate,
discriminate, objectify or subordinate individuals or
communities, reduce social cohesion by
exacerbating pre-existing inequalities or generating
novel inequalities that divide and antagonize
individuals against each other, and thereby threaten
the coexistence between humans, other living
beings and the natural environment.
III.1.6. Global Solidarity and International
Cooperation
31. The Recommendation should guide all actors in the Threaten is only “potential”, it is
development, deployment and use of important to include situations where
neurotechnology to act in solidarity and call for an infringement has happened
(violation or abuse).
accountability in instances where neurotechnology
may be misused in ways that threaten, violate or
abuse human rights.
32. International cooperation is essential to addressing
cross-border issues related to neurotechnology.
Particular attention must be given to differing
perspectives on acceptable use to prevent abuse
and uphold global ethical standards.
III.1.7. Sustainability If only ecological sustainability is
meant, this should be specified.
Sustainability is a very generic term
that is sometimes used in other
ways.
33. Considering that sustainability requires that New technologies (including AI) are
neurotechnology be developed and used with a very resource intensive. This should
deep respect for environmental stewardship, also be clearly mentioned, linked with
climate change objectives.
prioritizing the minimisation of ecological harm
throughout the lifecycle of the materials used,
including, for mining extraction, data processing and
storage, recycling and disposal practices.
34. The unregulated development of neurotechnology,
especially for non-medical purposes, might lead to
disproportionate consumption of resources and
energy and waste production.
35. Respect for Indigenous rights, in accordance with
the United Nations Declaration on the Rights of
Indigenous Peoples (UNDRIP), requires that
neurotechnology, through its whole lifecycle, be
guided by a profound respect for the rights of Terminology: the rights of Indigenous
Indigenous peoplesIndigenous rights, ensuring that people?
their lands (including during mining), knowledge,
communal rights, and privacy are honoured in all
activities, including those related to resource
extraction.
III.1.8. Integrity and Responsibility The paragraphs in this section are
written more like principles than
recommendations. Consider
rewriting.
36. Integrity requires that all actors in the whole lifecycle
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of neurotechnology field act with ethical
steadfastness. It includes adhering to ethical
guidelines and ensuring that all actions align with
both professional standards and societal values.
37. Integrity includes a commitment to taking
responsibility for one’s actions and being
accountable for their outcomes. This involves not
only acknowledging successes but also owning up
to mistakes and taking corrective actions when
necessary.
38. Scientific integrity is the commitment to the rigorous
pursuit of truth through evidence-based, objective
and transparent research practices. It ensures that
all scientific endeavours are conducted with
honesty, accuracy, and respect for the scientific
method of disciplines relevant for neurotechnology.
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III.2. ETHICAL PRINCIPLES AND HUMAN It might be worth considering
RIGHTS adding a definition of the term
“thoughts”: It is important
precisely with regard to the scope
of protection of the fundamental
human rights guarantee.
Thus, the right to freedom of thought,
conscience and religion also includes
the right not to have to reveal one's
thoughts, religion and belief, as
the ECtHR and the UN HRC have
repeatedly emphasized. The
measurement and decoding of
neuronal activity, i.e. the “reading” of
thoughts, e.g. via non-invasive EEG
headsets, therefore affects not only
the scope of protection of the right to
privacy or the right to (negative)
freedom of expression, but also of
the right to freedom of thought.
If the term “thoughts” is interpreted
too narrowly, certain brain data that
allow conclusions to be drawn about
attitudes, views and ideas would be
not included in the scope of
protection. It is therefore important
to interpret the term “thought”
rather broadly, in line with the
case law of the Human Rights
Committee and the ECtHR.
This means that no distinction can or
should be made between thoughts
and thought processes: any influence
on neurons could potentially
influence the outcome of a thought
process and should therefore be
protected by the human right to
freedom of thought. There are thus
good reasons to consider the term
“thought” as encompassing all
neuronal activity. According to this
interpretation, any use of
neurotechnology to influence brain
activity would fall within the scope of
protection of the human right to
freedom of thought. Furthermore, all
types of brain data would be
protected.
39. This Recommendation embraces a human-centred The principles from III.2.1
approach through fundamental ethical principles (hereunder) are missing here.
including but not limited to self-determination,
agency, freedom of thought, privacy, cognitive
liberty, personal and collective identity,
trustworthiness, respect, reciprocity, and justice.
Furthermore, it incorporates the respect, promotion
and protection of human rights.
III.2.1. Beneficence, Proportionality and Do No
Harm
40. Neurotechnology should promote health and well- The decisions should be made as
being, and empower individuals to make free and uninfluenced as possible.
informed decisions about their nervous system and
Informed decision making does not
mental health independently, while fostering a better
relate to the title (beneficence, do no
understanding of themselves. harm…) but rather to autonomy.
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41. Neurotechnology should contribute to human
flourishing without causing harm, discrimination or Add “discrimination”.
subordination, whether physically, economically,
socially, politically, culturally, or mentally. The “do
no harm” principle must guide the whole lifecycle of
neurotechnology, ensuring that the quality of life is
protected and promoted.
42. Embracing neurotechnology for enhancement may
lead to the risk of not only unexpected damage to
the nervous system, but also to amplified
inequalities within society.
43. Any restrictions to human rights must meet all
applicable requirements under international human Add “international”.
rights law, including the principles of legality,
legitimate aim, necessity and proportionality.
44. The principles of proportionality, balance and
legitimacy should govern the use of
neurotechnology and the data it enables, to ensure
their use is: (a) appropriate and proportional to the
objective and expected benefits that are aimed to
be achieved; (b) do not infringe upon the
foundational values of this document; (c)
appropriate to the context and target user group; (d)
based on safety principles and rigorous scientific
evidence.
III.2.2. Self-determination and Freedom of
Thought
45. Throughout the whole lifecycle of neurotechnology,
the protection and promotion of the rights of
freedom of thought, and self-determination must be
secured.
46. Individuals have the right to make free, informed, Concern: The recommendation
and voluntary decisions about their engagement emphasizes informed consent, yet
with neurotechnology throughout the whole the broad applications of
neurotechnology (e.g., in non-
lifecycle, in accordance with international human
medical settings or for enhancement)
rights law and other international obligations and risk eroding autonomy, especially for
standards, including the right to refuse or withdraw vulnerable populations such as
from its use, at any time, ensuring their autonomy children, persons with disabilities,
and respect for their decision-making capacity is and marginalized communities.
upheld and where surrogate consent is used, the The language around informed
consent needs to clarify the
best interests of the affected individual are
possibility of power imbalances that
considered. Individuals who are enrolled in research could impair true voluntariness,
should be informed of potential side effects and especially in workplace or
given the opportunity to disclose if they have any educational settings.
contraindications for the procedures used. Informed
consent procedures should be affirmative, dynamic, Improvement suggestion: Strengthen
iterative and require opt-in, comprehensive and the informed consent process by
requiring dynamic, iterative
transparent providing detailed information about the
consent (opt-in and ongoing),
purposes, risks, benefits, alternatives, and possible especially for children and those with
outcomes of the technology in all its application diminished autonomy. Include
domains, ensuring that consent is voluntary and that requirements for non-coercive
individuals fully understand the implications for their practices and stipulate protective
privacy, autonomy, and well-being. measures to prevent undue
influence, as emphasized in ICCPR
Article 7 and CRPD Article 12,
which affirm individuals' right to
control over their personal and
711
cognitive autonomy.
“Free” and “voluntary” consent is
usually used interchangeably
See again comment on para. 28 on
terminology (free and informed
consent).
The grammar of the first sentence is
unclear. What is exactly meant with
the surrogate consent? Would this
always be an option concerning the
use of neurotechnology, even if this
affects the core of a person’s identity
and personality? This would be at
odds with many laws saying that
certain highly intimate decisions can
never be made by surrogates (e.g.
sterilization, marriage…). Moreover,
the surrogate decisionmaker should
first and foremost consider the
previously expressed or presumed
will of the affected individual (before
its “best interests”).
47. Neurotechnology should never be used to exert
undue influence or manipulation, whether through
force, coercion, or other means that compromise
self-determination and freedom of thought. This
protection covers both the internal processing of
thoughts and their external expression, ensuring
freedom from any interference.
III.2.3. Protection of Neural and Cognitive Concern: Neurotechnology,
especially those used to monitor or
Biometric Data for Mental Privacy modify mental states, poses a risk to
cognitive liberty, which is implicitly
protected under ICCPR Article 18
(freedom of thought provision).
Techniques that could modify or
influence thoughts, emotions, or
perceptions, particularly without free
and informed consent, may infringe
on mental autonomy.
Improvement suggestion: Reinforce
protections on cognitive liberty by
requiring that any use of
neurotechnology respects an
individual's freedom of thought and
opinion. Explicitly prohibit
involuntary or covert cognitive
interventions in contexts like
employment, healthcare, or legal
settings.
Establish oversight mechanisms for
technologies that influence cognitive
processes, with safeguards that
prioritize human dignity and mental
autonomy. See below (“Data Policy”).
48. Neurotechnology and cognitive biometric
technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct
and indirect data about the nervous system that is
uniquely sensitive because they can be processed
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and analysed to provide deep insights into the
processes that underpin our mental states and
behaviour, including self-awareness and
introspection. As it becomes increasingly difficult to
anonymize data, there remains persistent risks of
misuse of this data by revealing neurobiological
correlates of diseases, disorders, or general mental
states without the authorization of the person from
whom data are collected.
49. Mental privacy is fundamental for the protection of Mental privacy needs to be defined
human dignity, personal identity, and agency. The and explained.
collection, processing, modification, and sharing of Shouldn’t the recommendation go
even further and say that
neural data must be conducted with full, free, prior
neurotechnology must never be used
and informed consent, in ways that respect the to limit or abolish freedom of the
ethical and human rights principles outlined in this human will?
Recommendation.
See comment on para. 28 on
terminology (free and informed
consent).
50. There should be clear safeguards against the
misuse or unauthorised access of neural and
cognitive biometric data, including affirmative
consent, data minimization and purpose
specification, data rights (such as rights to access,
correct and delete), and data security, particularly in
contexts where such data might be aggregated with
other sources.
III.2.4. Non-Discrimination and Inclusivity Concern: The recommendation
acknowledges fairness and
accessibility concerns but lacks
specific provisions to prevent
discriminatory practices against
individuals with mental health
conditions, disabilities, or from
marginalized backgrounds.
Neurotechnology applications could
inadvertently amplify biases,
particularly in contexts like hiring or
healthcare, if they fail to account for
diverse neurological profiles.
Improvement suggestion: Introduce
explicit anti-discrimination clauses
that prevent the use of
neurotechnology in ways that may
perpetuate or exacerbate
inequalities. For instance, add
provisions that require
neurotechnology to be rigorously
tested for bias and ensure equitable
access and usability across diverse
populations, in line with ICERD and
CRPD requirements.
51. All actors involved in the whole lifecycle of See comment above.
neurotechnology, particularly in its interface with
other technologies like AI, must should commit to
upholding ethical principles that prevent
discrimination, stigmatisation, targeting, or
exploitation of any individuals or groups, particularly
those in vulnerable situations.
52. There is a shared responsibility to ensure that these
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technologies do not perpetuate or amplify existing
inequalities or create new forms of direct or indirect Add “direct or indirect”.
discrimination based on neurological or mental
characteristics, or other grounds protected under
human rights law.
53. Non-inclusive technological development and This paragraph is too weak:
standardisation may drive a trend toward inclusion is an important principle
homogenisation and the dominance of that should be emphasized here, for
example as follows:
neurotypicality and capacities that may threaten
cultural and collective identity. “Lack of access to new technologies
can result in many people being
unable to realize their life and self-
designs in the digital or real space.
Human dignity demands that all
members of the human family can
invoke the protection of human
dignity and that no one is excluded or
considered inferior”.
54. Garnering the trust and acceptance of communities
in the whole lifecycle of neurotechnology requires
transparent engagement with the public, seeking
their input and validation to align these technologies
with societal values and the common good.
55. Discrimination on any grounds, including intellectual
differences or those related to atypicality, should be What is meant by “atypicality”?
condemned. Neurotechnology should not be used
to inform, justify, or reify such discrimination. Care
should be taken to evaluate neurotechnology
solutions promoted through governments for
essential services such as education.
56. Neurotechnology should not be used to perpetuate What about other vulnerable people
stereotypes, stigma, or discrimination against older and people living in vulnerable
persons. situations?
III.2.5. Accountability Concern: Accountability mechanisms
in the recommendation are vague,
which limits enforceability. There
is a risk of insufficient oversight for
neurotechnology deployment and
potential abuses, especially given the
document's emphasis on private
sector involvement.
Improvement suggestion: Enhance
transparency and accountability by
mandating independent oversight
bodies and public reporting for
neurotechnology research and
applications. Establish accessible
complaint and redress
mechanisms for individuals
affected by neurotechnology-
related violations, ensuring full
compliance with international
human rights standards.
57. Maintaining trust and integrity throughout the whole
lifecycle of neurotechnology requires all actors to
adhere to the highest ethical standards, remain
open to feedback, be committed to adjusting
practices in response to new evidence or ethical
concerns, and be held accountable for their actions.
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58. Accountability is grounded in responsibility, clear
and transparent communication, and a duty to
anticipate and address potential harms—whether
short-term, long-term or arising from unintended use
and impact.
59. A commitment to accountability requires global,
governmental, societal and collective action to
ensure those harmed by neurotechnology have
access to justice, and that those responsible for
wrongdoing are required to take meaningful steps to
identify, prevent, mitigate and account for how they
address and redress their adverse human rights
impacts, including through corrective actions and
reparations.
III.2.6. Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection Explain clearly why neurotechnology
of human rights and fundamental freedoms, all always should be traceable and
actors throughout the whole lifecycle of explainable. This is hardly possible
when using AI.
neurotechnology must should ensure that their
activities are transparent, grounded in scientific The meaning of “trustworthiness” is
evidence, and aligned with international principles of not entirely clear and should be
responsible conduct and scientific integrity. This explained.
includes preventing the replication or amplification
of biases, ensuring that neurotechnology is
traceable and explainable, its capacities and
limitations are accurately portrayed, the conditions
for accountability are clearly defined, adhering to
ethical guidelines in research and development,
including the registration of trials, fair participant
selection, and approval by independent ethics
committees.
III.2.7. Epistemic Justice, Inclusive
Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation
of knowledge about neurotechnology, including
recognizing diverse ways of knowing, and that all
individuals and communities can participate in its
creation, sharing, and applications.
62. Promoting open and accessible education, along
with public and community engagement, to ensure
diverse populations can gain and exchange
knowledge about nervous system functioning,
mental health, and medical and non-medical
applications and tools of neurotechnology.
63. Effective public and community engagement
throughout the whole lifecycle of neurotechnology
requires respect for diversity, including linguistic,
social, cultural, heritage, and identity, to respect
different ways of knowing and understanding. This
respect for diversity ensures that the knowledge and
perspectives of diverse communities are valued and
included in decision-making processes, and
respects self-determination.
64. Grounding education in human rights ensures that
the knowledge shared and produced respects the
rights of all individuals, preventing epistemic
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injustice where certain groups may be marginalized
or excluded from knowledge production and
dissemination.
65. All communities should have a voice in decisions
that affect them, particularly when it comes to the
development and use of neurotechnology.
III.2.8. Best Interests of the Child and
Protection of future generations
66. The nervous system is rapidly evolving during Some specific elements might need
childhood and critically changing during to be added with regard to free and
adolescence, which makes it crucial to preserve the informed consent linked to children.
privacy, self-determination and the right of children
and adolescents to participate in decisions that
affect them. Technology should be rigorously
assessed to ensure it serves the best interests, well-
being and healthy development of children, as they
grow into autonomous individuals and safeguard the
rights of future generations by ensuring that today’s
decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the
potential benefits of neurotechnology for early
diagnosis, instruction, education, and continuous
learning, it is equally important to make a
commitment to the holistic development of the child.
This includes nurturing their social life, fostering
meaningful relationships, and promoting a healthy
lifestyle encompassing nutrition and physical
activity.
III.2.9. Global and social justice, enjoying the
benefits of scientific progress and its
applications
68. Access to and benefits arising from research and
development in neurotechnology must should be “should”.
shared equitably among all contributors to that
research and development, with a particular focus
on ensuring global distribution that promotes
fairness and reduces disparities.
69. Neurotechnology developments should be
leveraged to reduce global health inequities. These
technologies should serve as catalysts for improving
the quality of life, particularly in resource-limited
settings.
70. Research, development, and trials in
neurotechnology must adhere to the highest ethical
standards, ensuring the non-exploitative
participation of all individuals involved. This includes
safeguarding the rights and well-being of
participants, and patients and their caregivers, as
well as ensuring the ethical collection and use of
data. Special attention should be given to ensure
that those contributing to research and development
have their fair share of the benefits and do not bear
disproportionately the risks.
71. Efforts, including international cooperation, should
be made to overcome, and never take advantage
of, the lack of necessary technological or medical
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infrastructure, education and skills, as well as
ethical-legal frameworks, particularly in LMICs, Have these abbreviations been
LDCs, LLDCs and SIDS, affecting communities. explained?
72. The development and impact assessment of novel
neurotechnology should consider the
implementation of human-centred paradigms in
which end-users are not merely passive recipients
of the technologies but active co-shapers on an
equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1. GOVERNMENT INVESTMENT, USE AND
REGULATION
73. Member States, private actors and international Include that they should support
institutions should actively support the research, “responsible” neurotechnology
development, and deployment of responsible development, not any kind of
neurotechnology.
neurotechnology for the public good. Investments
should prioritize applications that foster human Not sure what is meant here
flourishing, and the use of which respects, protects (“collective human rights”). Just
and promotes and protects individual and collective mention “human rights”.
human rights. This commitment should include
funding for interdisciplinary research that not only
advances neurotechnological innovation but also
studies the ethical, legal, social, environmental and
cultural implications of these technologies, and
supports the implementation and clinical translation
of technological prototypes. Particular attention
should be given to the development and
implementation of adequate technical, institutional,
procedural and other safeguards to ensure that they
equitably benefit society and that human rights and “and the rule of law”.
the rule of law are upheld.
74. Member States should establish clear prohibitions The general mention of unspecified
against the use of neurotechnology in contexts that weapon systems in the context of
violate individual and collective human rights. bans or regulations should not be
mentioned in this recommendation.
Member States should conduct human rights due
Corresponding discussions /
diligence, including regular, comprehensive human negotiations should be held in the
rights impact assessments, concerning adequate arms control and
neurotechnology that they develop, design, deploy, disarmament forums.
use, sell, operate or procure, in order to prevent and
mitigate their adverse human rights impacts. Concern: The recommendation lacks
Specifically, neurotechnology should not be used for clear prohibitions against the use of
neurotechnology for coercive
purposes such as non-consensual interrogation in purposes, such as in law
law enforcement, criminal and civil justice, enforcement or interrogation. CAT
development or deployment of weapons targeted at Articles 2 and 16, along with
the nervous system, social control, attempts at ICCPR Article 7, emphasize
coercive behavioural conformity based on personal protection against torture and
beliefs or thoughts, political or other opinion, gender inhumane treatment.
identity or sexual orientation, or surveillance of
Improvement suggestion: Add
mental states, among others. Governments should explicit prohibitions on using
adopt legislation that ensures neurotechnology is neurotechnology for coercive
deployed responsibly, and based on human rights, applications, including interrogation,
with robust and independent oversight mechanisms manipulation, or control of mental
to enforce adherence to these restrictions and states in ways that violate personal
protect mental privacy and freedom of thought for all autonomy or mental integrity. Add a
recommendation concerning
individuals. These policies should be developed in
penalties and oversight for misuse
consultation with diverse actors, including civil in these sensitive domains to
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society, end-users, neurotechnology experts, ensure alignment with CAT and
ethicists, and human rights advocates, to ensure ICCPR standards.
broad consensus and respect for global human
We support the inclusion of “mental
rights norms law.
integrity” here. Indeed, reference is
made to “integrity” in the draft
recommendation but only in relation
to “scientific integrity” and “bodily
integrity”, but not to “mental integrity”,
even though it is a major concern
when it comes to neurotechnology.
“Human rights law”: we suggest this
language as it also doesn’t exclude
regional framework.
75. Member States should ensure transparency and
accountability in their support, oversight, and
regulation of neurotechnology, particularly in
publicly funded initiatives such as brain research
and development programs. While recognizing the
limitations in disclosing certain sensitive information,
governments should require government sponsored
neurotechnology projects to publicly disclose the
objectives, methodologies, intended uses, and
societal impacts of their neurotechnology initiatives
wherever possible. This transparency is crucial for
fostering public trust and ensuring that
neurotechnology advances are aligned with ethical
standards and human rights.
76. Member States should apply a comprehensive
approach to regulatory and policy measures to
protect against human rights harms related to
neurotechnology developed, marketed, operated or
Reference to the Human Rights
used by the private sector. In accordance with the Council Advisory Committee report
UN Guiding Principles on Business and Human on the “Impact, opportunities and
Rights, States should establish a national challenges of neurotechnology
framework, including oversight mechanisms, and with regard to the promotion and
exercise their duty of due diligence with respect to protection of all human
neurotechnology companies. This includes rights” presented at the HRC’s 57th
session, and in accordance with the
legislative and regulatory measures and UN Guiding Principles on Business
accompanying guidance, incentives, and and Human Rights.
transparency requirements. This comprehensive
approach should also require human rights due
diligence, ensuring that businesses identify,
prevent, mitigate, and account for their adverse
human rights impacts through context-dependent
processes, including human rights impact
assessments, meaningful public and community
engagement, and transparent communications.
States should ensure access to effective remedy for In accordance with the UN Guiding
those affected by human rights violations in the Principles, States should also ensure
context of neurotechnology. access to effective remedy.
77. Member States should ensure that any use of
neurotechnology in the justice system, including its
consideration by the judiciary should be grounded in
robust scientific evidence, be implemented ethically
Add “the rule of law”.
and in accordance with human rights and the rule of
law, and be aimed at promoting public safety while
protecting the rights and dignity of all those
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involved. This requires respect for fundamental
rights, such as human dignity, bodily integrity,
confidentiality of personal data, due process and fair
trial rights, including the presumption of innocence,
and the right against self-incrimination, as well as
freedom from torture and ill-treatment, the right to
privacy, and the right to freedom of thought.
78. Member States should establish comprehensive The first sentence is unclear. What
incentive structures, such as tax incentives, grants, should MS incentivize? Make the link
and awards, with a particular focus on encouraging to neurotechnology clearer.
the construction and development of manufacturing,
computational resources, and data analytics
capabilities within public research institutions and
small and medium enterprises (SMEs). Member
States should also incentivize and support
partnerships that leverage the computational
resources and data analytics capabilities of private
firms to advance public research goals. These
incentives should prioritize rewarding transparency,
participatory development processes, and
contributions to societal benefits, aiming to foster an
environment where public institutions and
companies innovate responsibly and align with
human flourishing goals.
79. Member States should establish a coordinated, The term “technology assessment”
cross-sectoral approach to assessing the impacts of could be used here, which should be
neurotechnology across the whole lifecycle. This done in a comprehensive way
involving ethical aspects in addition
approach should include, but is not limited to:
to economical and social ones.
(a) Economic Impact Assessments: Conducted
by relevant national bodies responsible for
economic and labor policies to assess how
neurotechnology impacts economic growth,
jobs, social justice, and environmental
sustainability;
(b) Benefit-Risk Assessments: Managed by
entities responsible for public health, medical
research, and consumer protections, these
assessments should rigorously evaluate the
risks and benefits associated with the
development, deployment, and use of
neurotechnology, including research, clinical
applications, and consumer products. The
process should include thorough
documentation, ethical oversight, and
continuous monitoring to ensure the safety,
well-being, and equitable treatment of all
individuals involved;
(c) Privacy Impact Assessments (PIAs): under
the oversight of relevant national authorities
or agencies responsible for data protection
and privacy, these assessments should
evaluate and mitigate risks to individuals’
mental privacy posed by neurotechnology.
This includes ensuring that appropriate
safeguards are in place to protect neural and
cognitive biometric data in compliance with
719
national and international privacy standards,
and the data policy practices discussed
herein;
(d) Human Rights Impact Assessments (HRIAs): Important! Insert possible reference
with oversight from relevant national human to “UN Guiding Principles on Human
rights institutions or international bodies, Rights Impact Assessment of
Economic Reforms”, A/HRC/40/57
identify, prevent, and address potential
human rights impacts of neurotechnology.
The process should ensure that
neurotechnology respects and promotes
human rights, with particular attention to
vulnerable people and people living in
vulnerable situations. HRIAs should involve
meaningful public and community
engagement to incorporate diverse
perspectives.
80. Member States should promote equitable access to
neurotechnology worldwide. To achieve such goals,
efforts should be made to support the reduction of
final costs for end users, pursue the development,
adoption and continuous support of non-proprietary
software solutions, and explore reimbursement
strategies or subsidisation commensurate with
conventions in local jurisdictions, in sectors of
crucial potential benefits.
81. Member States should adopt agile regulatory
frameworks, including the use of regulatory
sandboxes—controlled environments for
developing, testing, and evaluating
neurotechnology—in response to rapid
advancements in neurotechnology and its
convergence with other technologies such as AI,
spatial computing, and immersive technologies.
These sandboxes should be used to explore
innovative applications, particularly in workplace
settings, with appropriate ethical oversight provided
by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure
ethical data processing, and safeguard rights by
incorporating mechanisms for regular monitoring,
evaluation, and dynamic policy adjustments in line
with technological and ethical developments.
IV.2. DATA POLICY
82. Member States should develop a robust regulatory Concern: The scope of cognitive
and legal framework to govern the collection, biometric data collection and storage
processing, sharing, and all other uses of neural raises significant privacy issues.
Neural data is highly sensitive and
and cognitive biometric data. This and existing
reveals personal aspects of identity,
frameworks should recognize this data to be both personality, and mental health.
personal and sensitive data in medical and non- Under ICCPR Article 17, privacy
medical contexts. rights protect individuals from
arbitrary or unlawful interference, but
the current recommendation does
not fully address the risks of
unauthorized access or potential
misuse of neural data.
Improvement suggestion: The
recommendation could benefit from
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embedding stricter privacy
safeguards, such as stringent
limitations on data collection, explicit
restrictions against using data for
predictive profiling without
consent, and clear guidelines on
data anonymization. Additionally,
include provisions for regular,
independent privacy audits to align
with ICCPR and CRPD privacy
mandates.
83. Member States should ensure that their existing
privacy policies comprehensively cover stringent
safeguards for individuals’ neural and cognitive
biometric data. If current policies do not adequately
address these areas, Member States should adopt
targeted legislation or regulatory frameworks to
secure these protections. These safeguards should
for example include explicit, affirmative informed
consent, data minimization and purpose limitation,
data rights (including the right to access, correct,
and delete data), and stringent data security
measures, such as advanced cybersecurity
protocols to prevent unauthorized access and
breaches. Such legislation or frameworks should
prohibit the practice of tying access to goods or
services to the disclosure of neural and cognitive
biometric data, require explicit opt-in for any data
sharing, and forbid the use of such data for targeted
advertising without the individual’s explicit,
affirmative informed consent.
84. Member States should develop and implement
specific policies to reduce the ecological footprint of
neurotechnology, particularly in relation to large-
scale data centers and computing resources used
for processing and storage of neural and cognitive
biometric data. These policies should emphasise
data minimisation, ensuring that only the necessary
amount of data is collected and processed, and
promote the proportional use of neurotechnology,
aligning its deployment with genuine needs and
minimising unnecessary environmental impact.
Measures should include optimising energy
efficiency, using renewable energy sources,
promoting the recycling and sustainable disposal of
neurotechnology-related equipment, and ensuring
the rehabilitation of affected environments.
85. Member States should support and incentivise the
development and implementation of technological
innovations and design standards for
neurotechnology that prioritize the protection of
mental privacy, such as state-of-the-art encryption,
secure databases with multi-factor authentication,
cutting-edge anonymization techniques, and edge-
processing and storage (processing and storing
data closer to where it is being generated), leading
to greater action-led results in real time storage of
neural and cognitive biometric data.
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86. Member States should incentivise neurotechnology
manufacturers to prioritize privacy and ethics by
design, requiring the incorporation of privacy-
preserving technologies as default features in their
devices.
87. Member States should encourage ethical data
sharing by establishing secure, data repositories for
neural and cognitive biometric data used in
research. These repositories should meet stringent
cybersecurity, data privacy, and ethical use
standards (including data minimisation and purpose
limitations), tiered access and other privacy-
enhancing approaches. Appropriate funding
mechanisms should be established for the curation
and maintenance of data and data governance
processes streamlined.
88. Member States should prioritize efforts to reduce
obstacles to cross-border data sharing in
neurotechnology research, working towards greater
alignment of data protection standards, particularly
concerning neural and cognitive biometric data, by
establishing clear protocols for data transfer that
ensure secure and compliant data exchanges
across borders, and standards for interoperability of
data, including governance frameworks for data
sharing.
89. Member States should consider specific guidelines
for the ethical use of neural and cognitive biometric
data in AI development and research, including
consent procedures for uses of neural and cognitive
biometric data in training and application of AI
models, ensuring transparency and respecting
individual and community rights.
IV.3. INTELLECTUAL PROPERTY (IP) It is not clear what added value this
section brings: consider deleting it
completely. The TRIPS Agreement
constitutes the international legal
framework with respect to the
protection of IP rights.
It envisages a balanced IP system
that incentivizes innovation and also
promotes access to and
dissemination of technology.
90. Member States should adopt policies to ensure that Deletion. There is no need to adopt
neural and cognitive biometric data, as individual specific policies with regard to neural
human activity derivatives, are not subject to and cognitive biometric data since
the international legal framework on
proprietary rights. IP protection should only apply to
IP (TRIPS Agreement) already sets
original data compilations (created through a the criteria for IP protection. Art. 10
process of aggregation, organization, or selection, already states that compilations of
resulting in a new dataset) that meet strict and data which by reason of the selection
ethical criteria. or arrangement of their contents
constitute intellectual creations shall
be protected as such. This provision
also clarifies that such protection
does not extend to the data itself.
This is regardless of the type of data
involved.
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The first sentence could be seen as
counterproductive in the context of
sensitive personal data protection
and the empowerment of individuals
over their (own) data.
91. Member States should collaboratively establish Why do we need IP guidelines for
clear, harmonised guidelines for IP rights applicable neurotechnology? Are there practical
to neurotechnology on an international scale. These problems that require this, what are
they? What should the content be
guidelines should address the patentability of AI-
about and who should be the
generated inventions and the ethical implications of addressee of such guidelines?
IP laws, ensuring they promote global accessibility
and innovation. There is no link between
neurotechnology and AI-based
inventions. These are two different
subjects.
The rest of the sentence is
unnecessary, as patent law, which is
largely harmonized, already takes
ethical aspects, technology
accessibility, and the promotion of
innovation into account.
92. Member States should ensure that all actors adopt Developing an IP management
IP management strategies that encourage strategy is first and foremost a matter
innovation and avoid overly restrictive patent use, for the rights holders. It is their
decision whether to develop a
fostering an open innovation ecosystem. This
strategy. On the contrary, “should
approach should continuously adapt to the evolving ensure” sounds more like a ‘top-
landscape of neurotechnology. The impact of IP down’ approach - Member States
policies on the neurotechnology sector should be cannot make this decision for rights
continuously monitored to ensure they stimulate holders. Such strategies are also
innovation while ensuring ethical use and broad developed primarily with the legal
accessibility. professions, in particular with lawyers
and thus with private sector actors. In
addition, adaptation to the evolving
landscape of neurotechnology
requires sector-specific knowledge -
How should this be implemented in
practice?
Such knowledge will generally also
be held by the relevant actors in this
sector, namely the rights holders
themselves.
Patent law reflects a balanced
innovation policy.
Member states should remain free to
determine the type of innovation
ecosystem they wish to support or to
support several different innovation
ecosystems.
93. Member States should foster an environment of co- The terms "policies and incentives for
creation in neurotechnology, by facilitating policies co-ownership" are unclear, as are
and incentives for co-ownership and preferential their potential effects.
licensing agreements to ensure equitable
Similarly, the terms "preferential
compensation and recognition for all contributors. licensing agreements" are unclear.
Who would they favor, and at whose
expense?
94. Member States should adopt policies with respect to It is not clear why IP protection
open science that balance the protection of IP with should be balanced with immediate
the promotion of immediate publication of results publication of result and data
sharing.
and data sharing. Particularly with the convergence
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of digital technologies and the increasing
concentration of those innovations in industry The additional and non-prescriptive
sectors, this balance is crucial to ensure that IP information muddles the content of
the article.
protection mechanisms do not hinder Those policies
should foster scientific research, innovation, and the
wide dissemination of knowledge and new Why are Indigenous Peoples
technologies. As a basic rule of equitable explicitly mentioned here, while other
partnership, when Indigenous Peoples are involved local communities are not?
in neurotechnology research and development,
open science processes, IP management strategy,
should be developed in collaboration with them from
the beginning.
IV.4. CYBERSECURITY
95. Member States should collaborate internationally to
establish comprehensive standards for
cybersecurity across all neurotechnology domains.
These standards should encompass hardware,
software, and data security measures to protect
against potential cyber threats. By implementing
uniform cybersecurity standards, Member States
should ensure the integrity, confidentiality, security,
and availability of neural data, as well as enhance
user trust and confidence in neurotechnology
devices. Additionally, these standards should evolve
in tandem with technological advancements and
emerging cyber threats to maintain robust protection
against evolving risks.
96. Member States should employ red-teaming
exercises—adversarial challenges to test the
efficacy of security systems—as a proactive
measure to assess and enhance the safety,
security, and resilience of neurotechnology systems.
By conducting regular red-teaming exercises,
Member States should could proactively identify and
address security gaps, test incident response
procedures, and strengthen the overall safety and
cybersecurity posture of neurotechnology devices.
IV.5. COMMUNICATION, PARTICIPATION,
AND INFORMATION
97. Member States should promote communication and
develop engagement policies for neurotechnology
that foster informed, inclusive, and respectful
dialogue between researchers, developers, diverse
users, and the broader public to respect individual
and community rights, promote public trust, and
harness the collective intelligence and diversity of
communities.
98. Member States should collaborate with international
organizations, educational institutions, and private
and non-governmental entities to develop and
disseminate accessible and engaging educational
materials tailored to diverse audiences to bridge
knowledge gaps, particularly in underserved regions Underserved regions? Terminology?
about the nervous system and mental health
functioning, as well as the benefits and risks of
neurotechnology. These programs should aim to
724
increase public understanding of the technologies’
functionality, safety, efficacy, and societal impact,
empowering individuals to make informed decisions
and to enable their ethical reflection about their use
of neurotechnology.
99. Member States should implement public and
community engagement processes that facilitate
genuine mutual learning and collaboration
throughout the whole lifecycle of neurotechnology.
These processes should include regular and
inclusive consultations with a wide array of actors.
The aim of these engagements should be to inform
policy development, shape ethical guidelines,
increase public awareness and understanding, align
investment priorities, and ensure that
neurotechnology deployment aligns with public
interests and values. Special attention should be
given to involving groups traditionally
underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation It may be better to speak of
of accurate, precise, and understandable accessible “understandable language” than of
language and terminology for discussing “accessible language”.
neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is
inclusive, non-stigmatizing, and accurately reflects
the technologies’ capabilities and limitations.
Member States should establish regulatory
frameworks that require clear and ethical
communication standards for neurotechnology.
These frameworks should require evidence-based
reporting of capabilities, risks, and limitations across
all applications to avoid exaggeration of claims,
including but not limited to applications in sleep,
attention, memory, and emotional regulation. Within
these frameworks should be specific guidelines for
ethical marketing and protocols for responsible
communications about early-stage research and
emerging technologies.
101. Member States should develop policies that foster
effective collaboration between end-users,
researchers and innovators throughout the whole
lifecycle of neurotechnology product development,
with special focus given to the places where the
neurotechnology is being developed. These policies
should mandate the creation of diverse advisory
panels, including representatives from various user
groups and respecting neurodiversity. Member
States should also establish platforms for ongoing
dialogue and feedback between users, researchers
and developers. Advisory panels should be involved
in the process of developing and testing new
neurotechnology products to optimize device
efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that
innovations in neurotechnology are context-
compatible and meet the needs of diverse user
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populations.
102. Member States should develop age-appropriate,
contextually-appropriate, culturally- appropriate, and
linguistically-appropriate education about
neurotechnology. This should include training
modules to aid in the supportive use of these
technologies at home, both for the user and for
caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6. CHILDREN AND ADOLESCENTS Concern: The recommendation
addresses neurotechnology’s use in
education but lacks specific
guidelines to protect children’s rights
under the CRC, particularly regarding
their evolving capacities and the
potential long-term psychological
impacts of neurotechnology use.
CRC Articles 3 and 12 mandate that
the best interests of the child be a
primary consideration, especially in
decisions affecting their well-being
and participation in technology use.
Improvement suggestion: Strengthen
protections by specifying that
neurotechnology in educational or
recreational settings should only be
used with child-friendly informed
consent, robust safeguards for
psychological well-being, and strict
limitations on data collection. Include
procedures for periodic review of the
technology’s impact on
developmental health to align with
the CRC’s protections.
103. Member States should promote healthy brain It should be noted that the brain
development through policies that evaluate the matures up until the age of 25 years
impact of neurotechnology on children and roughly, so beyond the age of
adulthood (18 years). The special
adolescents.
protection of the young should
therefore not stop at the age of 18
but last at least until 25 years. In
addition to children and adolescents
you could include the category of
“young adults”.
104. Member States should safeguard children and
adolescents from implicit and explicit coercion to
use neurotechnology. Member States should pay
attention to the autonomy of children and
adolescents through informed consent and assent
that is adapted to and respectful of age and
decision-making capacity.
105. Member States should fund research and
development grants focused on creating user-
friendly assistive neurotechnology tailored for
children and adolescents with disabilities. These
projects should involve children, adolescents,
parents and caregivers in the design process to
ensure the technologies meet their specific needs.
Educational programs should be developed to teach
children and adolescents and their caregivers how
726
to effectively use and maintain these technologies,
with support available in multiple languages and
accessible without discriminating against those who
either cannot or choose not to engage with the
proposed technology.
106. Member States should ensure research involves
strict oversight and close follow-up of all
neurotechnology research involving children and
adolescents. This oversight is crucial during the
developmental phases of childhood to address and
mitigate any unforeseen long- term effects. Such
research must should include comprehensive
monitoring protocols and periodic evaluations to
ensure the ongoing safety and well-being of young
participants, taking into account their unique
developmental needs and vulnerabilities. In the
framework of research, involving children and
adolescents in medically vulnerable situations (i.e.,
children in epilepsy monitoring units), special
attention will be given to consent and assent,
particularly considering particular aspects of
research (time, iterations) to prevent any form of
instrumentalization.
107. Member States should enact specific regulations
that prohibit the use of marketing techniques—such
as neuromarketing, biometric emotional analytics,
immersive advertising, and virtual or augmented
reality advertising—that rely on sensitive neural and
cognitive biometric data collected from children and
adolescents. Recognizing the heightened
vulnerability of children and adolescents in digital
environments, these regulations must explicitly
forbid any practices that use such data to influence
or exploit children and adolescents.
IV.7. OLDER PERSONS
108. Member States should promote healthy aging and
support elderly individuals by funding and
implementing evidence-based programs that
integrate neurotechnology into routine care. These
programs should involve the entire support
ecosystem, including family, caregivers, and
medical teams, to enhance quality of life. Priority
should be given to developing and implementing
tools that prevent, delay, and treat age-related
health conditions, impairments, and
neurodegenerative diseases. Member States should
ensure that access to these neurotechnology
programs is equitable and does not exacerbate
socioeconomic inequalities.
109. Member States should establish guidelines for
neurotechnology design sensitive to the needs of
older adults, carefully considering human-computer
interface factors for usability (such as fonts, buttons,
and colour) and experience for enhanced visual and
auditory cues.
110. Member States should preserve, support, and
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promote autonomous decision-making for older
people using neurotechnology for sensorimotor and
cognitive support. The consent process should
accommodate potential cognitive challenges faced
by older adults, ensuring that consent is informed,
ongoing, and adaptable to changing health
conditions. Policies should be in place to ensure
that assistive neurotechnology recognize changing
cognitive capacities over time and respect users’
preferences.
