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Contents

Part I Biobanks, Tissue Research and the Public

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Christian Lenk, Judit Sándor, and Bert Gordijn
2 Public Trust and Public Bodies: The Regulation of the Use
of Human Tissue for Research in the United Kingdom . . . . . . . 17
Julie Kent and Ruud ter Meulen
3 Biobanks and Research: Scientific Potential
and Regulatory Challenge . . . . . . . . . . . . . . . . . . . . . . 37
Bernice S. Elger and Nikola Biller-Andorno
4 A Sense of Entitlement: Individual vs. Public Interest
in Human Tissue . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Nils Hoppe
5 Social Aspects of Biobanking: Beyond the Public/Private
Distinction and Inside the Relationship Between the Body
and Identity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Federico Neresini

Part II The Rights of Donors and Patients

6 One Sample, One Share! A Proposal to Redress
an Inequity with Equity . . . . . . . . . . . . . . . . . . . . . . . . 81
Jasper Adriaan Bovenberg
7 Research on Human Biological Materials: What Consent
Is Needed, and When . . . . . . . . . . . . . . . . . . . . . . . . . 95
Eugenijus Gefenas, Vilius Dranseika, Asta Cekanauskaite,
and Jurate Serepkaite
8 Reconsidering Consent and Biobanking . . . . . . . . . . . . . . . 111
Emma Bullock and Heather Widdows

v
vi Contents

9 What’s Wrong with Forensic Uses of Biobanks? . . . . . . . . . . 127

Claudio Tamburrini

Part III Regulation of Tissue Research

10 A Unified European Approach on Tissue Research
and Biobanking? A Comparison . . . . . . . . . . . . . . . . . . . 143
Katharina Beier and Christian Lenk
11 Ireland and the United Kingdom’s Approaches
to Regulation of Research Involving Human Tissue . . . . . . . . 165
Elizabeth Yuko, Adam McAuley, and Bert Gordijn
12 Legal and Ethical Aspects of Biobanks for Research
in the European-Mediterranean Area . . . . . . . . . . . . . . . . 185
Renzo Pegoraro, Alessandra Bernardi, and Fabrizio Turoldo
13 The Circulation of Human Body Parts and Products:
When Exclusive Property Rights Mask the Issue of Access . . . . 201
Florence Bellivier and Christine Noiville
14 Anonymity and Privacy in Biobanking . . . . . . . . . . . . . . . 213
Judit Sándor and Petra Bárd
Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Contributors

Petra Bárd Center for Ethics and Law in Biomedicine, Budapest, Hungary,
[email protected]
Katharina Beier Department of Ethics and History of Medicine, University of
Göttingen, Göttingen, Germany, [email protected]
Florence Bellivier University Paris Ouest Nanterre la Défense, Paris, France,
[email protected]
Alessandra Bernardi Istituto Oncologico Veneto-IRCCS, Via Gattamelata,
64-35128, Padova, Italy, [email protected]
Nikola Biller-Andorno Institute of Biomedical Ethics, University of Zurich,
Zurich, Switzerland, [email protected]
Jasper Adriaan Bovenberg Legal Pathways Institute for Health and Biolaw,
Aerdenhout, The Netherlands, [email protected]
Emma Bullock Department of Philosophy, University of Birmingham,
Birmingham, England, [email protected]
Asta Cekanauskaite Department of Medical History and Ethics, Vilnius
University, Vilnius, Lithuania, [email protected]
Vilius Dranseika Department of Medical History and Ethics, Vilnius University,
Vilnius, Lithuania, [email protected]
Bernice S. Elger Center for Legal Medicine, University of Geneva, Geneva,
Switzerland, [email protected]
Eugenijus Gefenas Department of Medical History and Ethics, Vilnius
University, Vilnius, Lithuania, [email protected]
Bert Gordijn Institute of Ethics, Dublin City University, Dublin, Ireland,
[email protected]

