Course Title: Research and Publication

Ethics (RPE)
Course Level: Doctoral

Dr RS Rai

1
 Publications Ethics

• Publications ethics: definition,

introduction and importance
• Best practices in research / standards
setting initiatives and guidelines: COPE,
WAME, etc
• Conflicts of interest
 Introduction
Whether you are just starting out in your career or are a
more seasoned researcher, you are no doubt very much
aware of the importance of ethical conduct.

Plagiarism, research fraud, undisclosed competing

interests... these are just a few of the issues that can
threaten not only the integrity of the science, but also
one's standing in the scientific community.
An understanding of the ethical boundaries and "rules" is
paramount to ensuring your work and career get off to the
best start possible.
 Introduction
Academic research involves many coordinated steps and
processes – appropriate study design, study execution,
data collection, data analysis, and finally publication.

While going through these steps and culminating in a

publication can be an exhilarating experience, one should
be aware of ethical code of conduct that binds researchers
at every stage.
Ethical standards for publication exist to ensure high-
quality scientific publications, public trust in scientific
findings, and that people receive credit for their ideas
The origins of scientific publishing
 What is the importance of research ethics?
• Research ethics are moral principles that guide researchers to conduct and
report research without deception or intention to harm the participants of
the study or members of the society as a whole, whether knowingly or
unknowingly.
• Practising ethical guidelines while conducting and reporting research is
essential to establish the validity of your research.
• You must follow ethical guidelines issued by regulatory committees in order
to ensure the safety of the participants of a study, the public at large, and
that of the researcher himself/herself.
• Following ethical guidelines will ensure that your research is authentic and
error-free, and will allow you to gain credibility and support from the
public.
• You must adhere to ethical guidelines also while presenting your findings in
your manuscript.
• This will ensure that your article is plagiarism-free and also no unverified
data reaches the readers of your article.
• Apart from that, research ethics fill in a sense of responsibility among
researchers and make it easy to fix responsibility in case of misconduct.
Principles and Guidelines for Ethical Research
and Evaluation in Development
Ethical publishing
The publication of an article in a peer-reviewed journal is
an essential building block in the development of a
coherent and respected network of knowledge.

It is a direct reflection of the quality of work of the author

and the institutions that support them.

Peer-reviewed articles support and embody the

scientific method. It is therefore important to agree upon
standards of expected ethical behavior.
Top 5 reasons to publish ethically
Publication ethics to consider when publishing:

Authorship of the paper

Originality and plagiarism

Data access and retention

Multiple, redundant or concurrent publication

Disclosure and conflicts of interest

Fundamental errors in published works

Reporting standards
 Authorship
• Naming authors on a scientific paper ensures that the
appropriate individuals get credit, and are
accountable, for the research.
• Deliberately misrepresenting a scientist's relationship
to their work is considered to be a form of misconduct
that undermines confidence in the reporting of the
work itself.
• While there is no universal definition of authorship, an
“author” is generally considered to be an individual
who has made a significant intellectual contribution to
the study.
• Committee on Publication Ethics (COPE). Committee on Publication Ethics (COPE). How to handle
authorship disputes: a guide for new researchers. 2003. Available at:
https://publicationethics.org/files/2003pdf12.pdf Accessed on June 17, 2017.
 Who Is an Author?
• According to the guidelines for authorship
established by the International Committee of
Medical Journal Editors (ICMJE), "All persons
designated as authors should qualify for
authorship, and all those who qualify should be
listed.“
• Substantial contributions to the conception or
design of the work; or the acquisition, analysis,
or interpretation of data for the work; AND
• Drafting the work or revising it critically for
important intellectual content; AND
• Final approval of the version to be published;
AND
• Agreement to be accountable for all aspects of
the work in ensuring that questions related to
the accuracy or integrity of any part of the work
are appropriately investigated and resolved.
 Non-Author Contributors
• Contributors who meet fewer than all 4 of the above criteria for authorship should not
be listed as authors, but they should be acknowledged. Examples of activities that
alone (without other contributions) do not qualify a contributor for authorship are
acquisition of funding; general supervision of a research group or general
administrative support; and writing assistance, technical editing, language editing, and
proofreading.
• Those whose contributions do not justify authorship may be acknowledged individually
or together as a group under a single heading (e.g. "Clinical Investigators" or
"Participating Investigators"), and their contributions should be specified (e.g., "served
as scientific advisors," "critically reviewed the study proposal," "collected data,"
"provided and cared for study patients," "participated in writing or technical editing of
the manuscript").
• Because acknowledgment may imply endorsement by acknowledged individuals of a
study’s data and conclusions, editors are advised to require that the corresponding
author obtain written permission to be acknowledged from all acknowledged
individuals.
 • The following are some general guidelines,
which may vary from field to field
– The order of authorship should be "a joint
General decision of the coauthors".
– Individuals who are involved in a study but
don't satisfy the journal's criteria for
Guidelines authorship, should be listed as
"Contributors" or "Acknowledged
Individuals". Examples include: assisting
the research by providing advice, providing
research space, departmental oversight,
and obtaining financial support.
– For large, multi-center trials, the list of
clinicians and centers is typically
published, along with a statement of the
individual contributions made. Some
groups list authors alphabetically,
sometimes with a note to explain that all
authors made equal contributions to the
study and the publication.
• Three types of authorship are
considered unacceptable:
– "Ghost" authors, who contribute
substantially but are not acknowledged
(often paid by commercial sponsors);
– "Guest" authors, who make no discernible
contributions, but are listed to help increase
the chances of publication;
– "Gift" authors, whose contribution is based
solely on a tenuous affiliation with a study
When not appropriately addressed, authorship issues can
lead to dispute. Some disputes are based on misconduct
(such as lying about one's role); some stem from questions of
interpretation, such as the degree to which a person's
contribution can be considered "substantial," and if authorship
is justified.

Other potential issues could include: being involved in a study,

but not listed as an author or contributor; someone taking your
idea and publishing a paper claiming full authorship; and
finding your name on a publication without your permission.
If a complaint is filed over a dispute, an investigation may be conducted with
the journal editor and author's institution to reach a resolution. Because of the
potential for ambiguity and confused expectations, it is strongly advised that
before the research begins, a meeting take place to document how each
person will be acknowledged.

Issues around authorship can be complex and sensitive. Early career

researchers who encounter such situations may fear they will jeopardize their
reputation and career if they speak up.

Take the time to fully understand each journal's guidelines for authorship, and
industry requirements.