111. Member States should develop ethical guidelines to
ensure that neurotechnology such as robotic
caregivers enhance rather than replace human
interaction, particularly in the care of individuals with
neurodegeneration. These guidelines should
emphasize the augmentation of human care, not its
replacement.
IV.8. WOMEN AND GENDER
112. Member States should adopt and enforce
comprehensive policies that promote and respect
gender equality and diversity in the whole lifecycle
of neurotechnology. The policies should prioritize
inclusive research for addressing women and
gender specific needs and differences, require
targeted data collection and analysis, include
education and training programmes on inclusive
research practices, ensure public and community
engagement with women and gender health experts
and advocacy groups and, incentivise gender
responsive technology design, to meet the needs
and conditions specific to women and gender
minorities. Affirmative action policies are necessary
to close gender gaps in these fields, increase
representation, engagement and leadership.
113. Member States should establish clear guidelines
and legal frameworks to ensure that workplaces and
research environment, throughout the whole
lifecycle of neurotechnology, are inclusive and
supportive, particularly for women and gender
minorities, and safeguard against harassment and
discrimination. This should include robust
mechanisms for reporting and addressing incidents
of harassment and discrimination, ensuring
accountability and support.
114. Member States should adopt a range of measures
that prioritize ethical and equitable research and
innovation and support programs that foster
women’s and gender minorities’ participation in
neurotechnology. This should includesinclude
funding and other policies that prioritize ethical and
equitable research and innovation, but also
affirmative action initiatives to support the
participation of women and gender minorities in
neurotechnology through targeted education
programs, employment opportunities,
entrepreneurship support, and leadership
development within the sector. Member States
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should also provide support systems such as
mentorship programs, networking opportunities, and
resources to help women and gender minorities
overcome barriers to participation and succeed in
the neurotechnology field.
IV.9. PERSONS WITH PHYSICAL
DISABILITIES
115. Member States should adopt policies that harness
the potential of neurotechnology by removing
barriers experienced by persons with physical
disabilities and providing support thereby
contributing to achieving equal enjoyment of human
rights. They should implement regulatory
frameworks that require accessibility assessments
for all new neurotechnology products to ensure
these products do not perpetuate existing
disabilities or health disparities. These frameworks
should include protocols for testing with diverse
groups of persons with disabilities to ensure
technology meets a wide range of needs and does
not unintentionally exclude or disadvantage any
subgroup.
116. Member States should create incentive programs to
promote the development of neurotechnology for
people with disabilities to promote their quality of life
and functional independence. These programs
should include tax incentives for companies
investing in assistive neurotechnology research and
development, grants for research institutions
focusing on neurotechnology for disability support,
expedited regulatory reviews for technologies
offering significant advancements in mobility,
communication, or daily living assistance, and
innovation prizes for breakthroughs in affordable,
accessible neurotechnology solutions.
117. Member States should, whenever possible,
subsidise the cost of essential neurotechnology
devices, such as neuroprosthetics, for persons with
physical disabilities. They could encourage public-
private partnerships to make advanced
neurotechnology affordable and integrate
neurotechnology coverage into national health
insurance and other reimbursement schemes for
persons with physical disabilities. A national
database of available neurotechnology resources
and support services should be developed to
facilitate access and information sharing.
IV.10. PERSONS WITH MENTAL HEALTH
CONDITIONS
118. Member States should foster research and promote
awareness-raising initiatives to address the
increasing prevalence and special needs of people
with mental health conditions, including victims and
survivors of trauma and violence, and the relevance
of neurotechnology for these communities.
119. Member States should allocate funding for long-
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term advocacy and efficacy studies, post-market
oversight, and tiered scrutiny with special attention
to invasiveness and reversibility of neurotechnology
interventions. It is important to ensure that people
with mental health conditions are well-informed and
have reasonable expectations about the process.
120. Member States should prioritize funding for
neurotechnology that is designed to improve quality
of life and daily functioning of individuals with
mental health conditions. This should include
includes technologies that assist in managing
symptoms, improving cognitive functions, and
providing emotional support at home, in the
workplace, in their communities, and in society.
Research and development should be guided by
feedback and engagement with persons with mental
health conditions and their advocates.
121. Member States should establish policies that
improve access to timely advances in
neurotechnology for those with mental health
conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and
supports.
HEALTH AND RESEARCH ETHICS
IV.11. HEALTH
122. Member States should support the development of
health applications that prioritize the unmet needs in
the provision of neurological and mental health. This
should include establishing research funding
programs specifically targeted at addressing
identified gaps in nervous system care.
123. Member States should build and maintain
international solidarity, and foster dialogue and Add “foster dialogue and
cooperation, to address global health risks and cooperation”.
uncertainties, and ensure that their implementation
of healthcare for the nervous system is consistent
with international law and rigorous human rights
obligations. This could involve creating international
forums for sharing best practices in the
implementation of neurotechnology in healthcare.
124. Member States should establish oversight
mechanisms to evaluate the physical and mental
health impacts of long-term use of
neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology
interventions. This includes should include
implementing regulatory measures requiring long-
term follow-up studies for approved
neurotechnology devices and establishing clear
criteria for continued approval based on these
studies results.
125. Member States should consider the significant cost
and impact associated with pathologies related to
the nervous system, as well as the potential benefits
of early diagnosis and access to preventive and
assistive neurotechnology. Public policies should
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prioritize the promotion of access to these
technologies and ensure health cost coverage for
individuals in need.
126. Member States should promote the development of
reliable and durable neurotechnology for healthcare
applications. This includes should include
encouraging the design of devices and systems that
require minimal maintenance, ensuring they remain
functional and effective under everyday conditions.
Regulatory bodies or designated authorities should
oversee the enforcement of rigorous standards for
quality, safety, and longevity, thereby reducing the
burden on users and enhancing the dependability
and sustainability of neurotechnological solutions.
127. Member States should ensure the development or
strengthening of existing comprehensive
neurotechnology medical device reporting systems
that track and address adverse effects. In contexts
where such systems do not exist, Member States
should establish them. Where systems are already
in place, they should be updated to specifically
include neurotechnology. These systems should be
interoperable and contribute to a centralised, public,
and transparent international database, managed in
collaboration with international organizations, to
ensure that global standards are met and
accessible for public knowledge, international
oversight and research.
IV.12. RESEARCH ETHICS
128. Member States should reinforce the ethical
frameworks governing neurotechnology research to
ensure robust protection of human participants.
Member States should adopt clear guidelines or
policies that define the qualifications to ensure that
research is conducted by professionals with
appropriate knowledge about the nervous system
structure and function in addition to brain disorders
and is performed in adequate research settings.
Furthermore, research protocols, public or private,
in the medical as well as the non-medical domain,
should be carefully evaluated by registered ethics
boards (ethics committees) and specific attention
dedicated to individuals with special situations
regarding vulnerability such as diminished capacity
to consent or to make decisions. Member States
should ensure that all research institutions have
mandatory ethics training for researchers.
129. Member States should encourage multicentre
international research that involves various cultures
and ethnic groups. Member States should promote
international cooperation to develop common
reporting standards and protocols for
interoperability, particularly for implantable
neurotechnology devices. This cooperation should
aim to enhance the comparability and utility of
research globally, improving both the efficacy and
ethical integrity of research.
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130. Member States should ensure that the whole
lifecycle of neurotechnology is considered in the
design of a clinical trial, including policies to protect
patients in case of cessation of activities of the trial
sponsor or promoter. Member States should
establish requirements for clinical trials to be
included in relevant nationally or internationally
approved registries, and encourage registration with
community and patient registries. Also, clinical trials
should report on appropriate medical device
reporting systems developed within Member States.
131. Technology developers should ensure that the
validation of AI algorithms in neurotechnology
research include rigorous testing for biases, as well
as measures to enhance explainability and
transparency, including the provenance of training
datasets. Suitable techniques should be employed
to mitigate any biases present in AI models used in
neurotechnology applications.
132. Member States should ensure that research efforts
not only focus on biomedical risks associated with
neurotechnology but also investigate potential
effects on an individual’s subjective experience,
agency and personal identity. Understanding how
neurotechnology may impact aspects of self-
perception, consciousness, and identity is essential
for addressing ethical concerns and ensuring the
well-being of individuals using these technologies.
133. Member States should ensure those engaged in
research implement regular auditing and monitoring
of research practices to ensure adherence to ethical
standards. This should include evaluating the
adequacy of informed consent, particularly
concerning data reuse and the potential
commercialisation of neural data.
134. Member States should require researchers in
neurotechnology to establish clear and transparent
protocols for communicating clinically significant and
actionable incidental findings to participants. These
protocols should ensure that such findings are
conveyed promptly, respecting participants’ rights
and autonomy. Additionally, Member States should
mandate that researchers provide the necessary
support and coordination with healthcare providers
to address any health concerns that arise from
these findings.
135. Member States should ensure that individuals
involved in neurotechnology research or receiving
neurotechnological interventions are adequately
informed about the potential for incidental findings,
particularly those with significant health implications. See comment above about “informed
The full, free, prior and informed consent process consent”.
should clearly outline what these findings might
entail, the participants’ right to choose whether they
wish to be informed about such findings, and
guarantee that their decisions in this regard will be
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respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION
OUTSIDE OF HEALTH
IV.13. EDUCATIONAL SETTINGS
136. Member States should approach with caution the
integration of neurotechnology in education,
ensuring that its use is evidence-based and aligned
with the education goals and complements
traditional learning methods. Emphasis should be
placed on promoting the holistic development of
students, focusing not just on academic
performance but also on mental health, well-being,
and overall interests. To ensure inclusivity, Member
States should develop age-appropriate guidelines
for neurotechnology use across different
educational stages and learning styles. Regular
assessments of neurotechnology’s impact on
student development, including mental health,
should be conducted, with ethical review processes
established to oversee deployment. The primary
The term “emotional intelligence” is
focus should be on fostering critical thinking,
introduced here: a term that is highly
creativity, and emotional intelligence rather than open to interpretation. This point
solely enhancing academic performance. should be critically questioned.
137. Member States should adopt policies ensuring the
voluntary deployment of neurotechnology in
education, grounded in full, free, prior and fully
informed consent. These policies must include
clear, age-appropriate information about the
technology’s purpose, benefits, and risks, with
adequate consideration periods. Considering the
increased complexity of obtaining voluntary consent
in this context, consent and assent procedures
should involve children, adolescents, parents,
guardians and all actors necessary to obtain
approval required for minors. Ethical oversight
mechanisms should be established, including
regular consent renewal and immediate cessation of
neurotechnology use upon withdrawal, and ensure
anonymous feedback channels. Policies must
prohibit undue incentives or academic penalties for
non-participation and take measures to avoid
creating or reinforcing inequalities among students.
Additionally, Member States should support student
involvement in decision-making about
neurotechnology integration and fund training
programs on its ethical use, empowering educators
and students to critically assess its application.
138. Member States should establish a unified, robust
and independent oversight mechanism for Add “independent”.
neurotechnology use in educational settings,
incorporating regular audits, public and community
feedback, culturally appropriate and according to
local conventions, and strict adherence to safety, Add “human rights”.
human rights, and ethical standards, including an
assessment of reversibility on the nervous system.
Continuous research should be funded to assess
the long-term psychological and cognitive impacts of
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these technologies. Oversight should involve
periodic reviews based on empirical evidence to
adjust neurotechnology usage as needed, ensuring
it serves student development and addresses risks
like dependency or de-skilling. This comprehensive
approach will help maintain the safety,
effectiveness, and alignment of neurotechnology
with best practices for student well-being and
learning outcomes.
139. Member States should invest in educational and
professional development programs to equip
innovators and business leaders with the skills to
integrate ethical considerations throughout the
neurotechnology whole lifecycle. This training
should include ethical design, human rights law, and
societal impact assessment, preparing the next
generation of technologists to critically evaluate the
implications of their work.
IV.14. LABOUR AND EMPLOYMENT
140. Member States should establish workplace policies We encourage to reiterate here what
and incentives that harness the potential of is being laid out in the preamble:
neurotechnology while, at the same time, that harnessing the potential of
neurotechnology.
prioritize the health and well-being of employees in
the use of neurotechnology. These policies should Some linguistic and stylistic
ensure that any deployment of neurotechnology is adaptations have been made for
evidence-based, focusing on scientifically validated greater fluidity and clarity of the text
applications with a focus on applications that have (see paragraphs below).
been scientifically validated to promote employee
We also propose the integration of
well-being, such as reducing stress and enhance
references to ILO conventions since
workplace conditions for example by creating this chapter concerns workers' rights.
adaptive, responsive environments that adjust This can build credibility and these
workloads based on cognitive load. such as references show alignment with
reducing stress or enhancing workplace conditions recognized standards, particularly in
(i.e., adaptive and responsive environments that areas where the ILO has well-
adjust workloads based on cognitive load). In line established expertise and
frameworks.
with ILO Convention No. 111 on Discrimination
(1958), the deployment of such technologies
Deployment must be on a remain strictly voluntary
basis and employees must have the option to opt
out of using neurotechnology without facing any
negative consequences or discrimination.
Additionally, in accordance with ILO Convention No.
87 on Freedom of Association and Protection of the
Right to Organize (1948), it is essential that workers
be consulted and able to participate in decisions
about the introduction of new technologies affecting
their working conditions. Under no circumstances
should these technologies be used for punitive
measures, mental digital surveillance, or in ways
« Digital » surveillance in line with
that could compromise employee health. the Global Digital Compact.
141. Member States should require employers to clearly
provide employees with comprehensive information
about how neurotechnology used in their workplace
works, the benefits it offers, transparency about
what data are collected, how it is used, and who has
access to it, and clearly disclose any potential risks
734
of their use.
142. Member States should require employers who use
neurotechnology in the workplace to adopt
transparent policies that disclose the purpose of the
use, limit the scope of its use to legitimate purposes
in the interest of the employee and third parties (i.e.,
safety, monitoring fatigue in commercial drivers or
tracking attention in air traffic controllers). To
respect employees’ mental privacy, employers
should be prohibited from unauthorized access to
neural and cognitive biometric data that may be
collected incidentally during routine workplace
monitoring. Employers should be prohibited from
using neural and cognitive biometric data for any
non-consented purposes, particularly those that
could negatively impact an employee’s job security
or privacy.
143. Member States should require employers to adopt
best practices for data minimisation and secure
storage of neural and cognitive biometric data,
ensure that data is stored securely, with access
limited to authorised personnel only, is deleted once
its intended purpose has been fulfilled. Additionally,
upon an employee’s departure, all related records
should be fully deleted or individual data released to
the employee, ensuring that no data is retained after
the termination of employment.
144. Member States should ensure that when employees
are issued multifunctional devices (i.e., earbuds or
headphones that also include neural sensors) that
can be used at work or at home, employers should
be prohibited from collecting neural and cognitive
biometric data outside of workplace settings and
working hours and ensure that any data collected
during work is used exclusively for agreed-upon
purposes. Employers should implement
technological safeguards to automatically disable
data collection during non-work hours.
145. Members States should ensure that employers
respect the right of employees to obtain a copy of
any neural and cognitive biometric data collected
about them, along with any interpretations drawn
from it in an accessible and comprehensible
manner. To use these tools without consent
constitutes a breach of trust, undermining the value
they would otherwise create.
146. Member States should require, if necessary,
through new stringent regulations, that any use of
neurotechnology in the workplace require explicit
employee consent, and be used only for productivity
purposes that demonstrably enhance don’t
compromise workplace safety, employee well-being
and dignity, and not for. Eenhancing productivity
should not come at the expense of employee
health.
147. Member States should guard against the
735
exploitation of protect employees, and they should
by adapting existing or developing new stringent
regulations against using neural and cognitive
biometric data for profiling in the workplace,
including in hiring. These regulations should prohibit
the use of neural and cognitive biometric data to
discriminate against candidates, particularly
neurodiverse individuals, ensuring hiring practices
are fair and inclusive.
148. Member States should strictly regulate the use of
neurotechnology for hiring or maintaining
employment, to limit such use where such neural
and cognitive biometric data are directly relevant to
the specific requirements of the job.
IV.15. CONSUMER AND COMMERCIAL
DOMAINS
149. Member States should proactively establish a
regulatory framework that balances innovation in the
recreational and commercial domains with
protecting individual rights and well-being. This
framework should be dynamic, allowing for timely
updates as technology evolves and new insights are
gained about its impacts on society. This includes
providing adequate oversight to ensure that
neurotechnology does not cause harm, are used
consensually, and include robust mechanisms to
protect users from potential psychological distress
or manipulation.
150. Member States should strengthen comprehensive
consumer protection laws to include clear labelling
on commercial neurotechnology products, detailing
their effects, limitations, and risks to prevent
misleading claims and ensure transparency. This
also includes should include prohibiting practices of
“tying” or requiring the disclosure of neural and
cognitive biometric data as a condition to access
goods or services, and prohibition about third party
data sharing or the uses of this data without
affirmative opt-in option.
151. Member States should foster an environment that
ensures all claims about consumer, non-medical
technologies are supported by robust scientific
evidence. They should, by regulation, require that
any products claiming to treat, prevent, or diagnose
diseases or medical conditions be validated through
rigorous safety and efficacy testing, including clinical
trials where necessary, and be used under
appropriate medical supervision.
152. Member States must should enforce informed
consent processes that are thorough and
transparent across all neurotechnological
interventions, ensuring that participation is fully
voluntary and respects the privacy and autonomy of
individuals. This principle should apply uniformly in
various domains such as sports, arts, where robust
standards should safeguard against coercive use
736
and respect athletes’ and artists’ individual
autonomy, community interests, and IP rights.
153. Member States should steer the use and
development of neurotechnology in the arts toward
ensuring the enhanced learning and cultural
appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the
misuse of neurotechnology of consumer technology,
especially neurogaming and other devices that
exploit the dopamine reward system or seek to
induce problematic and unhealthy use and
overconsumption. Such regulations should mandate
clear labeling of risks, disclosures on their effects on
the nervous system, enforce game design
standards and safety, privacy and age-appropriate
design standards that prevent taking advantage of a
person’s physical, mental and emotional
vulnerability to lead to compulsive use or addiction
of gaming or digital recreational platforms combined
with neurotechnology, to promote healthy, balanced
use, especially among children.
155. Member States should ensure that devices capable
of multiple functions, such as XR glasses or smart
earbuds with neural sensors, include hardware-
based controls that allow users to selectively disable
neurotechnology features while maintaining basic
functionality. Regulations should ensure that ‘opt-
out’ features are accessible and straightforward,
promoting healthy, balanced use especially among
children and vulnerable populations.
156. Member States should address the profound ethical
and human rights related questions regarding self- Add “human rights related”.
determination, consent, privacy, and the potential
for manipulation raised by neurotechnology that
arise in the contexts of recommender systems,
priming and nudging, marketing during sleep and
dream, neuromarketing, and closed-loop
environments by adopting comprehensive policies
and regulations that:
(a) Recommender systems: explicitly prohibit the
use of neural and cognitive biometric data in
recommender systems for manipulative or
deceptive purposes, including in political
context. These regulations should require
that any use of such data within these
systems be based on explicit, informed opt-in
consent from users.
(b) Nudging: govern the use of neural and
cognitive biometric data for nudging—subtly
influencing individuals’ decisions or
behaviours, often without their explicit
awareness. This is particularly critical in
sensitive areas such as political messaging,
commercial advertisement, and healthcare.
These frameworks should require explicit,
informed consent for any use of such data to
737
influence decisions or behaviour, the right to
opt out of these systems, and transparency
and clear disclosures at the point of data
collection, with strict limitations on using data
for purposes beyond those explicitly
disclosed.
(c) Marketing during sleep and dream: prohibit
the use of neurotechnology that influences or
manipulates individuals during sleep, such as
marketing during sleep and dream.
Regulations should strictly prohibit
commercial, marketing, or political
applications that target individuals during
sleep, using neurotechnology or neural and
cognitive biometric data. Additionally, robust
oversight mechanisms should be required to
ensure that any research or application of
such technologies prioritizes the well-being,
privacy, and autonomy of individuals, with
particular attention to the potential long-term
psychological and cognitive impacts of
manipulating sleep states.
(d) Neuromarketing: safeguard against unethical
aims and practices in neuromarketing,
including by requiring comprehensive
disclosures to ensure that all neuromarketing
activities are conducted transparently, with
participants’ explicit informed consent. This
includes ensuring that participants in
neuromarketing research or campaigns are
fully aware of methods, risks, and intentions
and affirmatively opt-in to participation. The
use, storage, and potential reuse of the
collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear
regulatory guidelines on the design and use
of closed-loop environments—such as
immersive computing devices that adjust
experiences based on detected neural and
cognitive biometric data. These policies
should require clear and accessible
disclosure about how neural and cognitive
biometric data are used in these
environments, prohibit real-time behavioral
modification or manipulation without explicit,
informed consent, and implement safeguards
specifically designed to prevent abuses such
as unauthorized surveillance, manipulative
interventions, and practices that could
influence voting behavior, political opinions,
or exploit psychological and emotional
vulnerabilities in real-time.
IV.16. ENHANCEMENT
157. The use of neurotechnology to improve memory,
attention, or other aspects of human mental
performance outside of the medical context
introduces complex ethical, social, and legal
738
challenges, which can create new kinds of
disparities in the global world. When
neurotechnology is used in these contexts, it raises
crucial questions about equity, consent, individual
and community autonomy, and the nature of
enhancement of the nervous system itself. Member
States should ensure that any policies, law and
regulatory frameworks that govern the use of
neurotechnology in these contexts do not
exacerbate social inequalities or lead to
discrimination, address the potential risks (including
to reversibility, invasiveness, and risks to self-
determination) and fully comply with human rights
and dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in
this Recommendation should respect, promote and
protect the ethical values, principles and standards
related to this Recommendation, and should take all
feasible steps to give effect to its implementation.
159. Member States shallshould, according to their “Shall” is for binding treaties.
specific contexts, governing structures and
constitutional provisions, credibly and transparently
advance the ethics of neurotechnology, in line with
the UNESCO Recommendation. Member States
shall should monitor and evaluate policies,
programmes and mechanisms related to
neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and
qualitative approaches.
160. Member States should develop capacities in
governmental institutions and support government
officials to steer the technological development
ethically.
161. Member States should establish or designate
national organizations responsible for overseeing
and coordinating the regulation, vigilance, and
oversight of neurotechnology across relevant
government agencies. These coordinating bodies
should be tasked with ensuring that legal and
regulatory frameworks are consistently applied, that
public health and safety are protected, and that
ethical standards and human rights are upheld
throughout the whole lifecycle of neurotechnology.
This includes facilitating inter-agency collaboration,
monitoring compliance with national and
international standards, and ensuring that data and
insights from different regulatory domains are
shared effectively to inform decision-making and
policy development. These bodies should also help
coordinate public and community engagement.
162. Member States should strive to extend and
complement their own actions in respect of this
Recommendation, by cooperating with all relevant
national and international governmental and non-
governmental organizations, as well as
739
transnational corporations and scientific
organizations, whose activities fall within the scope
and objectives of this Recommendation. Civil Important. Keep.
society will be an important actor to advocate for the
public sector’s interests and therefore UNESCO
needs to ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this
Recommendation widely through all available
means, and share it with Member States, National
Commissions for UNESCO, relevant international
and regional partners, human rights institutions as
well as with UNESCO ethics advisory bodies for
dissemination to all levels and actors in this field.
164. To support Member States implementing this See Switzerland General Comment:
Recommendation by developing concrete programs the set-up of a full-fledged program
and policies and developing institutional capacities has to be discussed in the context of
the 43 C/5 debates.
in the ethics of neurotechnology, UNESCO shall
contribute by developing a full-fledged program with
the following elements:
(a) a UNESCO Readiness Assessment
Methodology (RAM) to assist Member
States in identifying their status at specific
moments of their readiness trajectory along
a continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact
Assessment (EIA) of neurotechnology
based on rigorous scientific research and
grounded in international human rights law,
along with specific guidance for its
implementation in the whole
neurotechnology lifecycle, and capacity-
building tools and materials to support
Member States’ efforts to train government
officials, policy-makers and other relevant
actors on the methodology;
(c) a UNESCO methodology to evaluate ex
ante and ex post the effectiveness and the
efficiency of the policies for the ethics of
neurotechnology and incentives against
defined objectives;
(d) a UNESCO research program that will
focus on the ethics of neurotechnology,
grounded on an appraisal that is informed
by the current state of technological
developments, to assess the current and
future impact of neurotechnology on
societies and the environment. This
evidence-based analysis will be gathered
in a UNESCO observatory, to become a
shared pool of knowledge and awareness
of good practices and innovations available
to all Member States and actors, in the
form of research reports, data, and
statistics regarding policies for ethics of
neurotechnology. The research program
should take into consideration the
converging developments of
neurotechnology with other technologies
such as artificial intelligence and quantum
technology, work to be conducted in
collaboration with other relevant UNESCO
initiatives.
740
(e) a UNESCO collaborative platform fostering
meaningful exchanges and facilitating
collaboration among Member States and
among all actors to promote a global policy
dialogue, including at Ministerial level in
the context of a Global Forum on the ethics
of Emerging Technologies. Supporting this
effort, UNESCO shall establish a network
of experts, with balanced representation of
all UNESCO’s regional groups, on the
neurotechnology.
165. Processes for monitoring and evaluation should
ensure broad participation of all actors, including,
but not limited to, under-represented, vulnerable
people or people in vulnerable situations and
ensuring social, cultural and gender diversity. The
monitoring and assessment of the impact of
neurotechnology and related ethics policies and
practices should be carried out continuously in a
systematic way proportionate to the relevant risks.
This should be based on internationally agreed
frameworks and involve evaluations of private and
public institutions. Data collection and processing
should be conducted in accordance with
international law, including international human Add “international human rights law”.
rights law, national legislation on data protection
and data privacy, and the values and principles
outlined in this Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a
whole, and the foundational values and principles
are to be understood as complementary and
interrelated.
167. Nothing in this Recommendation may be interpreted
as replacing, altering or otherwise prejudicing
Member States’ obligations or rights under
international law, or as approval for any State, other
political, economic or social actor, group or person
to engage in any activity or perform any act contrary
to human rights, fundamental freedoms, human
dignity and concern for the environment and
ecosystems.
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THAILAND/THAÏLANDE
Comments and Observations on the first draft of
the Recommendation on the Ethical of Neurotechnology
1. Safety and Long-Term Impact:
Ensure safety protocols for neurotechnologies, particularly regarding long- term
effects on the brain and mental health, with proper guidelines for their use under
professional supervision.
2. Human Rights and Informed Consent:
Emphasize protecting human rights, especially privacy and cognitive integrity, and
ensure patients provide fully informed consent before any intervention.
3. Ethical Oversight:
Balance scientific progress with ethical oversight by regularly updating ethical
standards as the field evolves.
4. Equitable Access:
Ensuring equitable access to the benefits of neuroscience and neurotechnologies
is vital to reducing social disparities, particularly in developing countries. By prioritizing
underprivileged and diverse populations, we can prevent further healthcare inequities
and ensure that advancements in neuroscience are accessible to all individuals,
promoting global health equity.
5. Education and Awareness:
Education and public awareness should be promoted to highlight both the benefits and
risks of neurotechnologies, and empower professionals and communities with essential
knowledge. Integrating ethics related to neurotechnology into educational curricula is
crucial to prepare future leaders for responsible and informed decision- making in this
rapidly evolving field.
6. Application of Neurotechnology in Business Contexts
Neuroscience has the potential to enhance marketing strategies, consumer behavior
analysis, and organizational management. However, there should be clear guidelines to
prevent the use of technology in ways that manipulate or influence individuals without
explicit consent.
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7. Impact inside the Workplace
Transparency and protection of employee data are essentials when applying
neuroscience in the workplace, such as for monitoring stress or improving productivity. It
is crucial to ensure that individual rights and privacy are not violated.
………………..
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TÜRKIYE
PRELIMINARY REPORT ON THE FIRST DRAFT OF THE RECOMMENDATION ON THE
ETHICS OF NEUROTECHNOLOGY
This preliminary report on the draft Recommendation on the Ethics of Neurotechnology, was prepared
in accordance with Article 10.1 of the Rules of Procedure concerning recommendations to Member
States and international conventions covered by the terms of Article IV, paragraph 4, of the
Constitution.
INTRODUCTION
1. Within the general advancement of scientific knowledge and technology, the disciplines that
study the brain and mind have made significant progress. According to UNESCO, during the last
decades, neuroscience has been one of the most dynamic areas of research and innovation, with
an increasing number of patents (from less than 500 in 2000 to over 12,000 in 2020), scientific
publications (reaching 1.2 million in 2021) and investments (the neurotechnology devices market is
expected to reach USD24.2 billion by 2027) 1 . This progress has substantively advanced our
understanding of the nervous system, offering the possibility to intervene on the brain and address
many unmet medical needs, related especially to neurological disorders and mental health. It is also
a major source of ethical challenges deeply interconnected with human rights and human dignity, as
the nervous system is the coordinating centre of behaviour and mental processes enabling the exercise
of self-determination, the capacity to act as moral agents, to exert responsibility, cooperate with others,
deliberate about individual or collective decisions and develop one's own personality. Considering
the major impact of these developments and their significance for the human rights framework, this
debate falls clearly within the scope of UNESCO's mandate to advance the ethics of science and
technology.
2. Neurotechnology refers to devices, systems, and procedures that directly access, monitor,
analyse, predict or modulate the nervous system to understand, influence, restore, or anticipate its
structure, activity, function, or intentions. Historically, neurotechnology tools have been developed
for laboratory research, such as observing the brain activity of patients or healthy volunteers. These
tools have been used in the clinic for decades as diagnostic tools or to mitigate the impacts of
neurological and neurodegenerative disorders such as Parkinson's disease by stimulating targeted
brain areas and partially restoring brain functions. The convergence of neurotechnology with other
scientific and technological developments, particularly artificial intelligence, has opened the door to
more powerful, precise, and ready-to-use applications.
3. Consequently, neurotechnology is being mobilised in a growing number of settings and
situations, and it is expected to increase its footprint. Besides the medical field that keeps expanding,
new application domains emerge, including in education, the workplace, and the direct-to-consumer
market for entertainment or personal use.
4. In this context, the ethical challenges raised by neurotechnology go beyond those linked with
the medical or research field, that are usually well framed in many countries, bringing new challenges
for human rights. In some instances, neurotechnology may pose new threats to human dignity and
integrity, and challenge fundamental freedoms such as freedom of thought. With its power to modify
our nervous system, neurotechnology can shape the lives of persons, and the developments that
may bring positive impact could also be misused or have unintended negative consequences. Tools
interfering with the brain might challenge our ability to make free decisions. It raises also critical
concerns over issues of manipulation in the political domain, in marketing, in the recreational domain,
and in other areas outside the medical realm, as well as concerns over threats to democracy,
especially if one considers the convergence of neurotechnology with artificial intelligence. Data about
the structure, activity and function of the nervous system (neural data) can be processed to provide
information related to the health and mental states of the person. The right to privacy may be
Figures from the UNESCO report Unveiling the Neurotechnolo qy Landscap e: Scientific Advancements . Innovations
and Maj or trends, 2023
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threatened, as some aspects of inner life that are naturally concealed - private thoughts that relate
to us intimately and personally - might be disclosed when neural data is processed or combined with
other data. The global circulation of data, which is a hallmark of contemporary science, makes this
issue even more pressing and difficult to handle.
5. The risks to human rights, fundamental freedoms and human dignity are real, and concern
everyone, from patients with severe disabilities to a larger population of potential technology users
of different applications, such as children whose developing brains are very sensitive. In the context
of increasing healthcare inequalities, neurotechnology development and commercialisation can
challenge the principles of justice and solidarity . There are millions of patients with unmet medical
and the potential benefits of neurotechnology for healthcare are enormous. At the same time, there
are also prospects of healthy individuals who can access the latest technological developments to
enhance their cognitive functions (e.g., attention, memory) at the detriment of others such as in
educational settings or in the workplace. In this context, an international and coordinated effort is
required to steer an ethical development of neurotechnology for the benefit of humankind and
mitigate its impacts on human rights.
6. Under the leadership of UNESCO's Director-General, and parallel to other normative work of
UNESCO, the need to tackle the challenges imposed by neurotechnology was based on the
research conducted by the International Bioethics Committee (IBC) of UNESCO, whose experts
prepared a report on the Ethical Issues of Neurotechnolo gy in 2021, and the mandate for the
elaboration of a Recommendation on the Ethics of Neurotechnology as provided by the General
Conference (42 C/Resolution 29).
7. The United Nations Secretary-General report on "Our Common Agenda" (2021) mentioned
neurotechnology as a frontier human rights issue, and Secretary General Antonio Guterres
established a working group at the Assistant Director-General level, co-led by UNESCO and the
Executive Office of the Secretary-General. The working group included other international
organizations, such as the Office of the United Nations High Commissioner of Human Rights and
the Organisation for Economic Co-operation and Development (OECD). The Working Group
convened two interdisciplinary expert consultation meetings in 2021 and 2022 to present key findings
and recommendations of the work done in the system (particularly the UNESCO- IBC reports) and
to advance a coordinated United Nations-wide system approach to the governance of
neurotechnology. Given its work in this field UNESCO was entrusted with the lead of this workstream .
8. UNESCO organised several events throughout this process, including a seminar for
Ambassadors and permanent delegates (April 2023) and an international conference in July 2023.
To inform the International Conference, UNESCO launched top notch research, based on machine
learning, mapping the technological developments, innovation and patents of neurotechnology,
(Unveiling the Neurotechnolo gy Landsca pe: Scientific Advancements . Innovations and Maj or Trends,
2023) filling a gap in the understanding of the research, investments and innovation trends, as well
as the distribution and access to knowledge on neurotechnology all around the world. UNESCO also
prepared an overview of the risks and challenges of neurotechnolo gies for human rights.
9. At the same time, initiatives providing normative guidance for neurotechnology development
have been burgeoning at the international and national levels. Some countries have updated their
laws or are engaged in processes to do so. Soft law instruments and declarations at the international
level have been published recently, such as the Inter-American Declaration of Principles
on Neuroscience , Neurotechnolo qies, and Human Rights by the Inter-American Juridical Committee
or the EU Le6n Declaration on Europ ean Neurotechnolo gy at the EU inter-ministry level, both published
in 2023. Other initiatives include guidelines for stakeholders and producers of the technology, such
as the OECD Recommendation on Resp onsible Innovation in Neurotechnolo g y (2019) or the French
Charter for the resp onsible development of neurotechnolo gy (2022). A European charter is now
under consideration by major scientific societies in this domain. The Council of Europe is also
currently leading a discussion on neurotechnolo gy and human rights. UNESCO has been working
in close collaboration with the Office of the United Nations High Commissioner for Human Rights
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and the United Nations Human Rights Council. The latter has launched a consultation process
analy sing the human rights implications of neurotechnolo gy. The different initiatives were reflected
in UNESCO's Towards a draft text of a Recommendation on the Ethics of Neurotechnolo gy : workin g
document , April 2024).
10. The frameworks mentioned above vary depending on their respective areas of application and
approaches. Given the increased activities in this domain, UNESCO has mapped these initiatives
and coordinated with them. The specific mandate on the ethics of science and technology as well as
its capacity to develop global standards with universal membership, position UNESCO well to
develop a global and pluralistic process, and to establish a platform for dialogue, bringing together
both developed and developing countries, different cultural perspectives, as well as various
stakeholders within the public and private sector. UNESCO has acted as a bridge between Member
States, civil society, the research community, academia, and the private sector, building on its record
of multi-stakeholder consultation and consensus building.
PROCESS
11. In line with 42 C/Resolution 29, on the basis of Member States proposals, and top experts
identified by the Secretariat of the Social and Human Sciences Sector (SHS) of UNESCO, an Ad
Hoc Expert Group (AHEG) was established by UNESCO's Director-General to prepare a first draft
text of a Recommendation on the Ethics of Neurotechnology. The AHEG is composed of 24
independent experts from all UNESCO regions, appointed on a geographical and gender balance
basis and bringing complementary disciplines. The first AHEG meeting was held at UNESCO's
Headquarters from 22 to 26 April 2024 and was opened and attended by the Assistant Director-
General for SHS and supported by the Bioethics Section. The AHEG elected a Bureau with members
from all UNESCO regions, including two co-chairs (from the United States of America and France)
and a rapporteur (from Kenya). The AHEG drew on its own expertise and the work and reflection
already conducted at UNESCO to advance its work on the first draft of a Recommendation.
12. To collect feedback on the first version of the draft Recommendation, SHS, with the support of
field offices, conducted a multi-stakeholder consultation process on the first version of the draft
Recommendation from 6 June to 12 July 2024. The consultation process was based on three
components: (i) a global public online consultation, which collected over 7000 comments
demonstrating high interest in the topic despite its highly specialised nature; (ii) 25 regional, sub-
regional and national online and in person consultations co-organised with host countries, institutions
and/or National Commissions for UNESCO in all of UNESCO's regions, involving some 800
participants from over 100 countries; and (iii) coordination with other international agencies, including
at the United Nations level, was conducted through the Inter-Agency Working Group on Artificial
Intelligence (IAWG-AI) as well as through the United Nations Inter-Agency Committee on Bioethics
(UNIACB).
13. The consultations generated a rich conversation that raised awareness and triggered regional
and sub-regional debates. The consultations have clearly shown the need and the strong appetite
to have an ethical framework on neurotechnology. Beyond the encouraging comments and positive
feedback collected during the regional and sub-regional debates, the consultation process provided
also concrete figures on the overall support to the document, with a majority of respondents
endorsing the choices made in the first draft. Many comments referred to the vocabulary and
language used in the draft, from fundamental concepts such as the definition of neurotechnology
and neural data to terms related to human rights and ethics of science. Thanks to the consultation,
points in need of clarification and passages requiring improvement were identified. Useful
suggestions were numerous, sometimes including concrete wording for some passages. The need
to revise the structure of the document to better reflect the articulation between values, ethical
principles, human rights, and policy actions, was also recognised. The consultation process fostered
also global discussions on the issue of consent and self-determination, the impact of
neurotechnology on children and the rising inequalities worldwide.
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14. The Bureau of the AHEG accompanied by the Secretariat prepared a preliminary revision of
the Recommendation draft taking into consideration the most relevant comments. A new structure
as well as many improvements in the text were suggested. The AHEG convened again during a
meeting week on 26-30 August at UNESCO Headquarters and finalised the first draft
Recommendation based on the feedback of the consultations and on its further discussions, and to
include the implementation and follow up section. As such, the first draft of the Recommendation is
transmitted to Member States, for their comments, together with this preliminary report.
THE FIRST DRAFT OF THE RECOMMENDATION
15. The AHEG decided to focus on the impacts of neurotechnology on humankind and human
rights. Given the spectrum of current and future applications of neurotechnology (from research and
clinic to education, workplace, entertainment) and the diversity of populations possibly affected by
these technological developments, the ambition was to produce a framework as comprehensive and
agile as possible. The discussion put the emphasis on recurring themes, such as the protection of
brain data collected by neurotechnology, the need to safeguard the self-determination of persons Commenté [A1]: Both "brain data" and "neural data"
while intervening on their brain, the respect for the principle of justice in neurotechnologyduring are used within this document without clarification as to
its whole lifecycle, the need for techniques to work for the benefit of humanity as a whole, and the their distinction. While neural data is defined in the draft
desire to refuse any practice of discrimination, unconsented standardisation and alignment with a recommendation, brain data is not explained. It is
dominant pattern. recommended to define "brain data" by showing
differences with neural data and ensure consistency in
16. One of the first tasks of the AHEG was the identification of critical ethical and human rights usage.
challenges as well as deciding on the scope of the Recommendation and providing specific a supprimé:
definitions that could capture the complexity of the subject matter. During the first meeting, different a supprimé: development and use
working groups were established to advance specific parts of the agenda, and to cover various
aspects and drafting chapters. During the second meeting week, the AHEG debated only in plenary a supprimé: i
session while the Bureau worked on the integration of the outputs of the plenary discussion into draft
proposals.