vii
viii Contributors

Nils Hoppe Institute for Philosophy, CELLS – Centre for Ethics

and Law in the Life Sciences, Leibniz Universitaet, Hannover, Germany,
[email protected]
Julie Kent Department of Health and Applied Social Science, Faculty of Health
and Life Sciences, University of the West of England, Bristol, UK,
[email protected]
Christian Lenk Department of Ethics and History of Medicine, University of
Göttingen, 37073 Göttingen, Germany, [email protected]
Adam McAuley School of Law and Government, Dublin City University, Dublin,
Ireland, [email protected]
Federico Neresini PaSTIS Research Unit, Department of Sociology, University
of Padua, Italy, [email protected]
Christine Noiville University Paris 1 Panthéon – Sorbonne, UMR 8103, President
of the CEES (Socio-Ethico-Economical Committee) of the HCB (High Council of
Biotechnologies), Paris, France, [email protected]
Renzo Pegoraro Fondazione Lanza, Via Dante, 55-35139, Padova, Italy,
[email protected]
Judit Sándor Central European University, 1051 Budapest, Hungary,
[email protected]
Jurate Serepkaite Department of Medical History and Ethics, Vilnius University,
Vilnius, Lithuania, [email protected]
Claudio Tamburrini Centre for Healthcare Ethics, Stockholm University,
Stockholm, Sweden, [email protected]
Ruud ter Meulen School of Social and Community Medicine, Centre for Ethics
in Medicine, University of Bristol, Bristol, UK, [email protected]
Fabrizio Turoldo Fondazione Lanza, Via Dante, 55-35139, Padova, Italy,
[email protected]
Heather Widdows Department of Philosophy, University of Birmingham,
Birmingham, England, [email protected]
Elizabeth Yuko Institute of Ethics, Dublin City University, Dublin, Ireland,
[email protected]
 Part I
Biobanks, Tissue Research and the Public
Chapter 1
Introduction

Christian Lenk, Judit Sándor, and Bert Gordijn

1.1 Tissue Collections and Public Trust

The procurement and storage of human tissue and body parts has a long tradition
in human history. The development of Western science – especially anatomy – was
based, among other prerequisites, on the collection of human corpses and their parts.
Similarly, a long-standing Western religious tradition involved retaining the remains
of saints and holy objects for religious practices. Although the Enlightenment led to
a kind of alienation of the public with regard to such habits and practices for reli-
gious purposes, our contemporary museums are full of human remains which were
collected for scientific demonstration, curiosity, or both. For example, there was a
discussion in Germany in 2010 as to whether two heads of Maori warriors could be
shown in public (in an anthropological collection) or should be given back to the
people of New Zealand. The German Hygiene Museum in Dresden has the com-
plete and well-prepared body of a Lilliputian on exhibition, with unknown scientific
value. And finally, thousands of spectators in Europe visited the Body Worlds exhi-
bition of Gunther von Hagens. Beneath this open public fascination with the secrets
of the human body in its various forms, institutions of medical therapy and research
routinely store thousands of samples each day. In particular, the organ retention
scandals in Ireland and the United Kingdom revealed that storing tissues and body
parts was often done without the consent or even the knowledge of the concerned
persons or their relatives in the past.
Although extensive tissue collections were built up in the past – for example in
pathology institutes – this did not cause much ethical or legal discussion, most likely
because of the diagnostic and therapeutic context. However, the situation obviously
changed some years ago with the introduction of genetic analysis in tissue research
and the new methodology of biobanks (i.e., the systematic and large-scale collec-
tion of body material for genetic analysis and linkage with personal health data)

C. Lenk (B)
Department of Ethics and History of Medicine, University of Göttingen,
37073 Göttingen, Germany
e-mail: [email protected]

C. Lenk et al. (eds.), Biobanks and Tissue Research, The International Library 3
of Ethics, Law and Technology 8, DOI 10.1007/978-94-007-1673-5_1,

C Springer Science+Business Media B.V. 2011
4 C. Lenk et al.

