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 Ethical Issues in Publication

Scientific Fraud and Misconduct

1. Fabrication and construction of data (forgery)
2. Data manipulation (selection, substitution, misleading
statistical methods)
3. Deliberate distortion of results or conclusions
4. Plagiarism of results, publications or ideas
5. Proposal applications containing incorrect information
6. Inappropriate author credit (omission or honorary author
credit)
7. Negligent filing and storage of data

NENT: Den nasjonale forskningsetiske komité for

2/6/2019
naturvitenskap og teknologi www.etikkom.no
Famous Plagiarists The New England Journal of Medicine

▪ Vijay Soman, an assistant professor at Yale,

was asked by his boss Philip Felig to peer
review a paper by Helena Wachslicht-
Rodbard. Felig and Soman sent back a
negative review, delaying publication, then
Soman turned around and submitted virtually
the same paper to another journal.

▪ Guess who got the paper to review?

2/6/2019
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Need of ethics
Equality versus equity
Equality versus equity
Equality versus equity
 Ethics
▪ What are ethics?
o Ethics is the philosophy of how morality
guides individual and group behavior
o In Study, it is an understood code that
guides practice
▪ Morality involves beliefs about what is
right or wrong
o Morality could be relative to culture;
ethical standards may change over
time and across cultures
History of ethics in medical research

▪ In the 18th century Edward Jenner was the pioneer of

vaccination against infectious diseases, however, his
research did not respect the principal rights of humans in
research because these had not yet been defined.
▪ Louis Pasteur understood the need for comprehensive
information generated by research in animals before
exposing a human being to an experiment. Urgent
patient need was the reason for his first medical
administration to humans in 1885.

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 History of ethics in medical research
▪ In the 20th century, medical research
experienced rapidly developing methodology,
precision measurements, and quick
development of new scientific disciplines.
▪ However, unethical experiments with human
beings were still being performed in many
countries, such as the Tuskegee Syphilis
Study, conducted between 1932 and 1972 by
the U.S. Public Health Service.
▪ Some unethical studies were carried out in
concentration camps during World War II.

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Post-WWII definition of principles of ethical
research in humans
▪ The unethical experiments performed on concentration
camp prisoners by Nazi doctors during World War II and
the subsequent Nuremberg trials in 1946 gave birth to
the Nuremberg Code (1947), which states that
“voluntary informed consent is absolutely necessary.”
▪ The United Nations (UN) and World Health Organization
(WHO) followed with a focus on the priority of the
wellbeing of the individual over the interests of the
patients at large.

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Declaration of Helsinki

▪ In 1961, public opinion around the world was shocked by

the Thalidomide scandal. 2,000 children died and
10,000 children were seriously disabled.
▪ Government Authorities were then required to take
action and make regulatory arrangements to oversee the
testing of new medicines.
▪ In 1964, the World Medical Association (WMA)
developed and indeed continues to review and adapt
the Declaration of Helsinki as a guide for performing
research in human beings.

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Declaration of Helsinki

▪ “The well-being of the human subject should take

precedence over the interests of science and society.”
 Factors that can affect ethics
▪ Even with our best intentions, in daily practice,
ethics can be threated by:

Scientifi Persona
c l
interest benefits

Profession
al
benefits

Conflict of
interest
Vulnerable populations
 Vulnerable populations

• Vulnerability refers to the inability

(of a system or a unit) to
withstand the effects of a hostile
environment.

– Vulnerability in research refers to

a power differential which opens
up opportunities for abuse or
misuse
of power.
 Study and vulnerability
– Vulnerability is not fixed or inherent
to any population.
▪ Depends on the context, situation,
and themes
▪ Examples:
o Health workers who have to provide
a service in dangerous settings
o Refugees or migrants seeking
health care
o Clinicians who provide abortions
o Women seeking abortions
Ethical Principles of Research

Hippocrates was the first physician to define the ethical

principles of research in humans. These principles are still
valid today:
▪ Autonomy – to respect the autonomy of the participant or
of their representative;
▪ Beneficence – to act always in the best interest of the
participant;
▪ Non-maleficence – to do as little harm as possible to the
participant;
▪ Justice – to act fairly to all.

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 Autonomy
– Respect the freedom of subjects:
Voluntary participation
▪ Informed consent
o Information

o Comprehension

o Decision

• Free from any pressure or coercion

• Free to leave the Study
at any point
 Definition
“Informed consent is a vital part of the research process, and as
such entails more than obtaining a signature on a form.
Investigators must educate potential subjects to ensure that they
can reach a truly informed decision about whether or not to
participate in the research. Their informed consent must be given
freely, without coercion, and must be based on a clear
understanding of what participation involves.”*
The documentation of informed consent (i.e., signing of the
consent form) is also a vital part of the research process.