17. Significant methodological choices were made with regard to definition and scope. Although
the definition of neurotechnology adopted in the draft Recommendation follows a classical distinction
between observational (those that collect and analyse data from the nervous system) and
interventional tools (modulation of brain and neural activity), defining neurotechnology is a delicate
exercise that has sparked many debates within the AHEG and elicited many comments in the
consultations. While the group wanted the definition to be as broad as possible so that it can apply
to a wide range of neurotechnology tools even in the future, the draft Recommendation provides also
some examples of current technologies for clarity. One notable aspect of the adopted definition by
AHEG is that attention should be put on the nervous system, beyond the brain (that is, consider the
peripheral nervous system along with the central nervous system). Indeed, neurotechnology can be
mobilised to restore function in cases of paralysis or motor disorders via stimulation of the spinal
cord. The AHEG was also aware of the fact that neurotechnology in a strict sense (recording of
signals or stimulation of neurons and nerves) is often combined with other tools and other data, such
as biometric data more generally (physiological measurements) and the processing of this data will
often involve artificial intelligence . The latter is crucial in many neurotechnology applications today.
This convergence of tools and data contributes increased power and efficacy when it comes to
observe, predict and modify mental states. As a consequence, it was decided that the
Recommendation should embrace a broad scope. It includes what the AHEG called "cognitive
biometric data", that is, data collected by non-neural biometric technologies that can be processed
to infer mental states: Consistent with this wide-ranging approach, it was decided that
neurotechnology ought to be considered in its whole lifecycle, from the early stages of mining for
materials, prototyping, research, design and development to deployment and use, including
maintenance, operation, trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. It also considers the intersection with other
converging technologies, such as artificial intelligence.
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18. The draft Recommendation relies on an extensive list of values and ethical principles that are
detailed in a dedicated chapter. Given the success and the record of UNESCO's work on Artificial
Intelligence, the discussion among the experts started from the values already established in the
Recommendation on the Ethics of Artificial Intelligence, which were further discussed and refined to
fit the specificity of neurotechnology. The following values were put forward: the respect, protection
and promotion of fundamental human rights, fundamental freedoms and human dignity; promoting
human health and well-being; ensuring and respecting diversity and fairness; consideration for cross-
cultural perspectives on human knowledge and its sharing; commitment to peace, fairness and
justice in society; global solidarity and international cooperation; sustainability; integrity and
responsibility. The values were developed into ethical principles and human rights at stake in
neurotechnology: beneficence, proportionality and do no harm; self-determination and freedom of
thought; protection of neural and cognitive biometric data for mental privacy; non-discrimination and
inclusivity; accountability; trustworthiness and transparency; epistemic justice, inclusive engagement
and public empowerment; best interests of the child and protection of future generations; global and
social justice, enjoying the benefits of scientific progress and its applications .
19. The AHEG delineated several areas of policy action and proposed concrete courses of action
by domain, including those that are less regulated up to now such as educational settings, labour
and employment, and the direct-to-consumer and commercial domains. It calls on Member States
to actively enforce policies that can protect human rights against possible infringements related to
neurotechnology development and use. Furthermore, the Recommendation recognises that data
about the structure, activity and function of the nervous system (neural data) should be considered
sensitive data, particularly when collected outside of the medical context. This element will likely
have deep implications for informed consent procedures and data processing in various settings, as
only data collected within the medical context is systematically recognised sensitive in most
jurisdictions today. A full list of actions directed at neural and cognitive biometric data policy,
intellectual property, and cybersecurity is provided. Attention is drawn to the end users of
neurotechnology that deserve special consideration, such as children, older persons, persons with
physical disabilities and persons with mental health conditions. Provisions on gender equality are
also included. For each population, the Recommendation provides a series of policy actions.
20. An implementation plan is included in the draft Recommendation. It proposes a UNESCO full-
fledged program on the ethics of neurotechnology, based on the successful program established for
the implementation of the UNESCO's Recommendation on the Ethics of Artificial Intelligence (2021).
Such a program could include a Readiness Assessment Methodology to assist Member States in
identifying their status at specific moments of their readiness trajectory and a methodology for Ethical
Impact Assessment of neurotechnology based on rigorous scientific research and grounded in
international human rights law. These tools would be backed up by a research program on the ethics
of neurotechnology gathered in a UNESCO observatory with the aim of becoming a shared pool of
knowledge and awareness of good practices and innovations. Another key element would be the
creation of a collaborative platform fostering meaningful exchanges and facilitating collaboration
among Member States and among stakeholders to promote a global policy dialogue, including at
Ministerial level in the context of a Global Forum on the Ethics of Emerging Technologies, combining
the current Global Forum on the Ethics of Artificial Intelligence, and its annual edition, with this other
platform that would deal with developments in neurotechnology. A network of experts on the ethics
neurotechnology with balanced representation of all UNESCO's regional groups could be
established to support this effort. Commenté [A3]: Considering the duties of the the Digital
Transformation Office (DTO) in the fields of digital
NEXT STEPS transformation, big data and artificial intelligence, and the
ongoing work in the field of responsible artificial intelligence
21. To be effective, the Recommendation needs to be accompanied by policy and support in and relevant ethical issues, it is considered that the DTO can
contribute to the unified platform to be established.
building national capacities for its implementation and transformation into concrete guidelines for
neurotechnology actors, legal and governance frameworks. As such, UNESCO will bring its 30 years
expertise in dealing with the ethics of emerging technologies, including bioethics and more recently
artificial intelligence, to assist Member States in fulfilling the provisions outlined in the
Recommendation once adopted. The comprehensive implementation programme mentioned above
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will be instrumental in that regard. The Recommendation will also provide a solid foundation for the
entire United Nations system in its collective response to the human rights challenges raised by
neurotechnology.
22. Member States are now invited to submit their comments and observations, in English or
French, on the first draft of the Recommendation annexed hereto, no later than 31 December 20242.
Responses should be addressed to Gabriela Ramos, Assistant Director-General for the Social and
Human Sciences, at the following email address: neuro-ethics @unesco.org. A final report containing
a draft text of the Recommendation will be prepared based on those comments and observations
and communicated to Member States by Spring 2025. The final report shall be submitted to the
intergovernmental meeting of a special committee (category 11 meeting) in Spring 2025 for finalization
and eventual adoption by UNESCO's General Conference at its 43rd session.
2 The first draft of the Recommendation is available in Arabic, Chinese, English, French, Russian and
Spanish on the following website:
https://www.unesco.or g/en/ethics-neurotech/recommendation?hub=83294
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FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY Commenté [A4]: It is suggested to establish a
whistleblower protection mechanism within the
PREAMBLE neurotechnology stakeholders.
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and
flourishing, and societies, environment, and ecosystems,
Considering the major and growing global prevalence of neurological and mental health conditions,
along with the profound suffering they cause for individuals and societies worldwide,
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better
preventive and therapeutic treatments for millions, benefitting humanity as a whole and providing
opportunities for health improvements in all countries,
Also considering that neurotechnology raises fundamental ethical issues for instance regarding
human dignity, self:-determination, privacy,personal data protection, personal identity, freedom of
opinion and expression , risk of discrimination, inequality and challenges to democracy, and that Commenté [A5]: It is suggested to:
justice, trust and fairness must be upheld so that no country and no one should be left behind, either 1) Explicitly include "human dignity" to strengthen the
by having fair access to neurotechnology and enjoying their benefits or in the protection against emphasis on its importance as a core value.
their risks, while recognizing the different circumstances of different countries and respecting the 2) Replace "freedom of thought" with "freedom of
desire of some people not to take part in all technological developments, opinion and expression" could provide broader
applicability and better align with established human
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security rights frameworks, such as the Universal Declaration of
by promoting collaboration among nations through education, the sciences, culture, and Human Rights.
communication and information, in order to further universal respect for justice, for the rule of law 3) Add "personal data protection" immediately after
and for the human rights and fundamental freedoms which are affirmed for the peoples of the world, "privacy" to underscore its significance, particularly in
the context of contemporary digital challenges.
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge It should be mentioned that if mental privacy is not
ensured, this technology may have a chilling-effect in
production and standard setting on the ethics of science and technology and bioethics,
the form of self-censorship.
Convinced that the Recommendation presented here, as a standard-setting instrument developed a supprimé: freedom of thought
through a global approach, based on international law, focusing on human dignity and human rights,
as well as gender equality, social and global justice and development, physical and mental well-
being and health, diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide neurotechnology in a
responsible direction,
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
Noting that ethical guidelines, frameworks and open science promote innovation, development and
policies aligned with international human rights law,
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General "to prepare a standard-
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setting instrument on the ethics of neurotechnology in the form of a recommendation", which is to be
submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International Covenant
on Civil and Political Rights (1966), the International Covenant on Economic, Social and Cultural
Rights (1966), the Convention on the Elimination of All Forms of Discrimination against Women
(1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights of Persons
with Disabilities (2006), the Convention against Discrimination in Education (1960), the Convention
on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well as any other
relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration on
the Responsibilities of the Present Generations Towards Future Generations (1997); the Universal
Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on the Rights of
Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate Change (2017);
the Recommendation on Science and Scientific Researchers (2017); the Recommendation on the
Ethics of Artificial Intelligence (2021); the Recommendation on Open Science (2021); the Human
Rights Council's resolution on 'The right to privacy in the digital age" (NHRC/RES/42/15) (2019);
the Human Rights Council's resolution on "New and emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), and the UN Guiding Principles on Business and Human Rights (2011),
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to Al-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations ,
non-governmental organizations, and the scientific community, related to the ethics and regulation
of neurotechnology,
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX
day of November 2025 ;
2. Recommends that Member States, with the support of UNESCO's Secretariat, apply
the provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other measures may be required, in conformity with the constitutional
practice and governing structures of each State, to give effect within their jurisdi ctions
to the principles and norms of the Recommendation in conformity with international law,
including international human rights law;
3. Also recommends that Member States engage all actors, to ensure that they play their
respective roles in the implementation of this Recommendation ; and bring the
Recommendation to the attention of international, regional and national authorities and
bodies, research and academic organizations, institutions and organizations in public,
private and civil society sectors involved in neurotechnology, so that the development
and use of neurotechnology are guided by both sound scientific research as well as
ethical analysis and evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
1.1 SCOPE
This Recommendation:
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1. Addresses ethical issues related to neurotechnology, as it can have many positive and
adverse impacts on, including but not limited to human health, human flourishing, human dignity
and autonomy, social order and on the enjoyment of human rights and fundamental freedoms.
2. Considers neurotechnology for people of diverse backgrounds and abilities, and various
fields, including health, non-medical direct-to-consumer (OTC), such as wellness devices,
neurogaming), addressing various settings where neurotechnology may be utilised.
3. Focuses on humans only but acknowledges important considerations that apply to animals
in research.
4. Approaches neurotechnology ethics as a systematic normative reflection based on a holistic,
multicultural, multidisciplinary, pluralistic and evolving framework of interdependent values,
principles, and actions that can guide societies in dealing responsibly with the impacts of
neurotechnology on human beings, societies, and the environment and ecosystems.
(a) It considers ethics as a basis for the normative evaluation and guidance of
neurotechnology, with human rights, human dignity, well-being, and the prevention of
harm as a compass and foundation.
(b) It draws upon a full range of scholarship, commentary and views from neuroscience,
medicine, engineering, psychology, ethics, human rights, law, sociology, anthropology
and other disciplines.
5. Covers the measurement, recording, and modification of the human nervous system, the
handling, analysis, treatment, storage, use and reuse of the data collected, along with other
societal and environmental impacts, including the emergence of new cognitive states.
6. Recognizes that interventions involving the nervous system are very sensitive because the
highly complex human nervous system is the coordinating centre of behaviour and mental
processes. It enables the exercise of self-determination, the capacity to act as moral agents, to be
responsible for actions, cooperate with others, deliberate about collective decisions and develop
personality.
7. Further recognizes that humans develop and flourish in their interaction with other human
beings and a nurturing material and cultural environment, highlighting that autonomy is not just
individual but also relational, as it arises from and impacts one's interactions and belonging with
the community.
8. Addresses the ethical and human rights concerns that arise from the rapid developments
and the convergence of neurotechnology with other technologies such as spatial computing,
extended reality (XR), artificial intelligence (Al), sensors and semi-conductors. Notably, other
biometric data when processed to infer sensory, motor, and mental states raises similar ethical
concerns. Therefore, this Recommendation applies to both neurotechnology and the use of
cognitive biometric data, ensuring that ethical principles and practices are consistently applied
across these domains.
9. Further addresses the integration of Al with neurotechnology, which can enhance precision
and predictive capabilities, such as improving processing speed, reducing cost, optimizing
neurotechnology systems. However, it also magnifies ethical threats, including cybersecurity
concerns, lack of transparency, the potential for algorithmic bias, and risks to autonomy, mental
privacy and of manipulation.
10. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the
profound ethical challenges and threats that come with the military and security applications of
neurotechnology. Calls on all concerned to act responsibly with regard to neurotechnology.
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1.2 DEFINITIONS Commenté [A6]: It would be helpful to define the term
"mental privacy," which is commonly used within this
11. Nervous system. The nervous system includes the central (brain, spinal cord) and draft, in order to clarify a new concept.
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that
nervous system activity is the basis of sensory, motor, and mental states (which include cognitive,
affective, and conative states), and supports consciousness, sleep and the experience of pain.
The nervous system activity and structure provide information inherent to all human beings and
the community, regardless of gender, ethnicity, language, or religion. The nervous system activity
is also instrumental in social and cultural interactions.
12. Neurotechnology. Neurotechnology refers to devices, systems, products, services and
procedures- encompassing both hardware and software-that /directly or a supprimé: directly
i n d i r e c t l y access, monitor, analyze, · predict or modulate the nervous system to understand, Commenté [A7]: "Directly" should be removed from (or
influence, restore, or anticipate its structure, activity, function, or intentions (speech, motor). "or indirectly" should be added) to the definition, as it
Neurotechnology combines elements of neuroscience, engineering, and computing, among narrows the scope of this recommendation down to the
others. neurotechnology that only "directly" access, monitor,
analyze, predict or modulate the nervous system; whereas it
13. Neurotechnology spans medical and non-medical applications and includes tools that is known that there are other neurotechnologies that
measure, infer, and influence nervous system activity, whether through direct interaction with the indirectly perform these activities. Restrictions in scope such
as this one are likely to pose significant risks of violating
nervous system or by interfacing it with devices and systems. It includes but is not limited to: fundamental rights and freedoms, particularly in the areas of
personal data protection and privacy.
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical, optical,
magnetic and/or mechanical), chemical and biological signals associated with the
structure of and functional signals from the nervous system. These may be used to
identify, record, and/or monitor properties of nervous system activity, understand how
the nervous system works, diagnose pathological conditions, or control external
devices (brain machine interfaces (BMI), often referred to as brain computer interfaces
(BCI)). Of note, both open-loop (i.e., fixed-parameter brain stimulation) and closed-
loop systems (i.e., state dependent stimulation) introduce complex ethical issues.
(i). Examples include but are not limited to Electroencephalography (EEG),
Magnetoencephalography (MEG), Magnetic resonance imaging (MRI),
Functional Magnetic resonance imaging (fMRI), Positron emission tomography
(PET), Functional Near-infrared spectroscopy (fNIRS), Implanted
microelectrodes, Optogenetics, Optical imaging, Diffusion weighted imaging,
Calcium imaging, Voltage dye sensors, or Microdialysis.
(b) Technical tools that interact with the nervous system to change its activity, for example,
to restore sensory input, such as hearing (i.e., cochlear implants) or Deep Brain
Stimulation (DBS) to treat tremors and other pathological conditions. They are meant
to either modulate the functions of the nervous system and/or send signals directly to
the nervous system by applying acoustic, electrical, magnetic or optical stimulation
and/or inhibition of the peripheral or central nervous system.
(i). Examples of this neurotechnology are implanted microelectrodes, BMI, DBS,
Optogenetic optical stimulation, Transcranial electrical stimulation (tES),
Transcranial Magnetic Stimulation (TMS) or Neuropharmacological infusion.
14. Of note, several sensor technologies collect data indirectly informing about neural activity.
Even if they are not neurotechnology per se, they raise similar ethical and human rights issues as Commenté [A8]: Considering the information provided in
neurotechnology when used to infer mental states. They include but are not limited to eye-tracking, paragraph 14, where it is stated that sensor technologies
Video Oculography, Typing dynamics, Voice recognition and analysis, Gait analysis, Skin collecting data indirectly related to neural activity are not
conductance, Heart rate variability, Sleep movement monitoring, Blood pressure measurement, classified as neurotechnology per se, merely acknowledging
or facial- emotion recognition systems. their potential to raise ethical and human rights issues
similar to neurotechnology is deemed insufficient. This
limitation is likely to create significant risks of violating
15. Neural data. Neural data are qualitative and quantitative data about the structure, activity
fundamental rights and freedoms, particularly in the areas of
and function of the nervous system. They encompass data relating to a nervous system's activity, personal data protection and privacy. Therefore, it is
recommended that such technologies be explicitly included
within the scope of this document.
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including both direct measurements of neuronal structure, activity and/or function (i.e., neuronal
firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e., blood flow
in fMRI and fNIRS). At the neurobiological level, neural data are the most direct correlates of
mental states.
16. Cognitive Biometric Data. Neural data, along with data collected by non-neural biometric
technologies can be processed to infer mental states, which this Recommendation refers to as
"cognitive biometric data".
17. Whole lifecycle. Neurotechnology should be considered from the early stages of mining for
materials, prototyping, research, design and development to deployment and use, including
maintenance, operation; trade, financing, monitoring and evaluation, validation, end-of-use,
disassembly, termination, disposal and recycling. The whole lifecycle of neurotechnology includes
its convergence with other technologies and the diversity of actors who are involved in every stage.
11. AIMS AND OBJECTIVES
18. This Recommendation has been created with the aim of guiding the whole lifecycle of a supprimé: development and use
neurotechnology in ways that are ethical, safe and effective for the good of humanity,
individuals, communities , societies, the environment and ecosystems, and to prevent harm in the
present and the future based on international law, in particular the Charter of the United Nations
and international human rights law.
19. The objectives of this Recommendation are:
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity, privacy and equality , including gender equality, and to
respect cultural diversity during the whole neurotechnology lifecycle;
(b) to guide the actions of Member States, individuals, groups, communities, institutions,
research organizations, private sector companies and every other relevant actor to
ensure the embedding of ethics in all stages of the neurotechnology lifecycle;
(c) to ensure that neurotechnology in its whole lifecycle is evidence-based , transparent,
proportionate, privacy-preserving, robust, reliable and reproducible;
(d) to provide a universal framework that not only articulates values and principles, but
also translates into concrete policy recommendations and effective implementation to
guide Member States in their engagement with neurotechnology in its whole lifecycle,
consistent with their obligations under international human rights law and other
international standards;
(e) to foster multi-stakeholder, multidisciplinary and pluralistic dialogue and consensus
building about ethical issues relating to neurotechnology;
(f) to promote justice and equitable access to developments and knowledge in the field of
neurotechnology and the sharing of benefits;
(g) to ensure accountability and solidarity among all actors involved in different stages
of whole lifecycle of the neurotechnology to prevent misuse of
neurotechnology and to uphold human rights, fundamental freedoms and ethical
standards.
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111. VALUES AND PRI NCI PLES
111.1 VALU ES
111.1 .1 Respect, protection and promotion of human rights, fundamental freedoms
and human dignity
20. The inviolable and inherent dignity of every human being is the foundation of universal
human rights and fundamental freedoms. Respect, protection, and promotion of human dignity,
as established by international human rights law, are essential in the whole lifecycle of
neurotechnology. Dignity encompasses the recognition of the intrinsic and equal worth of each
person tied solely to their humanity. Neurotechnology must never be designed, deve lope d
and used in ways that i d e n t i f y , objectify, exploit or expose individual vulnerabilities, or
undermine h u m a n a u t o n o m y a n d the dignity or rights of any individual, including people
living in vulnerable situations.
111.1.2 Promoting human health and well-being
21. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical, mental,
and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes that benefit the largest
number of people and those who stand to gain the most, rather than consumer-driven or
commercial applications.
111.1 .3 Ensuring and respecting diversity and fairness
23. Respect for diversity and fairness, must be upheld in the whole lifecycle of neurotechnology.
Special consideration should be given to neurodiversity, minority groups, Indigenous Peoples, and
underrepresented voices.
24. Given that widely recognized neurotechnological innovation largely occurs in the urban well-
resourced sector, specific attention to underserved and vulnerable groups is crucial to prevent Commenté [A9]: It is recommended that the term
bias, ongoing disparities in healthcare, stigma, neglect, and disrespect. Technological “marginalized people” be changed to “vulnerable groups”,
assimilation, or using technology as a tool of colonisation (a term the Recommendation refers to subject to confirmation by the Ministry of Foreign Affairs.
as "technological colonialism"), can threaten cultural diversity and heritage, therefore must be a supprimé: marginalised people
protected against.
25. Equitable access to neurotechnology should be prioritized globally, ensuring that its benefits
are accessible to all, regardless of socioeconomic status or geographical location. Special
attention must be given to low- and middle-income countries, resource-constrained settings, and
marginalised communities, including the specific needs of different groups, ages, segments,
cultural systems, languages, communities, and vulnerable populations, people with disabilities, a supprimé: marginalised and
neurological disorders, and mental health conditions.
26. Individuals and groups should be allowed to make lifestyle choices, express beliefs and
opinions, share personal experiences, and participate in co-designing technologies, provided that
these choices are made in ways that respect the rights of others.
111.1.4 Consideration for cross-cultural perspectives on human knowledge and its sharing
27. Respectful knowledge sharing on the human nervous system and its functions across
communities and cultures fosters trust and strengthens global cohesion in the pursuit of health
and quality of life.
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28. It is essential that any research and development involving diverse groups and communities
is done with their permission and guidance, and conducted with their full prior and informed
consent and partnership based on free will in ways that serve their interests and respect their Commenté [A10]: This part should be revised to:
traditional knowledge and epistemic contributions. "conducted with their full prior and informed consent
and partnership based on free will."
111.1.5 Commitment to peace, fairness and justice in society
29. The use of neurotechnology should be used to promote, not undermine freedom of opinion a supprimé: freedom of thought
and expression especially in situations where refusal to use the technology could lead to Commenté [A11]: It is recommended to replace the
competitive disadvantage. Such interferences include but are not limited to the use of force, term "freedom of thought" with "freedom of opinion
threats, undisclosed access , manipulation, potential misuse for surveillance or any scenario where and expression" to enhance the scope and ensure
consent is compromised, including as a result of power imbalances. broader protection under this provision.
a supprimé:
30. The use of neurotechnology should be particularly scrutinized to avoid uses that impose a
unified mindset, diminishing the diversity of thought and individuality among people, segregate, Commenté [A12]: It is suggested to include the
objectify or subordinate individuals or communities, reduce social cohesion by exacerbating pre- following after "avoid uses that": "impose a unified
existing inequalities or generating novel inequalities that divide and antagonize individuals or mindset, diminishing the diversity of thought and
groups against each other, and thereby threaten the coexistence between humans, other living individuality among people."
beings and the natural environment.
Commenté [A13]: suggested addition: "(...) antagonize
111.1.6 Global Solidarity and International Cooperation individuals or groups (...)"
31. The Recommendation should guide all actors in the whole lifecycle of neurotechnology to a supprimé: development, deployment and use
act in solidarity and call for accountability in instances where neurotechnology may be misused in
ways that threaten human rights and fundamental freedoms.
32. International cooperation is essential to addressing cross-border issues related to
neurotechnology. Particular attention must be given to differing perspectives on acceptable use to
prevent abuse and uphold global ethical standards.
111.1.7 Sustainability
33. Considering that sustainability requires that neurotechnology be developed and used with a
deep respect for environmental stewardship, prioritizing the minimisation of ecological harm
throughout the lifecycle of the materials used, including, for mining extraction, data processing and
storage, recycling and disposal practices.
34. The unregulated development of neurotechnology, especially for non-medical purposes,
might lead to disproportionate consumption of resources and energy and waste production.
35. Respect for Indigenous rights, in accordance with the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP}, requires that neurotechnology, through its whole
lifecycle , be guided by a profound respect for Indigenous rights, ensuring that their lands (including
during mining), knowledge, communal rights, and privacy are honoured in all activities, including
those related to resource extraction.
111.1.8 Integrity and Responsibility
36. Integrity requires that all actors in the whole lifecycle of neurotechnology field act with ethical
steadfastness. It includes adhering to ethical guidelines and ensuring that all actions align with
both professional standards and societal values . Commenté [A14]: This provision can be implemented
only when the relevant actors involved are identified,
37. Integrity includes a commitment to taking responsibility for one's actions and being and a responsibility assignment matrix has been
accountable for their outcomes. This involves not only acknowledging successes but also owning developed. Given the sensitivity of the impacts arising
up to mistakes and taking corrective actions when necessary. from the use of neurotechnology, this provision should
be detailed to emphasize the assignment of roles both
38. Scientific integrity is the commitment to the rigorous pursuit of truth through evidence-based, within and between organizations and to encourage the
objective and transparent research practices. It ensures that all scientific endeavours are development of a responsibility assignment matrix
across the supply chain.
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conducted with honesty , accuracy, and respect for the scientific method of disciplines relevant for
neurotechnology.
111.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS AND FUNDAMENTAL FREEDOMS
39. This Recommendation embraces a human-centred approach through fundamental ethical
principles including but not limited to self-determination, agency, freedom of opinion and a supprimé: freedom of thought
expression, human dignity, physical and mental integrity privacy, personal data protection, Commenté [A15]: It is recommended to:
cognitive liberty, personal and collective identity, trustworthiness, respect, reciprocity, and justice. 1) Include "human dignity" and "physical and mental
Furthermore, it incorporates the respect, promotion and protection of human rights and integrity" explicitly to strengthen the emphasis on its
fundamental freedoms. importance as a core value.
2) Replace "freedom of thought" with "freedom of
111.2.1 Beneficence, Proportionality and Do No Harm opinion and expression" to provide broader applicability
and better align with established human rights
40. Neurotechnology should promote health, physical and mental integrity, and well-being, and frameworks, such as the Universal Declaration of Human
empower individuals to make informed decisions about their nervous system and mental health Rights.
while fostering a better understanding of themselves. 3) Add "personal data protection" immediately after
"privacy" to underscore its significance, particularly in
41. Neurotechnology should contribute to human flourishing without causing harm or the context of contemporary digital challenges.
subordination, whether physically, economically, socially , politically, culturally, or mentally. The
"do no harm" principle must guide the whole lifecycle of neurotechnology, ensuring that the quality
of life is protected and promoted.
42. Embracing neurotechnology for enhancement may lead to the risk of not only
unexpecteddamage or change to the nervous system, physical and mental integrity, and well-being , Commenté [A16]: Any unexpected change in the
but also to amplified inequalities within society. physical or mental state should also be considered as a
risk. In this regard, this part should be revised as follows:
43. Any restrictions to human rights must meet all applicable requirements under human rights "damage or change to the nervous system, physical and
law, including the principles of legality, legitimate aim, necessity and proportionality. mental integrity, and well-being."
Besides, it must be noted that the outcomes of the
44. The principles of proportionality, balance and legitimacy should govern the use of damage to the nervous system does not only impact the
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional nervous system, but the whole physical body (e.g.:
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon the damage to the nervous system may result in blindness,
foundational values of this document; (c) appropriate to the context and target user group; (d) inability to move or speak etc.) This risk should be
included in the subparagraph.
based on safety principles and rigorous scientific evidence.
a supprimé:
111.2.2 Self-determination and F r e e d o m o f O p i n i o n a n d E x p r e s s i o n a supprimé: damage
a supprimé: to the nervous system
45. Throughout the whole lifecycle of neurotechnology , the protection and promotion of the
rights offreedom of opinion and expression, and self-determination must be secured. a supprimé: Freedom of Thought
a supprimé:
46. . Individuals have the right to make free, informed, and voluntary decisions about their a supprimé: freedom of thought
engagement with neurotechnology throughout the whole lifecycle, in accordance with international
human rights law and other international standards, including the right to refuse or withdraw from
its use, at any time, ensuring their autonomy and respect for their decision-making capacity is
upheld and where surrogate consent is used, the best interests of the affected .individual are
considered. Individuals who are enrolled in research should be informed of potential side effects
and given the opportunity to disclose if they have any contraindications for the procedures used.
Informed consent procedures should be affirmative, dynamic, and require opt-in, comprehensive
and transparent providing detailed information about the purposes, risks, benefits, alternatives ,
and possible outcomes of the technology in all its application domains, ensuring that consent is
voluntary and that individuals fully understand the implications for their privacy , autonomy, and
well-being .
47. Neurotechnology should never be used to exert undue influence or manipulation, whether
through force, coercion, or other means that compromise self-determination and freedom of
thought. This protection covers both the internal processing of thoughts and their external
expression, ensuring freedom from any interference.
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111.2.3 Protection of Neural and Cognitive Biometric Data for Mental Privacy
48. Neurotechnology and cognitive biometric technologies raise issues pertaining to the right to
privacy due to their increasing ability to collect direct and indirect data about the nervous system
that is uniquely sensitive because they can be processed and analysed to provide deep insights
into the processes that underpin our mental states and behaviour, including self-awareness and
introspection . As it becomes increasingly difficult to anonymize data, there remains persistent risks
of misuse of this data by revealing neurobiological correlates of diseases, disorders, or general
mental states without the authorization of the person from whom data are collected.
49. Mental privacy is fundamental for the protection of human dignity, personal identity, and
agency. The collection, processing, modification, and sharing of neural and cognitive biometric Commenté [A17]: This part should be revised as
data must be conducted with free and informed consent, in ways that respect the ethical and follows in a way that it covers cognitive biometric data:
human rights principles outlined in this Recommendation. "Sharing of neural and cognitive biometric data must be
conducted."
50. There should be clear safeguards against the misuse or unauthorised access of neural and
cognitive biometric data, including affirmative consent, data minimization and purpose
specification, data rights (such as rights to access, correct and delete), and data security,
particularly in contexts where such data might be aggregated with other sources .
111.2.4 Non-Discrimination and lnclusivity
51. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface with
other technologies like Al, must commit to upholding ethical principles that prevent discrimination,
stigmatisation, targeting, or exploitation of any individuals or groups, particularly those in
vulnerable situations.
52. There is a shared responsibility to ensure that these technologies do not perpetuate or
amplify existing inequalities or create new forms of discrimination based on neurological or mental
characteristics, state, function or activity, or other grounds protected under human rights law.
53. Non-inclusive technological development and standardisation may drive a trend toward
homogenisation and the dominance of neurotypicality and capacities that may threaten cultural
and collective identity.
54. Garnering the trust and acceptance of communities in the whole lifecycle of neurotechnology
requires transparent engagement with the public, seeking their input and validation to align these
technologies with societal values and the common good.
55. Discrimination on any grounds, including intellectual differences or those related to
atypicality, should be condemned. Neurotechnology should not be used to inform, justify, or reify
such discrimination. Care should be taken to evaluate neurotechnology solutions promoted
through governments for essential services such as education.
56. Neurotechnology should not be used to perpetuate stereotypes, stigma, or discrimination
againstagainst any individual or group of people based on features including but not limited to their a supprimé:
culture, age, education level, or nationality. Commenté [A18]: The scope of this provision should
be broader and revised as follows:
111.2.5 Accountability "against any individual or group of people based on
features including but not limited to their culture, age,
57. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology requires all education level, or nationality."
actors to adhere to the highest ethical standards, remain open to feedback, be committed to
adjusting practices in response to new evidence or ethical concerns, and be held accountable for a supprimé: older persons
their actions.
58. Accountability is grounded in responsibility, clear and transparent communication, and a
duty to anticipate and address potential harms-whether short-term, long-term or arising from
unintended use and impact.
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59. A commitment to accountability requires global, governmental , societal and collective action
to ensure those harmed by neurotechnology have access to justice, and that those responsible
for wrongdoing are required to take meaningful steps to identify, prevent, mitigate and account for
how they address and redress their adverse human rights impacts, including through corrective
actions and reparations.
111.2.6 Trustworthiness and Transparency
60. To guarantee the respect, promotion and protection of human rights and fundamental
freedoms, all actors throughout the whole lifecycle of neurotechnology must ensure that their
activities are transparent, grounded in scientific evidence, and aligned with international principles
of responsible conduct and scientific integrity. This includes preventing the replication or
amplification of biases, ensuring that neurotechnology is traceable and explainable, its capacities
and limitations are accurately portrayed, the conditions for accountability are clearly defined,
adhering to ethical guidelines in research and development, including the registration of trials, fair
participant selection, and approval by independent ethics committees.
111.2.7 Epistemic Justice, Inclusive Engagement and Public Empowerment
61. Ensuring fair and equitable distribution and creation of knowledge about neurotechnology,
including recognizing diverse ways of knowing, and that all individuals and communities can
participate in its creation, sharing, and applications.
62. Promoting open and accessible education, along with public and community engagement,
to ensure diverse populations can gain and exchange knowledge about nervous system
functioning, mental health, and medical and non-medical applications and tools of
neurotechnology.
63. Effective public and community engagement throughout the whole lifecycle of
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and
identity, to respect different ways of knowing and understanding. This respect for diversity ensures
that the knowledge and perspectives of diverse communities are valued and included in decision-
making processes, and respects self-determination.
64. Grounding education in human rights ensures that the knowledge shared and produced
respects the rights of all individuals, preventing epistemic injustice where certain groups may be
sidelinedor excluded from knowledge production and dissemination. a supprimé: marginalized
65. All communities should have a voice in decisions that affect them, particularly when it comes
to the development and use of neurotechnology.
111.2.8 Best Interests of the Child and Protection of future generations
66. The nervous system is rapidly evolving during childhood and critically changing during
adolescence, which makes it crucial to preserve the privacy, self-determination and the right of
children and adolescents to participate in decisions that affect them. Technology should be
rigorously assessed to ensure it serves the best interests, well-being and healthy development of
children, as they grow into autonomous individuals and safeguard the rights of future generations
by ensuring that today's decisions promote their future wellbeing.
67. From an ethical perspective, while recognizing the potential benefits of neurotechnology for
early diagnosis, instruction, education, and continuous learning, it is equally important to make a
commitment to the holistic development of the child. This includes nurturing their social life,
fostering meaningful relationships, and promoting a healthy lifestyle encompassing nutrition and
physical activity .
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111.2.9 Global and social justice, enjoying the benefits of scientific progress and its
applications
68. Access to and benefits arising from research and development in neurotechnology must be
shared equitably among all contributors to that research and development, with a particular focus
on ensuring global distribution that promotes fairness and reduces disparities.
69. Neurotechnology developments should be leveraged to reduce global health inequities .
These technologies should serve as catalysts for improving the quality of life, particularly in
resource-limited settings .
70. Research, development, and trials in neurotechnology must adhere to the highest ethical
standards, ensuring the non-exploitative participation of all individuals involved. This includes
safeguarding the rights and well-being of participants, and patients and their caregivers, as well
as ensuring the ethical collection and use of data. Special attention should be given to ensure that
those contributing to research and development have their fair share of the benefits and do not
bear disproportionately the risks.
71. Efforts, including international cooperation, should be made to overcome, and never take
advantage of, the lack of necessary technological or medical infrastructure, education and skills,
as well as ethical-legal frameworks , particularly in LMICs, LDCs, LLDCs and SIDS, affecting
communities.
72. The development and impact assessment of novel neurotechnology should consider the
implementation of human-centred paradigms in which end-users are not merely passive recipients
of the technologies but active co-shapers on an equal footing.
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
73. Member States, private actors and international institutions should actively support the
research, development, and deployment of neurotechnology for the public good. Investments
should prioritize applications that foster human flourishing , and the use of which respects,
promotes and protects individual and collective human rights. This commitment should include
funding for interdisciplinary research that not only advances neurotechnological innovation but
also studies the ethical, legal, social, environmental and cultural implications of these
technologies, and supports the implementation and clinical translation of technological prototypes.
Particular attention should be given to the development and implementation of adequate technical,
institutional , procedural and other safeguards to ensure that they equitably benefit society and that
human rights are upheld.
74. Member States should establish clear prohibitions against the use of neurotechnology in
contexts that violate individual and collective human rights. Member States should take necessary
measures to ensure that human rights due diligence, including regular , comprehensive human a supprimé: conduct
rights impact assessments , concerning neurotechnology that they develop, design, deploy, use,
sell, operate or procure, in order to prevent and mitigate their adverse human rights impacts.
Specifically, neurotechnology should not be used for purposes such as m a n i p u l a t i o n o f
s o c i e t y , non-consensual interrogation in law enforcement , criminal and civil justice,
development or deployment of weapons targeted at the nervous system, social control, attempts
at coercive behavioural conformity based on personal beliefs or thoughts , political or other opinion,
gender or surveillance of mental states, among others. Governments should adopt legislation a supprimé: gender identity or sexual orientation,
that ensures neurotechnology is deployed responsibly, and based on human rights, with robust
oversight mechanisms to enforce adherence to these restrictions and protect mental privacy and
freedom of opinion and expression for all individuals . These policies should be developed in a supprimé: freedom of thought
consultation with diverse actors, including civil society, end-users ,
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neurotechnology experts, ethicists, and human rights advocates , to ensure broad consensus and
respect for global human rights norms.
75. Member States should ensure transparency and accountability in their support, oversight,
and regulation of neurotechnology, particularly in publicly funded initiatives such as brain research
and development programs. While recognizing the limitations in disclosing certain sensitive
information, governments should require government sponsored neurotechnology projects to
publicly disclose the objectives, methodologies, intended uses, and societal impacts of their
neurotechnology initiatives wherever possible . This transparency is crucial for fostering public trust
and ensuring that neurotechnology advances are aligned with ethical standards,human rights and a supprimé: and
fundamental freedoms.
76. Member States should apply a comprehensive approach to regulatory and policy measures
to protect against human rights harms related to neurotechnology developed, marketed, operated
or used by the private sector. This includes legislative and regulatory measures and
accompanying guidance, incentives, and transparency requirements. This comprehensive
approach should also require human rights due diligence, ensuring that businesses identify,
prevent, mitigate, and account for their adverse human rights impacts through context-dependent
processes, including human rights impact assessments, meaningful public and community
engagement, and transparent communications.
77. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, be
implemented ethically in accordance with human rights, and be aimed at promoting public safety
while protecting the rights and dignity of all those involved. This requires respect for fundamental
rights, such as human dignity, bodily integrity, confidentiality of personal data, due process and
fair trial rights, including the presumption of innocence, and the right against self-incrimination, as
well as freedom from torture and ill-treatment, the right to privacy, and the right to freedom of
opinion and expression. a supprimé: thought.
78. Member States should establish comprehensive incentive structures , such as tax incentives,
grants, and awards, with a particular focus on encouraging the construction and development of
manufacturing, computational resources, and data analytics capabilities within public research
institutions and small and medium enterprises (SMEs). Member States should also incentivize and
support partnerships that leverage the computational resources and data analytics capabilities of
private firms to advance public research goals . These incentives should prioritize rewarding
transparency, oversight, participatory development processes, and contributions to societal
benefits, aiming to foster an environment where public institutions and companies innovate
responsibly and align with human flourishing goals.
79. Member States should establish a coordinated, multi-stakeholder, cross-sectoral approach
to assessing the impacts of neurotechnology across the whole lifecycle. This approach should
include, but is not limited to: Commenté [A19]: Considering the sensitive nature of
the impacts arising from the use of neurotechnology, it
(a) Economic Impact Assessments: Conducted by relevant national bodies responsible is deemed necessary to conduct a continuous and
for economic and labor policies to assess how neurotechnology impacts economic separate assessment, which could be referred to as a
growth, jobs, social justice, and environmental sustainability; "Human Autonomy Impact Assessment." Within the
scope of this assessment, there should be ongoing
(b) Benefit-Risk Assessments: Managed by entities responsible for public health, medical oversight to determine whether the neurotechnology
research, and consumer protections, these assessments should rigorously evaluate exerts control over the human mind or subconsciously
the risks and benefits associated with the w h o l e l i f e c y c l e o f neurotechnology, influences the human brain.
including research, clinical applications , and consumer products. The process a supprimé: development, deployment, and use of
should include thorough documentation, ethical oversight, and continuous
monitoring to ensure the safety, well-being , and equitable treatment of all individuals
involved;
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(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these assessments
should evaluate and mitigate risks to individuals' mental privacy posed by
neurotechnology. This includes ensuring that appropriate safeguards are in place to
protect neural and cognitive biometric data in compliance with national and
international privacy standards, and the data policy practices discussed herein;
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights impacts of neurotechnology . The process should ensure that
neurotechnology respects and promotes human rights, with particular attention to
vulnerable people and people living in vulnerable situations. HRIAs should involve
meaningful public and community engagement to incorporate diverse perspectives.