as well as genome-wide association studies. Tissue research as such is usually not

invasive, when, for example, tissue which was already taken in the course of biop-
sies or other surgical interventions can be used for research purposes. Therefore, the
existing risks of tissue research clearly do not fall under the category of physical
harm. Rather, the crucial point seems to be the linking of private data on lifestyle
with the outcomes of large-scale genetic studies; namely, the genetic testing of large
groups of donors which are not necessarily patients. Such an expansion of genetic
research and knowledge regarding genetic dispositions is obviously a new feature of
research, while the social impact of those new methods is still unclear. The previous
collection of “person-related” data was sparse, selective and isolated. This situation
is changing at present in many areas such as the World Wide Web and social or
economical activities, as well as in medical research.
Thus, a future scenario is emerging in which there is always existing data stored
on every citizen in many areas of life (i.e. social life, social contacts, financial sit-
uations, professional backgrounds, living and working conditions, health, and also
the genetic outfit) by public or private players. If a person or institution had the
opportunity to combine and use this data altogether, fundamentally new dimensions
of knowledge about a person or a larger group of people might well occur. The shift
towards this potential scenario will therefore challenge our existing ideas of privacy
and the normal situation of relative anonymity that most of us experience in public,
and in turn, is likely to alter these ideas and perceptions dramatically. Astonishingly,
the citizens themselves often reveal their data – step by step – to the public with
some unintended side effects. Such behaviour is contradictory to known principles
of data protection, such as the principle of “data austerity”. The idea behind this
principle is that data which will not be stored can also not be misused. Therefore,
the default position should be that data should only be stored in cases with a defi-
nite and reasonable purpose which is accepted by the concerned person. However,
today’s techniques – such as automatic data storage in the context of internet usage
or marketing practices – aim to circumvent this principle.
It is a fundamental principle of the EU Data Protection Directive that a person
should have control over his or her personal data (cf. the Directive’s Art. (12)).
Some countries have had bad experiences with data collection (e.g. Germany) or
lack of provisions made for data protection (e.g. the UK). Most likely resulting from
the problematic experiences in Germany under totalitarian rule, there was an acri-
monious debate about the accomplishment of a population census in the 1980s. It
resulted in a landmark decision of the German Federal Constitutional Court1 which
was subsequently very influential for all matters of data protection in Germany.
One newly-developed principle of data protection from this decision was a right to
informational self-determination. From the ethical perspective, such a right can be
interpreted as a part of a broader and more general right to self-determination, which
today is usually seen as one of the most fundamental human rights.

1 The so-called “Volkszählungsurteil”: Urteil vom 15. Dezember 1983 (BVerfGE 65, 1). Available
at: http://zensus2011.de/fileadmin/material/pdf/gesetze/volkszaehlungsurteil_1983.pdf (accessed
17 March 2011).
1 Introduction 5

In 2007, it caused a government crisis in the UK, when two unencrypted CDs
with 25 million personal records from the UK Department for Revenue and Customs
(HMRC) got lost in the post. The CDs contained “the names, addresses and bank
details of 9.5 million adults and the names, dates of birth and National Insurance
numbers of all 15.5 million children in the country.”2 Due to such experiences, it
is a central goal of genetic research with human tissue and biobanking to estab-
lish a system of data protection that is as safe as possible. This task is especially
important in the case of vulnerable patient groups like children, HIV patients or
schizophrenic patients who have been systematically involved in recent biobank
projects. However, securing data protection in this kind of project is not an easy
task because there are often scientific requirements stipulating that the data input and
data output should be possible from a huge number of partner institutions (for exam-
ple, general practitioners are responsible to feed data from their patients directly
into a central database; or, international research groups can gain access to data of a
national biobank). Therefore, data protection in the area of human tissue research is
a very important, complex, difficult and sensitive issue.
Thus the question of trust comes into the discussion about tissue research and
biobanks. Indeed, a considerable number of publications examine this issue. The
individual must be able to trust public and other research institutions that infor-
mation disclosed for scientific purposes will not be misused or abused for other
purposes; for example, that scientific activities will not lead to single persons or
groups of patients or donors being disadvantaged or socially stigmatised. These
concerns were also explicitly considered in the EU Convention on Human Rights
and Biomedicine and the EU Data Protection Directive.3 However, a current study
out of Germany shows that concerns over genetic discrimination are not unwar-
ranted.4 Therefore, it is obviously not only in the interest of patients and donors,
but also of researchers and research institutions, that strict confidentiality in this
area of research is ensured. From a socio-economical perspective, trust means that
an interpersonal transaction can take place without further negotiations and work,
and therefore without additional “transaction costs”. Hence, trust is clearly a neces-
sary precondition of projects which need a huge amount of such transactions, such
as biobank projects. On the other hand, the distrust of the public in such projects
would be an eliminating criterion for their further work. All parties therefore have
an interest to find arrangements that will facilitate donor confidence in research.