If you find yourself in a challenging situation that you are not sure how to
handle, consult with a trusted mentor or supervisor.
Guide to Authorship Disputes and How to Prevent Them
Guide to Authorship Disputes and How to Prevent Them
Guide to Authorship Disputes and How to Prevent Them
• References
– 1. Committee on Publication Ethics (COPE). Committee on Publication Ethics (COPE). How to
handle authorship disputes: a guide for new researchers. 2003. Available at:
publicationethics.org/files/2003pdf12.pdf. Accessed on June 17, 2017.
– 2. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of
Research: Authorship and Contributorship. Available at:
icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-
contributors.html. Accessed on June 17, 2017.
– 3. Scott-Lichter D and the Editorial Policy Committee, Council of Science Editors. CSE’s White
Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update. 3rd Revised
Edition. Wheat Ridge, CO: 2012. Available at: councilscienceeditors. org/wp-
content/uploads/entire_whitepaper.pdf. Accessed on June 17, 2017.
– 4. World Association of Medical Editors (WAME) policy statement on ghost writing initiated by
commercial companies. Available at: wame.org/policy-statements#Ghost Writing - ghost.
Accessed on June 17, 2017.
– 5. Jacobs A, Wager E. European Medical Writers Association (EMWA) Guidelines on the role of
medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005;21:317-
321. Available at: emwa.org/Mum/EMWAguidelines.pdf. Accessed on June 17, 2017.
– 6. AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers.
Available at: c.ymcdn.com/sites/
www.amwa.org/resource/resmgr/about_amwa/JointPositionStatement.Profe.pdf. Accessed on
June 17, 2017.
Ethics of authorship from a journal editor's perspective
Committee on
Publication
Ethics
About
COPE • The Committee on Publication Ethics
(COPE) is a forum for editors of peer-
reviewed journals to discuss issues
related to the integrity of the scientific
record. It supports and encourages
editors to report, catalogue and
instigate investigations into ethical
problems in the publication process.
 History
• COPE was founded in 1997 by a group of medical
journal editors concerned about publication
misconduct, e.g. plagiarism, attempted or actual
redundant publication, attempts to pass off
fraudulent data, unethical research, breaches of
confidentiality, and so on. Originally a loose
gathering of individuals COPE is now a limited
company ("incorporated") and registered charity
("not-for-profit organisation").
COPE
HISTORY
TIMELINE
Role
• When a complaint is raised, COPE
does not attempt to investigate, nor
to offer judgment on, the rights or
wrongs of specific allegations of
research or publication misconduct.
COPE’s investigations and reports
are therefore focused solely on
whether the journals involved
behaved according to the COPE
code of conduct and best practice
guidelines for editors.
 COPE members can bring cases to
the quarterly COPE Forum for advice.
The COPE Forum meets in London,
UK and is open to members and
appropriate guests. Invitations and
minutes (including advice and follow-
up information on all cases discussed)
are circulated to all COPE members.
Cases Members who are signed in, are
invited to submit a case in advance,
which are anonymised before
circulation and then discussed during
the Forum, with advice given on
appropriate action. Members are
asked to provide feedback about their
cases at subsequent meetings.
 • All cases submitted to the Forum
Cases (suitably anonymised and without any
information about the submitting
journal) are entered into the Database.
This database is accessible to COPE
members and may be helpful in
answering queries about cases similar
to those that have been discussed
before. It will also form a useful
research tool.
• Members furthermore have the facility
to obtain confidential advice on
sensitive ethical issues or between
Forum meetings from COPE's chairman
or officers.
 What is WAME?
• Established in 1995, WAME (pronounced “whammy”) is a
501(c)(3) nonprofit voluntary association of editors of peer-
reviewed medical journals from countries throughout the
world who seek to foster international cooperation among
and education of medical journal editors. Membership in
WAME is free and all decision-making editors of peer-
reviewed medical journals are eligible to join. Membership
is also available to selected scholars in journal editorial
policy and peer review. WAME has more than
1830 members representing more than 1000 journals from
92 countries (as of July 27, 2017).
 to facilitate worldwide cooperation
and communication among editors
of peer-reviewed medical journals;

WAME to improve editorial standards, to

has the promote professionalism in medical
editing through education, self-
following criticism and self-regulation;

goals: to encourage research on the

principles and practice of medical
editing.
• WAME's founding members also agreed that members of WAME shall be dedicated to
high ethical and scientific principles in the pursuit of the following common goals:
• to publish original, important, well-documented peer-reviewed articles on clinical and laboratory
research;
• to provide continuing education in basic and clinical sciences to support informed clinical
decision making;
• to enable physicians to remain informed in one or more areas of medicine;
• to improve public health internationally by improving the quality of medical care, disease
prevention and medical research;
• to foster responsible and balanced debate on controversial issues and policies affecting
medicine and health care;
• to promote peer review as a vehicle for scientific discourse and quality assurance in medicine
and to support efforts to improve peer review;
• to achieve the highest level of ethical medical journalism;
• to promote self-audit and scientifically supported improvement in the editing process;
• to produce publications that are timely, credible and enjoyable to read;
• to forecast important issues, problems and trends in medicine and health care;
• to inform readers about non-clinical aspects of medicine and public health, including political,
philosophic, ethical, environmental, economic, historical and cultural issues;
• to recognize that, in addition to these specific objectives, a medical journal has a social
responsibility to improve the human condition and safeguard the integrity of sciences.
 • Recommendations re Retracting Work of an Editor
Convicted of a Serious Criminal Offense
– February 2017
• Publishing Corrections Regarding Possibly
WAME:Ethics Misleading Information
– November 2011

Case • Ethical Dilemmas in Scientific Publication

– September 2005

Discussions • Self-Plagiarism of Textbook Chapters

– October 2004
• Editorial Decision Overridden By Marketing
Department
– January 2004
• Using Patient Names Reported In the Press
– February 2004
• Authors Do Not Respond to Critical Letters to the
Editor
– May 2003
• Reviewer Conflict of Interest
– September 2002
• Duplicate Submission
– September 2002
• Post-Acceptance Rejection of a Manuscript
– March 2002
• Journal Sidebar Referrals to Commercial CME
Materials
– February 28, 2001
 Conflicts of interest