80. Member States should promote equitable access to neurotechnology worldwide . To achieve
such goals, efforts should be made to support the reduction of final costs for end users, pursue
the development, adoption and continuous support of non-proprietary software solutions, and
explore reimbursement strategies or subsidisation commensurate with conventions in local
jurisdictions, in sectors of crucial potential benefits.
81. Member States should adopt agile regulatory frameworks, including the use of regulatory
sandboxes- controlled environments for designing, developing, testing, evaluating, ver if ying a supprimé: and
and valid at ingneurotechnology- in response to rapid advancements in neurotechnology and its a supprimé:
convergence with other technologies such as Al, spatial computing, and immersive technologies.
These sandboxes should be used to explore innovative applications, particularly in workplace
settings, with appropriate ethical oversight provided by regulatory bodies or national authorities.
These frameworks should facilitate innovation, ensure ethical data processing, and safeguard
rights by incorporating mechanisms for regular monitoring, evaluation, and dynamic policy and
regulatory adjustments in line with technological and ethical developments .
IV.2 DATA POLICY
82. Member States should develop a robust regulatory and legal framework to govern the
collection, processing, sharing, and all other uses of neural and cognitive biometric data. This and
existing frameworks should recognize this data to be both personal and sensitive data in medical
and non-medical contexts.
83. Member States should ensure that their existing privacy policies comprehensively cover
stringent safeguards for individuals' neural and cognitive biometric data. If current policies do not
adequately address these areas, Member States should adopt targeted legislation or regulatory
frameworks to secure these protections. These safeguards should for example include affirmative
informed consent, data minimization and purpose limitation, data rights (including the right to
access, correct, and delete data), and stringent data security measures, such as advanced
cybersecurity protocols to prevent unauthorized access and breaches. Such legislation or
frameworks should prohibit the the real-time, processing of neural and cognitive biometric data and
any other type of processing activities for purposes of monitoring or manipulating individuals, or a supprimé: practice of
practive of tying access to goods or services to the disclosure of neural and cognitive biometric
data, require explicit opt-in or opt-out for any data sharing, and forbid the use of such data for targeted
advertising without the individual's explicit, affirmative informed consent based on free will.
84. Member States should develop and implement specific policies to reduce the ecological
footprint of neurotechnology, particularly in relation to large-scale data centers and computing
resources used for processing and storage of neural and cognitive biometric data. These policies
should emphasise data minimisation, ensuring that only the necessary amount of data is collected
and processed, and promote the proportional use of neurotechnology, aligning its deployment with
genuine needs and minimising unnecessary environmental impact. Measures should include
optimising energy efficiency, using renewable energy sources, promoting the recycling and
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sustainable disposal of neurotechnology-related equipment, and ensuring the rehabilitation of
affected environments.
85. Member States should support and incentivise the development and implementation of
technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, such · as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
86. Member States should incentivise neurotechnology manufacturers to prioritize privacy and
ethics by design, requiring the incorporation of privacy-preserving technologies as default features
in their devices.
87. Member States should encourage ethical data sharing by establishing secure, data
repositories for neural and cognitive biometric data used in research. These repositories should
meet stringent cybersecurity, data privacy, and ethical use standards (including data minimisation
and purpose limitations), tiered access and other privacy-enhancing approaches . Appropriate
funding mechanisms should be established for the curation and maintenance of data and data
governance processes streamlined.
88. Member States should prioritize efforts to reduce obstacles to cross-border data sharing in
neurotechnology research, working towards greater alignment of data protection standards,
particularly concerning neural and cognitive biometric data, by establishing clear protocols for data
transfer that ensure secure, risk-based and compliant data exchanges across borders, and
standards for interoperability of data, including governance frameworks for data sharing.
89. Member States should consider specific guidelines for the ethical, processing and sharing of a supprimé: use
neural and cognitive biometric data in Al development and research, including consent procedures a supprimé:
for processing and sharing of neural and cognitive biometric data in training and application of Al
a supprimé: uses,
models, ensuring transparency and respecting individual and community rights.
IV.3 INTELLECTUAL PROPERTY (IP)
90. Member States should adopt policies to ensure that neural and cognitive biometric data, as
individual human activity derivatives, are not subject to proprietary rights. IP protection should only
apply to original data compilations (created through a process of aggregation, organization, or
selection, resulting in a new dataset) that meet strict and ethical criteria.
91. Member States should collaboratively establish clear, harmonised guidelines for IP rights
applicable to neurotechnology on an international scale. These guidelines should address the
patentability of Al-generated inventions and the ethical implications of IP laws, ensuring they
promote global accessibility and innovation.
92. Member States should ensure that all actors adopt IP management strategies that
encourage innovation and avoid overly restrictive patent use, fostering an open innovation
ecosystem. This approach should continuously adapt to the evolving landscape of
neurotechnology. The impact of IP policies on the neurotechnology sector should be continuously
monitored to ensure they stimulate innovation while ensuring ethical use and broad accessibility .
93. Member States should foster an environment of co-creation in neurotechnology, by
facilitating policies and incentives for co-ownership and preferential licensing agreements to
ensure equitable compensation and recognition for all contributors.
94. Member States should adopt policies with respect to open science that balance the
protection of IP with the promotion of immediate publication of results and data sharing.
Particularly with the convergence of digital technologies and the increasing concentration of those
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innovations in industry sectors, this balance is crucial to ensure that IP protection mechanisms do
not hinder scientific research, innovation, and the wide dissemination of knowledge and new
technologies. As a basic rule of equitable partnership, when Indigenous Peoples are involved in
neurotechnology research and development, open science processes, IP management strategy,
should be developed in collaboration with them from the beginning.
IV.4 CYBERSECURITY
95. Member States should collaborate internationally to establish comprehensive standards for
cybersecurity across all neurotechnology domains. These standards should encompass
hardware, software, and data security measures to protect against potential cyber threats. By
implementing uniform cybersecurity standards, Member States should ensure the integrity,
confidentiality, security, and availability of neural data, as well as enhance user trust and
confidence in neurotechnology devices. Additionally, these standards should evolve in tandem
with technological advancements and emerging cyber threats to maintain robust protection against
evolving risks.
96. Member States should employ red-teaming exercises-adversarial challenges to test the
efficacy of security systems-as a proactive measure to assess and enhance the safety, security,
and resilience of neurotechnology systems. By conducting regular red-teaming exercises, Member
States should proactively identify and address security gaps, test incident response procedures,
and strengthen the overall safety and cybersecurity posture of neurotechnology devices.
IV.5 COMMUNICATION, PARTICIPATION, AND INFORMATION
97. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
98. Member States should collaborate with international organizations, educational institutions,
and private and non-governmental entities to develop and disseminate accessible and engaging
educational materials tailored to diverse audiences to bridge knowledge gaps, particularly in
underserved regions about the nervous system and mental health functioning, as well as the
benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies' functionality, safety, efficacy, and societal impact, empowering
individuals to make informed decisions and to enable their ethical reflection about their use of
neurotechnology.
99. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a wide
array of actors. The aim of these engagements should be to inform policy development, shape
ethical guidelines, increase public awareness and understanding, align investment priorities, and
ensure that neurotechnology deployment aligns with public interests and values. Special attention
should be given to involving groups traditionally underrepresented in technological policymaking,
thereby fostering responsible innovation in the field.
100. Member states should collaborate in the co-creation of accurate, precise, and accessible
language and terminology for discussing neurotechnology that involves actors from diverse
backgrounds to ensure that the language used is inclusive, non-stigmatizing, and accurately
reflects the technologies' capabilities and limitations. Member States should establish regulatory
frameworks that require clear and ethical communication standards for neurotechnology. These
frameworks should require evidence-based reporting of capabilities, risks, and limitations across
all applications to avoid exaggeration of claims, including but not limited to applications in sleep,
attention, memory, and emotional regulation. Within these frameworks should be specific
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guidelines for ethical marketing and protocols for responsible communications about early-stage
research and emerging technologies.
101. Member States should develop policies that foster effective collaboration between end-
users, researchers and innovators throughout the whole lifecycle of neurotechnology product
development, with special focus given to the places where the neurotechnology is being
developed. These policies should mandate the creation of diverse advisory panels, including
representatives from various user groups and respecting neurodiversity. Member States should
also establish platforms for ongoing dialogue and feedback between users, researchers and
developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy , usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations.
102. Member States should develop age-appropriate, contextually-appropriate, culturally-
appropriate, and linguistically-appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user and
for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6 CHILDREN AND ADOLESCENTS
103. Member States should promote healthy brain development through policies that evaluate
the impact of neurotechnology on children and adolescents .
104. Member States should safeguard children and adolescents from implicit and explicit
coercion to use neurotechnology . Member States should pay attention to the autonomy of children
and adolescents through informed consent and assent that is adapted to and respectful of age
and decision-maki ng capacity.
105. Member States should fund research and development grants focused on creating user-
friendly assistive neurotechnology tailored for children and adolescents with disabilities. These
projects should involve children , adolescents, parents and caregivers in the design process to
ensure the technologies meet their specific needs. Educational programs should be developed to
teach children and adolescents and their caregivers how to effectively use and maintain these
technologies, with support available in multiple languages and accessible without discriminating
against those who either cannot or choose not to engage with the proposed technology.
106. Member States should ensure research involves strict oversight and close follow-up of all
neurotechnology research involving children and adolescents. This oversight is crucial during the
developmental phases of childhood to address and mitigate any unforeseen long- term effects.
Such research must include comprehensive monitoring protocols and periodic evaluations to
ensure the ongoing safety and well-being of young participants, taking into account their unique
developmental needs and vulnerabilities. In the framework of research, involving children and
adolescents in medically vulnerable situations (i.e., children in epilepsy monitoring units), special
attention will be given to consent and assent, particularly considering particular aspects of
research (time, iterations) to prevent any form of instrumentalization .
107. Member States should enact specific regulations that prohibit the use of marketing
techniques-such as neuromarketing, biometric emotional analytics, immersive advertising, and
virtual or augmented reality advertising-that rely on sensitive neural and cognitive biometric data
collected from children and adolescents. Recognizing the heightened vulnerability of children and
adolescents in digital environments, these regulations must explicitly forbid any practices that use
such data and technologies to influence or exploit children and adolescents.
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IV.7 OLDER PERSONS
108. Member States should promote healthy aging and support elderly individuals by funding and
implementing evidence-based programs that integrate neurotechnology into routine care. These
programs should involve the entire support ecosystem, including family, caregivers, and medical
teams, to enhance quality of life. Priority should be given to developing and implementing tools
that prevent, delay, and treat age-related health conditions, impairments, and neurodegenerative
diseases. Member States should ensure that access to these neurotechnology programs is
equitable and does not exacerbate socioeconomic inequalities.
109. Member States should establish guidelines for neurotechnology design sensitive to the
needs of older adults, carefully considering human-computer interface factors for usability (such
as fonts, buttons, and colour) and experience for enhanced visual and auditory cues.
110. Member States should preserve, support, and promote autonomous decision-making for
older people using neurotechnology for sensorimotor and cognitive support. The consent process
should accommodate potential cognitive challenges faced by older adults, ensuring that consent
is informed, ongoing, and adaptable to changing health conditions . Policies should be in place to
ensure that assistive neurotechnology recognize changing cognitive capacities over time and
respect users' preferences.
111. Member States should develop ethical guidelines to ensure that neurotechnology such as
robotic caregivers enhance rather than replace human interaction, particularly in the care of
individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement.
IV.8 WOMEN AND GENDER
112. Member States should adopt and enforce comprehensive policies that promote and respect
gender equality and diversity in the whole lifecycle of neurotechnology. The policies should
prioritize inclusive research for addressing women and gender specific needs and differences,
require targeted data collection and analysis, include education and training programmes on
inclusive research practices, ensure public and community engagement with women and gender
health experts and advocacy groups and, incentivise gender responsive technology design, to
meet the needs and conditions specific to women and vulnerable groups. Affirmative action policies a supprimé: gender minorities
are necessary to close gender gaps in these fields, increase representation , engagement and
leadership.
113. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environment, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women andvulnerable groups, and safeguard against a supprimé:
harassment and discrimination. This should include robust mechanisms for reporting and a supprimé: gender minorities
addressing incidents of harassment and discrimination , ensuring accountability and support.
114. Member States should adopt a range of measures that prioritize ethical and equitable
research and innovation and support programs that foster women's and vulnerable groups’ a supprimé: gender minorities'
participation in neurotechnology. This includes funding and other policies that prioritize ethical and
equitable research and innovation, but also affirmative action initiatives to support the participation
of women and vulnerable groups in neurotechnology through targeted education programs, a supprimé: gender minorities
employment opportunities, entrepreneurship support, and leadership development within the
sector. Member States should also provide support systems such as mentorship programs,
networking opportunities, and resources to help women and vulnerable groups overcome barriers a supprimé: gender minorities
to participation and succeed in the neurotechnology field.
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IV.9 PERSONS WITH PHYSICAL DISABILITIES
115. Member States should adopt policies that harness the potential of neurotechnology by
removing barriers experienced by persons with physical disabilities and providing support thereby
contributing to achieving equal enjoyment of human rights. They should implement regulatory
frameworks that require accessibility assessments for all new neurotechnology products to ensure
these products do not perpetuate existing disabilities or health disparities. These frameworks
should include protocols for testing with diverse groups of persons with disabilities to ensure
technology meets a wide range of needs and does not unintentionally exclude or disadvantage
any subgroup.
116. Member States should create incentive programs to promote the development of
neurotechnology for people with disabilities to promote their quality of life and functional
independence. These programs should include tax incentives for companies investing in assistive
neurotechnology research and development, grants for research institutions focusing on
neurotechnology for disability support, expedited regulatory reviews for technologies offering
significant advancements in mobility, communication, or daily living assistance, and innovation
prizes for breakthroughs in affordable, accessible neurotechnology solutions.
117. Member States should, whenever possible, subsidise the cost of essential neurotechnology
devices, such as neuroprosthetics, for persons with physical disabilities. They could encourage
public-private partnerships to make advanced neurotechnology affordable and integrate
neurotechnology coverage into national health insurance and other reimbursement schemes for
persons with physical disabilities. A national database of available neurotechnology resources and
support services should be developed to facilitate access and information sharing.
IV.10 PERSONS WITH MENTAL HEALTH CONDITIONS
118. Member States should foster research and promote awareness-raising initiatives to address
the increasing prevalence and special needs of people with mental health conditions, including
victims and survivors of trauma and violence, and the relevance of neurotechnology for these
communities.
119. Member States should allocate funding for long-term advocacy and efficacy studies, post-
market oversight, and tiered scrutiny with special attention to invasiveness and reversibility of
neurotechnology interventions. It is important to ensure that people with mental health conditions
are well-informed and have reasonable expectations about the process.
120. Member States should prioritize funding for neurotechnology that is designed to improve
quality of life and daily functioning of individuals with mental health conditions. This includes
technologies that assist in managing symptoms, improving cognitive functions, and providing
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
121. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11 HEALTH
122. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system
care.
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123. Member States should build and maintain international solidarity to address global health
risks and uncertainties, and ensure that their implementation of healthcare for the nervous system
is consistent with international law and rigorous human rights obligations. This could involve
creating international forums for sharing best practices in the implementation of neurotechnology
in healthcare.
124. Member States should establish oversight mechanisms to evaluate the physical and mental
health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies results.
125. Member States should consider the significant cost and impact associated with pathologies
related to the nervous system, as well as the potential benefits of early diagnosis and access to
preventive and assistive neurotechnology. Public policies should prioritize the promotion of access
to these technologies and ensure health cost coverage for individuals in need.
126. Member States should promote the development of reliable and durable neurotechnology
for healthcare applications. This includes encouraging the design of devices and systems that
require minimal maintenance, ensuring they remain functional and effective under everyday
conditions. Regulatory bodies or designated authorities should oversee the enforcement of
rigorous standards for quality, safety, and longevity, thereby reducing the burden on users and
enhancing the dependability and sustainability of neurotechnological solutions.
127. Member States, to the extent permitted by their national laws and regulations, should ensure
the development or strengthening of existing comprehensive neurotechnology medical device
reporting systems that track and address adverse effects. In contexts where such systems do
not exist, Member States should establish them. Where systems are already in place, they should
be updated, in case it is permitted by their national laws and regulations, to specifically include
neurotechnology. These systems should be, to the extent permitted by their national laws and
regulations, interoperable and contribute to a centralised, public, and transparent international a supprimé:
database, managed in collaboration with international organizations, to ensure that global
standards are met and accessible for public knowledge, international oversight and research.
IV.12 RESEARCH ETHICS
128. Member States should reinforce the ethical frameworks governing neurotechnology
research to ensure robust protection of human participants. Member States should adopt clear
guidelines or policies that define the qualifications to ensure that research is conducted by
professionals with appropriate knowledge about the nervous system structure and function in
addition to brain disorders and is performed in adequate research settings. Furthermore, research
protocols, public or private, in the medical as well as the non-medical domain, should be carefully
evaluated by registered ethics boards (ethics committees) and specific attention dedicated to
individuals with special situations regarding vulnerability such as diminished capacity to consent
or to make decisions. Member States should ensure that all research institutions have mandatory
ethics training for researchers.
129. Member States should encourage multicentre international research that involves various
cultures and ethnic groups. Member States should promote international cooperation to develop
common reporting standards and protocols for interoperability, particularly for implantable
neurotechnology devices. This cooperation should aim to enhance the comparability and utility of
research globally, improving both the efficacy and ethical integrity of research.
130. Member States should ensure that the whole lifecycle of neurotechnology is considered in
the design of a clinical trial, including policies to protect patients in case of cessation of activities
of the trial sponsor or promoter. Member States should establish requirements for clinical trials to
be included in relevant nationally or internationally approved registries, and encourage registration
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with community and patient registries, in case it is permitted by their national laws and regulations.
Also, clinical trials should report on appropriate medical device reporting systems developed
within Member States, in case it is permitted by their national laws and regulations.
131. Technology developers should ensure that the validation of Al algorithms in
neurotechnology research include rigorous testing and monitoring for biases, as well as
measures to enhance explainability and transparency, including the provenance of training
datasets. Suitable techniques should be employed to mitigate any biases present in Al models
used in neurotechnology applications.
132. Member States should ensure that research efforts not only focus on biomedical risks
associated with neurotechnology but also investigate potential effects on an individual's subjective
experience, agency and personal identity. Understanding how neurotechnology may impact
aspects of self-perception, consciousness, and identity is essential for addressing ethical concerns
and ensuring the well-being of individuals using these technologies. ·
133. Member States should ensure those engaged in research implement regular auditing and
monitoring of research practices to ensure adherence to ethical standards . This should include
evaluating the adequacy of informed consent, particularly concerning data reuse and the potential
commercialisation of neural data.
134. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings to
participants. These protocols should ensure that such findings are conveyed promptly, respecting
participants' rights and autonomy. Additionally, Member States should mandate that researchers
provide the necessary support and coordination with healthcare providers to address any health
concerns that arise from these findings.
135. Member States should ensure that individuals involved in neurotechnology research or
receiving neurotechnological interventions are adequately informed about the potential for
incidental findings, particularly those. with significant health implications. The informed consent
process should clearly outline what these findings might entail, the participants' right to choose
whether they wish to be informed about such findings, and guarantee that their decisions in this
regard will be respected throughout the study or treatment.
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH
IV.13 EDUCATIONAL SETTINGS
136. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age-
appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology's impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
137. Member States should adopt policies ensuring the voluntary deployment of neurotechnology
in education, grounded in fully informed consent. These policies must include clear, age-
appropriate information about the technology's purpose, benefits, and risks, with adequate
consideration periods. Considering the increased complexity of obtaining voluntary consent in this
context, consent and assent procedures should involve children, adolescents, parents, guardians
and all actors necessary to obtain approval required for minors. Ethical oversight mechanisms
should be established, including regular consent renewal and immediate cessation of
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neurotechnology use upon withdrawal, and ensure anonymous feedback channels. Policies must
prohibit undue incentives or academic penalties for non-participation and take measures to avoid
creating or reinforcing inequalities among students. Additionally, Member States should support
student involvement in decision-making about neurotechnology integration and fund training
programs on its ethical use, empowering educators and students to critically assess its application.
138. Member States should establish a unified, robust oversight mechanism for neurotechnology
use in educational settings, incorporating regular audits, public and community feedback, culturally
appropriate and according to local conventions, and strict adherence to safety and ethical
standards, including an assessment of reversibility on the nervous system. Continuous research
should be funded to assess the long-term psychological and cognitive impacts of these
technologies. Oversight should involve periodic reviews based on empirical evidence to adjust
neurotechnology usage as needed, ensuring it serves student development and addresses risks
like dependency or de-skilling. This comprehensive approach will help maintain the safety,
effectiveness, and alignment of neurotechnology with best practices for student well-being and
learning outcomes.
139. Member States should invest in educational and professional development programs to
equip innovators and business leaders with the skills to integrate ethical considerations throughout
the neurotechnology whole lifecycle. This training should include ethical design, human rights law,
and societal impact assessment, preparing the next generation of technologists to critically
evaluate the implications of their work.
IV.14 LABOUR AND EMPLOYMENT Commenté [A20]: Considering the power imbalance
between employees and employers, Member States
140. Member States should establish workplace policies and incentives that prioritize the health should establish oversight and enforcement
and well-being of employees in the use of neurotechnology. These policies should ensure that any mechanisms to ensure the lawfulness of the use of this
deployment of neurotechnology is evidence-based, with a focus on applications that have been technology. These mechanisms should also enable
scientifically validated to promote employee well-being, such as reducing stress or enhancing employees to report any instances where they are
workplace conditions (i.e., adaptive and responsive environments that adjust workloads based on required to use this technology against their will.
cognitive load). Deployment must be on a voluntary basis and employees must opt-in actively and
in an informed fashion if they choose to use neurotechnology and they must have the right to opt-
out at any time without facing any negative consequences or discrimination. Under no a supprimé: have the option to opt out of using
circumstances should these technologies be used for punitive measures, mental surveillance, neurotechnology …
or in ways that could compromise employee health.
141. Member States should require employers to clearly provide employees with comprehensive
information about how neurotechnology used in their workplace works, the benefits it offers,
transparency about what data are collected, how it is used, and who has access to it, and clearly
disclose any potential risks of their use.
142. Member States should require employers who use neurotechnology in the workplace to
adopt transparent policies that disclose the purpose of the use, limit the scope of its use to
legitimate purposes in the interest of the employee and third parties (i.e., safety, monitoring fatigue
in commercial drivers or tracking attention in air traffic controllers). To respect employees' mental
privacy, employers should be prohibited from unauthorized access or processing of neural and a supprimé: to
cognitive biometric data that may be collected incidentally during routine workplace monitoring.
Employers should be prohibited from accessing and processing, including collecting and using,
neural and cognitive biometric data for any non-consented purposes, particularly those that could a supprimé: using neural and cognitive biometric data
negatively impact an employee's job security or privacy.
143. Member States should require employers to adopt best practices for data minimisation and
secure storage of neural and cognitive biometric data, ensure that data is stored securely, with
access limited to authorised personnel only, is deleted once its intended purpose has been fulfilled
or the employee uses its right to opt-out. Additionally, upon an employee's departure, all related
records should be fully deleted or individual data released to the employee, ensuring that no data
is retained after the termination of employment.
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144. Member States should ensure that when employees are issued multifunctional devices (i.e.,
earbuds or headphones that also include neural sensors) that can be used at work or at home,
employers should be prohibited from collecting neural and cognitive biometric data outside of
workplace settings and working hours and ensure that any data collected during work is used
exclusively for agreed-upon purposes. Employers should implement technological safeguards to
automatically disable data collection during non-work hours.
145. Members States should ensure that employers respect the right of employees to obtain a
copy of any neural and cognitive biometric data collected about them, along with any interpretations
drawn from it in an accessible and comprehensible manner. To use these tools without consent
constitutes a breach of trust, undermining the value they would otherwise create.
146. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit employee consent, and be used only for purposes
that demonstrably enhance workplace safety, employee well-being and dignity, and not for
enhancing productivity at the expense of employee health.
147. Member States should guard against the exploitation of employees, and they should develop
stringent regulations against using neural and cognitive biometric data for profiling in the workplace,
including in hiring. These regulations should prohibit the use of neural and cognitive biometric
data to discriminate against candidates, particularly neurodiverse individuals, ensuring hiring
practices are fair and inclusive.
148. Member States should strictly regulate the use of neurotechnology for hiring or maintaining
employment, to prohibitsuch use even where such neural and cognitive biometric data are directly Commenté [A21]: In order to uphold right to work, as
relevant to the specific requirements of the job. enshrined in international human rights instruments
such as the Universal Declaration of Human Rights, use
IV.15 CONSUMER AND COMMERCIAL DOMAINS of neurotechnology for hiring and maintaining
employment should be prohibited.
149. Member States should proactively establish a regulatory framework that balances innovation a supprimé: limit
in the recreational and commercial domains with protecting individual rights and well-being. This
framework should be dynamic, allowing for timely updates as technology evolves and new insights
are gained about its impacts on society. This includes providing adequate oversight to ensure that
neurotechnology does not cause harm, are used consensually, and include robust mechanisms to
protect users from potential psychological distress or manipulation.
150. Member States should strengthen comprehensive consumer protection laws to include clear
labelling on commercial neurotechnology products, detailing their effects, limitations, and risks to
prevent misleading claims and ensure transparency. This also includes prohibiting practices of
"tying" or requiring the disclosure of neural and cognitive biometric data as a condition to access
goods or services, and prohibition about third party data sharing or the uses of this data without
affirmative opt-in option along with information presented in clear and understandable language.
151. Member States should foster an environment that ensures all claims about consumer, non-
medical technologies are supported by robust scientific evidence. They should, by regulation,
require that any products claiming to treat, prevent, or diagnose diseases or medical conditions
be validated through rigorous safety and efficacy testing, including clinical trials where necessary,
and be used under appropriate medical supervision.
152. Member States must enforce informed consent processes that are thorough and transparent
across all neurotechnological interventions, ensuring that participation is fully voluntary and respects
the privacy and autonomy of individuals. This principle should apply uniformly in various domains
such as sports, arts, where robust standards should safeguard against coercive use and respect
athletes' and artists' individual autonomy, community interests, and IP rights.
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153. Member States should steer the use and development of neurotechnology in the arts toward
ensuring the enhanced learning and cultural appreciation without compromising individual
autonomy or leading to cultural homogenisation.
154. Member States should adopt policies to prevent the misuse of neurotechnology of consumer
technology, especially neurogaming and other devices that exploit the dopamine reward system
or seek to induce problematic and unhealthy use and overconsumption. Such regulations should
mandate clear labeling of risks, disclosures on their effects on the nervous system, enforce game
design standards and safety, privacy and age-appropriate design standards that prevent taking
advantage of a person's physical, mental and emotional vulnerability to lead to compulsive use or
addiction of gaming or digital recreational platforms combined with neurotechnology, to promote
healthy, balanced use, especially among children.
155. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that 'opt-out' features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
156. Member States should address the profound ethical questions regarding human dignity, self-
determination, consent, privacy, and the potential for manipulation raised by neurotechnology
that arise in the contexts of recommender systems, priming and nudging, marketing during
sleep and dream, neuromarketing, and closed-loop environments by adopting comprehensive
policies and regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive biometric
data in recommender systems for manipulative or deceptive purposes, including in
political context. These regulations should require that any use of such data within
these systems be based on explicit, informed opt-in consent from users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging-subtly
influencing individuals' decisions or behaviours, often without their explicit awareness.
This is particularly critical in sensitive areas such as political messaging, commercial
advertisement, and healthcare. These frameworks should require explicit, informed
consent for any use of such data to influence decisions or behaviour, the right to opt
out of these systems, and transparency and clear disclosures at the point of data
collection, with strict limitations on using data for purposes beyond those explicitly
disclosed. Commenté [A22]: Considering the operating principles
of nudging, it is inherently impossible (as they are
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that influences mutually exclusive) to get an informed consent for
or manipulates individuals during sleep, such as marketing during sleep and dream. nudging.
Regulations should strictly prohibit commercial, marketing, or political applications that Due to its negative impacts on human autonomy/self
target individuals during sleep, using neurotechnology or neural and cognitive determination, right to opinion and expression and
biometric data. Additionally, robust oversight mechanisms should be required to human dignity, nudging should be banned.
ensure that any research or application of such technologies prioritizes the well-being,
privacy, and autonomy of individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in neuromarketing,
including by requiring comprehensive disclosures to ensure that all neuromarketing
activities are conducted transparently, with participants' explicit informed consent. This
includes ensuring that participants in neuromarketing research or campaigns are fully
aware of methods, risks, and intentions and affirmatively opt-in to participation. The
use, storage, and potential reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and use
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of closed-loop environments-such as immersive computing devices that adjust
experiences based on detected neural and cognitive biometric data. These policies
should require clear and accessible disclosure about how neural and cognitive
biometric data are used in these environments, prohibit real-time behavioral
modification or manipulation without explicit, informed consent, and implement
safeguards specifically designed to prevent abuses such as unauthorized surveillance,
manipulative interventions, and practices that could shape or alter habits, ways of
thinking, decision-making processes, or behaviors ranging from voting preferences a supprimé: influence
and political opinions to consumer choices, or that might exploit psychological and a supprimé: behavior,
emotional vulnerabilities.
a supprimé: in real-time
IV.16 ENHANCEMENT
157. The use of neurotechnology to improve memory, attention, or other aspects of human mental
performance outside of the medical context introduces complex ethical, social, political and legal
challenges, which can create new kinds of disparities in the global world. When neurotechnology
is used in these contexts, it raises crucial questions about equity, consent, individual and
community autonomy, and the nature of enhancement of the nervous system itself. Member States
should ensure that any policies, law and regulatory frameworks that govern the use of
neurotechnology in these contexts do not exacerbate social inequalities or lead to discrimination,
address the potential risks (including to reversibility, invasiveness, and risks to self-determination)
and fully comply with human rights and dignity.
V. IMPLEMENTATION
158. Member States and all other actors as identified in this Recommendation should respect,
promote and protect the ethical values, principles and standards related to this Recommendation,
and should take all feasible steps to give effect to its implementation.
159. Member States shall, according to their specific contexts, governing structures and
constitutional provisions, credibly and transparently advance the ethics of neurotechnology, in line
with the UNESCO Recommendation. Member States shall monitor and evaluate policies,
programmes and mechanisms related to neurotechnology and its ethics. Progress monitoring
could rely on a combination of quantitative and qualitative approaches.
160. Member States should develop capacities in governmental institutions and support
government officials to steer the technological development ethically.
161. Member States should establish or designate national organizations responsible for
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance
with national and international standards, and ensuring that data and insights from different
regulatory domains are shared effectively to inform decision-making and policy development.
These bodies should also help coordinate public and community engagement.
162. Member States should strive to extend and complement their own actions in respect of this
Recommendation, by cooperating with all relevant national and international governmental and
non-governmental organizations, as well as private sector and scientific organizations, whose a supprimé: transnational corporations
activities fall within the scope and objectives of this Recommendation. Civil society will be an
important actor to advocate for the public sector's interests and therefore UNESCO needs to
ensure and promote its legitimacy.
163. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
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advisory bodies for dissemination to all levels and actors in this field.
164. To support Member States implementing this Recommendation by developing concrete
programs and policies and developing institutional capacities in the ethics of neurotechnology,
UNESCO shall contribute by developing a full-fledged program with the following elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States in
identifying their status at specific moments of their readiness trajectory along a
continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of neurotechnology
based on rigorous scientific research and grounded in international human rights law,
along with specific guidance for its implementation in the whole neurotechnology
lifecycle, and capacity-building tools and materials to support Member States' efforts
to train government officials , policy-makers and other relevant actors on the
methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and the
efficiency of the policies for the ethics of neurotechnology and incentives against
defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in a
UNESCO observatory , to become a shared pool of knowledge and awareness of
good practices and innovations available to all Member States and actors, in the form
of research reports, data, and statistics regarding policies for ethics of
neurotechnology. The research program should take into consideration the
converging developments of neurotechnology with other technologies such as
artificial intelligence and quantum technology , work to be conducted in collaboration
with other relevant UNESCO initiatives.
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating
collaboration among Member States and among all actors to promote a global policy
dialogue , including at Ministerial level in the context of a Global Forum on the ethics
of Emerging Technologies. Supporting this effort, UNESCO shall establish a network
of experts, with balanced representation of all UNESCO's regional groups, on the
neurotechnology. Commenté [A23]: Considering the duties of the the Digital
Transformation Office (DTO) in the fields of digital
165. Processes for monitoring and evaluation should ensure broad participation of all actors, transformation, big data and artificial intelligence, and the
including, but not limited to, under-represented, vulnerable people or people in vulnerable ongoing work in the field of responsible artificial intelligence
situations and ensuring social, cultural and gender diversity . The monitoring and assessment of and relevant ethical issues, it is considered that the DTO can
contribute to the unified platform to be established.
the impact of neurotechnology and related ethics policies and practices should be carried out
continuously in a systematic way proportionate to the relevant risks. This should be based on
internationally agreed frameworks and involve evaluations of private and public institutions. Data
collection and processing should be conducted in accordance with international law, national
legislation on data protection and data privacy, and the values and principles outlined in this
Recommendation.
VI. FINAL PROVISIONS
166. This Recommendation needs to be understood as a whole, and the foundational values and
principles are to be understood as complementary and interrelated.
167. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
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prejudicing Member States' obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or perform
any act contrary to human rights, fundamental freedoms, human dignity and concern for the
environment and ecosystems.
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UNITED KINGDOM/ROYAUME-UNI
UNESCO ETHICS OF NEUROTECHNOLOGY RECOMMENDATION – FIRST DRAFT
UNITED KINGDOM WRITTEN INPUT
The UK welcomes the UNESCO Expert Group’s work in preparing this Recommendation, and the
opportunity to provide input on the first draft text.
We welcome many aspects of the current text, including the consideration of end user needs and key
ethical concerns including safety, privacy and autonomy. We fully support the multistakeholder-led
approach described in the text, including their involvement in its implementation. We are also firmly
supportive of a human rights-based approach and welcome the efforts made to clarify States’ obligations
under international human rights law with regards to neurotechnology. We have also recommended
where human rights language could be further strengthened and clarified in places.
We would like to see greater attention paid in the text to the opportunities of neurotechnologies, and how
UNESCO and member states can work towards ensuring that these benefits are shared fairly. We also
recommend that the role of industry and creators is better reflected in the Recommendation, specifically
how they will be involved in implementation.
The UK also submits the following comments for changes we recommend are made in the next version of
this Recommendation:
Preamble and scope
• The UK believes that the Recommendation should define terms where they are new or essential
to understanding. We would like to see definitions and a clear scope for the terms set out in
Annex A.
• Rather than only being ‘conscious’ (preamble 11) of existing work, we suggest that UNESCO,
through building this Recommendation, actively works in partnership with the work already taking
place in the other international organizations such as OECD Recommendation on Responsible
Innovation in Neurotechnology (2019) and the OECD Neurotechnology Toolkit (2024). UNESCO
should also work in partnership with other international organisations who are already actively
considering the ethics of emerging tech, including the Global Forum on Bioethics Research,
located in the WHO Global Bioethics Programme.
Ethics and values
• Whilst there are clear risks from neurotechnology that are well covered by UNESCO in this
Recommendation, such as the risk of human enhancement exacerbating inequalities, greater
attention should also be given to the potential for the technology to support human attainment
and quality of life overall. This should include the potential benefits for those currently
disadvantaged by medical conditions, disabilities, access to education or other forms of support.
There should be a greater emphasis on the substantial opportunities from neurotechnologies,
with clear examples or case studies included.
• The UK recognises the importance of ensuring technological developments do not threaten
cultural diversity and heritage but strongly suggests the term ‘technological colonialism’ (P24) is
removed as this term has not been defined elsewhere or is widely understood. Instead, we would
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suggest framing this point as promoting and protecting cultural diversity and heritage against
exploitation.
• Reference to ‘collective rights’ should be removed throughout the text. International human rights
treaties make it clear that rights are held by the individual and not by the collective.
• All human rights are of equal importance, as stated under International Human Rights Law.
Therefore, UNESCO should avoid using the term ‘fundamental rights’ (P77) but rather reference
International Human Rights Law. Additionally, the examples in paragraph 77 are not stand-alone
human rights, specifically human dignity, bodily integrity, and confidentiality of personal data.
Neurodata
• UNESCO should acknowledge that there are situations where consent is not the only appropriate
basis for processing neural data. For example, in a research setting, there are several other
bases for capturing and processing data that could be acknowledged.
• UNESCO should also acknowledge that there are times when consent may not be appropriate as
the basis for processing at all, notably when there is a power imbalance; or when reliance on
consent is an impractical purpose of use for this category of data. We recommend drawing on
insights from other fields such as genomics research where similar challenges apply, and broader
purpose of use is accepted.
• UNESCO should consider incorporating further discussion on an appropriate legal definition of
‘neurodata’, acknowledging that there are benefits and risks to a broad or narrow definition. We
recommend UNESCO pay special attention to the definition of both neural data and sensitive
data and consider carefully whether neural data is always sensitive data.
Research ethics
• References to proposed training and experience requirements for research professionals should
be appropriate and proportionate to the research activity they are expected to deliver. References
to ‘mandatory ethics training’ in ‘all research institutions’ is too broad. UNESCO should consider
revising the text to recommend that ‘all research institutions should ensure that their staff are
qualified by education, training and experience to perform their task’.
• The requirement in paragraph 130 that ‘Member States should ensure that the whole lifecycle of
neurotechnology is considered in the design of a clinical trial, including policies to protect patients
in case of cessation of activities of the trial sponsor or promoter’ should be expanded to include
provisions for post-trial support and continued access for patients where needed.
• A stronger stance should be taken on addressing maintenance and obsolescence instead of only
‘encouraging the design of devices and systems that require minimal maintenance’ as set out in
paragraph 126. UNESCO should consider recommending that Member States require companies
to provide transparent information on how to repair their devices and explore obsolescence laws
requiring manufacturers to support products for a longer period.
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• The Recommendation should acknowledge that someone's ability to provide ongoing consent
may be affected by changes to their mental state throughout treatment.
• Throughout the text, the Expert Group has placed more emphasis on potentially burdensome
regulation, rather than on soft law approaches such as guidelines and self-created agreements
such as a code of ethics. UNESCO should outline the potential benefits of implementing soft law
interventions.
• The Recommendation should acknowledge the dual-use potential of these technologies, and
attention needs to be paid to research that could be done for malign purposes.
User groups
• Regarding children and future generations (P111), given the neuroplasticity of children and
adolescents, the recommendation should include a sentence that neurotechnology should not
adversely impact their health and ‘the otherwise typical development of their nervous system’.
• The risk of racial bias and systematic discrimination as it relates to clinical trials should be
included in the ‘ensuring and respecting diversity section’.
• The Recommendation should acknowledge the potential for interventions during pregnancy that
have a nervous system dimension.
• The opportunity for older persons and those with disabilities to participate in the design of
neurotechnologies should be emphasised.
Implementation Section
• The Recommendation would strongly benefit from collaboration with other parts of the UN
system. We request that the Recommendation sets out how UNESCO will work with the wider UN
system on implementation of its Recommendation. For example, by working with the Office of the
United Nations High Commissioner for Human Rights (OHCHR) on the human rights aspects.
This could be included as part of P164 and its subsequent commitments.
• Under P164e, the rationale for establishing a new 'Global Forum on ethics of Emerging
Technologies' is not clear. We would like to request additional information on what this would
involve and what gap this forum is currently trying to fill. We are also concerned that this forum
goes beyond the defined scope of neurotechnology and risks duplicating existing global fora.
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Annex A: terms that should be defined in next version of the Recommendation
• ‘Ethical’
• ‘Human flourishing’ (phrase is not used in other international instruments so we would be benefit
from clarity about what is intended to be in scope)
• ‘Cognitive states’
• ‘Self-determination’ (self-determination has a specific meaning in international law concerning the
rights of a group of people, which appears to be different to its intended meaning in this
Recommendation i.e. of an individual’s autonomy)
• ‘Enhancement’
• ‘Subjective identity’ (changes to subjective identity is a new risk that should be further defined in
the text, in particular its ramifications for consent and freedom of choice)
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UNITED STATES OF AMERICA/ÉTATS-UNIS D'AMÉRIQUE
U.S. comments to the UNESCO Recommendation for Ethics in Neurotechnology
1. Strongly recommend merging the "values and principles" and "ethical principles and human
rights" sections to a single "values and principles" section to be consistent with the UNESCO AI
Recommendations, or “values-based principles” to be consistent with OECD Recommendations.