2 G. Rayner, Ch. Hope, and A. Porter, “Ministers ‘ignored data security warnings’,” The Telegraph,
November 22, 2007, accessed October 21, 2010, http://www.Telegraph.co.uk.
3 EU Convention on Human Rights and Biomedicine, 4. IV. 1997, Art. 11 – Non-discrimination:
“Any form of discrimination against a person on grounds of his or her genetic heritage is pro-
hibited.” EU Data Protection Directive (95/46/EC), Art. 8.1: “Member States shall prohibit the
processing of personal data revealing racial or ethnic origin, political opinions, religious or philo-
sophical beliefs, trade-union membership, and the processing of data concerning health or sex
life.”
4 Th. Lemke, “‘A slap in the face’: An exploratory study of genetic discrimination in Germany,”
Genomics, Society and Policy 5 (2): 2009, 22–39.
6 C. Lenk et al.

1.2 Tissue Research Between the Individual and the Public

It is a longstanding principle of Western thought and one of the tenets of
Enlightenment philosophy that a person cannot be somebody’s property. Indeed,
when one looks into the publications of that time, authors like the German philoso-
pher Immanuel Kant went even so far as to proclaim that nobody, including the
concerned person himself or herself, has property in his or her body and therefore
can also not dispose freely of his or her own body. For example, that people should
not be allowed to commit suicide, to mutilate themselves or to sell parts of their
own bodies. This radical “unavailability” (in German: “Unverfügbarkeit”) of the
human body (i.e., the idea that the body, like the person, should not be used as a
mere means), even for the person himself or herself, was also a platform for the
protection of the individual against the exploitation by others or demands of the
society.
However, the development of the biosciences established a situation where, for
example, the leftovers of surgical interventions are no longer worthless waste, but
become a valuable raw material for the progress of medicine. Therefore, there has
been an explicit demand for the individual to take part in research projects of public
importance, when this poses only a minor burden on the individual, such as in the
area of tissue research. In the end, the question is whether the government can suc-
cessfully claim a kind of “public interest” in the individual body and its parts. For
centuries, the dissection of human corpses for scientific or educational purposes was
carried out on bodies recruited from the poor, welfare recipients and convicted crim-
inals. To save costs and to acquire an additional benefit from these groups, it was
traditionally assumed that those persons had forfeited certain civil rights and claims
after their death, and that their corpses could be used for anatomical examination
and demonstration without their consent. Totalitarian regimes showed in the past
and perhaps also still in present – for example, in the People’s Republic of China –
that the dead bodies of certain individuals are seen as a disposable commodity used
for the benefit of society.5
In a sense, the new possibilities of tissue and organ transplantation, as well as
medical tissue research, seem to blur the established normative borders between
the rights and duties of the individual and the rights and duties of the collective.
A further example of this trend is the discussion of the use of medical biobanks
for forensic aims: whether it is acceptable for the police to gain access to tissue
collections which were established for medical research or disease prevention. This
example also shows the significance of adopting a human-rights or a utilitarian per-
spective respectively when it comes to the evaluation and solution of such problems.
While it is the central aim of the human-rights approach to protect the individual cit-
izen against the powers of the state and society, the utilitarian approach insists, with

