1. Conflict of Interests in Health
Research
Ghaiath M. A. Hussein
MBBS, MHSc. (Bioethics)

2. Outline
• What is an interest?
• What is the Conflict of Interests (COI)?
• What are the levels of COI?
• What comprises COI?
• Is it always ―bad‖?
• Practical Steps to avoid and manage COI

3. Integrity in Scientific Research: Creating an
Environment that Promotes Responsible Conduct
―For the individual scientist, integrity
embodies above all a commitment to
intellectual honesty and personal
responsibility for one’s actions …‖
Accessed at www.nap.edu/openbook/0309084792/html/5.html

4. What is an interest?
• An interest may be defined as a
commitment, goal, or value held by an
individual or an institution.
• Examples include a research project to be
completed, gaining status through promotion
or recognition, and protecting the
environment. Interests are pursued in the
setting of social interactions.

5. What is COI?
• COI exists when two or more contradictory interests relate
to an activity by an individual or an institution.
• Conflicts of interest are “situations in which financial or
other personal considerations may compromise, or have
the appearance of compromising, an investigator’s
judgement in conducting or reporting research.” AAMC,
1990
• “A conflict of interest in research exists when the
individual has interests in the outcome of the research that
may lead to a personal advantage and that might therefore,
in actuality or appearance compromise the integrity of the
research.” NAS, Integrity in Scientific Research

6. Levels of COI
• Researchers
• The REB should assess the likelihood that the
researcher’s judgement may be influenced, or
appear to be influenced, by private or personal
interests, and assess the seriousness of any
harm that is likely to result from such influence or
from the mere appearance of undue influence
(TCPS, 200)

7. Levels of COI
Conflicts of Interest by REB Members
• It is of the highest importance that members of
the REB avoid real or apparent conflicts of
interest .
• For example: when their own research projects
are under review by their REB or
• when they have been in direct academic conflict
or collaboration with the researcher whose
proposal is under review.

8. Levels of COI
Institutional Conflicts of Interest
• Situations may arise where the parent organization
has a strong interest in seeing a project approved
before all ethical questions are resolved.
• The REB must act independently from the parent
organization.
• Institutions must respect the autonomy of the REB
and ensure that the REB has the appropriate
financial and administrative independence to fulfill its
primary duties.

9. What comprises COI?
• Stock ownership
• Paid employment Board membership
• Patent applications (pending or actual)
• Research grants (from whatever source)
• Travel grants and honoraria for speaking or
participation at meetings
• Gifts Membership of lobbying organizations
• Relationship with the National Research Ethics
Review Committee, or with possible reviewers of the
paper
• Relationship with organizations and funding bodies
Membership of a government advisory board

10. Is it always bad?
• 33% of guideline authors have financial interests in
the drug
• 50% guidelines had no COI documentation
• 34% of guidelines stated no COIs
• 50% had at least one author receiving research
support
• 43% had at least one author who had been a paid
speaker for the company Derived from National
Guideline Database
Nature, Oct 20,2005

11. Is it always bad?
• COIs may result in:
1. Loss of objectivity
2. Reordering of priorities towards applied
research
3. Degradation of the nature of science as an
open and collegial enterprise
4. Exploitation of trainees
5. Transfer of time and interest to Commercial
ventures

12. • In May 2004, the pharmaceutical giant Pfizer
agreed to pay $430 million to settle a lawsuit by
a former employee turned whistle-blower, who
was joined in the lawsuit by the U.S. federal
government and 11 state governments.
• The lawsuit exposes various marketing practices
by the company Warner-Lambert – later bought
by Pfizer.

13. • Leading academic researchers were
paid to deliver promotional lectures at
educational events and to publish
favourable reports on the off-label use
of its epilepsy drug, Neurontonin.
L. Kowalczyk ―Pfizer Drug Strategy Probed: States Question Marketing
Tactics for Neurontin,‖ Boston Globe, October 18, 2002,

14. Conflicts Can Occur at all Levels of
Research
• In reviews/awarding of grant
• In ethics review of grant
• In recruitment of participants
• In analysis of data
• In presentation of data

15. The Case of Nancy Oliveiri
• In 1996, Olivieri found that the drug she was
researching (deferiprone, active iron-chelating
agent ) at the Hospital for Sick Children in
Toronto was showing unexpected potential risks
to some patients in the trials.
• The drug company sponsoring her research
abruptly terminated the trials and issued
warnings of legal action against Olivieri should
she inform her patients at the Hospital for Sick
Children of the risks, or publish her findings.

16. The Case of Nancy Oliveiri
• The manufacturer (Apotex) issued more legal
warnings to deter Dr Olivieri from communicating
this second unexpected risk of L1 to anyone.
• However, she published her findings in the New
England Journal of Medicine and
• She was subsequently dismissed from her
position as Director of the Hospital for Sick
Children Program of Hemoglobinopathies.
• Apotex was planning to donate USD 100 Million
to the University of Toronto

17. The Case of Nancy Oliveiri
• After more than seven years of legal battle, an
independent committee of inquiry into the matter
vindicated Olivieri and concluded that neither
the university nor the hospital offered her
appropriate support in her conflict with the
drug company.
• Olivieri was reinstated to her position at the
Hospital for Sick Children and her actions have
also been vindicated by several other
independent reports.

18. The other side of the story
• Deferiprone which is the only effective orally
active iron-chelating agent licensed for the
treatment of patients with thalassaemia major
and other disorders of transfusional iron
overload.
• It is the only alternative to deferoxamine—a drug
that has to be given by daily subcutaneous
infusions and fails in many patients worldwide
because of lack of compliance, high
cost, toxicity, or hypersensitivity.

19. The other side of the story
• No other clinicians using the drug had found
evidence for long-term liver damage and her
interpretation of the data was immediately
questioned in letters to the New England Journal
of Medicine.
• Four of her patients in whom liver fibrosis had
been suggested also had hepatitis C and all five
had iron overload—both causes of liver fibrosis.

20. OR ?
What do you think?
LET’S DEBATE…!

21. Practical Steps to resolve
• Disclosure / transparency
• Stringent analysis of COI,
• Review of contracts between funders and
researchers
• Close external monitoring
• Blinding of study, when possible
• Restrict review of colleague’s work
• Peer review of manuscripts

22. ―It is a condition and not a
behaviour, and there is nothing
wrong with having a conflict of
interest. It is common.‖
Richard Smith
Editor, BMJ

23. Thank you
DISCUSSION… Q & A