In some cases, the values should be further scoped, as there is significant overlap between
certain sections (e.g. portions of trustworthiness/ transparency and scientific integrity)
2. Throughout the document, legally-binding language (e.g. “must”) should be replaced with
alternative language (e.g. “should”), unless specifically referencing a requirement in an existing
legal instrument.
3. Throughout, we recommend caution in using the word “ensure”, instead opting for terminology
with more realistic expectations, such as “promote” or “seek to ensure”.
4. Passages throughout combine reference to "access" and "benefit sharing" as though they are a
singular and inseparable concept. This plays into the hands of demandeurs to pursue creation of
various “access and benefit-sharing” regimes – whether apt to circumstances or not and which
often disadvantage commercial interests. Suggest softening or at least breaking up references to
these principles throughout. (The U.S. BBNJ delegation, for example, took care not to use
“access and benefit sharing” as a singular phrase throughout that instrument’s negotiation, and
instead asked for parties to treat access and benefit sharing as separate principles in separate
language and commitments.
5. When referencing existing laws, strongly recommend expanding the scope beyond international
human rights laws. In some cases, IHRL are not appropriate in the context, and in other cases,
other international law may also be applicable and appropriate.
6. The United States is concerned with using the term "freedom of thought" throughout this
document as it implies the human right enumerated in the ICCPR and UDHR in articles focused
on religious belief, rather than on a more abstract right to thoughts without technological
interference and/or manipulation. The term “cognitive freedom" is strongly recommended as a
replacement throughout.
7. The United States is also concerned with using the term “right to self determination” in this
document. Given that self-determination is a right of peoples, not of individuals, under
international law and has a different, discrete meaning in that context, we strongly recommend
using instead the term "personal autonomy" which is closer to what is meant here.
8. Rather than using less-defined terms like “human mind, lives, and flourishing”, strongly
recommend pointing to international human rights and sustainable development goals to
provide a well-defined, internationally recognized set of values, concepts, and objectives.
9. The terms “flourishing” and “well-being” seem to be used interchangeably in this document-
recommend sticking to one or the other, or seeking to distinguish between the two.
10. The United States strongly recommends scoping the document exclusively towards civil
applications, and not address weapons, defense, or law enforcement applications that fall under
the remit over other international organizations.
11. In many cases the document refers to neurotechnology when it should instead refer to
applications of neurotechnology.
12. Throughout the document, the authors should be more circumspect in drawing conclusions
about neurotechnology given its relatively nascent stage. We must be cautious to not overstate
the impacts of current neurotechnology and imply impacts that are not yet substantiated/
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realized. We do not yet know all the risks and benefits at this time and not all aspects will pose
ethical concerns.
13. In some cases (e.g. para 36), the document implies that actors are ethically responsible for both
actions and outcomes, even in cases where outcomes may be unintended or unexpected. The
United States recommends softening language around the responsibility of actors related to
outcomes write large.
14. In several cases the document notes “prevent misuse”(e.g. para 18g). The United States
recommends adding “to mitigate the risks of unintended harm and”, as both unintended harm
and intentional misuse are important to consider and seek to mitigate/prevent.
15. On Scope: Scope is quite expansive and includes non-neurotechnology cognitive biometric,
which may have different ethical implications than traditional neurotechnology applications.
16. Throughout the document, recommend rescoping the framing of assertions on "cosmetic"
applications or uses of neurotech for "enhancement" to be less oppositional, as the USG does
not oppose the development and innovation for such purposes with appropriate safeguards.
Further, “enhancement” is poorly defined in the sense that the same technology could be used
in different people to achieve different outcomes along a spectrum of outcomes (e.g. in one
case it may allow a patient to function within average societal parameters and in another, may
provide advantage in excess of societal parameters.
17. Further, the document makes broad (potentially inaccurate) assertions with respect to how
“cosmetic” and “enhancement” applications of neurotechnologies may impact human rights or
inequities (e.g. in para 3 of 111.2.1). For example, neurosensory devices, which are currently
being considered in many cases as assistive devices, could be argued to both simultaneously
reduce and amplify inequalities based on the population groups you chose to compare and be a
neurotechnology designed for "enhancement." These assertions should be tempered to
accurately reflect the impacts of neurotech applications.
18. In the document, we note several opportunities to merge sections. For example, the section on
sustainability (111.1.7) should take a more wholistic view towards SDGs—the approach taken in
the AI Recommendations-- rather than focusing on environmental sustainability, and when
doing so, should fold in some elements from 111.2.9. The authors should also consider merging
the sections on “Integrity and Responsibility” (111.1.8) with key elements from the section on
“Accountability” (111.2.5)
19. Under Recommended policy actions, the text frequently refers to legislation or judicial action,
which in the United States fall outside of the remit of the Executive Branch. As such, the
Executive Branch cannot agree to these inclusions.
20. Several Sections in the latter half of the document (e.g. on clinical trials, intellectual property
rights, etc) fall outside of the expertise and mandate of UNESCO and are addressed in other
international fora. In these sections, edits as tracked are required.
21. Recommend adding the below language in Section V.14 (Safety and Cybersecurity). We think it
would be good to add the following new paragraph:
a. Member States should adopt and maintain a cybersecurity standards framework that
implements existing international frameworks and leading methodologies from
industries to model and predict cybersecurity threats. Such framework should employ,
but not limited to, policy protocols, risk assessment prioritization, security controls, data
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encryption, key performance indicator (KPI) optimization, and privacy compliance for
cybersecurity effectiveness.
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es
FIRST DRAFT OF THE RECOMMENDATION
ON THE ETHICS OF NEUROTECHNOLOGY Commented [A1]: UNESCO recommendations are
widely scoped;
Ensure these are recommendations only. They should
PREAMBLE not include legally binding language.
Commented [A2]: Recommend addition of "current
Recognizing the profound and dynamic impacts of neurotechnology on human mind, lives and and potential", so as to not overstate the current
flourishing, and societies, environment, and ecosystems, impacts or imply impacts that are not yet
realized/substantiated
U.S. Proposed: Recognizing the current and potential profound and dynamic impacts of
Commented [A3]: Rather than using less
neurotechnology on individuals, societies, the environment, and ecosystems, including the internationally-defined terms like ‘human mind, lives,
enjoyment of human rights and advancement toward the sustainable development goals. and flourishing,”, Pointing to international human rights
and sustainable development goals provides a well-
Considering the major and growing global prevalence of neurological and mental health conditions, defined, internationally recognized set of values,
concepts, and objectives.
along with the profound suffering they cause for individuals and societies worldwide,
Commented [A4]: Comment: Unclear whether the true
U.S. Proposed: Considering the significant prevalence and growing global recognition of prevalence of neurological mental health conditions is
growing, or if instead we have greater recognition and
neurological and mental health conditions, along with the profound suffering they cause for diagnosis in part due to improved measurement and
individuals and societies worldwide, diagnostic tools to assess these conditions.
Commented [A5]: Technical edit: Perhaps mention
Acknowledging the potential of neurotechnology to offer innovative solutions and deliver better here that at least some people might want to use the
preventive and therapeutic treatments for millions, [Potential Add: as well as the potential for technology for “enhancement” purposes
enhancement] benefitting humanity as a whole and providing opportunities for health improvements
Commented [A6]: Challenges related to democracy
in all countries, are not wholly orthogonal/separate from the
"fundamental ethical issues" described earlier in this
Also considering that neurotechnology raises fundamental ethical issues for instance regarding sentence.
self:-determination, privacy, personal identity, freedom of thought, risk of discrimination, inequality
Commented [A7]: Prescriptive/binding language. Use
and challenges to democracy… “should” instead of “must.” See alternatives below
and that justice, trust and fairness must be upheld so that no country and no one should be left behind, Commented [A8]: Neurotechnology itself does not
raise fundamental ethical issues and not all
either by having fair access to neurotechnology and enjoying their benefits or in the protection against applications of neurotechnology will raise such issues.
their risks, while recognizing the different circumstances of different countries and respecting the
Commented [A9]: Recommend replacing “Freedom of
desire of some people not to take part in all technological developments,
thought” with “cognitive freedom”. Rationale: Current
terminology may conflate with "freedom of thought" as
U.S. Proposed: Also considering that certain applications of neurotechnology may raise enumerated in the ICCPR and UDHR, which frames
fundamental ethical issues, for instance, regarding personal autonomy, privacy, personal identity, the right as part of the right to freedom of thought,
cognitive freedom, risk of discrimination, inequality and other opportunities and challenges conscience and religion, in a section focused on
religious belief. The U.S. has not yet endorsed this
related to human rights and democracy, … language, and further, using this language here would
stretch the definition beyond the scope of the original
Alt 1: and that justice, trust and fairness should be upheld so that no country and no one is left language, e.g. to include a more abstract right to
behind, either through a lack of fair access to neurotechnology and its benefits or through a lack thought free of technological interference/manipulation.
of protection against its risks, while recognizing the different circumstances of different countries, Commented [A10]: Comment: neurotechnologies offer
bearing in mind national security considerations or commercial restrictions on proprietary potential benefits related to these fundamental areas,
information, and respecting the desire of some people not to take part in all technological not just challenges/risks.
developments, Commented [A11]: neurotechnologies offer also
potential benefits related
Alt 2: and that human rights and sustainable development goals may be best achieved by Commented [A12]: Same as comment in para above:
promoting equitable access to neurotechnology and its benefits, while mitigating against potential challenges related to democracy are not wholly
risks, recognizing the different circumstances of different countries, bearing in mind national orthogonal/separate from the "fundamental ethical
security considerations or commercial restrictions on proprietary information, and respecting the issues" described earlier in this sentence.
desire of some people not to take part in all technological developments. Commented [A13]: This is a normative point, not
obligatory or logical
Commented [A14]: This is consensus language from
other multilateral discussions on emerging technologies
Recalling that, by the terms of its Constitution, UNESCO seeks to contribute to peace and security (CCW GGE on LAWS). There will be restrictions on
by promoting collaboration among nations through education, the sciences, culture, and what can be provided to other countries.
communication and information, in order to further universal respect for justice, for the rule of law and Commented [A15]: Added additional consensus
for the human rights and fundamental freedoms which are affirmed for the peoples of the world, language from other multilateral discussions on
emerging technologies to note that certain technologies
will not be able to be fully shared internationally.
783
Given the leading role of UNESCO, at the forefront of the international dialogue, knowledge
production and standard setting on the ethics of science and technology and bioethics,
Convinced that the Recommendation presented here, as a standard-setting instrument developed
through a global approach, based on international law, focusing on human dignity and human rights,
as well as gender equality, social and global justice and development, physical and mental well-
being and health, diversity, interconnectedness, global solidarity, fairness, non-discrimination,
inclusiveness, and environmental and ecosystem protection, can guide neurotechnology in a
responsible direction,
U.S. Proposed: Convinced that the Recommendation presented here, as guidance developed Commented [A16]: Recommended rewording to avoid
through a global approach, based on international law, focusing on human dignity and human confusion with more technical, standard-setting bodies
rights, as well as gender equality, social and global justice and development, physical and mental
well- being and health, diversity, interconnectedness, global solidarity, fairness, non-
discrimination, inclusiveness, and environmental and ecosystem protection, can guide the
development and use of neurotechnology in a responsible direction, Commented [A17]: Important to clarify the specifics of
what aspects of neurotechnology are intended to be
informed by this document
Guided by the purposes and principles of the Charter of the United Nations,
Emphasizing that specific attention must be paid to low- and middle-income countries (LMICs),
including but not limited to least developed countries (LDCs), landlocked developing countries
(LLDCs) and small island developing States (SIDS), as they have their capacity but have been
underrepresented in the development and access to neurotechnology,
U.S. Proposed: Emphasizing that specific attention must should be paid to low- and middle- Commented [A18]: Replace Must with Should: This is
income countries (LMICs), including but not limited to least developed countries (LDCs), a normative point, not obligatory or logical
landlocked developing countries (LLDCs) and small island developing States (SIDS), as they
have their capacity but have been underrepresented in the development and access to emerging Commented [A19]: Unclear what is intended by “their
technologies such as neurotechnologies, capacity”, suggest deleting.
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
Underscoring that global cooperation and solidarity facilitates fair access to neurotechnology and
enables the realization of the full potential of neurotechnology, while addressing the ethical
challenges, mitigating against potential misuse, and ensuring that national neurotechnology
strategies are guided by ethical principles in full respect of international human rights law,
U.S. Proposed: Underscoring that global cooperation and solidarity facilitates fair access to
neurotechnology and enables the realization of the full potential benefits of neurotechnology,
while addressing the potential ethical challenges, mitigating against unintended harmful
consequences and potential misuse, and ensuring that national neurotechnology strategies are Commented [A20]: Technical edit: Against unintended
guided by ethical principles in that fully respect of international human rights law and are harmful consequences and misuse?
consistent with internationally recognized human rights, Commented [A21]: Expanding Scope to include
broader international laws that could apply depending
on the neurotechnology in questions
Noting that ethical guidelines, frameworks and open science can promote innovation, development Commented [A22]: Addition to avoid overly broad
and policies aligned with international human rights law, statement
Also recalling that in November 2023, the General Conference of UNESCO, at its 42nd session,
adopted 42 C/Resolution 29, by which it mandated the Director-General "to prepare a standard-
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setting instrument on the ethics of neurotechnology in the form of a recommendation", which is to be
submitted to the General Conference at its 43rd session in 2025,
Bearing in mind the Universal Declaration of Human Rights (1948), the instruments of the
international human rights framework, including the Convention Relating to the Status of Refugees
(1951), the Discrimination (Employment and Occupation) Convention (1958), the International
Convention on the Elimination of All Forms of Racial Discrimination (1965), the International
Covenant on Civil and Political Rights (1966), the International Covenant on Economic, Social and
Cultural Rights (1966), the Convention on the Elimination of All Forms of Discrimination against
Women (1979), the Convention on the Rights of the Child (1989), and the Convention on the Rights
of Persons with Disabilities (2006), the Convention against Discrimination in Education (1960), the
Convention on the Protection and Promotion of the Diversity of Cultural Expressions (2005), as well
as any other relevant international instruments, recommendations and declarations,
Also noting the United Nations Declaration on the Right to Development (1986); the Declaration on
the Responsibilities of the Present Generations Towards Future Generations (1997); the Universal
Declaration on Bioethics and Human Rights (2005); the United Nations Declaration on the Rights of
Indigenous Peoples (2007); the Declaration of Ethical Principles in relation to Climate Change (2017);
the Recommendation on Science and Scientific Researchers (2017); the Recommendation on the
Ethics of Artificial Intelligence (2021); the Recommendation on Open Science (2021); the Human
Rights Council's resolution on 'The right to privacy in the digital age" (NHRC/RES/42/15) (2019); the
Human Rights Council's resolution on "New and emerging digital technologies and human rights"
(NHRC/RES/41/11) (2019), the International Labour Organization Declaration on Fundamental
Principles and Rights at Work, as amended (2022), and the UN Guiding Principles on Business and Commented [A23]: Given the labor and employment
Human Rights (2011), section subsequently in the text, recommend also
noting the ILO Declaration on Fundamental Principles
and Rights at Work, as amended in 2022.
Recalling that the 2021 Recommendation on the Ethics of Artificial Intelligence, recognizes ethical
questions related to Al-powered systems for neurotechnology and brain-computer interfaces,
Also conscious of the existing ecosystem of national policies, and other frameworks and initiatives
elaborated by relevant United Nations entities, intergovernmental organizations such as OECD,
including regional organizations, as well as those by the private sector, professional organizations,
non-governmental organizations, and the scientific community, related to the ethics and
regulationgovernance of neurotechnology, Commented [A24]: Governance can take many forms,
of which regulation is only one
1. Adopts the present Recommendation on the Ethics of neurotechnology on this XXX
day of November 2025;
2. Recommends that Member States, with the support of UNESCO's Secretariat, apply
the provisions of this Recommendation by taking appropriate steps, including whatever
legislative or other appropriate measures may be, in conformityconsistent with the
constitutional practice and governing structures of each State, to give effect within their
jurisdictionsadhere to the principles and norms of the Recommendation, in conformityin
a manner consistent with conformity with international law, including international
human rights law; Commented [A25]: The Recommendations are
principles/guidance for UN member states - not semi-
3. Also recommends that Member States engage all actors, as appropriate, to ensure that legal instruments to be brought into effect in domestic
law. Adjusting language to avoid creating legal norms
they playwith respect to their respective roles in the implementation of this
Recommendation; and bring the Recommendation to the attention of international, Commented [A26]: Softening language. States
regional and national authorities and bodies, research and academic organizations, cannot ensure the behavior or actions of non-State
institutions and organizations in public, private and civil society sectors involved in entities or actors
neurotechnology, so that the development and use of neurotechnology are guided by
both sound scientific research as well as (comprehensive?) ethical analysis and
evaluation.
I. SCOPE OF APPLICATION AND DEFINITIONS
1.1 SCOPE
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This Recommendation:
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1. Addresses ethical issues related to neurotechnology, as it can have be applied to result
in many positive and adverse impacts on human health, human flourishing and on the enjoyment Commented [A27]: Technical edit: Mention identity?
of human rights.
Commented [A28]: Consider making this text
consistent with the terminology in the first para of the
2. Considers applications of neurotechnology for people of diverse backgrounds and abilities, preamble.
and various fields, including health, non-medical direct-to-consumer (DOTC), such as wellness
Commented [A29]: Is this intended to refer to over-
devices, neurogaming), addressing various settings where neurotechnology may be utilised. the-counter (OTC) or direct-to-consumer (DTC)?
3. Focuses on humans only but acknowledges important ethical considerations that apply to
Commented [A30]: Para 4 seems to be a bit more
animals in research. commentary and superfluous language in an already
wordy document Recommend deleting and upping A
4. Approaches neurotechnology ethics as a systematic normative reflection based on a holistic, and B as Para 4. At a minimum, recommend removing
multicultural, multidisciplinary, pluralistic and evolving framework of interdependent values, “systematic normative reflection” and considering what
actors are included in the mention of society (e.g.
principles, and actions that can guide societies in dealing responsibly with the impacts of businesses and other research entities as well as
neurotechnology on human beings, societies, and the environment and ecosyste govts?)
Commented [A31]: Technical edit: Flourishing was
(a) It considers ethics as a basis for the normative evaluation and guidance of used before; are these phrases intended to be
neurotechnology, with human rights, human dignity, well-being, and the prevention of interchangeable?
harm as a compass and foundation.
Commented [A32]: Technical
(b) It draws upon a full range of scholarship, commentary and views from neuroscience, Commented [A33]: What does this mean? “New
medicine, engineering, psychology, ethics, human rights, law, sociology, anthropology cognitive states” is not recognized as a term of art, and
therefore recommend deleting.
and other disciplines.
Commented [A34]: Meaning risky? Controversial?
5.4. Covers the measurement, recording, and modification of the human nervous system, the Managed with caution? Something else?
handling, analysis, treatment, storage, use and reuse of the data collected, along with other Commented [A35]: Unnecessary. There are other
societal and environmental impacts, including the emergence of new cognitive states. ways to understand autonomy and its essential, salient
characteristics.
6.5. Recognizes that interventions involving the nervous system are veryparticularly sensitive Commented [A36]: It’s not clear that this
because the highly complex human nervous system is the coordinating centre of behaviour and recommendation addresses, but rather identifies.
mental processes. It enables the exercise of self-determination, the capacity to act as moral agents, Commented [A37]: Should robotics be added?
to be responsible for actions, cooperate with others, deliberate about collective decisions and
develop personality. Commented [A38]: Technical - not sure
semiconductors deserve to be at the same level of
some of the other related technologies here. If anything
7.6. Further recognizes that humans develop and flourish in their interaction with other human their impact on neurotechnologies seems to stem
beings and a nurturing material and cultural environment, highlighting that autonomy is not just through their relevance to AI and algorithms.
individual but also relational, as it arises from and impacts one's interactions and belonging with Commented [A39]: It’s not clear this recommendation
the community. addresses, but rather discusses
8.7. Addresses theIdentifies ethical and human rights concerns that arise from the rapid Commented [A40]: Technical - consider replacing this
with "improve the performance and cost of
developments and the convergence of neurotechnology with other technologies such as spatial neurotechnology systems". As drafted much of the
computing, extended reality (XR), artificial intelligence (Al) techniques, and sensors technologies highlighted passage seems vague (precision of what?
and semi-conductors. Notably, other biometric data when processed to infer sensory, motor, and optimizing what?)
mental states may raises similar ethical concerns. Therefore, this Recommendation applies to both Commented [A41]: Technical Edits to better articulate
neurotechnology and the use of cognitive biometric data to infer neural states, ensuring to, seek these points-- unclear that the following examples are
to ensureing that ethical principles and practices are consistently applied across these domains. ethical in nature, but they are risks. Also edited to try
to avoid mixing threats (e.g., harmful bias) and risks
(e.g., lack of transparency).
9.8. Further addresses discusses the integration of Al techniques with neurotechnology, which
can enhance precision and predictive capabilities, such as improving processing speed, reducing Commented [A42]: Technical edit: Not sure who this
cost, and optimizing neurotechnology systems. However, AI techniques it can also magnifies refers to
magnifyies ethical threatspotential risks, including by increasing risks related to cybersecurity Commented [A43]: We believe military and security
concerns, reducing lack of transparency, increasing the potential for harmful algorithmic bias, and applications are outside of the scope of this
introducing risks related to autonomy, mental and physical privacy and of manipulation. recommendation
Commented [A44R43]: Alt text: Promotes the
10.9. Promotes the peaceful use of neurotechnology and seeks to raise awareness on the peaceful use of neurotechnology and but does not
profound ethical challenges and threats that come with the military and security applications of seeks to raise awareness on the profound address
ethical challenges and threats that come with the
neurotechnology. Calls on all concerned to act responsibly with regard to the development and
military and security applications of neurotechnology.
use of neurotechnology. Calls on all concerned to act responsibly with regard to
neurotechnology.
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1.2 DEFINITIONS
11.10. Nervous system. The nervous system includes the central (brain, spinal cord) and
peripheral (somatic, autonomic, enteric) nervous system. Scientific evidence demonstrates that Commented [A45]: These are examples and should
nervous system activity is the basis of sensory, motor, and mental states (which include cognitive, be restructured to indicate as such, “supports states
such as consciousness, sleep, experience of pain, etc.”
affective, and conative states), and supports states such as consciousness, sleep and the
experience of pain. The nervous system activity and structure provide informationare inherent to Commented [A46]: Technical Edit: "Provide
all human beings and the community, regardless of gender, ethnicity, language, community or information" is unclear and inaccurate. Nervous system
activity and structure are attributes of an individual, not
religion. The nervous system activity is also instrumental in social and cultural interactions. the community.
12.11. Neurotechnology. Neurotechnology refers to devices, systems, and procedures- Commented [A47]: Technical edit: Not fully sure why
this is mentioned here
encompassing both hardware and software-that directly access, monitor, analyze, .predict or
modulate the nervous system to understand, influence, restore, or anticipate its structure, activity, Commented [A48]: FROM 2019 OECD
function, or intentions (such as speech and, motor activity). Neurotechnology combines elements Recommendations:
Neurotechnology: devices and procedures used to
of neuroscience, engineering, and computing technologies, among others. access, monitor, investigate, assess, manipulate,
and/or emulate the structure and function of the neural
13.12. Neurotechnology spans medical and non-medical applications and includes tools that systems of natural persons.
measure, infer, and influence nervous system activity whether through invasive or non-invasive interaction Commented [A49R48]: Definitional questions to
with the nervous system through the use of devices, systems, and/or pharmacological agents, whether through consider:
direct interaction with the nervous system or by interfacing it with devices and systems. It includes - Our preference would be to strike "directly" if it is not
but is not limited to: in the OECD definition. Understand the desire to try to
circumscribe the definition a little bit (since otherwise
most anything could be argued to be
(a) Technical tools that measure and analyse physical (i.e., acoustic, electrical, optical, neurotechnology)...but "directly" might go too far in the
magnetic and/or mechanical), chemical and biological signals associated with the other direction. [see also para 14]
structure of and functional signals from the nervous system. These may be used to
Commented [A50]: These are examples, but not all
identify, record, and/or monitor properties of nervous system activity, understand how encompassing, and therefore should be designated as
the nervous system works, diagnose pathological conditions, or control external examples.
devices (brain machine interfaces (BMI), often referred to as brain computer interfaces
Commented [A51]: Technical Edit: For Clarity
(BCI)). They may provide real-time feedback and associated stimulation or inhibition
based on an open-loop system. Of note, both open-loop (i.e., fixed-parameter brain Commented [A52]: Question - are "predict" (para 12)
and "infer" (here) meant to refer to the same concept?
stimulation) and closed- loop systems (i.e., state dependent stimulation) ) may
Should the terminology used be consistent?
introduce complex ethical issues.
Commented [A53]: “Direct interaction” and “interfacing
(i). Examples include but are not limited to Electroencephalography (EEG), it with devices and systems” often go hand in hand and
are not mutually exclusive, therefore making this
Magnetoencephalography (MEG), Magnetic resonance imaging (MRI), current phrasing imprecise. For example, Deep Brain
Functional Magnetic resonance imaging (fMRI), Positron emission tomography Stimulation is an implanted electrode system directly
(PET), Functional Near-infrared spectroscopy (fNIRS), Implanted interfacing with the brain.
microelectrodes, Optogenetics, Optical imaging, Diffusion weighted imaging, Commented [A54]: Many tools can both measure and
Calcium imaging, Voltage dye sensors, or Microdialysis. interact with the nervous system. Separating into A
and B may create false dichotomies. Recommend
(b) Technical tools that interact with the nervous system to change its activity, for example, cutting these distinctions, folding the definition into para
13, and providing a few examples.
to restore sensory input, such as hearing (i.e., cochlear implants) or Deep Brain
Stimulation (DBS) to treat tremors and other pathological conditions. They are meant Commented [A55]: Section 13(b) separates
to either modulate the functions of the nervous system and/or send signals directly to stimulating devices into their own section, however,
closed-loop devices are in this section (a). Would
the nervous system by applying acoustic, electrical, magnetic or optical stimulation suggest moving the mention of closed-loop devices into
and/or inhibition of the peripheral or central nervous system. (b) below.
Commented [A56]: Suggest rephasing as “real-time
(i). Examples of this neurotechnology are implanted microelectrodes, BMI, DBS, feedback based” stimulation. Open loop stimulation can
Optogenetic optical stimulation, Transcranial electrical stimulation (tES), also be state-dependent, but unlike closed-loop
Transcranial Magnetic Stimulation (TMS) or Neuropharmacological infusion. stimulation, would not have the capability to modulate
stimulation levels in real time based the on neural
14.13. Of note, several sensor technologies collect data indirectly informing about neural feedback from the resulting state change.
activity. Even if they are not neurotechnology per se, they raise similar ethical and human rights Commented [A57]: Recommend cutting para 14, as it
issues as neurotechnology when used to infer mental states. They include but are not limited to eye- risks creating definitions that are overly broad. Rather
tracking, Video Oculography, Typing dynamics, Voice recognition and analysis, Gait analysis, Skin than make a statement here about neurotechnology-
adjacent technologies, it might be better to clarify,
conductance, Heart rate variability, Sleep movement monitoring, Blood pressure measurement, or immediately before or after paragraph 16, what classes
facial- emotion recognition systems. of technologies relate to cognitive biometric data. Then
it would also be clearer how the definitions apply to the
rest of the document.
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15.14. Neural data. Neural data are qualitative and quantitative data about the structure,
activity and function of the nervous system. They encompass data relating to a nervous system's
activity,
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including both direct measurements of neuronal structure, activity and/or function (i.e.,.e.g., Commented [A58]: Technical - presumably neuronal
firing / averaged EEG signals are intended to be
neuronal firing or averaged bioelectric signals from EEG) and indirect functional indicators (i.e.e.g., examples, not the only type, of "neuronal structure,
blood flow in fMRI and fNIRS). At the neurobiological level, neural data can be used as a valuable metric to activity and/or function."
correlate to mental stateAt the neurobiological level, neural data are the most direct correlates of
Commented [A59]: For definitional purposes, this last
mental states. sentence seems unnecessary, as the rest of the
definition as written will hold without it. If keeping,
16.15. Cognitive Biometric Data. Neural data, along with data collected by non-neural suggested edits as tracked, noting that it still takes
biometric technologies can be processed to infer mental states, which this Recommendation refers precise and controlled measuring, mapping, and
machine learning modeling to predict a mental state
to as "cognitive biometric data".". from neural data. “direct” correlate may be a bit of a
stretch.
17.16. Whole lifecycle. Neurotechnology should be considered from the early stages of
Commented [A60]: Question - is "cognitive biometric
mining for materialsobtaining raw materials, prototyping, research, design and development to data" intended to refer only to "mental states"? Is this
deployment and use, including maintenance, operation; trade, financing, monitoring and sufficiently broad to incorporate the wide variety of
evaluation, validation, end-of-use, disassembly, termination, disposal and recycling. The whole sensitive personal data related to the brain that could
lifecycle of neurotechnology includes its convergence with other technologies and the diversity of be considered as part of a plain reading of the ter
actors who are involved in every stage. "cognitive biometric data"?
Commented [A61]: Technical edits for clarity, and
11. AIMS AND OBJECTIVES removing assertions of value
Commented [A62]: Explicitly stating additional values
18.17. This Recommendation has been created with the aim of guiding the development here
and use of neurotechnology in ways that are ethical, safe, secure, transparent, and effective for
Commented [A63]: What does “humanity” add that is
the good of humanity, individuals, communities, societies, the environment and ecosystems, and not encompassed in "individuals, communities, and
to prevent harm in the present and the future based onrelated to a failure to comply with or respect societies"?
international law, in particular the Charter of the United Nations and international human rights law.
Commented [A64]: Overly superfluous and implied as
we cannot prevent harm in the past.
19.18. The objectives of this Recommendation are:
Commented [A65]: Technical edit for clarification.
Unclear what “harm based on international law” meant.
(a) to ensure the protection, promotion and respect of human rights and fundamental
freedoms, human dignity and equality, including gender equality, and to respect Commented [A66]: We have concern about the use of
cultural diversity during the whole neurotechnology lifecycle; ethics vice ethical considerations, as it implies ethics is
a set of defined, tangible values with authoritative
instruments or case law that we can commit to in an
(b) to guide the actions of Member States, individuals, groups, communities, institutions, informed manner.
private sector companies and every other relevant actors to ensure that ethical
considerations are embedded the embedding of ethics where relevant in all stages of Further, addition of “where relevant” as ethical
considerations may not be relevant to every aspect or
the neurotechnology lifecycle;
stage of the life-cycle (especially considering the
breadth of the term lifecycle as defined in this
(c) to ensure that activities related to the whole lifecyle of neurotechnology in its whole document).
lifecycle isare evidence-based, reliable and reproducible;
Commented [A67]: Technical - this statement is
directed to actions such as the research, development,
(d) to provide a universal ethical framework that not only articulates values and principles, and use of neurotechnologies, not the technology itself.
but also translates into concrete policy recommendations and effective implementation
Commented [A68]: To frame within scope of this
to guide Member States in their engagement with neurotechnology in its whole Recommendation
lifecycle, consistent with their obligations under international human rights law and
consistent with international human rightspractices and commitments under other Commented [A69]: See overarching comments
regarding potential applicability of international laws
international standards; beyond IHRL. Keeping consistent with preamble edits.
Further, standards are not binding under international
(e) to foster inclusive, multi-stakeholder, multidisciplinary and pluralistic dialogue and law so can’t describe them as creating
consensus building about ethical issues relating to neurotechnology; obligations….should avoid using standards unless ... [1]
Commented [A70]: Addition of inclusive. May also
(f) to promote justice and equitable access to developments and knowledge in the field consider mentioning the inclusion of views from the
of neurotechnology and the sharing of potential benefits and risks,; public
Commented [A71]: To clarify the scope of what a
(g) to ensure support accountability and solidarity among all actors to mitigate the State can achieve
likelihood of unintended harm and prevent misuse of neurotechnology and to uphold
Commented [A72]: See overarching comments. Both
human rights and ethical standards. unintended harm and intentional misuse are important
to consider. Consistent edit needed throughout
Commented [A73]: Cannot endorse a vaguely defined
ethical standard. Further, prefer to keep standards
scoped to technical standards to avoid confusion
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111. VALUES AND PRINCIPLES
111.1 VALUES
111.1.1 Respect, protection and promotion of human rights, and fundamental Commented [A74]: Fundamental freedoms are a
freedoms and human dignity subset of human rights; the title to this section was
correct in the AI ethics recommendation.
20.19. The inviolable and inherent dignity of every human being is the foundation of universal Commented [A75]: Edited to reflect retaining the
human rights and fundamental freedoms. Respect, protection, and promotion of human dignity, as same language as found in UDHR and ICCPR, noting
established by international human rights law, in the development and application of are essential dignity is violable or we wouldn’t need IHRL
in the whole lifecycle of neurotechnologiesy. Dignity encompasses the recognition of the intrinsic Commented [A76]: Noting the broad definition of the
and equal worth of each person. Neurotechnology must should never be used in ways that whole lifecycle in previous section, the “whole lifecycle”
objectify, exploit individual vulnerabilities, or undermine the dignity or rights of any individual, may be overly broad to assert IHRL applies
including people living in vulnerable situations. Commented [A77R76]: [Mention was removed] As
edited this is no longer a full sentence. Need a verb.
111.1.2 Promoting human health and well-being Commented [A78]: Technical Edit: Reminder about
earlier issue related to flourishing vs. well-being
21.20. Prioritizing the development and application of neurotechnology that promotes
comprehensive human health and well-being, viewing health as a holistic state of physical, mental,
and social well-being.
22. The responsible allocation of resources for neurotechnology should be directed toward
preventative, diagnostic, therapeutic, assistive, and rehabilitative purposes, rather than
purely toward consumer-driven or commercial applications, that with an eye to benefiting
the largest number ofall people and those who stand to gain the most, rather than
consumer-driven or commercial applications. Commented [A79]: Modifying language to reflect a
more wholistic view of applications that may benefit
111.1.3 Ensuring and rRespecting diversity and fairness human health and well-being, and towards promoting
benefit for all.
1. Respect for diversity and fairness, must should be upheld in the whole lifecycle of Commented [A80]: Ensuring a stretch.
neurotechnology. Special consideration should be given to neurodiversity, minority groups, Commented [A81]: Ensuring is beyond realistic
Indigenous Peoples, and underrepresented voices. expectations
2. Given that widely recognized neurotechnological innovation largely occurs in the urban well- Commented [A82]: What is “widely recognized”
resourced sectorcontexts, specific attention to underserved and marginalised people is crucial to adding here with respect to meaning? Suggest cutting
prevent and mitigate potentially harmful bias, ongoing disparities in healthcare, stigma, neglect, Commented [A83]: "contexts"?
and disrespect, or in ways that . Technological assimilation, or using technology as a tool of
Commented [A84]: Edit to reflect that in many cases
colonisation (a term the Recommendation refers to as "technological colonialism"), can threaten
it may not be feasible to prevent these harms. In this
cultural diversity and heritage, therefore must be protected against. case efforts should be undertaken to mitigate the
harms.
3. Equitable access to neurotechnology should be prioritized globally, ensuring that its benefits
Commented [A85]: What is intended by this term
are accessible to all, regardless of socioeconomic status or geographical location. , while bearing “technological colonialism”? Recommended edits seek
in mind national security considerations or commercial restrictions on proprietary information. to more directly convey a value of respecting diversity
Special attention must should be given to low- and middle-income countries, resource-constrained without creating new terminology.
settings, and marginalised communities, including the specific needs of different groups, ages, Commented [A86]: Addition to reflect consensus
segments, cultural systems, languages, communities, and marginalised and vulnerable language from other multilateral discussions on
populations, people with disabilities, neurological disorders, and mental health conditions [to emerging technologies (CCW GGE on LAWS).
enable the equitable sharing of potential benefits and risks of its use and development].. Commented [A87]: [Mention was removed] - flagging
this text in the draft UNESCO Recommendation on the
4. Individuals and groups should be allowed to make lifestyle choices, express beliefs and Ethics of Neurotechnology for your review. State input
opinions, share personal experiences, and participate in co-designing technologies, provided that is due by 10am on Dec 2.
these choices are made in ways that respect the rights of others.
111.1.4 Consideration for cross-cultural perspectives on human knowledge and its sharing
5. Respectful knowledge sharing across communities and cultures on the human nervous
system and its functionsRespectful knowledge sharing on the human nervous system and its
functions across communities and cultures fosters trust and strengthens global cohesion in the Commented [A88]: Technical edit: Rephrasing for
pursuit of health and quality of life. clarity
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6. It is essential that any research and development involving diverse groups and communities
is done with their permission and guidance, and conducted with their full prior and informed
consent, or the prior and informed consent of their legally-authorized decision maker, and Commented [A89]: Technical edit: Or the consent of
partnership in ways that serve their interests and respect their traditional knowledge and epistemic their legally authorized decision-maker? (e.g., when
contributions. recruiting minor children for research)
111.1.5 Commitment to peace, fairness and justice in society
7. The use of neurotechnology should be used to promote, not undermine cognitive freedom of
thought especially in situations where refusal to use and should avoid uses that segregate,
objectify or subordinate individuals or communities, or threaten the technology could lead to Commented [A90]: Modified language to provide
competitive disadvantage. coexistence between humans, other living beings and the natural clarity and bring relevant points from the following
environment. Such interferences include but are not limited to the use of force, threats, paragraph into this one. See general comments re:
use of the term “cognitive freedom” vice “freedom of
undisclosed access, manipulation, or any scenario where consent is compromised, including as a thought”
result of power imbalances.
Commented [A91]: What interferences does this
trace back to? In general, this sentence seems
8. The use of neurotechnology should be particularly scrutinized to avoid uses that segregate, disjointed from prior sentence.
objectify or subordinate individuals or communities, reduce social cohesion by exacerbating pre-
existing inequalities or generating novel inequalities that divide and antagonize individuals against
each other, and thereby threaten the coexistence between humans, other living beings and the
natural environment. Commented [A92]: This whole para can be deleted.
The relevant points can be moved to above para as
noted in tracked changes.
111.1.6 Global Solidarity and International Cooperation
Commented [A93]: See previous comments re: a
strong preference to not use the term “standards”
9. The Recommendation should guide all actors in the development, deployment and use of
unless referring to technical standards. Current
neurotechnology to act in solidarity and call for accountability in instances where neurotechnology language implies a legal obligation under a global
may be misused in ways that threaten human rights. ethical standard that we are not familiar with.
Reworded to reference existing international law.
10. International cooperation is essential to addressing cross-border issues related to Alternatively, if this Recommendation is what is
intended here, Principles or guidance would be
neurotechnology. Particular attention must be given to differing perspectives on acceptable use to terminology that is more consistent with the character
prevent abuse and uphold global ethical standardsinternational law, including international human of this document.
rights law.
Commented [A94]: Edit to reflect definitional assertion
not an obligation.
111.1.7 Sustainability
Commented [A95]: Strongly recommend that a
11. Considering that sustainability requires means that neurotechnology be developed and used section on sustainability should reflect the globally
recognized sustainable development goals. The
with a deep respect for environmental stewardship, prioritizing the minimisation of ecological harm approach in the AI Recommendations is the right one.
throughout the lifecycle of the materials used, including, for mining extraction, data processing and
storage, recycling and disposal practices. Commented [A96]: This para may be better placed in
section 111.1.3 on “Respecting Diversity and
Fairness”?