• When an investigator, author, editor, or

reviewer has a financial/personal interest or
belief that could affect his/her objectivity, or
inappropriately influence his/her actions, a
potential competing interest exists. Such
relationships are also known as dual
commitments, conflict of interest, or
competing loyalties.
• Public trust in the scientific process and the
credibility of published articles depend in part
on how transparently an author’s
relationships and activities, directly or
topically related to a work, are handled during
the planning, implementation, writing, peer
review, editing, and publication of scientific
work.
 Conflicts of interest
• The potential for conflict of interest and bias exists when professional
judgment concerning a primary interest (such as patients' welfare or
the validity of research) may be influenced by a secondary interest
(such as financial gain).
• Perceptions of conflict of interest are as important as actual conflicts
of interest.
• Individuals may disagree on whether an author’s relationships or
activities represent conflicts. Although the presence of a relationship
or activity does not always indicate a problematic influence on a
paper’s content, perceptions of conflict may erode trust in science as
much as actual conflicts of interest.
• Ultimately, readers must be able to make their own judgments
regarding whether an author’s relationships and activities are
pertinent to a paper’s content. These judgments require transparent
disclosures. An author’s complete disclosure demonstrates a
commitment to transparency and helps to maintain trust in the
scientific process.
 Conflicts of interest
• Financial relationships (such as employment, consultancies, stock
ownership or options, honoraria, patents, and paid expert
testimony) are the most easily identifiable, the ones most often
judged to represent potential conflicts of interest and thus the most
likely to undermine the credibility of the journal, the authors, and of
science itself. Other interests may also represent or be perceived
as conflicts, such as personal relationships or rivalries, academic
competition, and intellectual beliefs.
• Authors should avoid entering into agreements with study
sponsors, both for-profit and non-profit, that interfere with authors’
access to all of the study’s data or that interfere with their ability to
analyze and interpret the data and to prepare and publish
manuscripts independently when and where they choose. Policies
that dictate where authors may publish their work violate this
principle of academic freedom. Authors may be required to provide
the journal with the agreements in confidence.
Conflicts of interest

Conflicts of interest (COIs, also known as ‘competing

interests’) occur when issues outside research could be
reasonably perceived to affect the neutrality or
objectivity of the work or its assessment.

This can happen at any stage in the research cycle,

including during the experimentation phase, while a
manuscript is being written, or during the process of
turning a manuscript into a published article.
 Conflicts of interest

If unsure, declare a potential interest or discuss with

the editorial office.

Undeclared interests may incur sanctions.

Submissions with undeclared conflicts that are later
revealed may be rejected.

Published articles may need to be re-assessed, have

a corrigendum published, or in serious cases be
retracted
 Conflicts of interest
Conflicts of interest do not always stop work from being published or
prevent someone from being involved in the review process.
However, they must be declared.

A clear declaration of all possible conflicts – whether they actually

had an influence or not – allows others to make informed decisions
about the work and its review process.

If conflicts of interest are found after publication, this may be

embarrassing for the authors, the Editor and the journal. It may be
necessary to publish a corrigendum or reassess the review process.
Conflicts
Financial — funding and other payments, goods and services
received or expected by the authors relating to the subject of
the work or from an organization with an interest in the
outcome of the work

include Affiliations — being employed by, on the advisory board for,

or a member of an organization with an interest in the

the
outcome of the work

Intellectual property — patents or trademarks owned by

following
someone or their organization

Personal — friends, family, relationships, and other close

personal connections

Ideology — beliefs or activism, for example, political or

religious, relevant to the work

Academic — competitors or someone whose work is critiqued

COI and Authors must declare all potential
Authors interests in a ‘Conflicts of interest’
section, which should explain why
the interest may be a conflict.

If there are none, the authors should

state “The author(s) declare(s) that
there are no conflicts of interest
regarding the publication of this
paper.”

Submitting authors are responsible

for coauthors declaring their
interests.
COI and Authors must declare current or recent funding

Authors
(including article processing charges) and other
payments, goods or services that might influence the
work. All funding, whether a conflict or not, must be
declared in the ‘Funding Statement’.