5 S.E.
Forsythe, “China’s organ market: A tale of prisoners, tourists, and lies,” The New Atlantis,
Summer 2009, 121–24.
1 Introduction 7

some justification, on the assertion of the public good. In this regard, how we per-
ceive the individual body and the individual genome is also of some interest. Do we
share the opinion that the individual body and genome belong to the person who
then has the right to control these entities? Or do we see the human genome – and
then also the individual genomes – as a “common heritage of mankind” as argued by
the Ethics Committee of the Human Genome Organisation. This latter conception
of the human genome may sound altruistic and generous – but does it not also pose
risks for the individual who possibly has something in himself or herself which is
not fully owned by him or her?

1.3 The Rights of Donors and Patients

We normally distinguish between legal and moral rights. Legal rights are typically
defined in national law (so-called “positive law”) while moral rights result from
(sometimes internationally, sometimes nationally) shared values, normative tradi-
tions, ethical guidelines or so-called “soft-law”. Nevertheless, due to the fact that
only a minor part of human co-operation and communal life can be ruled by posi-
tive law, there remains a huge part of public life which is guided by our perception
of moral rights. The treatment of the human body, although it is regulated in many
respects (for example, the appropriate treatment of the human body after death in
funeral law) obviously leaves a lot of space for culturally-different normative tradi-
tions. The treatment of bodily material after the separation from the human body –
and, for example, the discussion on benefit-sharing in the context of genetic research
and biobanking – is a striking example of this thesis. In this context of property, jus-
tice and body material, it seems to be more a question of equity or even bioequity6
than of positive law to find an adequate balance between the interests of patients and
donors on one hand, and researchers on the other.
Very similar problems occur concerning the question of control over bodily
material once it is separated from the living body. Should donors have the right
to control the use of their samples, even when the property rights in this sam-
ple have been explicitly transferred to a research institution? And why should we
aim to control our donated tissue for science? There are indeed a number of initia-
tives to integrate the perspectives of patients and donors into research activities and
research institutions (for example, in the form of the integration of patient represen-
tatives into institutional boards, or regular donor meetings and information events).
However, the participation and information of patients and donors in the practice
of research is in the end different from an explicit right to control the use of one’s
sample.
The decisive point in this regard seems to be the invention of genetic analysis
and the dual character of human tissue: on the one hand it is tangible material, but

6 To use a term which was coined by the German lawyer Nils Hoppe in his book entitled Bioequity –
Property and the Human Body. Surrey, UK: Ashgate Publishing (2009).
8 C. Lenk et al.

on the other hand it can reveal a number of very important characteristics about the
person from whom it stems. In the German-speaking countries (Austria, Germany,
Switzerland), which have a distinct tradition of “personality law”, this leads to the
interpretation that because of these “informational” or “intellectual” characteristics
of genetic data derived from human tissue, there is a right to control the use of
human tissue which is beyond the mere assignment of property in human tissue. The
different treatment of anonymised (no link between the donor and the sample) and
identifiable or pseudonymised (the identity of the donor can be reconstructed via a
code) samples in tissue research also show the importance of the “personal relation”
of human tissue to a specific donor. When the identity of the donor of a specific
sample cannot be reconstructed, most of the international documents demand fewer
requirements for the use of that sample.
A further important area regarding patients’ rights is the question of an appropri-
ate informed consent in the area of tissue research and biobanking. In this context,
it has also been shown that biobank research is different from more traditional
medical research projects, especially when compared to controlled clinical trials.
In particular, this concerns the fact that biobanks are primarily systematic collec-
tions of different bodily materials: not single, exactly-defined research projects for
their own. Most of the large epidemiological – but also disease-related – public
biobank projects offer the possibility for external researchers to gain access to the
stored material for scientific reasons. But specifically, the type of research projects
which will be carried out with this material is, in this case, unknown at the time
when the tissue is collected. Therefore, some authors conclude (cf. the contribu-
tion of Bullock and Widdows in Chapter 8, this volume) that informed consent as
such is not an appropriate ethical-legal instrument for the regulation of research
with human tissue. Such a perspective is also partly supported by the Declaration
of Helsinki which is equally applicable to “research on identifiable human material
and data” (Declaration of Helsinki, part A, para. 1). The respective passage (part B,
para. 25) of the Declaration reads as follows:

For medical research using identifiable human material or data, physicians must normally
seek consent for the collection, analysis, storage and/or reuse. There may be situations
where consent would be impossible or impractical to obtain for such research or would pose
a threat to the validity of the research. In such situations the research may be done only after
consideration and approval of a research ethics committee. (Italics by the authors)

The Declaration of Helsinki here supports the option to refer to the local research
ethics committee. One of the cases where it is “impossible” to obtain the donor’s
informed consent is the case of deceased persons. However, the named solu-
tion is incompatible with jurisdictions which explicitly demand the consent of
the relatives in such a case. Additionally, it is not really clear why the rights of
patients to be informed should ever “pose a threat to the validity” of research
outcomes. The waiver of patient information is also contradictory to Art. 7, 10,
1 Introduction 9

and 12 of the EU Data Protection Directive. This short overview already demon-
strates the difficulties which are connected with the regulation of this important
issue.

1.4 Types and Definitions of Biobanks

The most important distinction regarding research biobanks is the distinction
between population (or epidemiological) biobanks and disease-related biobanks.
While population biobanks focus on a larger population (with individuals with a
normal, i.e. mixed health condition), disease-related biobanks typically only collect
samples from a specific group of patients. For example, most university hospitals
have established tumour biobanks for research, and the scientific aims for these
projects lie therefore in the area of cancer research. While disease-related biobanks
focus on the molecular or genetic particularities of one disease or a group of con-
nected diseases, population biobanks can in principle be used for research on all
kind of diseases, provided that it contains an adequate amount of samples of bod-
ily material to draw conclusions on the connection between a specific genotype
and a disease. While disease-related biobanks have more similarities with classi-
cal collections from pathology and a “retrospective” methodology (the samples are
extracted for diagnosis or in the course of the treatment), population-based biobanks
are definitely a new approach for genetic research with a “prospective” methodol-
ogy (samples are collected from persons with and without manifest diseases and the
development of health conditions is then followed via regular reports).
Although the most specific European recommendation document in this area, the
Recommendation Rec (2006)4 of the Committee of Ministers to member states on
research on biological materials of human origin, would in principle be valid for
both types of biobanks, Art. 17 only contains a definition for population biobanks:

1. A population biobank is a collection of biological materials that has the following

characteristics:
i. the collection has a population basis;
ii. it is established, or has been converted, to supply biological materials or data
derived therefrom for multiple future research projects;
iii. it contains biological materials and associated personal data, which may include or
be linked to genealogical, medical and lifestyle data and which may be regularly
updated;
iv. it receives and supplies materials in an organised manner.

However, a broader definition of biobanks which would also contain disease-related

biobanks would be a collection of samples of body material which is connected with
genetic data and/or health data from patients or donors (in general: associated
personal data).
10 C. Lenk et al.

1.5 Pseudonymisation and Anonymization

Regarding the connection between a tissue’s source (the donor), the sample and
associated personal data,7 the most important distinction seems to be between
anonymized and pseudonymised samples – a distinction which, in the practice of
research, often causes confusion. Anonymized means that there is no link obtained
between the donor and his or her sample. Neither the researcher nor the biobank
know or can re-identify the original donor of a body material. Some critics say that
this case is only theoretical regarding the genetic characteristics of bodily mate-
rial and that genetic material can in the end – with appropriate efforts – always be
matched to its source. But although this may be true regarding the technical side
of the question, this does not exclude the fact that there are sufficient ethical and
legal safeguards to prevent such reidentification. Pseudonymised means that a code
or a specifying characteristic links the donor’s identity with a sample, but that the
donor’s identity is concealed from an external person (i.e. from a researcher of an
external research group who wants to use a biobank’s tissue collection) who is given
the code but not the donor’s name, address, birth date and so on. Normally, only the
biobank management has access to the list of codes which can re-identify the single
donors.
The pairs of words anonymized – pseudonymised and non-identifiable – identi-
fiable are equivocal, although Art. 3 of the Council of Europe’s Recommendation
Rec(2006)4 provides further differentiation:
Biological materials referred to in Article 2 may be identifiable or non-identifiable:

i. Identifiable biological materials are those biological materials which, alone or in com-
bination with associated data, allow the identification of the persons concerned either
directly or through the use of a code.