12. The unregulated development and use of neurotechnology, especially for non-medical
purposes, might lead to disproportionate consumption of resources and energy and waste Commented [A97]: Rewording to reflect that the
UNDRIP is a nonbinding instrument. "Accordance" and
production. "requires" suggests that it is legally-binding. We
cannot agree to language that suggests that meeting
13. Respect for Indigenous rights, in accordance with the United Nations Declaration on the our commitments to the UNDRIP requires these
Rights of Indigenous Peoples (UNDRIP), requires that Nneurotechnology, through its whole actions.
lifecycle, should be guided by a profound respect for Indigenous rights, ensuringas set forth in the Commented [A98]: Strongly recommend moving
United Nations Declaration on the Rights of Indigenous Peoples, ensuring such that that their lands accountability point from below to this section
(including during mining), knowledge, communal rights, and privacy are honoured in all activities, Commented [A99]: Definitional assertion not
including those related to resource extraction. obligation
Commented [A100]: Technical edits, including to
111.1.8 Integrity and Responsibility reflect that “ethical steadfastness” is not a term
commonly used in US contexts. We prefer to avoid
14. Integrity requires means that all actors related to in the whole lifecycle of neurotechnology field unclear and novel terminology such as "ethical
act responsibly, with ethical steadfastness. It includes includinges by seeking to ensure that all steadfastness" in favor of references to better defined
actions respect human rights and adheringe to relevant ethical guidelines and ensuring that all concepts. Suggested reformulation replaces "ethical
steadfastness" with "responsibility" (for consistency
actions align with both professional standards and societal values. with the subsection title) then clarifies what
"responsibility" is meant to entail in terms of well-
15. Integrity includes being responsible and accountable a commitment to taking responsibility for defined concepts.
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one's actions and conduct, and as appropriate taking being accountable for their outcomes. This
involves not only acknowledging successes but also owning up to mistakes and taking corrective
actions when necessary to prevent adverse outcomes... Commented [A101]: Accountability does not
necessarily relate to the outcome of an activity. Many
23.16. legal rules are obligations of conduct. For these rules,
one is accountable for conduct rather than the outcome
that necessarily results.
15. Scientific integrity is evidence-based professional practices, ethical behavior, and the
principles of honesty, objectivity, inclusivity, transparency, and protection from inappropriate Commented [A102]: Technical edit: Perhaps clarify
the difference between this and the phrase “Integrity” in
influence in research practices, including when conducting, managing, and using the results of and 36 above
communicating science and scientific activities the commitment to the rigorous pursuit of truth
through evidence-based, objective and transparent research practices. It ensures that all Commented [A103R102]: Also noting the Scientific
integrity at the US Federal level is defined as “Scientific
scientific endeavours are integrity is the adherence to professional practices,
ethical behavior and the principles of honesty and
objectivity when conducting, managing, using the
results of and communicating about science and
scientific activities. Inclusivity, transparency and
protection from inappropriate influence are hallmarks of
scientific integrity.”
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Commented [A104]: defining some principles as
conducted with honesty, accuracy, and respect for the scientific method of disciplines relevant for fundamental and others as not seem beyond the scope
neurotechnology. of this recommendation.
Commented [A105]: Equity should be included in
111.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS ethical principles.
Commented [A106]: Delete proportionality: we
16.17. This Recommendation embraces a human-centred approach through fundamental reiterate our longstanding position that there is no
based on ethical principles such as personal autonomy, cognitive freedom,including but not limited textual basis in the ICCPR, or other international
to self-determination, agency, freedom of thought, privacy, cognitive liberty, personal and collective human rights conventions to which the U.S. is a party,
for asserting states have an obligation under
identity, trustworthiness, respect, reciprocity, equity and justice. Furthermore, the human-centered international human rights law to apply or act in
approach it incorporates the respect, promotion and protection of human rights. accordance with such a principle on proportionality
Commented [A107]: Justification: Many emerging
111.2.1 Beneficence, Proportionality and Do NoLimiting Harm
technologies may have dual nature capacities. Further,
softening language to “seeking to reduce potential
17.18. Neurotechnology should promote health and well-being, and empower individuals to harms”, since many areas of neurotech are nascent in
make informed decisions about their nervous system and mental health while fostering a better development and full consequences may not be
understanding of themselves. known, such that assuring no harm may be difficult to
attain.
18.19. Neurotechnology should contribute to human flourishing without causing harm or Commented [A108]: End is superfluous
subordination, whether physically, economically, socially, politically, culturally, or mentally, while Commented [A109]: Suggest cutting, as does not
seeking to reduce potential harms. The "do no harm" This principle must should guide the whole accurately reflect the complexity of the topic. For
lifecycle of neurotechnology,ensuring ingthat the quality of life is protected and promoted. example, neurosensory devices, which are currently
being considered in many cases as assistive devices,
could be argued to both simultaneously reduce and
19.20. Embracing neurotechnology for enhancement may lead to the risk of not only amplify inequalities based on the population groups
unexpected damage to the nervous system, but also to amplified inequalities within society. you chose to compare and be a neurotechnology
designed for "enhancement."
20.21. Any restrictions to on the exercise or enjoyment of human rights must meet all
Commented [A110]: Technical Edit for clarity
applicable requirements under human rights law, including the principles of legality, legitimate aim,
necessity and proportionality. Commented [A111R110]: Not all rights can be
"exercised" (e.g. the right not to be subject to torture
and the right not to be subject to arbitrary or unlawful
21.22. The principles of proportionality, balance and legitimacy should govern the use of interference with one's privacy) in the same way as
neurotechnology and the data it enables, to ensure their use is: (a) appropriate and proportional others (e.g. fundamental freedoms like freedoms of
to the objective and expected benefits that are aimed to be achieved; (b) do not infringe upon the expression and association), so if adding 'exercise'
foundational values of reflected in this document; (c) appropriate to the context and target user here should also add 'enjoyment' so as to cover all
types of human rights.
group; (cd) based on safety principles and rigorous scientific evidence.
Commented [A112]: In regards to the references to
111.2.2 Self-determination Personal Autonomy and Cognitive Freedom of Thought the principle of proportionality, we reiterate our ... [2]
Commented [A113]: Technical - consider "neural
22.23. Throughout the whole lifecycle of neurotechnology, the protection and promotion of data" or "cognitive biometric data" (as defined above"
... [3]
the rights of cognitive freedom of thought, andas well as self-determination to personal autonomy Commented [A114]: Unclear what the “foundational
must should be secured. values of this document” are but values and this ... [4]
Commented [A115]: Self-Determination has a discrete
23.24. Individuals have the rightshould be able to make free, informed, and voluntary legal meaning in international law related to a people's
... [5]
decisions about their engagement with neurotechnology throughout the whole lifecycle, consistent
in accordance with international human rights law, including human rights law, and other Commented [A116]:
international standards, as applicable national and local law. , including the right to refuse or Commented [A117]: This is a very broad statement of
withdraw from its their use, at any time, ensuring their autonomy and respect for their decision- unclear provenance. Is there an internationally ... [6]
making capacity is upheld and where surrogate consent is used, the best interests of the affected. Commented [A118]: This may be implied by the next
.. individual are considered. Individuals who are enrolled recruited to participate in research should, part of the sentence but assuming it is legal to use the
... [7]
along with other informed consent guidelines/requirements, be informed of potential side effects
Commented [A119]: Replacing “in Accordance” with
and given the opportunity to disclose if they have any contraindications for the procedures used. “consistent”, as “consistent with” covers a broader ... [8]
Informed consent procedures should be affirmative, dynamic, and require opt-in, comprehensive,
Commented [A120]: See comments above that IHRL
and transparent , including by providing detailed information about the purposes, risks, benefits,
may not be applicable.
alternatives, and possible outcomes of the technology in all its application domains, thereby
ensuring that consent is voluntary and that individuals fully understand the implications for their Commented [A121]: Unclear what international
standards are being highlighted here and should ... [9]
privacy, autonomy, and well-being.
Commented [A122]: Para past this point is extremely
24.25. Neurotechnology should never be used to exert undue influence or manipulation, wordy, suggest refining significantly
whether through force, coercion, or other means that compromise self-determination personal Commented [A123]: Question: How does the author
intend to address circumstances when the use of ... [10]
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autonomy and cognitive freedom of thought. This pProtection should covers both the internal Commented [A124]: Question for the authors: Would
processing of thoughts and their external expression, ensuring that the nervous system is freedom this include interventions aimed to dull violent
from any interference without consent of the user. tendencies? How does this intersect, if at all, with
treating mental conditions such as schizophrenia?
Commented [A125]: “freedom from any interference”
should be clarified. In this context, it would be useful to
relate it to the nervous system and consent.
Individuals can consent to uses of neurotechnology
that would help them address bad behaviors (e.g.,
smoking or other additions).
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Commented [A126]: Due to differences in views as to
111.2.3 Protection of Neural and Cognitive Biometric Data for Mental Privacy the meaning and scope of privacy as an international
human right, we do not support the specific phrasing
"right to privacy" unless it is explicitly connected to the
25.26. Neurotechnology and cognitive biometric technologies may raise issues pertaining to right set forth in UDHR Art 12 or ICCPR Art 17.
the right to privacy due to theiras their use may increasing ability to collect direct and indirect data In this context, since the concern is broader than
about the nervous system that is could be uniquely sensitive because they can could be processed government interference with privacy, we think
and analysed to provide deep insights into the processes that underpin our mental states and referencing UDHR Art 12 or ICCPR Art 17 would be too
limiting. As such we support referring to "privacy"
behaviour, including self-awareness and introspection. As it becomes increasingly difficult to
(without specifying "rights").
anonymize data, there remains persistent risks of misuse [or unauthorized access] of this data by
revealing neurobiological correlates of diseases, disorders, or general mental states without the Commented [A127]: Technical edit for clarity.
Neurotechnologies and CBTs do not inherently have
authorization consent of the person from whom data are collected. abilities. It is their application that confers the ability to
collect data...
27. Mental privacy is fundamental for the protection of human dignity, personal identity,
and agency. The collection, processing, modification, and sharing of neural data must should Commented [A128]: Softening assertions to “could”.
As the technology is still at a nascent stage, these
be conducted with free and informed consent, consistent with international law, in ways that assertions are quite strong/ premature and not all of the
respect human rights and the ethical values and and human rights principles outlined in this processing and analysis can be done at this time.
Recommendation, while respecting relevant national, regional and international legal
Commented [A129]: Question- is Misuse the right
frameworks.. characterization here? Should we include unauthorized
access here?
26.
Commented [A130]: Adds length without value to
already length section
27.28. There should be clear safeguards against the misuse or unauthorised unauthorized
access of neural and cognitive biometric data, including affirmative iconsent, data minimization and Commented [A131]: Technical edit: Does this need to
be more directly defined?
purpose specification, data rights (such as rights to access and, correct and delete), and data
security, particularly in contexts where such data might be aggregated with other sources. , Commented [A132]: “Mental Privacy” does not have
an internationally recognized definition under
international human rights law. Is this sentence
111.2.4 Non-Discrimination and lnclusivity needed?
28.29. All actors involved in the whole lifecycle of neurotechnology, particularly in its interface Commented [A133]: What specific international law
obligation regarding free and informed consent are we
with other technologies like Al, must commit to upholding ethical principles thatshould work to
intending to invoke here? I think we have covered any
prevent prevent prohibit unlawful discrimination, stigmatisation, targeting, manipulation or potentially applicable IL with the reference to relevant
exploitation of any individuals or groups, particularly those in vulnerable situations. international legal frameworks at the end of this
sentence, so recommend deleting this additional
29.30. There is a shared responsibility to ensure that these technologies do not international law reference.
perpetuate or amplify existing inequalities or create new forms of discrimination based on Commented [A134]: Replacing “ethical and human
neurological or mental characteristics, or other grounds protected under human rights applicable rights” with “values and principles” and adding ... [11]
international law. Commented [A135]: Updated language. Original
language too closely resembles GDPR and is not ... [12]
30.31. Non-inclusive technological development and standardisation may drive a trend
Commented [A136]: Question for authors- why does
toward homogenisation and the dominance of neurotypicality and capacities that may threaten aggregation with data from other sources make these
... [13]
cultural and collective identityies.
Commented [A137]: Technical - note somewhat
inconsistent use throughout of "lifecycle of ... [14]
31.32. Garnering the trust and acceptance of communities in the whole lifecycle of
neurotechnology requires transparent engagement with the public, seeking their input and Commented [A138]: Question for author- why is AI
validation to align these technologies with societal values and the common good. of all. relevant to this principle?
Commented [A139]: ethical principles are not legal
32.33. Unlawful dDiscrimination on any grounds, including intellectual differences or those obligations - this is a normative point.
related to atypicality, should be condemned. Neurotechnology should not be used to inform, justify, Commented [A140]: Added “unlawful” because
or reify such discrimination. Care should be taken to evaluate neurotechnology solutions promoted “discrimination” in the context of international ... [15]
through governments for essential services such as education.
Commented [A141]: Recommend adding
“manipulation” unless this is implied in “exploitation”?
33.34. Neurotechnology should not be used to perpetuate stereotypes, stigma, or unlawful
discrimination against any person regardless of age, gender, identity, and race. older persons. Commented [A142]: Unclear what commons are
being referenced here.
111.2.5 Accountability Commented [A143]: See note above on inclusion of
“unlawful” when referencing discrimination, which ...
is [16]
34.35. Maintaining trust and integrity throughout the whole lifecycle of neurotechnology Commented [A144]: Unclear why this was limited in
requires all actors to adhere to the highest ethical standards, remain open to feedback, be scope to “older persons”. This principle should ... [17]
committed to adjusting practices in response to new evidence or ethical concerns, and be held Commented [A145]: Note to Author: Accountability
accountable for their actions. was included to define integrity in 111.1.8. Strongly
... [18]
796
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35.36. Accountability is grounded in acting responsibility,responsibly, clear and transparent Commented [A146]: Replacing “responsibility” with
communication, and a duty to exercise reasonable care to anticipate and address potential harms- “acting responsibly” to avoid confusion with
whether short-term, or long-term or whether arising from intended use and impact or from international responsibility under international law.
unintended use and impact. Commented [A147]: Softening language to reflect
appropriate obligations. The duty to address possible
harmful consequences is not an obligation of result.
Rather, it is an obligation to exercise reasonable care.
797
-15-
36.37. A commitment to accountability requires global, governmental, societal and collective action
to ensure those harmed by neurotechnology have access to justice, and that those
responsible for wrongdoing are required to take meaningful steps to identify, prevent, mitigate
and account for how they address and redress their adverse human rights impacts, including
through corrective actions and reparations.
U.S. Proposed Edits: Governments and societies should work together to ensure those unlawfully
harmed by neurotechnology have access to justice, and that those responsible for engaged in Commented [A148]: Given overlaps between
wrongdoing are required to take meaningful steps to identify, prevent, mitigate and account for how definitions in accountability and integrity as noted in
they address and redress their adverse human rights impacts, including through corrective actions 111.1.8, strongly recommend not starting with a
“commitment to accountability”. Further, there is not
and reparations. consensus that global and collective action” is needed
to achieve the desired outcome. Added “unlawfully” as
not all harms are the result of legal violations or
111.2.6 Trustworthiness and Transparency, Safety, and Security injustice. For example, a company may go out of
business due to competitors that use neurotechnology,
but this is not necessarily an “injustice”. starting this
37.38. To guarantee the respect, promotion and protection of human rights and fundamental sentence with “
freedoms, aAll actors throughout the whole lifecycle of neurotechnology must should must ensure
that their activities are transparent, safe, and secure, grounded in scientific evidence, and aligned Commented [A149]: Wrongdoing can be broader
than human rights impacts. Not all harms or adverse
with international principles of responsible conduct. and scientific integrity. This includes preventing impacts are going to be harms or adverse impacts to
the replication or amplification of unlawful or harmful biases, ensuring that neurotechnology is human rights (see original para 41).
traceable and explainable and, its capacities and limitations are accurately portrayed, the
Commented [A150]: Mandatory language here is not
conditions for accountability are clearly defined, adhering to ethical guidelines in research and appropriate. While these principles are important and
development, including the registration of trials, fair participant selection, and approval review by could contribute to the respect, promotion and
independent ethics committees. protection of human rights they are not necessarily
required to guarantee the respect, promotion or
protection of human rights.
111.2.7 Epistemic Justice, Inclusive Engagement and Public Empowerment
Commented [A151]: Infused principles of scientific
38.39. Ensuring fair and equitable distribution and creation of knowledge about integrity (e,g, transparency, safety and security) in the
neurotechnology, including recognizing diverse ways of knowing, and that all individuals and above, but want to remove the mention here so as to
allow “responsible conduct” to not imply to conduct of
communities can participate in its creation, sharing, and applications. research, but also include frameworks on business
conduct (OECD), etc.
39.40. Promoting open and accessible education, along with public and community
Commented [A152]: Not all biases are problematic.
engagement, to ensure diverse populations can gain and exchange knowledge about nervous Some may be intended and useful.
system functioning, mental health, and medical and non-medical applications and tools of
neurotechnology. Commented [A153]: What is intended by traceable
here?
40.41. Effective public and community engagement throughout the whole lifecycle of Commented [A154]: Portrayed to whom?
neurotechnology requires respect for diversity, including linguistic, social, cultural, heritage, and Commented [A155]: review” is recommended
identity, to respect different ways of knowing and understanding. This respect for diversity can herebecause “approval” should not be a foregone
ensures that the knowledge and perspectives of diverse communities are valued and included in conclusion.
decision- making processes, and respects self-determination. Commented [A156]: Technical edit: Meaning? E.g.,
would an internal ethics review board within a company
41.42. Grounding education in human rights can ensures that the knowledge shared and be sufficient or not independent enough?
produced respects the rights of all individuals,. This can also preventing epistemic injustice, where Commented [A157]: Accuracy -replacing “ensures”
certain groups may be marginalized or excluded from knowledge production and dissemination. with “can ensure” as it can ensure but can’t know ex
ante if it will in fact ensure
42.43. All communities should have a voice in decisions that affect them, particularly when it Commented [A158]: See justification in previous para
comes to the development and use of neurotechnology.
Commented [A159]: Technical edit to make explicit
that "prevent[ing] epistemic injustice" is only one of
111.2.8 Best Interests of the Child and Protection of future generations many potential benefits of "grounding education in
human rights."
43.44. The nervous system is rapidly evolving during childhood and critically changing
Commented [A160]:
during adolescence, which makes it crucial to preserve the privacy, and self-determination
personal autonomy and the right of children and adolescents to participate in decisions that affect
them. Technology should be rigorously assessed to ensure it serves the best interests, well-being
and healthy development of children, as they grow into autonomous individuals and safeguard the
rights of future generations by ensuring that today's decisions promote their future wellbeing.
44.45. From an ethical perspective, while recognizing the potential benefits of
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neurotechnology for early diagnosis, instruction, education, and continuous learning, it is equally
important to make a commitment to the holistic development of the child. This includes nurturing
their social life, fostering meaningful relationships, and promoting a healthy lifestyle encompassing
nutrition and physical activity.
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Commented [A161]:
111.2.9 Global and social justice, enjoying the benefits of scientific progress and its Commented [A162]: Suggest cutting this section
applications altogether, and blending some elements (not all, as
others are potentially problematic) into the section on
45. Access to and benefits arising from research and development in neurotechnology must sustainability, noting interest to expand the scope of
this section to address SDGs vice environmental
should be shared equitably among all contributors to that research and development, with a sustainability.
particular focus on ensuring global distribution that promotes fairness and reduces
disparitiesdisparities. Notes on problematic language in this section: The
benefits sharing language in paras 68 and 70 are
46. Neurotechnology developments should be leveraged to reduce global health inequities. unclear and potentially problematic for the USG.. Does
this mean that any financial or substantive benefits
These technologies should serve as catalysts for improving the quality of life, particularly in from R&D would be equally given/provided to anyone
resource-limited settings. who “contributed” (the meaning of that term is also
unclear)?
47. Research, development, and trials in neurotechnology must should adhere to the highest In the United States, the intellectual property derived
ethical standards, ensuring the non-exploitative participation of all individuals involved. This from discovery belongs to the innovator, not those who
participated in the clinical trial. Inherent to collaboration
includes safeguarding the rights and well-being of participants, and patients and their caregivers, are previously agreed terms for how that intellectual
as well as ensuring thethe ethical collection and use of data is transparent, safe, and secure. property may be shared.
Special attention should be given to ensure that those contributing to research and development The United States would be supportive of making note
have enjoy their fair share of the benefits and do not bear disproportionately the risks. of how the principles of open science can further drive ... [19]
Commented [A163R162]: Further noting how this is
48. Efforts, including international cooperation, should be made to overcome, and never take not exactly open science but moreso aligned with open
advantage of, the lack of strengthen necessary technological or medical infrastructure, education innovation which was defined in the G20 as: a ... [20]
and skills, as well as ethical-legal frameworks, particularly in LMICs, LDCs, LLDCs and SIDS, Commented [A164]: Noting the principles and values
affecting communities. explicitly
Commented [A165]: This sentence should be deleted
49. The development and impact assessment of novel neurotechnology applications should as the ‘benefits’ are vague and not defined and could
consider the implementation of human-centred paradigms in which end-users are not merely pose unnecessary burdens to manufacturers and ... [21]
passive recipients of the technologies but active co-shapers on an equal footing. Commented [A166]: Edits for clarity to frame this point
more positively. There are existing ethical-legal
IV. AREAS OF POLICY ACTIONS frameworks, so we do not want to say that there is...a[22]
Commented [A167]: Question - is this term used
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION elsewhere?
Commented [A168]: Doing an impact assessment
50. Member States, private actors and international institutions should actively support the
requires considering specific applications.
research, development, and deployment of neurotechnology for the public good of all. Investments
should prioritize applications that foster human flourishing, and the use of which respects, Commented [A169]: Is flourishing the right word?
Well-being? Improvement? Strongly encourage
promotes and protects individual and collective human rights. This commitment should include
consistency with first para in preamble,,….note US... [23]
funding for interdisciplinary research that not only advances neurotechnological innovation but also
studies the ethical, safety and security, legal, social, environmental and cultural implications of Commented [A170]: This needs clarification. What
collective human rights is this meant to refer? The only
these technologies, and supports the implementation and clinical translation of technological collective human right otherwise potentially referred to
... [24]
prototypes. Particular attention should be given to the development and implementation of adequate
technical, institutional, procedural and other safeguards to ensure that they equitably benefit society Commented [A171]: See Comment and Question
above as to what collective human rights this is
and that human rights are upheld. intended to refer to.
51. Member States should establish clear prohibitions against thenot use of neurotechnology in Commented [A172]: Consistent with previous edits:
should seek to mitigate all potential negative impacts
contexts that violate individual and collective human rights. Member States should conduct human
rights due diligence, including regular, comprehensive human rights impact assessments, Commented [A173]: Added to align this with human
concerning neurotechnology that they develop, design, deploy, use, sell, operate or procure, in rights law, which applies domestically.
order to prevent and or mitigate their adverse human rights impacts. Specifically, neurotechnology Commented [A174]: Recommend deletion of
should not be used for purposes such as non-consensual interrogation in law enforcement, criminal sentence beginning with “Specifically.” Also noting
and civil justice, development or deployment of weapons targeted at the nervous system, social that Coercive measures to which a person consents... [25]
control, attempts at coercive non-consensual behavioural conformity based on or at non- Commented [A175]: Laws are developed by
consensual conformity of personal beliefs or thoughts, political or other opinion, gender identity or Congress, and thus our Executive Branch cannot
sexual orientation, or as well as non-consensual surveillance of mental states, among the domestic commit to adopt legislation.
population, among others. Governments should adopt legislation policies that aim to ensures Commented [A176]: adding "respect for" helps to
neurotechnology is developed and deployed responsibly, and with based on respect for human make clear that we are encompassing coverage of
rights , with robust oversight mechanisms to enforce adherencewith respect to these restrictions private actors.
and protect mental privacy and cognitive freedom of thought for all individualsend-users. These Commented [A177]: Question for author: What
policies should be developed in inclusive consultation with diverse actors, including civil society, restrictions is this referencing? The latter half of this
sentence is a bit weedy and unclear.
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end-users,
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neurotechnology experts, ethicists, and human rights advocates, and consistent with international law
and respect for human rights. to ensure broad consensus and respect for global human rights norms.
52. Member States should ensure transparencybe transparentcy and accountableility in their
support, oversight, and regulation of neurotechnology, particularly in publicly funded initiatives such
as brain research and development programs. While recognizing the limitations in disclosing
certain sensitive information, including national security considerations or commercial restrictions
on proprietarysuch as information protected by intellectual property rights including trade secrets,
governments should require government - sponsored neurotechnology projects to publicly Commented [A178]: Changed “individuals” to “end-
disclosetake into consideration the objectives, methodologies, intended uses, and societal impacts users” because neurotechnology could enable end-
of their neurotechnology initiatives, and wherever possible provide appropriate transparency... This users to conduct lawful surveillance of others.
transparency is crucial for fostering public trust and ensuring that neurotechnology advances are Commented [A179]: Consistent with language in other
aligned with ethical standards and human rights. international frameworks
53. Member States should apply a comprehensive approach to regulatory and policy
measures to protect against human rights related harms related to neurotechnology developed, Commented [A180]: Technical edits for clarity
marketed, operated or used by the private sector. This includes legislative and regulatory
Commented [A181]: Should add "related" as private
measures and accompanying guidance, incentives, and transparency requirements. This actors do not have the same obligations as States with
comprehensive approach should also require human rights due diligence, ensuring regard to human rights and therefore do not have the
thatincluding efforts of businesses to identify, prevent, mitigate, and account for their adverse same capacity to harm human rights as States.
human rights impacts through context-dependent processes, including human rights impact
assessments, meaningful public and community engagement, and transparent
communications.
54. Member States should ensure that any use of neurotechnology in the justice system,
including its consideration by the judiciary should be grounded in robust scientific evidence, should
be implemented ethically in accordance with human rights, and be aimed at promoting public safety
while protecting the rights and dignity of all those involved, and . This requires respect for
fundamental rights, such as human dignity, bodily integrity, confidentiality of personal data, respect Commented [A182]: See above note re: laws made by
for intellectual property rights, due process and fair trial rights, including the presumption of Congress and the executive branch cannot commit to
innocence, and the right against self-incrimination, as well as freedom from torture and ill- legislative measures
treatment, the right to privacy, rights, and the right to freedom of thought. Commented [A183]: These are not all specific rights
as such and unclear the link between the first part of
55. Member States should explore opportunities to establish comprehensive incentive structures, this paragraph and this sentence. If this is retained,
need to add “be free of unlawful or arbitrary
such as tax incentives, grants, and awards, to promote and enable innovation ecosystems for interference with” to “privacy.”
neurotechnology development. [with a particular focus on encouraging the construction and
development of manufacturing, computational resources, and data analytics capabilities within Commented [A184]: The term "fundamental rights"
does not have an agreed upon meaning under
public research institutions and small and medium enterprises (SMEs). Member States should also international law and has different meanings under
incentivize and support partnerships that leverage the computational resources and data analytics domestic and regional legal systems.
capabilities of private firms to advance public research goals. These incentives should prioritize
rewarding transparency, participatory development processes, and contributions to societal
benefits, aiming to foster an environment where public institutions and companies innovate
responsibly and align with human flourishing goals.] Commented [A185]: Given the U.S. divided nature of
government, we could not “ensure” the judiciary acts in
56. Member States should establish a coordinated, cross-sectoral approach to assessing the any manner.
impacts of neurotechnology across the [its/the technology’s?] whole lifecycle. This approach Commented [A186]: This seems overly prescriptive.
should include, but is not limited to: Perhaps consider striking.
(a) Economic and Social Impact Assessments: Conducted by relevant national bodies Commented [A187]: This section may exceed what
responsible for economic and labor policies to assess how neurotechnology impacts countries can commit to. Recommend cutting this
economic growth, jobs, social justice, and environmental sustainability; section and folding into an agile framework for
governance in subsequent paragraphs,
(b) Benefit-Risk Assessments: Managed by entities responsible for public health, medical Commented [A188]: Technical.
research, and consumer protections, these assessments should rigorously evaluate
the risks and benefits associated with the development, deployment, and use of
neurotechnology, including research, clinical applications, and consumer products.
The process should include thorough documentation, ethical oversight, and continuous
monitoring to ensure the safety, well-being, and equitable treatment of all individuals
802
-20-
involved;
803
-21-
(c) Privacy Impact Assessments (PIAs): under the oversight of relevant national
authorities or agencies responsible for data protection and privacy, these assessments
should evaluate and mitigate risks to individuals' mental privacy posed by
neurotechnology. This includes ensuring that appropriate safeguards are in place to
protect neural and cognitive biometric data in compliance with applicable national and Commented [A189]: Technical edit: Meaning ethical,
international privacy standards, and the data policy practices discussed herein; economic, both, or something else?
(d) Human Rights Impact Assessments (HRIAs): with oversight from relevant national
human rights institutions or international bodies, identify, prevent, and address
potential human rights -related impacts of neurotechnology. The process should
ensure that neurotechnology respects and promotes human rights, with particular
attention to vulnerable people and people living in vulnerable situations. HRIAs should
involve meaningful public and community engagement to incorporate diverse
perspectives.
57. Member States should promote equitable access to neurotechnology when shown to be
safe, effective, and better than alternative options worldwide. To achieve such goals, efforts should
be made to support the reduction of final costs for end users, including as appropriate to pursue
the development, adoption and continuous support of non-proprietary software solutions, and
explore reimbursement strategies or subsidisation commensurate with conventions in local
jurisdictions, in sectors of crucial potential benefits.. Commented [A190]: Recommend including
"applicable" or "relevant" here as the reference to
Member States should seek to develop and adopt adopt agile regulatory governance frameworks, "international privacy standards" is vague and could
encompass standards to which the State has not
including participation across governments and in consultation with external stakeholders, including as
committed.
appropriate, the use of regulatory sandboxes (i.e.-controlled environments for developing, testing, and
evaluating neurotechnology, including in response to rapid advancements in neurotechnology and its
convergence with other technologies such as Al, spatial computing, and immersive technologies). Such Commented [A191]: Consider softer verbs so as to
mechanisms should consider assessments on the economic and social impacts, risk-benefits, and not limit innovators
impacts on human rights of neurotechnologies and their applications. , as appropriate, the use of
regulatory sandboxes (i.e.-controlled environments for developing, testing, and evaluating
neurotechnology, including -in response to rapid advancements in neurotechnology and its
convergence with other technologies such as Al, spatial computing, and immersive technologies).
These sandboxes should be used to explore innovative applications, particularly in workplace settings,
with appropriate ethical oversight provided by regulatory bodies or national authorities. These
frameworks should facilitate innovation, ensure ethical data processing, and safeguard rights by Commented [A192]: Overly detailed, and should not
incorporating mechanisms for regular monitoring, evaluation, and dynamic policy adjustments in line be pre-prescribed
with technological and ethical developments.
58.
IV.2 DATA POLICY
58.59. Member States should develop a robust regulatory and legal frameworks to govern Commented [A193]: Overly detailed, and should not
the collection, processing, sharing, and all other uses of neural and cognitive biometric data. This be pre-prescribed
and existing frameworks should recognize this data to be both personal and sensitive data in
medical and non-medical contexts.
59.60. Member States should ensure that their existing privacy policies comprehensively
cover stringent safeguards for individuals' sufficiently cover neural and cognitive biometric data. If
current policies do not adequately address these areas, Member States should adopt targeted
safeguards in existing legislation or regulatory frameworks to secure these protections. These
safeguards should for example include affirmative informed consent, data minimization and
Commented [A194]: Deleted “and legal” to preserve
purpose limitation, data rights (including the right to access, correct, and delete data while discretion and flexibility about the nature of the
respecting intellectual property laws), and stringent data security measures, such as advanced regulatory framework. Some regulations are reflected
cybersecurity protocols to prevent unauthorized access and breaches. Such legislation or in law (adopted by the legislature), while others are
frameworks should prohibit the practice of tying access to goods or services to the disclosure of issued by the executive.
neural and cognitive biometric data, require explicit opt-in for any data sharing, and forbid the use Commented [A195]: As stated, this would prohibit
of such data for targeted advertising without the individual's explicit, affirmative informed consent. something like an Apple Watch to requiring you to
disclose biometric data to use its biometric services.
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60.61. Member States should develop and implement specific policies to reduce the
ecological footprint of neurotechnology, particularly in relation to large-scale data centers and
computing resources used for processing and storage of neural and cognitive biometric data.
These policies should emphasise data minimisation, ensuringto ensureing that only the necessary Commented [A196R195]: Support this prohibition in
amount of data is collected and processed, and promote the proportional use of neurotechnology, certain cases, such as access to essential goods or
aligning its deployment with genuine needs and minimising unnecessary environmental impact. services (e.g., government services, food, shelter,
health services, etc.), but there may be some private
Measures should include optimising energy efficiency, using renewable energy sources, sector scenarios in which companies may create
promoting the recycling and products whose functionality is limited without the
collection of background biometric data (e.g., sleep
trackers, fitness trackers, etc.). In those cases,
affirmative informed consent should be obtained from
users in advance of accessing services that would
disclose neural and cognitive biometric data to the
company. Additionally, all of the safeguards mentioned
in the sentence before this should apply. Should also
include additional framing to distinguish state and
essential services use cases from discretionary
consumer use cases.
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-23-
sustainable disposal of neurotechnology-related equipment, and ensuring to ensureing the Commented [A197]: Technical
rehabilitation of affected environments.
Commented [A198]: Technical
61.62. Member States should support and incentivise the development and implementation
of technological innovations and design standards for neurotechnology that prioritize the protection
of mental privacy, suchꞏ as state-of-the-art encryption, secure databases with multi-factor
authentication, cutting-edge anonymization techniques, and edge-processing and storage
(processing and storing data closer to where it is being generated), leading to greater action-led
results in real time storage of neural and cognitive biometric data.
62.63. Member States should incentivise neurotechnology manufacturers to prioritize
privacy and ethics by design, requiring the incorporation of privacy-preserving technologies as Commented [A199]: Technical
default features in their devices. Commented [A200]: “Rights-respecting” provides a
firmer foundation as States may vary widely on what
63.64. Member States should encourage ethical rights-respecting data sharing by constitutes ethical data sharing by generally recognize
the same human rights.
establishing secure, data repositories for neural and cognitive biometric data used in research.
These repositories should meet stringent cybersecurity, data privacy, and ethical use other data Commented [A201]: Describing these GDPR-like
governance standards (including, as applicable, related to data minimisation and purpose principles as ethical use standards suggests the
existence of an overarching internationally recognized
limitations), tiered access and other privacy-enhancing approaches. Appropriate funding ethical framework on data governance, which is not the
mechanisms should be established for the curation and maintenance of data and data governance case.
processes streamlined.
Commented [A202]: Protocols can’t ensure this ex
ante
64.65. Member States should prioritize efforts to reduce obstacles to cross-border data
sharing in neurotechnology research, working towards greater alignment of data protection Commented [A203]: Technical
standards, particularly concerning neural and cognitive biometric data, by establishing clear Commented [A204]: Must add reference to IPRs,
protocols for data transfer that ensurefor secure and compliant data exchanges across borders, since they may also be entailed in this context.
and standards for interoperability of data, including governance frameworks for data sharing.
Also, transparency commitments in the context of AI
training might be a little ahead of domestic
65.66. Member States should consider specific guidelines for the ethical use of neural and policymaking.
cognitive biometric data in Al development and research, including consent procedures for uses of
Commented [A205]: Comment: “Transparency”
neural and cognitive biometric data in the training and application of Al models, ensuring cannot always be ensured and “community rights”
transparency and respecting individual and community rights, as applicableand intellectual would not always be applicable.
property rights.
Commented [A206]: This section outside of the
mandate/expertise of UNESCO. Edits reflect U.S.
IV.3IV.2 INTELLECTUAL PROPERTY (IP) redlines for IP
66.67. Member States should adopt appropriate IP policies to ensure that regarding neural Commented [A207]: What IP protection should and
should not apply to is outside of the scope of this
and cognitive biometric data, as individual human activity derivatives remain accessible, as forum.
appropriate, while respecting intellectual property rights.., are not subject to proprietary rights. IP
protection should only apply to original data compilations (created through a process of Commented [A208]: What does global accessibility
entail here? Perhaps we could say “global
aggregation, organization, or selection, resulting in a new dataset) that meet strict and ethical availability”?
criteria.
Commented [A209]: This work seems to be outside of
scope of what UNESCO should be doing. We can
67.68. Member States should collaboratively establish clear, harmonised guidelines for the either suggest striking it or reframe it.
protection and promotion of IP rights applicable to neurotechnology on an international scale. ,
encouraging global accessibility and innovation. These guidelines should address the patentability Member States should collaboratively consider specific
of Al-generated inventions and be developed with consideration of the ethical implications of IP guidelines for the development and use of
neurotechnology, which respect intellectual property
laws, ensuring they and goal to promote global accessibility and innovation.. rights.
24.69. Member States should encourageensure thatthat all actors to adopt IP management Commented [A210]: Edited for clarity and unclear
what AI generated inventions had to do with the
strategies that encourage foster innovation and avoid overly restrictive patent use, fostering an a sentence.
robustn open innovation ecosystem. This approach should continuously adapt to the evolving
Commented [A211]: guidelines on patentability of AI-
landscape of neurotechnology. The impact of IP policies on the neurotechnology sector should be generated inventions is completely outside of scope
continuously monitored to ensure examine how they stimulate innovation while ensuring promoting here. Strongly recommend deleting.
ethicaland supporting rights-respecting use and broad accessibility. Commented [A212]: Unclear how States could ensure
this
68.70. Member States should foster an environment of co-creation in neurotechnology, by
Commented [A213]: What does “broad accessibility”
promoting facilitating policies and incentives for partnerships, co-ownership and preferential entail?
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facilitated by voluntary licensing agreements, to supportensure equitable appropriate Commented [A214]: “rights-respecting” provides a
compensation and recognition for all contributors. clearer more inclusive foundation, as there is broad
international recognition of what is meant when
discussing rights. Considering ethical points of view
69. Member States should adopt policies with respect to open science that balance thesupport
are important, of course, but there is no consensus on
protection of IP andwith the promotion ofpromoteion of data sharing and research publicly what constitutes THE ethical way to do use emerging
accessible without embargo on their free and public release. immediate publication of results and technologies.
data sharing. Particularly with the convergence of digital technologies and the increasing
concentration of those
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-25-
innovations in industry sectors, this balance is crucial to ensure that IP protection mechanisms do
not hinder scientific research, innovation, and the wide dissemination of knowledge and new
technologies. As a basic rule of equitable partnership, whenwWhen Indigenous KnowledgePeoples
isare involved in neurotechnology research and development, open science processes and, IP Commented [A215]: Unclear what “equitable”
management strategy, should be developed in collaboration with the Indigenous Peoplesthem from compensation would mean in this context (e.g.,
the beginning. voluntary v. mandatory schemes). “Appropriate” seems
a more neutral term here that allows more flexibility.
IV.4IV.3 CYBERSECURITY Commented [A216]: Technical Edit for Grammar.
70.71. Member States should collaborate internationally to establish comprehensive
standards for cybersecurity across all neurotechnology domains. These standards should
encompass hardware, software, and data security measures to protect against potential cyber
threats. By implementing establishing uniform cybersecurity standards, Member States should Commented [A217]: Delete “as a basic rule of
enable an environment that fosters ensureand promotes the integrity, confidentiality, security, and equitable partnership”- This is a normative point. Not
availability of neural data, as well as enhance user trust and confidence in neurotechnology sure why it is being styled as if it is deduced from some
purportedly internationally recognized framework on
devices. Additionally, these standards should evolve in tandem with technological advancements equitable partnerships.
and emerging cyber threats to maintain robust protection against evolving risks.
Commented [A218]: Often it will not be member states
but private, commercial, and other non-governmental
71.72. Member States should employ, encourage, and facilitate, as appropriate, red- actors that will implement cybersecurity standards.
teaming exercises-adversarial challenges to test the efficacy of security systems-as a proactive
measure to assess and enhance the safety, security, and resilience of neurotechnology systems. Commented [A219]: Modifying language, as States
cannot ensure
By conducting regular red-teaming exercises, Member States should seek to proactively identify
and address security gaps, test incident response procedures, and strengthen the overall safety
and cybersecurity posture of neurotechnology devices.
IV.5IV.4 COMMUNICATION, PARTICIPATION, AND INFORMATION
72.73. Member States should promote communication and develop engagement policies for
neurotechnology that foster informed, inclusive, and respectful dialogue between researchers,
developers, diverse users, and the broader public to respect individual and community rights,
promote public trust, and harness the collective intelligence and diversity of communities.
73.74. Member States should collaborate with international organizations, educational
institutions, and private and non-governmental entities to develop and disseminate accessible and
engaging educational materials tailored to diverse audiences to bridge knowledge gaps,
particularly in underserved regions, about the nervous system and mental health functioning, as
well as the benefits and risks of neurotechnology. These programs should aim to increase public
understanding of the technologies' functionality, safety, efficacy, and societal impact, empowering
individuals to make informed decisions and to enable their ethical reflection about their use of
neurotechnology.