*Partners Healthcare: Founded by Brigham & Women’s Hospital & Massachusetts General Hospital
 8 Required Elements of Informed Consent:
1. Research – statement that study involves research, its purpose,
duration, procedures, & identification of experimental procedures.
2. Risks - or discomforts, that are reasonably foreseeable.
3. Benefits – to subject or others, that are reasonably expected.
4. Alternative - procedures or treatments available, if any.
5. Confidentiality - of records identifying subject, though may be
inspected by authorized entities (i.e., FDA, IRB, UCD/UCH, Sponsor).
6. Research-Related Injury – available treatment & compensation (if
study is greater than minimal risk).
7. Contact – person for questions regarding the study, subject’s rights,
or research-related injury.
8. Voluntary – no penalty or loss of benefits for choosing not to
participate & may discontinue at any time.
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 Additional Elements of Informed Consent:
1. Unforeseeable Risks – may be involved.
2. Participation Termination – circumstances under which PI may
terminate subjects participation without their consent.
3. Additional Costs – to subject due to participation.
4. Withdrawal – consequences of subject’s decision to withdraw &
withdrawal procedures.
5. Significant New Findings – subjects will be notified of new
findings which develop during the course of research that may
relate to their willingness to continue participation.
6. Subject Numbers – approximate number involved in study.
The 8 basic elements are required in all consents. Additional elements
are used when appropriate and as required by IRBs. They are typically
incorporated in the IRB templates with instruction for use.
 Types of informed consent
▪ Type of informed consent is determined by the level of risk
that human subjects could experience when participating
in research.
1. No informed consent format required
▪ Database analysis
▪ Blood bank samples analysis
1. No risk
▪ Clinical records analysis
2. Oral informed consent appropriate
2. Minimal ▪ No vulnerable subjects
risk ▪ Social
▪ Researcher leaves data card with
3. Greater informants
3. Written informed consent is required
than
▪ Vulnerable populations
minimal ▪ Any medical and physical procedure
risk ▪ Two signatures (subject and witness) may
be required
▪ Copy of informed consent is given
to subject
Source: Saunders et al. (2009)
 Voluntary participation?
• Power differentials occur with:
▪ Beneficiaries of the program
▪ Program officers, employees,
or volunteers
▪ Different social/economic/
educational status
 Obtaining voluntary participation
▪ Create an informed consent form that is easy
to understand
o Pilot it before fieldwork
▪ Considerations
o Attitude in approaching participants
o Illiterate subjects
o Walking/driving to homes
o How you dress and identify yourself
o Appropriate setting
o Allow sufficient time to review form
 Informed consent
• Challenges in the field
▪ Informed consent forms (ICF) could scare
people and create discomfort between
the evaluator and subject
▪ Confidentiality may not be desired
by informants
▪ Anonymity could be contradictory to
signatures and names on informed
consent forms
▪ ICF for participative Study can be
impossible to create before going to
the field
 Informed consent
• Challenges in the field (2)
▪ Populations
o People in jail, children, people with mental
disabilities, migrants in transit, refugee camps,
etc.
▪ Sensitive topics
o You may need to state, in a general way, on ICF
• Use of contraception in unmarried people,
male use of condoms in prisons, use of drugs
with young people
▪ Unintended coercion
o Leaders or gatekeepers put pressure on people
to participate (sampling issues)
Importance of internal review
▪ All Studys must be reviewed by Research
supervisors or ethical committee or internal
review board (IRB)
▪ Review concerned with protection
of participants
▪ IRB can be challenging and may not be
well-suited to qualitative procedures
 Anonymity

• Don’t collect names from people:

▪ When names are totally irrelevant
▪ When there are no follow-ups planned
▪ When no written consent is needed
(low risk)
 Confidentiality

In order to protect informants:

▪ Personal information must not be
revealed outside the research

▪ Study team members must

follow protocol at all levels
 Ethical issues checklist

Explaining purpose ▪ Be clear, honest, and tran

Promises ▪ If you make promises, keep them

Risk assessment ▪ First of all, do no harm

▪ Know the ethical and legal dimensions

Confidentiality of confidentiality

▪ Know and follow the standards of your

Informed consent discipline or field
 Ethical issues checklist
Data access and ▪ Deal with data ownership and access issues from the
ownership beginning; don’t wait until report/publication

Interviewer mental ▪ Take care of yourself and your co-researchers

health

▪ Plan ahead and know with whom you will

Ethical advice consult on emergent ethical issues

Data collection ▪ Don’t let the ends justify the means in overstepping
boundaries boundaries

Intersection of ethical and ▪ Have a discussion on ethical choices as part

methodological choices of your methods.

▪ Know your profession’s ethical standards; know what

Ethical vs. legal the law in your jurisdictions requires