In the latter case, the user of the biological materials may either:
a. have access to the code: the materials are hereafter referred to as “coded materi-
als”; or
b. not have access to the code, which is under the control of a third party: the material
are hereafter referred to as “linked anonymised materials”.
ii. Non-identifiable biological materials, hereafter referred to as “unlinked anonymised
materials”, are those biological materials which, alone or in combination with associated
data, do not allow, with reasonable efforts, the identification of the persons concerned.

However, the distinction between (a) and (b) seems to have no major signifi-
cance, either in scientific practice, or in ethical or legal theory. Recommendation
Rec(2006)4 also draws a normative conclusion from the distinction between

7 Personal data is defined in the EU Data Protection Directive (95/46/EC) as “any information
relating to an identified or identifiable natural person (‘data subject’); an identifiable person is one
who can be identified, directly or indirectly, in particular by reference to an identification number
or to one or more factors specific to his physical, physiological, mental, economic, cultural or
social identity; [. . .]”.
1 Introduction 11

identifiable or pseudonymised and non-identifiable and anonymised samples, i.e.

that it is preferable in the context of the protection of privacy to use anonymised
samples and that the use of pseudonymised samples has to be justified (Art. 8).
However, most of the large biobank projects currently use pseudonymised samples,
so that the work with anonymised samples is rather unusual.

1.6 Chapter Summaries8

Chapter 2 by Julie Kent and Ruud ter Meulen starts with the assumption that a
primary purpose of regulation is to secure public trust. In the United Kingdom in
the 1990s, public trust in those who procured, stored and used human tissues for
research or other purposes was severely damaged following controversies surround-
ing the retention and use of post-mortem organs and tissue at the Bristol Royal
Infirmary and the Alder Hey Royal Infirmary in Liverpool. Pathologists at both
hospitals had retained large quantities of tissue and other remains of children with-
out the knowledge or consent of their parents. Reports of unacceptable practices
in Bristol and Alder Hey led to major revisions of laws and regulations of the use
of all human tissue in the context of research and therapy, including the donation
and transplantation of human organs. A new regulatory body, the Human Tissue
Authority, was set up. Together with the previously-established Human Fertilisation
and Embryology Authority, these two public bodies have had responsibility for key
aspects of the regulation and oversight of human tissue use for research in the United
Kingdom. The authors explore the role of these entities in securing public trust and
confidence in current practices relating to research use of human tissue. These prac-
tices include the use of ova, embryos and aborted foetal tissue for stem cell research
and most recently, the approved use of “human admixed embryos”. Equally, the eth-
ical principles underlying the current policies and legal frameworks in the United
Kingdom regarding the research use of human tissue and their divergence from other
European countries are discussed.
In Chapter 3, Bernice Elger and Nikola Biller-Andorno focus on the regula-
tory challenges of biobank research. From their perspective, biobank research is
an essential element of new fields such as epigenetics, metagenetics and pharma-
cogenetics. Many European countries have invested considerably in this important
research tool, which is expected to further the understanding of the interaction
between genes and the environment and its implication for human diseases, as
well as the development of efficient medical treatments. However, biobanks will
be able to reach their full potential only if certain preconditions are met regarding
the harmonisation of databank structures and their regulation. The collection and
storage of DNA and cell tissue samples – as well as the collection of phenotypic,
environmental and lifestyle data from medical records and patient questionnaires –
needs to be standardised in order to guarantee sufficient quality of research, and to

8 The summaries of the single chapters were provided by the authors.