74.75. Member States should implement public and community engagement processes that
facilitate genuine mutual learning and collaboration throughout the whole lifecycle of
neurotechnology. These processes should include regular and inclusive consultations with a wide
array of actors. The aim of these engagements should be to inform policy development, shape
ethical guidelines, increase public awareness and understanding, alignshape investment priorities, Commented [A220]: States can organize, but also
and ensure that neurotechnology deployment aligns with public interests and values. Special should encourage and facilitate private sector
attention should be given to involving groups traditionally underrepresented in technological participation
policymaking, thereby fostering responsible innovation in the field. Commented [A221]: Not sure what constitutes an
“ethical communications standard” but requiring
75.76. Member Sstates should collaborate in the co-creation of accurate, precise, and people to communicate in a particular way seems
accessible language and terminology for discussing neurotechnology that involves actors from inconsistent with freedom of expression obligations and
not something that our government can commit to
diverse backgrounds to ensureso that the language used is inclusive, non-stigmatizing, and given our system of constitutional rights.
accurately reflects the technologies' capabilities and limitations. Member States should establish
regulatory frameworks that require clear and ethical communication standards for Commented [A222]: Suggest cutting sentence on
regulations without additional clarity on which
neurotechnology. These [Regulatory Rframeworks should require evidence-basedtarget technological applications this would impact (e.g.
fraudulent or misleading reporting of capabilities, risks, and limitations across all applications to health applications overseen by FDA, commercial
avoid exaggeration of claims, including but not limited to applications in sleep, attention, memory, applications, etc). Further, see above comment wrt
mandating communication
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-26-
and emotional regulation.] Within these frameworks should be specific
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guidelines for ethical marketing and protocols forMember States should encourage responsible
evidence-based communications about early-stage research and capabilities, risks, and limitations
across all neurotechnology applications to avoid exaggeration of claims. and emerging technologies. Commented [A223]: Again, we need to be careful
about how we characterize government restrictions on
76.77. Member States should develop agile policies that foster effective collaboration private speech. There is some latitude in the
commercial space, but it is not a free for all.
between end- users, researchers and innovators throughout the whole lifecycle of neurotechnology
product development, with special focus given to the places where the neurotechnology is being
developed. These policies should includemandate interative consultation withthe creation of Commented [A224]: With Freedom of Speech, we can
inclusive and diverse advisory panels and public stakeholders, including representatives from encourage evidence-based communication
various academic communities and user groups and respecting neurodiversity. Member States
should also establish platforms for ongoing dialogue and feedback between users, researchers
and developers. Advisory panels should be involved in the process of developing and testing new
neurotechnology products to optimize device efficacy, usability, longevity, and sustainability. This
collaborative approach aims to ensure that innovations in neurotechnology are context-compatible
and meet the needs of diverse user populations. Commented [A225]: Unclear what this means, and
without clarity, suggest deleting
77.78. Member States should develop age-appropriate, contextually -appropriate, culturally-
appropriate, and linguistically -appropriate education about neurotechnology. This should include
training modules to aid in the supportive use of these technologies at home, both for the user and
for caregivers and family members.
CONSIDERATION FOR SPECIFIC USERS
IV.6IV.5 CHILDREN AND ADOLESCENTS
78.79. Member States should promote healthy brain development through policies that
evaluate the impact of neurotechnology on children and adolescents.
79.80. Member States should safeguard children and adolescents from implicit and explicit
coercion to use neurotechnology. Member States should pay attention to the autonomy of
children and adolescents through informed consent and assent that is adapted to and
respectful of age and decision-making capacity, while also considering the rights and
responsibilities of guardians to protect children and adolescents in their care, including
considering the guardian’s often exclusive capacity to vindicate the rights of their ward or
make legal decisions on their ward’s behalf..
80.81. Member States should fund facilitate research and development grants focused on Commented [A226]: Suggest cutting to avoid being
creating user- friendly, risk mitigated assistive neurotechnology tailored for children and overly prescriptive, noting the need for agility in the first
adolescents with disabilities. These projects should involve children, adolescents, parents and sentence.
caregivers in the design process to ensure the technologies meet their specific needs. Educational
programs should be developed to teach children and adolescents and their caregivers how to
effectively use and maintain these technologies, with support available in multiple languages and
accessible without discriminating against those who either cannot or choose not to engage with
the proposed technology.
81.82. Member States should seek to ensure research involves strict oversight and close
follow-up of all neurotechnology research involving children and adolescents. This oversight is
crucial during the developmental phases of childhood to address and mitigate any unforeseen
long- term effects. Such research must include comprehensive monitoring protocols and periodic
evaluations to ensure the ongoing safety and well-being of young participants, taking into account
their unique developmental needs and vulnerabilities. In the framework of research, involving
children and adolescents in medically vulnerable situations (e.g.i.e., children in epilepsy monitoring
units), special attention will be given to consent and assent, particularly considering particular
aspects of research (time, iterations) to prevent any form of instrumentalization.
82.83. Member States should enact specific regulations that prohibit the use of problematic Commented [A227]: Cannot agree to fund, funding
marketing techniques-such as neuromarketing, biometric emotional analytics, immersive subject to Congress and Executive Branch priorities
advertising, and virtual or augmented reality advertising-that rely on sensitive neural and cognitive
810
-28-
biometric data collected from children and adolescents. Recognizing the heightened vulnerability
of children and adolescents in digital environments, these regulations must should explicitly forbid
any practices that use such data to influence or exploit children and adolescents.
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IV.7IV.6 OLDER PERSONS
83.84. Member States should promote healthy aging and support older adults elderly Commented [A228]: Technical: This appears to be
individuals by funding and implementing evidence-based programs that integrate neurotechnology missing an adjective. Misleading marketing is another
into routine care. These programs should involve the entire support ecosystem, including family, alternative.
caregivers, and medical teams, to enhance quality of life. Priority should be given to developing
and implementing tools that prevent, delay, and treat, or assist individuals overcome age-related Commented [A229]: We recommend use of “older
health conditions, impairments, and neurodegenerative diseases. Member States should aim to adults” vs other possibly stigmatizing language. We
ensure that access to these neurotechnology programs is equitable and does not exacerbate also recommend defining who is considered an older
adults (e.g. over 65?)
socioeconomic inequalities.
Commented [A230]: Technical: "prevent, delay, or
84.85. Member States should establish guidelines for neurotechnology design sensitive to treat" could be limiting factors on innovation, e.g. the
Synchron BCI may not be considered to "prevent,
the needs of older adults, carefully considering human-computer interface factors for usability delay, or treat" the existing medical issues, instead it
(such as fonts, buttons, and colour) and experience for enhanced visual and auditory cues. creates a bypass around the failed systems to assist
the patient and/or restore functionality.
85.86. Member States should preserve, support, and promote autonomous decision-making
for older people using neurotechnology for sensorimotor and cognitive support. The consent
process should accommodate potential cognitive challenges faced by older adults, ensuring to,
ensureing that consent is informed, ongoing, and adaptable to changing health conditions. Policies Commented [A231]: States can’t ensure this ex ante.
should be in place to ensure that assistive neurotechnologyies recognize changing cognitive
capacities over time and respect users' preferences. Commented [A232]: Technical
86.87. Member States should develop ethical guidelines to ensure that neurotechnologyies
such as robotic caregivers enhance rather than replace human interaction, particularly in the care
of individuals with neurodegeneration. These guidelines should emphasize the augmentation of
human care, not its replacement., unless its replacement offers additional benefits such as
increased privacy or accessibility. Commented [A233]: And when appropriate, to involve
legally authorized decision-makers (e.g., for those with
IV.8IV.7 WOMEN AND GENDER dementia)?
87.88. Member States should adopt and enforce comprehensive policies that promote and
respect gender equality and diversity in the whole lifecycle of neurotechnology. The policies should
prioritize inclusive research for addressing women and gender specific needs and differences,
require targeted and sex-disaggregated data collection and analysis, include education and Commented [A234]: Automation of medical
training programmes on inclusive research practices, ensure public and community engagement technologies could be used to provide care to persons
with women and gender health experts and advocacy groups and, incentivise gender responsive who otherwise would not receive it or to increase
privacy, among other potential benefits.
technology design, to meet the needs and conditions specific to women and gender minorities.
Affirmative action policies are necessary to close gender gaps in these fields, increase
representation, engagement and leadership.
88.89. Member States should establish clear guidelines and legal frameworks to ensure that
workplaces and research environments, throughout the whole lifecycle of neurotechnology, are
inclusive and supportive, particularly for women and gender minorities, and safeguard against
harassment, and discrimination., and algorithmic bias. This should include robust mechanisms for Commented [A235]: "Targeted" data
reporting and addressing incidents of harassment and discrimination, ensuringto ensureing collection/analysis isn't specific or strong enough. We
accountability and support. should ask to specify "sex (or gender) disaggregated."
Commented [A236]: Recommend including
89.90. Member States should adopt a range of measures that prioritize ethical and equitable "algorithmic bias" here in addition to harassment and
research and innovation and support programs that foster women's and gender minorities' discrimination.
participation in neurotechnology. This includes funding and other policies that prioritize ethical and Commented [A237]: Technical
equitable research and innovation, but also affirmative action initiatives to support the participation
of women and gender minorities in neurotechnology through targeted education programs,
employment opportunities, entrepreneurship support, and leadership development within the
sector. Member States should also provide support systems such as mentorship programs,
networking opportunities, and resources to help women and gender minorities overcome barriers
to participation and succeed in the neurotechnology field.
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IV.9IV.8 PERSONS WITH PHYSICAL DISABILITIES
90.91. Member States should adopt policies that harness the potential of neurotechnology
by removing barriers experienced by persons with physical disabilities and providing support
thereby contributing to achieving equal full enjoyment of human rights. They should implement Commented [A238]: Cannot promiseto fund unless an
regulatory frameworks that require accessibility assessments for all new neurotechnology products agency has been affirmatively identified as having the
to ensure these products do not perpetuate existing disabilities or health disparities. These appropriations, authories, and intent to fund.
frameworks should include protocols for testing with diverse groups of persons with disabilities to
ensure technology meets a wide range of needs and does not unintentionally exclude or
disadvantage any subgroup.
91. 115. Member States should consider createing incentive programs to promote the Commented [A239]: We want everyone to fully enjoy
development or deployment of neurotechnology for people with disabilities to promote improve the free exercise of human rights. That is one way to
their quality of life and functional independence. These programs should could include tax be equal but that seems to miss the point that we
would not support limiting someone’s enjoyment of
incentives for companies investing in assistive neurotechnology research and development, grants human rights just to reach an equal state of partial
for research institutions focusing on neurotechnology for disability support, expedited regulatory enjoyment of human rights.
reviews for technologies offering significant advancements in mobility, communication, or daily
Commented [A240]: Recommend adding deployment
living assistance, and innovation prizes for breakthroughs in affordable, accessible and affordability references, and combine paras.
neurotechnology solutions, or affordability programs to help users access such technologies.
92. Member States should, whenever possible, subsidise the cost of essential neurotechnology
devices, such as neuroprosthetics, for persons with physical disabilities. They could encourage
public-private partnerships to make advanced neurotechnology affordable and integrate
neurotechnology coverage into, as applicable, national health insurance and other reimbursement Commented [A241]: Technical: promote could be
schemes for persons with physical disabilities. A national database of available neurotechnology understood to mean supporting the status quo but
resources and support services should be developed to facilitate access and information sharing. many existing neurotechnologies are focused on
restoring a lost functionality and/or improving quality of
life.
IV.10IV.9 PERSONS WITH MENTAL HEALTH CONDITIONS
93. Member States should foster research and promote awareness-raising initiatives to address
the increasing prevalence and special needs of people with mental health conditions, including
victims and survivors of trauma and violence, and the relevance of neurotechnology for these
communities.
94. Member States should allocate funding forenable long-term advocacy and efficacy studies, Commented [A242]: To be more inclusive as not all
post- market oversight, and tiered scrutiny with special attention to invasiveness and reversibility countries have or primarily rely on national health
of neurotechnology interventions. It is important to ensure that people with mental health conditions systems or insurance schemes.
are well-informed and have reasonable expectations about the process.
95. Member States should prioritize funding for neurotechnology that is designed to improve Commented [A243]: Cannot promise to fund unless
quality of life and daily functioning of individuals with mental health conditions. This includes an agency has been affirmatively identified as having
technologies that assist in managing symptoms, improving cognitive functions, and providing the appropriations, authorities, and intent to fund.
emotional support at home, in the workplace, in their communities, and in society. Research and
development should be guided by feedback and engagement with persons with mental health
conditions and their advocates.
96. Member States should establish policies that improve access to timely advances in
neurotechnology for those with mental health conditions to ensure that cost is not a barrier to
accessing potentially life-altering treatments and supports.
HEALTH AND RESEARCH ETHICS
IV.11IV.10 HEALTH
97. Member States should support the development of health applications that prioritize the
unmet needs in the provision of neurological and mental health. This should include establishing
research funding programs specifically targeted at addressing identified gaps in nervous system Commented [A244]: Cannot promise to fund unless
care. an agency has been affirmatively identified as having
the appropriations, authorities, and intent to fund.
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-31-
98. Member States should build and maintain international solidarity to address global health
risks and uncertainties, and ensure that their implementation of healthcare for the nervous system
is consistent with international law including and rigorous human rights obligations. This could Commented [A245]: Cannot promise to fund unless
involve creating international forums for sharing best practices in the implementation of an agency has been affirmatively identified as having
neurotechnology in healthcare. the appropriations, authorities, and intent to fund.
99. Member States should establish oversight mechanisms to evaluate the physical and mental
health impacts of long-term use of neurotechnological devices, with special attention to
invasiveness and reversibility of neurotechnology interventions. This includes implementing
regulatory measures requiring long-term follow-up studies for approved neurotechnology devices
and establishing clear criteria for continued approval based on these studies’ results.
100. Member States should consider the significant cost and impact associated with pathologies
related to the nervous system, as well as the potential benefits of early diagnosis and access to
preventive and assistive neurotechnology. Public policies should prioritize the promotion of access
to these technologies and aim to ensure health cost coverage for individuals in need. Commented [A246]: Unclear what is meant by
"rigorous" human rights obligations. Is this calling for
101. Member States should promote the development of reliable and durable neurotechnology the creation of new human rights obligations or only
consistency with only certain existing human rights
for healthcare applications. This includes encouraging the design of devices and systems that obligations (i.e. those deemed "rigorous")?
require minimal maintenance, ensuring to, ensureing they remain functional and effective under
everyday conditions. Regulatory bodies or designated authorities should oversee the enforcement Commented [A247]: Pubic policies can’t ensure this
of rigorous standards for quality, safety, and longevity, thereby reducing the burden on users and
enhancing the dependability and sustainability of neurotechnological solutions.
102. Member States should ensure the development or strengthening of existingexisting Commented [A248]: Technical
comprehensive neurotechnology medical device reporting systems that track and address adverse
effects according to best international best practices. The tracking and aggregation of Commented [A249]: Add “according to best
neurotechnology-derived data should be performed in such a way to maximize safeguarding international best practices” in order to prevent
patient data and IP consistent with appropriate security requirements. In contexts where such diverging, competing, or contradicting member state
policies.
systems do not exist, Member States should establish them. Where systems are already in place,
they should be updated to specifically include neurotechnology. These systems should be Commented [A250]: Technical
interoperable and contribute to a centralised, public, and transparent international database,
managed in collaboration with international organizations, to ensure that global international
technical standards are met and accessible for public knowledge, international oversight and Commented [A251]: Agree that there needs to be a
research.., while ensuring patient privacy, data security, and intellectual property rights are way to track the adverse effects of neurotechnologies
protected. and that the stakeholders, including the public, need to
be aware of them. However, there may need to be a
nod to doing this more securely? The tracking of
IV.12IV.11 RESEARCH ETHICS adverse effects in aggregation and making the
reporting systems public could present a vulnerability
103. Member States should reinforce the ethical frameworks governing neurotechnology research for dual-use/exploitation.
to ensure promote robust protection of human participants. Member States should adopt clear Commented [A252]: To avoid confusion. If the idea is
guidelines or policies that define the qualifications to ensure that research is conducted by that it should be consistent with this recommendation
professionals with appropriate knowledge as well as knowledge of the communities where they and its principles that should be clarified rather than
are working about the nervous system structure and function (in addition to including where trying to invoke a quasi-legal category of global
standard.
relevant, information about brain disorders ) and is performed in adequate research settings.
Furthermore, research protocols, public or private, in the medical as well as the non-medical Commented [A253]: Would want to make sure any
domain, should be carefully evaluated by registered ethics boards (ethics committees) and specific such sharing platform is not violating privacy or other
rights. Perhaps also include IP rights in the list of items
attention dedicated to individuals with special situations regarding vulnerability such as diminished that should be protected.
capacity to consent or to make decisions. Member States should ensure seek to ensure that all
research institutions benefiting from federal research funds have mandatory ethics training for Commented [A254]: Not all research would involve
brain disorders
researchers.
104. Member States should encourage multicentre international research, including those that
involvespromote various diversity of cultures and ethnic groups, scientific backgrounds, and
gender inclusivity. Member States should promote the utilization of FAIR principles and
international cooperation to develop common reporting standards and protocols for interoperability,
particularly for implantable neurotechnology devices. This cooperation should aim to enhance the
comparability and utility of research globally, improving both the efficacy and ethical integrity of
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research.
105. Member States should aim to ensure that the whole lifecycle of neurotechnology is
considered in the design of a clinical trial, including policies to protect patients in case of cessation
of activities of the trial sponsor or promoter. Member States should establish requirements for
clinical trials to be included in relevant nationally or internationally approved registries, and
encourage registration
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with community and patient registries. Also, clinical trials should report on appropriate medical
device reporting systems developed within Member States.
106. Technology developers should ensure that the validation of Al algorithms in neurotechnology
research include rigorous testing for biases, as well as measures to enhance fairness,
explainability and transparency, including the provenance of training datasets. Suitable techniques
should be employed to mitigate any unintended biases present in Al models used in
neurotechnology applications.
107. Member States should ensure thatencourage research efforts to not only focus on Commented [A255]: We recommend
biomedical risks associated with neurotechnology but also investigate potential effects on an expanding/revising language to the effect of:
individual's subjective experience, agency and personal identity. Understanding how
“... professionals with appropriate scientific knowledge
neurotechnology may impact aspects of self-perception, consciousness, and identity is essential for as well as knowledge of the communities where
addressing ethical concerns and ensuring the well-being of individuals using these technologies. they are working…”
•
108. Member States should ensure those engaged in research to comply with applicable legal
obligations, which may include implement ing regular auditing and monitoring of research practices Commented [A256]: States can’t ensure this ex ante
to ensure adherence to ethical standards. This schould include evaluating the adequacy of to the extent that the assumption is that we are not just
informed consent, particularly concerning data reuse and the potential commercialisation of neural talking about gov’t / publicly funded research.
data.
109. Member States should require researchers in neurotechnology to establish clear and
transparent protocols for communicating clinically significant and actionable incidental findings to
participants. These protocols should ensure that such findings are conveyed promptly, respecting
participants' rights and autonomy. Additionally, Member States should mandate that researchers
provide the necessary support and coordination with healthcare providers to address any health
concerns that arise from these findings. Commented [A257]: Unclear how governments could
ensure extra legal criteria on non-government actors or
110. Member States should ensure that iIndividuals involved in neurotechnology research or research
receiving neurotechnological interventions are adequatelyshould be adequately informed about Commented [A258]: This section has overlap and
the potential for incidental findings, particularly those with significant health implications. The consequences with clinical research
informed consent process should clearly outline what these findings might entail, the participants' regulations/policies. For example, how will data from
unintentional concerns or findings be used and
right to choose whether they wish to be informed about such findings, and guarantee that their protected? For example are data from negative findings
decisions in this regard will be respected throughout the study or treatment. going to be protected from release to health or life
insurance companies or other entities that may pose an
SPECIFIC DOMAINS OF APPLICATION OUTSIDE OF HEALTH adverse action be taken against the lifestyle or
coverage of the participant.
IV.13IV.12 EDUCATIONAL SETTINGS
111. Member States should approach with caution the integration of neurotechnology in
education, ensuring that its use is evidence-based and aligned with the education goals and
complements traditional learning methods. Emphasis should be placed on promoting the holistic
development of students, focusing not just on academic performance but also on mental health,
well-being, and overall interests. To ensure inclusivity, Member States should develop age-
appropriate guidelines for neurotechnology use across different educational stages and learning
styles. Regular assessments of neurotechnology's impact on student development, including
mental health, should be conducted, with ethical review processes established to oversee
deployment. The primary focus should be on fostering critical thinking, creativity, and emotional
intelligence rather than solely enhancing academic performance.
112. Member States should adopt policies ensuring the voluntary deployment of neurotechnology
in education, grounded in fully informed consent. These policies must should include clear, age- Commented [A259]: Unclear how governments could
appropriate information about the technology's purpose, benefits, and risks, with adequate ensure this ex ante for non-government or publicly
consideration periods. Considering the increased complexity of obtaining voluntary consent in this funded research
context, consent and assent procedures for minors should involve children, adolescents, parents,
guardians and all actors necessary to obtain approval required for minors. Ethical oversight
mechanisms should be established, including regular consent renewal and immediate
cessation of
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neurotechnology use upon withdrawal, and ensure anonymous feedback channels. Policies must Commented [A260]: This is a normative point - not a
prohibit undue incentives or academic penalties for non-participation and take measures to avoid legal obligation.
creating or reinforcing inequalities among students. Additionally, Member States should support Commented [A261]: Cannot promise to fund unless
student involvement in decision-making about neurotechnology integration and fund training an agency has been affirmatively identified as having
programs on its ethical use, empowering educators and students to critically assess its application. the appropriations, authorities, and intent to fund.
Commented [A262]: Ethical standards is vague -
113. Member States should establish a unified, robust oversight mechanism for neurotechnology should look to the internationally recognized baselines
use in educational settings, incorporating regular audits, public and community feedback, culturally like international human rights law.
appropriate and according to local conventions, and strict adherence to safety and ethical Commented [A263]: Cannot promise to fund unless
standards, including an assessment of reversibility on the nervous system. Continuous research an agency has been affirmatively identified as having
should be funded conducted to assess the long-term psychological and cognitive impacts of these the appropriations, authorities, and intent to fund.
technologies. Oversight should involve periodic reviews based on empirical evidence to adjust Commented [A264]: Technical
neurotechnology usage as needed, ensuring to, ensureing it serves student development and
Commented [A265]: We cannot know this ex ante
addresses risks like dependency or de-skilling. This comprehensive approach will can help
maintain the safety, effectiveness, and alignment of neurotechnology with best practices for Commented [A266]: The original language assumes
student well-being and learning outcomes. the State as the primary economic actor (or a
Scandinavian/German-style close collaboration
between unions, enterprises and the State, but in many
114. Member States should invest in educational and professional development programs to cases the State may only be responsible for the overall
equip innovators and business leaders with the skills to integrate ethical considerations throughout environment in which the relevant economic
the neurotechnology whole lifecycle. This training should include ethical design, human rights law actor/policymaker is acting.
(where relevant), and societal impact assessment, preparing the next generation of technologists Commented [A267]: We should take a comprehensive
to critically evaluate the implications of their work. approach to protect not only the employee, but
his/her/their coworkers.
IV.14IV.13 LABOUR AND EMPLOYMENT Commented [A268]: Should be a specific reference to
workers’ rights here alongside reference to well-being.
115. Member States should encourage the establishment of workplace policies and incentives This could be either “workers’ rights” “internationally
that prioritize the health and well-being of employees in the use of neurotechnology. These policies recognized workers’ rights” or (more limited) “workers’
fundamental principles and rights at work” (i.e.,
should ensureaim to ensure that any deployment of neurotechnology is evidence-based, with a freedom of association and collective bargaining, no
focus on applications that have been scientifically validated to promote employeeworker well-being forced labor, child labor or discrimination, promoting a
and protect and promote internationally recognized worker’s rights, includinga safe and healthy safe and healthy working environment.).
working environment, and workplace safety and security, the right to organize, and anti- ... [26]
discrimination, such as reducing stress or enhancing workplace conditions (i.e., adaptive and Commented [A269]: DOL overarching comment in this
responsive environments that adjust workloads based on cognitive load). Deployment must should section: recommend using “workers” instead of
be on a voluntary basis and workersemployees must should havhavee the option to opt out of using employees since many workplaces have both ... [27]
neurotechnology without facing any negative consequences or discrimination. Under no Commented [A270]: There could be certain duties or
circumstances should these technologies be used for punitive measures, non-consensual mental types of equipment that require neurotechnology to
surveillance, or in ways that could compromise employee healthwhen the risks outweigh the respectively perform or operate.
potential benefits. Commented [A271]: These are normative points in the
international level. I suspect there are relevant legal
116. Member States should require employers to clearly provide employees workers and job obligations at some domestic level, but to the extent
... [28]
seekers with comprehensive information about how neurotechnology used in their workplace Commented [A272]: Monitoring fatigue or other kinds
works, the benefits it offers, transparency about what data are collected, how it is used, and who of mental surveillance could be beneficial.
has access to it, and clearly disclose any potential risks of their use. Commented [A273]: There could be cases where
mental surveillance could be beneficial, such as
117. Member States should require employers who use neurotechnology in the workplace to monitoring when an employee is overly tired and may
... [29]
adopt transparent policies that disclose the purpose of the use, limit the scope and location of its Commented [A274]: To the extent that
use to legitimate purposes in the interest of the workeremployee and third parties (i.e.e.g., safety, neurotechnology may be used for job applications (e.g.,
monitoring fatigue in commercial drivers or tracking attention in air traffic controllers). To respect to demonstrate cognitive ability, decision-making, ...
etc.),
[30]
workers’employees' mental privacy, employers should be prohibited from unauthorized access to Commented [A275]: Technical edit: Is it implied here
neural and cognitive biometric data that may be collected incidentally during routine workplace that this would be non-invasive forms of neurotech
monitoring. should be prohibited. Employers should also work to mitigate the risks and comply with (e.g., that employers would not be offering surgically
... [31]
relevant laws related to the collection and retention of information regarding workers’ disabilities Commented [A276R275]: also highlight cognitive
or genetic information, including any worker’s family medical history. Employers should be biometric data?
prohibited from using neural and cognitive biometric data for any non-consented purposes,
Commented [A277]: This could be more specific to
particularly those that could negatively impact an worker’semployee's job security or privacy. limit to the location.
Employers should not share workers' data outside the employer's business and employer's agents ... [32]
without workers' freely given, informed, and specific consent or unless required by law.
Commented [A278]: This paragraph is already quite
long, but to the extent employers’ are collecting
118. Member States should require employers to adopt best practices for data minimisation and workers’ data, this further qualifies the limited scope.
817
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secure storage of neural and cognitive biometric data, ensure that data is stored securely, with
access limited to authorised personnel only, is deleted once its intended purpose has been fulfilled.
Additionally, upon an employee's departure, all related records should be fully deleted or individual
data released to the employee, ensuring that no data is retained after the termination of
employment.
818
-22-
119.118. Member States should ensure that when workersemployees are issued multifunctional
devices (i.e., earbuds or headphones that also include neural sensors) that can be used at work
or at home, employers should be prohibited from collecting neural and cognitive biometric data
outside of workplace settings and working hours and ensure that any data collected during work is
used exclusively for agreed-upon purposes. Employers should implement technological
safeguards to automatically disable data collection during non-work hours.
120.119. Members States should ensure that employers respect the right of employees to
obtain a copy of any neural and cognitive biometric data collected about them, along with any
interpretations drawn from it in an accessible and comprehensible manner. To use these tools
without consent constitutes a breach of trust, undermining the value they would otherwise create.
121.120. Member States should require, through stringent regulations, that any use of
neurotechnology in the workplace require explicit workeremployee consent, and be used only for
purposes that demonstrably enhance workplace safety, and health or enjoyment of other workers’
rights, employeeworker well-being and dignity, and not for enhancing productivity at the expense Commented [A279]: Suggest making more specific to
of employee health. clarify the inclusion of “third parties” in the preceding
paragraph.
122.121. Member States should guard against the exploitation of employees, and they should Commented [A280]: Suggest expanding to include
develop stringent regulations against using neural and cognitive biometric data for profiling in the other workers’ rights as applicable.
workplace, including in hiring. These regulations should prohibit the use of neural and cognitive
biometric data to discriminateand discrimination against employees and job candidates,
particularly neurodiverse individuals, ensuring hiring practices and workplace policies regarding
the use of neurotechnology are fair and inclusive. Commented [A281]: The beginning of the sentence,
which lists the exclusive purposes for which the
123.122. Member States should strictly regulate the use of neurotechnology for hiring or technology can be used, already excludes the
possibility of using the tech to enhance productivity.
maintaining employment, to limit such use where such neural and cognitive biometric data are
directly relevant to the specific requirements of the job and be transparent with workers and job
seekers about the collection and use of such data.. Commented [A282]: Some occupations may depend
upon consent-based profiling for specific duties.
IV.15IV.14 CONSUMER AND COMMERCIAL DOMAINS
124.123. Member States should proactively establish a regulatory framework, according to best
international best practices, that balances innovation in the recreational and commercial domains
with protecting individual rights and well-being. This framework should be dynamic, allowing for Commented [A283]: Redundant with some of the
timely updates as technology evolves and new insights are gained about its impacts on society. This preceding, but worth repeating if the construction of the
includes providing adequate oversight to ensure that neurotechnology does not cause harm, are section remains as drafted to make clear this also
applies here.
used consensually, and include robust mechanisms to protect users from potential psychological
distress or manipulation.
125.124. Member States should strengthen comprehensive consumer protection laws to
include clear labelling on commercial neurotechnology products, detailing their effects, limitations,
and risks to prevent misleading claims and ensure transparency. This also includes prohibiting Commented [A284]: As above, add “according to best
practices of "tying" or requiring the disclosure of neural and cognitive biometric data as a condition international best practices” in order to prevent
to access goods or services, and prohibition about third party data sharing or the uses of this data diverging, competing, or contradicting member state
policies.
inconsistent with applicable lawwithout affirmative opt-in option.
Commented [A285]: Technical
126. Member States should foster an environment that ensures all claims about consumer, non- Commented [A286]: Data sharing should be
medical technologies are supported by robust scientific evidence. They should, by regulation, consistent with applicable law (domestic or
require that any products claiming to treat, prevent, or diagnose diseases or medical conditions be international). This criteria, which has no basis in
validated through rigorous safety and efficacy testing, including clinical trials where necessary, and international law, may be in some domestic systems
but not in others. This recommendation should be
be used under appropriate medical supervision. generally inclusive of the legal frameworks of member
states.
127.125. Member States must need to enforce informed consent processes that are thorough
Commented [A287]: Okay to talk about addressing
and transparent across all neurotechnological interventions, ensuring to ensureing that fraudulent of misleading claims, but we are generally
participation is fully voluntary and respects the privacy and autonomy of individuals. This principle not so amenable to such broad restrictions on speech /
should apply uniformly in various domains such as sports, arts, where robust standards should prior restraint..
safeguard against coercive use and respect athletes' and artists' individual autonomy, community Commented [A288]: This is a normative point and not
interests, and IP rights. a legal obligation.
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128.126. Member States should steer incentivize the use and development of neurotechnology
in the arts toward ensuring thepromoting enhanced learning and cultural appreciation without
compromising individual autonomy or leading to cultural homogenisation.
129.127. Member States should adopt policies to prevent the misuse of neurotechnology of
consumer technology, especially neurogaming and other devices that exploit the dopamine reward
system or seek to induce problematic and unhealthy use and overconsumption. Such regulations
should mandate clear labeling of risks, disclosures on their effects on the nervous system, enforce
game design standards and safety, privacy and age-appropriate design standards that prevent
taking advantage of a person's physical, mental and emotional vulnerability to lead to compulsive
use or addiction of gaming or digital recreational platforms combined with neurotechnology, to
promote healthy, balanced use, especially among children.
130.128. Member States should ensure that devices capable of multiple functions, such as XR
glasses or smart earbuds with neural sensors, include hardware-based controls that allow users
to selectively disable neurotechnology features while maintaining basic functionality. Regulations
should ensure that 'opt-out' features are accessible and straightforward, promoting healthy,
balanced use especially among children and vulnerable populations.
131.129. Member StatesStates should address the profound ethical questions regarding self-
determination, consent, privacy, and the potential for manipulation raised by neurotechnology that
arise in the contexts of recommender systems, priming and nudging, marketing during sleep and
dream, neuromarketing, and closed-loop environments by adopting comprehensive policies and
regulations that:
(a) Recommender systems: explicitly prohibit the use of neural and cognitive biometric
data in recommender systems for manipulative or deceptive purposes, including in
political , medical, and commercial context. These regulations should require that any Commented [A289]: Technical
use of such data within these systems be based on explicit, informed opt-in consent
from users.
(b) Nudging: govern the use of neural and cognitive biometric data for nudging-subtly
influencing individuals' decisions or behaviours, often without their explicit awareness.
or understanding. This is particularly critical in sensitive areas such as political
messaging, commercial advertisement, and healthcare. These frameworks should
require explicit, informed consent for any use of such data to influence decisions or
behaviour, the right to opt out of these systems, and transparency and clear
disclosures at the point of data collection, with strict limitations on using data for
purposes beyond those explicitly disclosed.
(c) Marketing during sleep and dream: prohibit the use of neurotechnology that influences
or manipulates individuals during sleep, such as marketing during sleep and dream.
Regulations should strictly prohibit commercial, marketing, or political applications that
target individuals during sleep, using neurotechnology or neural and cognitive
biometric data. Additionally, robust oversight mechanisms should be required to
ensure that any research or application of such technologies prioritizes the well-being,
privacy, and autonomy of individuals, with particular attention to the potential long-term
psychological and cognitive impacts of manipulating sleep states.
(d) Neuromarketing: safeguard against unethical aims and practices in neuromarketing,
including by requiring comprehensive disclosures to ensure that all neuromarketing
activities are conducted transparently, with participants' explicit informed consent. This
includes ensuring that participants in neuromarketing research or campaigns are fully
aware of methods, risks, and intentions and affirmatively opt-in to participation. The
use, storage, and potential reuse of the collected data should be strictly regulated.
(e) Closed Loop Environments: provide clear regulatory guidelines on the design and use
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of closed-loop environments-such as immersive computing devices that adjust
experiences based on detected neural and cognitive biometric data. These policies
should require clear and accessible disclosure about how neural and cognitive
biometric data are used in these environments, prohibit real-time behavioral
modification or manipulation without explicit, informed consent, and implement
safeguards specifically designed to prevent abuses such as unauthorized surveillance,
manipulative interventions, and practices that could influence voting behavior, political
opinions, or exploit psychological and emotional vulnerabilities in real-time.
IV.16IV.15 ENHANCEMENT Commented [A290]: Added to provide additional
contexts.
132.130. The use of neurotechnology to improve memory, attention, or other aspects of human
mental performance outside of the medical context can introduces complex ethical, social, and Commented [A291]: As noted above, we need a
legal challenges, which can create new kinds of disparities in the global world. When definition for enhancement.
neurotechnology is used in these contexts, it may raises crucial questions about equity, consent, The following article may provide a useful model.
Neurotechnology and ethics guidelines for human
individual and community autonomy, and the nature of enhancement of the nervous system itself. enhancement: The case of the hippocampal cognitive
Member States should ensure that anyseek to prevent policies, law and regulatory frameworks prosthesis (2023)
that govern the use of neurotechnology in these contexts dothat may not exacerbatee social
Commented [A292]: Not all enhancements will
inequalities or lead to unlawful discrimination, address the potential risks (including to reversibility, necessarily lead to the described challenges.
invasiveness, and risks to self-determination) and fully comply with respect human rights and
protect dignity. Commented [A293]: Either you don’t agree with this
communitarian characterization of autonomy so would
not want community autonomy referenced OR you do
V. IMPLEMENTATION and individual and community autonomy are the
universe of autonomy so “individual and community”
133.131. Member States and all other actors as identified in this Recommendation should autonomy is superfluous.
respect, promote and protect the ethical values, principles and standards related to thisset forth in Commented [A294]: “Respect” is more appropriate in
this Recommendation, and should take all feasible steps to give effect to its implementation. relation to “human rights and dignity”. “comply with” is
generally used with regard to specific rules.
134.132. Member States shallare expected to, according to their specific contexts, governing Commented [A295]: Unclear what it means to "fully
structures and constitutional provisions, credibly and transparently advance the ethics ethical comply" with "dignity". Recommend adding "protect" or
consideration of neurotechnology, in line with the UNESCO Recommendation. Member States "respect" in regards to dignity.
shouldall monitor and evaluate policies, programmes and mechanisms related to neurotechnology Commented [A296]: Unclear what ethical
and its ethics. Progress monitoring could rely on a combination of quantitative and qualitative values/standards related to this Recommendation
approaches. entail and, as such, what we would be making a
political commitment to respect, promote and protect.
135.133. Member States should develop capacities in governmental institutions and support Commented [A297]: This is an non-binding
government officials to steer the technological development ethically. instrument, language of legal obligation such as shall,
must, agree, require should not be included in a non-
binding instrument, if it is to retain its non-binding
136.134. Member States should establish or designate national organizations responsible for
character.
overseeing and coordinating the regulation, vigilance, and oversight of neurotechnology across
relevant government agencies. These coordinating bodies should be tasked with ensuring that Commented [A298]: Technical
legal and regulatory frameworks are consistently applied, that public health and safety are
protected, and that ethical standards and human rights are upheld throughout the whole lifecycle Commented [A299]: This is an non-binding
of neurotechnology. This includes facilitating inter-agency collaboration, monitoring compliance instrument, language of legal obligation such as shall,
with national and international technical standards, and ensuring that data and insights from must, agree, require should not be included in a non-
binding instrument, if it is to retain its non-binding
different regulatory domains are shared effectively to inform decision-making and policy character.
development. These bodies should also help coordinate public and community engagement.
Commented [A300]: Technical edit: And well-being?
137.135. Member States should strive to extend and complement their own actions in respect
of this Recommendation, by cooperating with all relevant national and international governmental
and non-governmental organizations, as well as transnational corporations and scientific
organizations, whose activities fall within the scope and objectives of this Recommendation. Civil
society will be an important actor to advocate for the public sector's interests and therefore
UNESCO needs to ensure and promote its legitimacy.
138.136. UNESCO should publicize and disseminate this Recommendation widely through all
available means, and share it with Member States, National Commissions for UNESCO, relevant
international and regional partners, human rights institutions as well as with UNESCO ethics
821
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advisory bodies for dissemination to all levels and actors in this field.
139.137. To support Member States implementing this Recommendation by developing
concrete programs and policies and developing institutional capacities in the ethics of
neurotechnology, UNESCO shall contribute by developing a full-fledged program with the following
elements:
(a) a UNESCO Readiness Assessment Methodology (RAM) to assist Member States in
identifying their status at specific moments of their readiness trajectory along a
continuum of dimensions;
(b) a UNESCO methodology for Ethical Impact Assessment (EIA) of neurotechnology
based on rigorous scientific research and grounded in international human rights law, Commented [A301]: To avoid confusion given the way
along with specific guidance for its implementation in the whole neurotechnology that standards have been deployed in the draft
lifecycle, and capacity-building tools and materials to support Member States' efforts recommendation
to train government officials, policy-makers and other relevant actors on the
methodology;
(c) a UNESCO methodology to evaluate ex ante and ex post the effectiveness and the
efficiency of the policies for the ethics of neurotechnology and incentives against
defined objectives;
(d) a UNESCO research program that will focus on the ethics of neurotechnology,
grounded on an appraisal that is informed by the current state of technological
developments, to assess the current and future impact of neurotechnology on
societies and the environment. This evidence-based analysis will be gathered in a
UNESCO observatory, to become a shared pool of knowledge and awareness of good
practices and innovations available to all Member States and actors, in the form of
research reports, data, and statistics regarding policies for ethics of neurotechnology.