The involvement of anyone other than the authors who

1) has an interest in the outcome of the work; 2) is
affiliated to an organization with such an interest; or 3)
was employed or paid by a funder, in the
commissioning, conception, planning, design, conduct,
or analysis of the work, the preparation or editing of the
manuscript, or the decision to publish must be declared.

Declared conflicts of interest are considered by the

editor and reviewers and included in the published
article.
 COI and Editors and Reviewers
• Editors and reviewers should decline to be
involved with a submission when they
• Have a recent publication or current
submission with any author
• Share or recently shared an affiliation with any
author
• Collaborate or recently collaborated with any
author
• Have a close personal connection to any
author
• Have a financial interest in the subject of the
work
• Feel unable to be objective
• Reviewers must declare any remaining interests in
the ‘Confidential’ section of the review form, which
will be considered by the editor.
• Editors and reviewers must declare if they have
previously discussed the manuscript with the
authors.
 Sanctions
• If publisher becomes aware of breaches of
publication ethics policies, whether or not the
breach occurred in a journal published by the
publisher, the following sanctions may be applied
across the journals of the publisher:
• Rejection of the manuscript and any other
manuscripts submitted by the author(s).
• Not allowing submission for 1–3 years.
• Prohibition from acting as an editor or
reviewer.
– The publisher may apply additional sanctions
for severe ethical violations.
 Investigations

Suspected breaches of publication ethics

policies, either before and after publication,
as well as concerns about research ethics,
can be reported to the journal.

Claimants are at times kept anonymous if

requested.

Publisher may ask the authors to provide the

underlying data and images, consult editors,
and contact institutions or employers to ask
for an investigation or to raise concerns.
 Corrections and retractions
When errors are identified in published articles, the publisher will
consider what action is required and may consult the editors and the
authors’ institution(s).

Errors by the authors may be corrected by a corrigendum and errors by

the publisher by an erratum.

If there are errors that significantly affect the conclusions or there is

evidence of misconduct, this may require retraction or an expression of
concern following the COPE Retraction Guidelines.

All authors will be asked to agree to the content of the notice.

 ICMJE and
Participants • All participants in the peer-review
and publication process—not only
authors but also peer reviewers,
editors, and editorial board
members of journals—must
consider and disclose their
relationships and activities when
fulfilling their roles in the process of
article review and publication.
 ICMJE and Participants
: Authors
• When authors submit a manuscript of any
type or format they are responsible for
disclosing all relationships and activities
that might bias or be seen to bias their
work. The ICMJE has developed
a Disclosure Form to facilitate and
standardize authors’ disclosures. ICMJE
member journals require that authors use
this form, and ICMJE encourages other
journals to adopt it.
 Peer Reviewers
• Reviewers should be asked at the time they
are asked to critique a manuscript if they
have relationships or activities that could
complicate their review.
• Reviewers must disclose to editors any
relationships or activities that could bias their
opinions of the manuscript, and should
recuse themselves from reviewing specific
manuscripts if the potential for bias exists.
• Reviewers must not use knowledge of the
work they’re reviewing before its publication
to further their own interests.
 Editors and Journal Staff
• Editors who make final decisions about manuscripts should recuse
themselves from editorial decisions if they have relationships or
activities that pose potential conflicts related to articles under
consideration
• Other editorial staff members who participate in editorial decisions
must provide editors with a current description of their relationships
or activities (as they might relate to editorial judgments) and recuse
themselves from any decisions in which an interest that poses a
potential conflict exists.
• Editorial staff must not use information gained through working with
manuscripts for private gain.
• Editors should regularly publish their own disclosure statements and
those of their journal staff. Guest editors should follow these same
procedures.
• Journals should take extra precautions and have a stated policy for
evaluation of manuscripts submitted by individuals involved in
editorial decisions. Further guidance is available
from COPE and WAME.
 Undisclosed conflict of
interest in a published article

• A reader suspects an author’s

undisclosed conflict of interest
which becomes apparent after
publication. The flowchart offers
the editor a step by step
process on handling this issue.
• Document
• Undisclosed conflict of interest in
a published article PDF 101 KB
 COI: COPE Cases

Cases

Authorship of a commentary

Deceased author

Undisclosed conflict of interest

Elsevier Guide to Declaration of Competing Interests
• Thank You