The research program should take into consideration the converging developments of
neurotechnology with other technologies such as artificial intelligence and quantum
technology, work to be conducted in collaboration with other relevant UNESCO
initiatives. Commented [A302]: Other bodies of international law
may be relevant. Human rights law would not always
(e) a UNESCO collaborative platform fostering meaningful exchanges and facilitating be applicable.
collaboration among Member States and among all actors to promote a global policy Commented [A303]: This can be done in the context
dialogueintegrate ethical considerations in global policy dialogues on emerging of existing fora. It does not require the creation of a
technologies, including at the Ministerial level in the context of a Global Forum on the new forum.
ethics of Emerging Technologies. Supporting this effort, UNESCO shall is directed to Commented [A304]: Edited to avoid legally binding
establish an open network of experts, with that includes balanced representation of language.
from all UNESCO's regional groups- and invites participation from any State willing to
Commented [A305]: This is an non-binding
contribute an expert or expertsstakeholders, on the neurotechnology. instrument, language of legal obligation such as shall,
must, agree, require should not be included in a non-
140.138. Processes for monitoring and evaluation should ensure broad participation of all binding instrument, if it is to retain its non-binding
actors, including, but not limited to, under-represented, vulnerable people or people in vulnerable character.
situations and ensuring social, cultural and gender diversity. The monitoring and assessment of Commented [A306]: Strongly recommend this network
the impact of neurotechnology and related ethics policies and practices should be carried out be open to participation from States rather than a list of
continuously in a systematic way proportionate to the relevant risks. This should be based on persons selected by UNESCO.
internationally agreed affirmed frameworks and involve evaluations of private and public Commented [A307]: Suggest this change unless only
institutions. Data collection and processing should be conducted in accordance with international interested in frameworks that have been formally
law, and applicable national domesticl legislation on data protection and data privacy, and and concluded as international agreements.
intellectual property rights,, and in a manner that respects the values and principles outlined in this Commented [A308]: Only accord with applicable law -
Recommendation. for example, while others may want to act consistent
with the GDPR while outside EU jurisdiction, they are
VI. FINAL PROVISIONS not legally bound to do so, so we would not describe
them as actin gin accordance with the GDPR.
141.139. This Recommendation needs to be understood as a whole, and the foundational Commented [A309]: Technical: all national legislation
values and principles described in it are to be understood as complementary and interrelated. is domestic but not all domestic legislation is national,
so to collect everything I suspect was intended to be
included here, suggest this revision.
822
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142.140. Nothing in this Recommendation may be interpreted as replacing, altering or otherwise
823
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prejudicing Member States' obligations or rights under international law, or as approval for any
State, other political, economic or social actor, group or person to engage in any activity or perform
any act contrary to applicable international law, human rights, and fundamental freedoms, human Commented [A310]: The values and principles
dignity and concern for the environment and ecosystems. outlined in this Recommendation do not have a legal
character such that they can be accorded with.
Commented [A311]: Added because not all uses will
be subject to international human rights law.
824
Page 7: [1] Commented [A69] Author
See overarching comments regarding potential applicability of international laws beyond IHRL. Keeping
consistent with preamble edits. Further, standards are not binding under international law so can’t
describe them as creating obligations….should avoid using standards unless referencing technical
standards when discussing emerging technologies, to avoid confusion.
Page 11: [2] Commented [A112] Author
In regards to the references to the principle of proportionality, we reiterate our longstanding position that
there is no textual basis in the ICCPR, or other international human rights conventions to which the U.S.
is a party, for asserting states have an obligation under international human rights law to apply or act in
accordance with such a principle. We note further that whether the application of other principles, such as
necessity, are required under a state’s obligations is determined by the text of the specific obligation at
issue. There is, for example, a necessity requirement under ICCPR Art 19 but there no necessity
requirement stated in ICCPR Article 17.
Page 11: [3] Commented [A113] Author
Technical - consider "neural data" or "cognitive biometric data" (as defined above" to avoid questions
about whether neurotechnology enables data or data enables neurotechnology.
Page 11: [4] Commented [A114] Author
Unclear what the “foundational values of this document” are but values and this document do not have
sufficient legal character to be “infringed.”
Page 11: [5] Commented [A115] Author
Self-Determination has a discrete legal meaning in international law related to a people's ability to self-
govern and in certain cases form a new state. Since that is not what we are talking about here, I think we
should avoid that legal term of art.
Perhaps personal autonomy or self-expression? That said, we should not frame these as rights.
Page 11: [6] Commented [A117] Author
This is a very broad statement of unclear provenance. Is there an internationally recognized right that
matches this? Further, unclear that every individual is covered by a domestic law right to cover this
assertion.
Page 11: [7] Commented [A118] Author
This may be implied by the next part of the sentence but assuming it is legal to use the technology based
on local or national laws?
Page 11: [8] Commented [A119] Author
Replacing “in Accordance” with “consistent”, as “consistent with” covers a broader scope of activity than
“in accordance with”, which would generally only cover bad acts from, or on behalf of, State actors.
Page 11: [9] Commented [A121] Author
Unclear what international standards are being highlighted here and should generally reserve this
terminology for technical standards, as noted previously.
Page 11: [10] Commented [A123] Author
Question: How does the author intend to address circumstances when the use of neurotechnology by one
individual may impact another? For example, if a person uses a neurotechnology device to hear another
person. The person who is speaking does not necessarily have the right to withdraw from the use of the
hearing aid by another person.
Page 13: [11] Commented [A134] Author
Replacing “ethical and human rights” with “values and principles” and adding additional language with
825
regards to respecting relevant legal frameworks, consistent with the AI Recommendations.
Note: To the extent this is setting forth principles, they are ethical principles not human rights principles.
that incorporate the respect, promotion and protection of human rights (see para 39). It is not setting forth
principles of human rights.
Page 13: [12] Commented [A135] Author
Updated language. Original language too closely resembles GDPR and is not appropriate in this global
context.
Page 13: [13] Commented [A136] Author
Question for authors- why does aggregation with data from other sources make these safeguards more
important? Should they not stand on their own?
Page 13: [14] Commented [A137] Author
Technical - note somewhat inconsistent use throughout of "lifecycle of neurotechnology" and "whole
lifecycle of neurotechnology."
Page 13: [15] Commented [A140] Author
Added “unlawful” because “discrimination” in the context of international humanitarian law is lawful and
obligatory (e.g. favorable discrimination for older populations)
Page 13: [16] Commented [A143] Author
See note above on inclusion of “unlawful” when referencing discrimination, which is lawful under
humanitarian law
Page 13: [17] Commented [A144] Author
Unclear why this was limited in scope to “older persons”. This principle should consider broader unlawful
discrimination against any person.
Page 13: [18] Commented [A145] Author
Note to Author: Accountability was included to define integrity in 111.1.8. Strongly recommend moving
second para-- with tracked modifications--from this section to 111.1.8 and removing 111.2.5
Page 17: [19] Commented [A162] Author
Suggest cutting this section altogether, and blending some elements (not all, as others are potentially
problematic) into the section on sustainability, noting interest to expand the scope of this section to
address SDGs vice environmental sustainability.
Notes on problematic language in this section: The benefits sharing language in paras 68 and 70 are
unclear and potentially problematic for the USG.. Does this mean that any financial or substantive
benefits from R&D would be equally given/provided to anyone who “contributed” (the meaning of that
term is also unclear)?
In the United States, the intellectual property derived from discovery belongs to the innovator, not those
who participated in the clinical trial. Inherent to collaboration are previously agreed terms for how that
intellectual property may be shared.
The United States would be supportive of making note of how the principles of open science can further
drive innovation and promote equitable access to scientific outputs.
Page 17: [20] Commented [A163R162] Author
Further noting how this is not exactly open science but moreso aligned with open innovation which was
defined in the G20 as: a distributed innovation process based on partnership, cooperation, and voluntary
knowledge flow across organizational boundaries, on mutually agreed terms. Open innovation leverages
both internal and external resources for researchers and others in the innovation ecosystem to unlock the
latent economic value of ideas and knowledge. This collaborative process highlights the importance of a
strong innovation ecosystem and innovator-led approach based on voluntary partnerships and respect for
826
intellectual property. It also includes respect for diverse cultures and human rights; the protection of
national security; and principles and rules related to academic freedom, research ethics and integrity, and
privacy and personal data. Link: G20 agree on open innovation strategy and recommendations for
diversity, equity, inclusion, and accessibility in science, technology and innovation - European
Commission
Page 17: [21] Commented [A165] Author
This sentence should be deleted as the ‘benefits’ are vague and not defined and could pose unnecessary
burdens to manufacturers and innovators.
Page 17: [22] Commented [A166] Author
Edits for clarity to frame this point more positively. There are existing ethical-legal frameworks, so we do
not want to say that there is a lack of ethical-legal frameworks.
Page 17: [23] Commented [A169] Author
Is flourishing the right word? Well-being? Improvement? Strongly encourage consistency with first para
in preamble,,….note US Edits to that.
Page 17: [24] Commented [A170] Author
This needs clarification. What collective human rights is this meant to refer? The only collective human
right otherwise potentially referred to herein is the right of self determination but, as noted, that term is not
being used in this draft consistent with its meaning as a collective right under international human rights
law.
Page 17: [25] Commented [A174] Author
Recommend deletion of sentence beginning with “Specifically.” Also noting that Coercive measures to
which a person consents should not be prohibited.
In some cases persons may consent to surveillance because it would be beneficial to them.
Page 34: [26] Commented [A268] Author
Should be a specific reference to workers’ rights here alongside reference to well-being. This could be
either “workers’ rights” “internationally recognized workers’ rights” or (more limited) “workers’ fundamental
principles and rights at work” (i.e., freedom of association and collective bargaining, no forced labor, child
labor or discrimination, promoting a safe and healthy working environment.).
Phrasing in line with the ILO Declaration on fundamental principles and rights at work (i.e., “a safe and
healthy working environment.”)
Page 34: [27] Commented [A269] Author
DOL overarching comment in this section: recommend using “workers” instead of employees since many
workplaces have both employees and subcontractors working at the same site. Governments should
encourage companies to develop and implement policies that ensure everyone working at the worksite is
aware of their rights, understand how neurotechnology is being used in the workplace, etc., not just those
that fall under the definition of “employee.”
Page 34: [28] Commented [A271] Author
These are normative points in the international level. I suspect there are relevant legal obligations at
some domestic level, but to the extent this is not confirmed for every State, we should not assert this as a
legal obligation.
Page 34: [29] Commented [A273] Author
There could be cases where mental surveillance could be beneficial, such as monitoring when an
employee is overly tired and may pose a workplace safety risk.
Page 34: [30] Commented [A274] Author
To the extent that neurotechnology may be used for job applications (e.g., to demonstrate cognitive
827
ability, decision-making, etc.), this should apply both to current workers and job seekers.
Page 34: [31] Commented [A275] Author
Technical edit: Is it implied here that this would be non-invasive forms of neurotech (e.g., that employers
would not be offering surgically implanted devices)?
Page 34: [32] Commented [A277] Author
This could be more specific to limit to the location.
DOL AI principles’ language could be adapted to highlight:
Workers' data collected, used, or created should be limited in scope and location, used only to support
legitimate business aims, and protected and handled responsibly.
828
URUGUAY
Ministerio de Relaciones Exteriores de la República Oriental del Uruguay
Dirección General para Asuntos Políticos
Dirección de Derechos Humanos y Derecho Humanitario
Inputs- draft Recommendation on the Ethics of Neurotechnology- UNESCO
Regulatory and Control Unit of Personal Data
After analyzing the document resulting from the first meeting of the GEAH called "First
draft of a recommendation on the ethics of neurotechnology" (First Version), from the
perspective of personal data protection, the following comments are made:
- It is considered essential to further develop the topic of personal data protection
throughout the entire document. In the current document it is observed that the topic is
briefly identified between points 75 to 77, being a reference only to "Mental privacy and
protection of neural data". In this sense, both in the United Nations document "Effects,
opportunities and challenges of neurotechnology in relation to the promotion and
protection of all human rights" there is greater emphasis on the matter in a more general
way that is fully shared. Along the same lines, it is also recommended to keep in mind
the recommendations of international organizations that have been expressed on the
matter, such as the case of documents issued by the Council of Europe within the
framework of Convention No. 108 and the Ibero-American Data Protection Network.
- In several parts of the document, reference is made to the consent of the owner. In this
sense, it is recommended to follow international guidelines on the characteristics of
consent (free, prior and informed). Besides, vulnerable populations must be considered,
such as consent in the case of minors, elderly people or people with disabilities, where
emphasis must be placed on the form and validity of the form in which it is collected.
- Likewise, the categories of personal data that are processed within the framework of
activities related to neurotechnologies must be considered. In particular, identify which
are sensitive data and which are biometric data in order to identify the legal framework
applicable in each case.
- It is important to indicate the need to have guarantees of protection of personal data in
the framework of medical research carried out in the matter.
829
- Regarding the use of technologies, consider that, prior to their use, it is important to
have endorsements from both health and data protection authorities to provide
guarantees regarding the use of this type of tools.
- Finally, it is recommended to link this recommendation with the recommendations
related to Artificial Intelligence given that they are linked topics that have points in
common and that are considered to be coordinated.
Ministry of Education and Culture
In reference to the "Preliminary report on the first draft of the Recommendation on the
ethics of neurotechnology", we send the following contributions:
In paragraph 136 it is proposed to incorporate the text in bold.
"Member States should approach the integration of neurotechnology in education with
caution, ensuring that its use is evidence-based and in line with educational objectives
and complements traditional learning methods. Emphasis should be placed on
promoting holistic development of students, focusing not only on academic
performance, but also on mental health, well-being and general interests. To ensure
inclusion, Member States should develop age-appropriate guidelines for the use of
neurotechnology in different areas. educational stages and styles of learning with
corresponding implementation protocols. Periodic assessments of the impact of
neurotechnology on student development, including mental health, should be conducted
and ethical review processes established to monitor its implementation. The primary
focus should be on fostering critical thinking. , creativity and emotional intelligence,
rather than just improving academic performance."
In 138, it is proposed to change "audits" to "evaluation processes"
138. Member States should establish a unified and robust oversight mechanism for the
use of neurotechnology in educational settings, incorporating periodic audits,
evaluation processes in educational centers, public and community feedback, that is
culturally appropriate and in accordance with local conventions, and strict compliance
with safety and ethical standards, including an evaluation of reversibility in the nervous
system. Continued research should be funded to evaluate the long-term psychological
and cognitive impacts of these technologies. Supervision should include periodic
reviews based on empirical evidence to adjust the use of neurotechnology as necessary,
ensuring that it serves the development of students and addresses risks such as
dependency or loss of skills. This comprehensive approach will help maintain
neurotechnology safety, effectiveness, and alignment with best practices for student
well-being and learning outcomes.
830
Faculty of Law- University of the Republic (UDELAR)
1) Need to advance specific legal regulation regarding neurorights.
2) Unify concepts in order to use clear and coherent language. Differences between
brain and neural data (define conscious, subconscious, unconscious, among other
terms).
3) The neural data to be protected should include data from the central nervous system
as well as data from the peripheral nervous system (CNS / PNS), since through the latter
brain activity can be decoded (see law on neurorights approved in California – EE
.USA).
4) The proposed regulation should have a public policy perspective.
5) Control body regarding the use of neurotechnologies (it would be necessary to define
what type of body, in what orbit it would be located, who would be its members, powers
and attributions, among others).
6) Consent (Differences between express and informed consent).
7) Pay special attention to the privacy policies of neurotechnology companies. The
emphasis should be placed on these, since it is not desirable for the responsibility to fall
solely on the user. Companies should have a greater responsibility based on an ethical
procedure in the development and use of these neurotechnological devices, assuming
unequivocal responsibility before, during and after their useful life.
8) Sensitive or ultra-sensitive data?
9) Judicial measures: quick access route in this type of cases. One possibility would be
to establish a specific judicial process based on the amparo action procedure provided
for in Law No. 16,011.
10) In the workplace, the asymmetric relationship between employer and worker should
be kept in mind when imposing the use of certain devices, as well as the processing that
may be carried out on the data obtained. Another aspect to consider is adolescent work
in our country, therefore, it would be necessary to address the type of authorization
required for the use of certain technological devices, while determining the type of
consent required in these cases.
Ministry of Social Development- National Secretariat of Care and Disability
831
In point 5 or where it refers to patients with severe disabilities, it is advisable to clarify
what the risks are. We suggest including the risk posed by the International Disability
Alliance: "It is crucial to challenge ableism within its development and implementation.
Ableism is a discriminatory ideology that favors able-bodied norms, perpetuates
stereotypes, and devalues individuals with disabilities. It is essential to ensure that the
development and utilization of neurotechnology prioritize the needs, preferences, and
rights of persons with disabilities, rather than reinforcing existing ableist paradigms.
This entails involving individuals with disabilities in the design process, promoting
accessibility, and avoiding stigmatization or objectification. Related to the above point,
neurotechnology should not be solely driven by the goal of enhancing human
capabilities, and must be put in the context of understanding and respecting diversity as
per the Convention on the Rights of Persons with Disabilities. Pressuring individuals to
pursue enhancement interventions risks perpetuating ableism and undermining the right
to mental integrity.”
In point 11 it is important to point out "The challenges that arise from the constitution
of this Ethical Committee solely integrated by experts from the bioethics and medical
fields. There is a need to think carefully about what is counted as 'expertise',
recognizing the priority that “should be given to lived experience from a human rights-
based approach. This Committee must consult and include people with disabilities in
their work.”
Comments on the text of the Recommendation
PP 4
Add “integrity”
Paragraph 4
Add a point c) that expresses “takes into account the opinion and experience of different
groups of the population (people with disabilities, among others)”
Paragraph 19 a)
Replace “cultural” with “human”
Paragraph 23
Here we subscribe to what IDA points out that "Avoid pressuring individuals to pursue
enhancement interventions risks perpetuating ableism and undermining the right to
mental integrity".
832
Paragraph 30
It is suggested to add “stigmatize”
Paragraph 39
In point 39 on informed consent it is necessary to include that "Informed consent is the
cornerstone of ethical neurotechnological interventions. Persons with disabilities should
have access to comprehensive information about potential risks, benefits, and
alternatives. The consent process should be accessible, accommodating diverse
communication needs and ensuring that individuals understand the implications of their
choices." This is taken from the IDA document and Uruguay subscribes and would like
to see it reflected in the document.
Paragraph 46
Consider accessible formats (easy reading, sign language, among others)
Paragraph 56
Add “or people with disabilities” at the end
Paragraph 115
This paragraph (115) is poorly expressed. The barriers are not in people but in society,
therefore "neurotechnology" could not eliminate the barriers faced by people with
physical disabilities. We do not understand what is meant by "accessibility evaluations"
of products so that " do not perpetuate disabilities." This language is not appropriate.
Member States should adopt policies that harness the potential of neurotechnology so
that people with disabilities can exercise their human rights on equal terms. They should
apply regulatory frameworks that ensure the participation and consultation of people
with disabilities in the development of neurotechnology products that prioritize their
needs, preferences and rights and that do not reinforce ableist attitudes. It is essential to
ensure that the development and utilization of neurotechnology prioritize the needs,
preferences, and rights of persons with disabilities, rather than reinforcing existing
ableist paradigms. This entails involving individuals with disabilities in the design
process, promoting accessibility, and avoiding stigmatization or objectification.
Paragraph 146
Add “and integrity” between “health” and “employee”.
833
Ministerio de Relaciones Exteriores de la República Oriental del Uruguay
Dirección General para Asuntos Políticos
Dirección de Derechos Humanos y Derecho Humanitario
Insumos- proyecto de Recomendación sobre la Ética de la Neurotecnología-
UNESCO
Unidad Reguladora y de Control de Datos Personales
Analizado el documento resultante de la primera reunión del GEAH denominado
"Primer borrador de una recomendación sobre la ética de la neurotecnología" (Primera
Versión), desde la perspectiva de la protección de datos personales se realizan los
siguientes comentarios:
- Se considera esencial realizar un mayor desarrollo del tema protección de datos
personales a lo largo de todo el documento. En el documento actual se observa que
actualmente el tema está identificado en forma breve entre los puntos 75 a 77 siendo
una referencia solamente a la "Privacidad mental y protección de datos neuronales". En
ese sentido, tanto en el documento de Naciones Unidas "Efectos, oportunidades y
retos de la neurotecnología en relación con la promoción y la protección de todos los
derechos humanos" se hace mayor hincapié en la materia en una forma más general que
se comparte plenamente. En la misma línea, también se recomienda tener presente las
recomendaciones de los organismos internacionales que se han expresado en la materia,
como por ej. el caso de los documentos emitidos por el Consejo de Europa en el marco
del Convenio N° 108 y de la Red Iberoamericana de Protección de Datos.
- En varias partes del documento, se hace referencia al consentimiento del titular. En ese
sentido, se recomienda seguir las pautas internacioanles sobre las características del
consentimiento (libre, previo e informado). Además. se debe considerar las poblaciones
vulnerables como ser el consentimiento en caso de menores de edad, personas mayores
o personas con discapacidad en donde se debe hacer hincapie en la forma y válidez en
forma en que se recaba.
- Asimismo, se debe considerar la categorías de datos personales que se tratan en el
marco de actividades relacionadas con las neurotecnologías. En especial, identificar
cuáles son datos sensibles y cuáles datos biométricos a los efectos de poder identificar
el marco jurídico aplicable en cada caso.
- Es importante indicar la necesidad de contar con garantías de protección de datos
personales en el marco de las investigaciones médicas que se desarrollen en la materia.
834
- En cuanto al uso de tecnologías considerar que, previa a su utilización, es importante
contar con avales de las autoridades tanto sanitarias como de protección de datos para
brindar garantías ante el uso de este tipo de herramientas.
- Por último, se recomienda vincular esta recomendación con las recomendaciones
relacionadas con Inteligencia Artificial dado que son temas vinculados que tienen
puntos en común y que se considera deben estar coordinados.
Ministerio de Educación y Cultura
En referencia al "Informe prelimiar sobre el primer borrador de la Recomendación
sobre la ética de la neurotecnología", enviamos los siguientes aportes:
En el parrafo 136 se propone incorporar el texto en negrita.
"Los Estados Miembros deberían abordar con cautela la integración de la
neurotecnología en la educación, asegurándose de que su uso esté basado en
evidencias y en consonancia con los objetivos educativos y complemente los métodos
tradicionales de aprendizaje. Se debería hacer hincapié en promover el desarrollo
integral de los estudiantes, centrándose no solo en el rendimiento académico, sino
también en la salud mental, el bienestar y los intereses generales. Para garantizar la
inclusión, los Estados Miembros deberían elaborar directrices adecuadas a la edad
para el uso de la neurotecnología en las diferentes etapas educativas y estilos de
aprendizaje con sus correspondientes protocolos de aplicación. Se deberían realizar
evaluaciones periódicas del impacto de la neurotecnología en el desarrollo de los
estudiantes, incluida la salud mental, y establecer procesos de revisión ética para
supervisar su implementación. El enfoque principal debería ser fomentar el
pensamiento crítico, la creatividad y la inteligencia emocional, en lugar de solo
mejorar el rendimiento académico."
En el 138, se propone cambiar "auditorías" por " procesos de evalauación"
138. Los Estados Miembros deberían establecer un mecanismo de supervisión unificado
y sólido y para el uso de la neurotecnología en entornos educativos, que
incorpore auditorías procesos de evaluación periódicos en los centros educativos,
retroalimentación pública y comunitaria, que sea culturalmente apropiada y de acuerdo
con las convenciones locales, y un estricto cumplimiento de las normas de seguridad y
éticas, incluida una evaluación de la reversibilidad en el sistema nervioso. Se debe
financiar una investigación continua para evaluar los impactos psicológicos y cognitivos
a largo plazo de estas tecnologías. La supervisión debe incluir revisiones periódicas
basadas en evidencia empírica para ajustar el uso de la neurotecnología según sea
necesario, asegurando que sirva al desarrollo de los estudiantes y aborde riesgos como
la dependencia o la pérdida de habilidades. Este enfoque integral ayudará a mantener la
seguridad, la eficacia y la alineación de la neurotecnología con las mejores prácticas
para el bienestar de los estudiantes y los resultados de aprendizaje.
835
Facultad de Derecho- UDELAR
1) Necesidad de avanzar en una regulación jurídica específica en materia de
neuroderechos.
2) Unificar conceptos a efectos de utilizar un lenguaje claro y coherente.
Diferencias entre datos cerebrales y neuronales (definir consciente,
subconsciente, inconsciente, entre otros términos).
3) Los datos neuronales a proteger deberían incluir los datos del sistema
nervioso central como los datos del sistema nervioso periférico (SNC / SNP), ya
que a través de estos últimos se puede decodificar actividad cerebral (ver ley
sobre neuroderechos aprobada en California – EE.UU.).
4) La regulación que se proponga debería tener una perspectiva de política
pública.
5) Organismo de contralor en materia de uso de neurotecnologías (habría
que definir qué tipo de organismo, en qué orbita se ubicaría, quienes serían sus
integrantes, competencias y atribuciones, entre otras).
6) Consentimiento (Diferencias entre consentimiento expreso e informado).
7) Prestar especial atención a las políticas de privacidad de las empresas
neurotecnológicas. El énfasis debería colocarse en éstas, ya que no es deseable
que la responsabilidad recaiga únicamente en el usuario. Las empresas deberían
tener una responsabilidad mayor basado en un proceder ético en el desarrollo y
utilización de dichos dispositivos neurotecnológicos, asumiendo una inequívoca
responsabilidad antes, durante y después de la vida útil de los mismos.
8) Datos sensibles ¿o ultrasensibles?
9) Medidas judiciales: vía de acceso rápido en este tipo de casos. Una
posibilidad sería establecer un proceso judicial específico tomando como base el
procedimiento de la acción de amparo previsto en la Ley Nº 16.011.
10) En el ámbito laboral debería tenerse presente la relación de asimetría
entre empleador y trabajador a la hora de imponer el uso de determinados
dispositivos, así como también, el tratamiento que de los datos obtenidos se
pueda realizar. Otro aspecto a considerar es el trabajo adolescente en nuestro
país, con lo cual, sería necesario atender al tipo de autorización requerida para el
uso de determinados dispositivos tecnológicos, al tiempo que determinar el tipo
de consentimiento requerido en estos casos.
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SECRETARÍA NACIONAL DE CUIDADOS Y DISCAPACIDAD- Ministerio de
Desarrollo Social
Comentarios sobre el Informe Preliminar
En el punto 5 o donde se refiere a pacientes con discapacidades graves es conveniente
aclarar cuáles son los riesgos. Sugerimos incluir el riesgo que plantea la International
Disability Alliance: "It is crucial to challenge ableism within its development and
implementation. Ableism is a discriminatory ideology that favors able-bodied norms,
perpetuates stereotypes, and devalues individuals with disabilities. It is essential to
ensure that the development and utilization of neurotechnology prioritize the needs,
preferences, and rights of persons with disabilities, rather than reinforcing existing
ableist paradigms. This entails involving individuals with disabilities in the design
process, promoting accessibility, and avoiding stigmatization or objectification. Related
to the above point, neurotechnology should not be solely driven by the goal of
enhancing human capabilities, and must be put in the context of understanding and
respecting diversity as per the Convention on the Rights of Persons with Disabilities.
Pressuring individuals to pursue enhancement interventions risks perpetuating ableism
and undermining the right to mental integrity.”
En el punto 11 es importante señalar "The challenges that arise from the constitution of
this Ethical Committee solely integrated by experts from the bioethics and medical
fields. There is a need to think carefully about what is counted as ‘expertise’,
recognising the priority that should be given to lived experience from a human rights-
based approach. This Committee must consult and include persons with disabilities in
their work.”
Comentarios sobre el texto de la Recomendación
PP 4
Añadir “la integridad”
Párrafo 4
Añadir un punto c) que exprese “tiene en cuenta la opinión y la experiencia vivida por
diferentes grupos de la población (personas con discapacidad, entre otros)”
Párrafo 19 a)
Sustituir “cultural” por “humana”
Párrafo 23
Aquí suscribimos lo que señala IDA de que "Se debe evitar presionar a los individuos a
perseguir intervenciones que procuren mejorar sus capacidades, ya que esto puede
perpetuar el capacitismo y afectar el derecho a la integridad mental" o en inglés "Avoid
837
pressuring individuals to pursue enhancement interventions risks perpetuating ableism
and undermining the right to mental integrity".
Párrafo 30
Se sugiere añadir “estigmaticen”
Párrafo 39
En el punto 39 sobre el consentimiento informado es necesario incluir que "Informed
consent is the cornerstone of ethical neurotechnological interventions. Persons with
disabilities should have access to comprehensive information about potential risks,
benefits, and alternatives. The consent process should be accessible, accommodating
diverse communication needs and ensuring that individuals understand the implications
of their choices." Esto está tomado del documento de IDA y Uruguay suscribe y
quisiera verlo reflejado en el documento.
Párrafo 46
Contemplar formatos accesibles (lectura fácil, lenguaje de signos, entre otros)
Párrafo 56
Añadir al final “o las personas con discapacidad”
Párrafo 115
Este párrafo (115) está mal expresado. Las barreras no están en las personas sino en la
sociedad por lo tanto la "neurotecnología" no podría eliminar las barreras que enfrentan
las personas con discapacidad física". No entendemos a qué se refiere con "evaluaciones
de acesibilidad" de los productos para que "no perpetúen discapacidades". Este lenguaje
no es adecuado.
Los Estados Miembros deberían adoptar políticas que aprovechen el potencial de la
neurotecnología para que las personas con discapacidad puedan ejercer sus derechos
humanos en igualdad de condiciones. Deberían aplicar marcos reglamentarios que
aseguren la participación y consulta de las personas con discapacidad en el desarrollo de
productos de neurotecnología que prioricen sus necesidades, preferencias y sus derechos
y que no refuercen actitudes capacitistas It is essential to ensure that the development
and utilization of neurotechnology prioritize the needs, preferences, and rights of
persons with disabilities, rather than reinforcing existing ableist paradigms. This
entails involving individuals with disabilities in the design process, promoting
accessibility, and avoiding stigmatization or objectification.
Párrafo 146
Añadir “e integridad” entre “salud” y “de los empleados”.
838
HOLY SEE/SAINT-SIÈGE
Holy See’s Comments and Observations
First draft of the Recommendation on the ethics of neurotechnology of UNESCO
Premise
The document is of great importance since the issue of neurotechnology has not yet received due
consideration, especially from an ethical and legal point of view. In the present debate, more attention
is paid to artificial intelligence (AI), without adequate awareness of the convergence between AI and
neuroscience and neurotechnology.
The text rightly urges states to implement policies that would provide a comprehensive regulatory
framework regarding neurotechnology, highlighting the importance of adequately including ethical
dimensions. The process of regulation is difficult for several reasons, including: the complexity of
neurotechnologies, the convergence of various technologies, the breadth of application and the speed
of development of these technologies. All of this is to be considered within the context of ethical
pluralism, where moral standards and ethical norms are not recognized or interpreted in a universal
manner.
Several aspects of the document are most welcome, including its aim, which is focused on ensuring
that the concrete application of technologies is at the service of human beings and humanity as a
whole. The document also takes an important and clear stance regarding the commercialization of
neurotechnologies: economic concerns should never take priority over investments in favour of the
good health and well-being of all human beings, with special protection provided to those in
vulnerable situations. Of considerable interest are the lines for applications in the educational, labour
and commercial fields.
The following elements should be considered in this consultation phase, for possible revision.
General comments
1. The scope of the document is not evident. It is not clear which neurotechnologies are being
considered. Less technical language is recommended (since the document is aimed at politicians and
citizens), with also a glossary for the explanation of technical terms. In particular, the risks of damage
must be better described, with reference to the invasiveness and potential irreversibility of the
interventions.
2. The document lacks systematic coherence: many themes are taken up in different sections, often
with repetitions that do not facilitate reading.
3. There is a lack of an anthropological foundation for ethical reflection. The document mentions
'inherent' human dignity, it would be preferable 'intrinsic', an adjective that better highlights that
dignity is proper to every human being and therefore to all human beings. Often the theme 'human
dignity' is inserted after 'fundamental freedoms', but it should be mentioned earlier, as it is dignity
that anthropologically founds freedom and the ability to exercise freedom. Indeed, if human dignity
is not respected, it is not possible to be free. Paragraph 20 is fully acceptable, but it is not always
consistently applied within the document.
4. Furthermore, without an adequate anthropological foundation, the concept of human rights risks
being reduced to a positivistic norm, which is determined and bestowed by the legal authority. From
839
such a perspective, rather than being inalienable and intrinsic to all human beings, human rights
become a sort of “privilege” which is granted to them by States or other authorities. On the contrary,
human rights are not granted to anyone, but are rather acknowledged to everyone, as a result of our
personal and universal human dignity, without any sort of discrimination. The purpose of legal
recognition at the international, national and local levels has as its scope the appropriate promotion
and protection of human dignity.
5. Integrity is mentioned several times in the text, with specific reference to the integrity of scientific
research and the integrity of the body. While welcoming these affirmations, it is important not to
overlook integrity of mind or mental integrity, which is particularly relevant considering the
invasiveness of technologies. Indeed, neurotechnologies may alter personal perceptions and
continuity in time, and adequate attention must be placed on mental integrity.
6. On self-determination. The term 'autonomy' would be preferable to 'self-determination': as self-
determination is part of an individualistic theory, while the concept of autonomy also has a relational
meaning, i.e. with reference to others (cfr. title of III.2.2; para 45; para 47, para. 66; etc.)
7. The topic of human enhancement is addressed only briefly, in a short paragraph, but it should be
better developed in the text. Indeed, this aspect is one of the most significant challenges for human
beings and society. It is a question not of medical therapy, but rather of neurotechnological
interventions on healthy individuals to increase/enhance physical, mental, emotional, and moral
capacities. The theme of enhancement is treated only with reference to the theme of equity and justice,
but it should also be treated with reference to inter alia: i) human dignity, since enhancing one’s
capacity implies a rejection of the limits of human nature; ii) bodily and mental integrity, since the
body and mind are exposed to invasive and potentially irreversible risks for a non-therapeutic benefit;
iii) autonomy/independency, since the competitive nature of society could pressure a subject to make
a choice that he or she would not otherwise want. It should also be said that while some of these
technologies may already be in use, insufficient testing has been conducted to ensure the safety and
efficacy of those interventions. Additionally, there are potential ethical problems raised by the testing
process itself. Indeed, recruited healthy volunteer subjects and submitting them to processes whose
risks are unknown would contrast with the researcher's deontological duty of proportionality in
balancing benefits and risks.
Observations on the document
PREAMBLE
PP1: ‘recognizing the profound and dynamic impacts of neurotechnology on human mind’. It is
important to recognize the impact not only on the mind, but also on the body. It would be better to
say ‘on human beings’.
PP4: ‘also considering that neurotechnology raises fundamental ethical issues for instance regarding
self-determination…)’. Human dignity should be put as the first ethical issue in this list, since it is
the foundation for the other anthropological and ethical issues that arise. Also, it is preferable to use
autonomy/independence, instead of self-determination, as noted in the general comments.
III.1 VALUES
III.1.1: ‘Respect promotion of human rights, fundamental freedom and human dignity’: for the
reasons mentioned above, it is preferable to place “human dignity” as the first aspect in this list.
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Para. 21: In describing health as a “holistic state”, the draft mentions physical, mental and social well-
being. It would be appropriate to also include “spiritual” well-being in that list.
Para. 23: the term ‘neurodiversity’ does not have a clear and accepted meaning and should be
removed.
Para. 24: the meaning of ‘technological colonialism’ should be further clarified.
Para. 25: the meaning of ‘segments’ in this context should be clarified.
Para. 26: while the paragraph affirms the freedom of individuals and groups to choose their own
lifestyle, express beliefs and opinions, it could be interpreted in the sense of an absolute subjectivism.
Para. 28: the meaning of ‘epistemic contributions’ should be clarified.
III.2 ETHICAL PRINCIPLES AND HUMAN RIGHTS
Para. 39: ‘This Recommendation embraces a human-centred approach, through fundamental ethical
principles including but not limited to self-determination, agency…’. For the reasons mentioned
above, “human dignity” should be placed at the beginning of this list. It would be preferable to include
“integrity” (physical, mental and social) as one of the ethical principles listed here.
Para. 42: as mentioned above, on the issue of enhancement, additional factors should be taken into
account. At a minimum, the lack of clinical trials, and the consequent uncertainty regarding the safety
and effectiveness of interventions, should be mentioned.
III.2.7: ‘Epistemic justice’ should be explained and clarified (§§ 61-65).
Para. 66: “self-determination” should be avoided and replaced instead with “autonomy”. Moreover,
“as they grow into autonomous individuals” should be replaced with “as they grow into responsible
individuals”.
IV. AREAS OF POLICY ACTIONS
IV.1 GOVERNMENT INVESTMENT, USE AND REGULATION
Para. 73: “[…] This commitment should include funding for interdisciplinary research that not only
advances neurotechnological innovation but also studies the ethical, legal, social, environmental and
cultural implications of these technologies […]”. It would be appropriate to include “psychological”
implications in the list on interdisciplinarity.
Para. 74: the reference to “gender identity or sexual orientation” in this context does not seem
warranted or appropriate.
Para. 77: “[…] This requires respect for fundamental rights, such as human dignity, bodily integrity
[…]”. For the reasons mentioned in PP4, “human dignity” should be put as the first ethical issue in
this list, since it is the foundation of fundamental human rights. Moreover, it would be appropriate to
add a reference here to mental integrity as well.
Para. 78: “[…] These incentives should prioritize rewarding transparency, participatory development
processes, and contributions to societal benefits, aiming to foster an environment where public
institutions and companies innovate responsibly [add: and ethically] and align with human
flourishing goals”.
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Para. 79: the benefit/risk assessment should be prioritized over the economic assessment; it would
therefore be preferable to have §79b placed before §79a.
Para. 79(b): It would be advisable to mention oversight of ethical considerations; the paragraph could
therefore benefit from a reference to ethics committees.
IV.5 COMMUNICATION, PARTICIPATION AND INFORMATION
Para. 102: with regard to education, reference should be made for the need to provide educators with
the appropriate formation, the resources to ‘educate educators’. Additionally, scientists and
journalists need to be mutually informed so as to communicate accurate scientific data in a way that
is understandable to society as a whole. This is important so as to avoid hype, polemics and fear-
mongering, which provoke irrational emotional responses which are not based in fact.
IV.6 CHILDREN AND ADOLESCENTS
Para 104: it would be more appropriate to replace “pay attention to the autonomy of children and
adolescents through informed consent and assent that is adapted to and respectful of age and decision-
making capacity” with “pay attention to the importance of educating children and adolescents to
personal judgement and critical thinking so as to develop their decision-making capacity in a way
that is adapted to and respectful of age”.
IV.7 OLDER PERSONS
Para. 110: It would be more appropriate to replace “promote autonomous decision-making for older
people” with “promote older people’s autonomy”.
Para. 111: concerning the reference of ‘human care’, the need for empathy and the value of
interpersonal interaction should be emphasized.
IV.8 WOMEN AND GENDER the title is redundant. Women should be the title of the paragraph
or it could be replaced with “WOMEN AND GIRLS”.
Para 112: “gender diversity” is ambiguous and undefined. “Promote and respect gender equality and
diversity” should be replaced with “promote and respect gender equality”.
For better clarity, “addressing women and gender specific needs and differences” should be replaced
with “addressing women specific needs”.
For better clarity, “women and gender health expert and advocacy groups” should be replaced with
“women health experts”.
“women and gender minorities” should be replaced with “women and girls”.
Para 113: “women and gender minorities” should be replaced with “women and girls”.
Para 114: “women’s and gender minorities’ participation” should be replaced with “women’s and
girls’ participation”.
The two other occurrences of “women and gender minorities” should be replaced with “women and
girls”.
IV.12 RESEARCH ETHICS
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Para. 128: with regard to the recommendation for ethics boards, reference should be made of the need
for qualified experts, selected with reference to their specialized competencies (in scientific, ethical
and legal fields), while avoiding conflicts of interests.
Para. 134: the meaning of ‘actionable incidental findings’ should be clarified. The paragraph should
also specify that, if the participant in a study is a minor, the obligation to report findings also must be
applied with regard to the parents/caregivers of the participant.
IV.13 EDUCATIONAL SETTINGS
Para. 136: to avoid confusion, ‘enhancing academic performance’ could be replaced with ‘promoting
academic performance’, so as not to give the impression of legitimizing “enhancement” technologies
in the educational field.
IV.16 ENHANCEMENT
Para. 157: the question of neurotechnological enhancement should take other considerations into
account, as mentioned above (cf. General comment n. 7).
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