1. Managing conflicts of interest
Professor Colin Thomson
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong

2. What are conflicting interests in human research?
University official who participates in competitive funding decision in favour of her university.
Researcher who participates in the ethical review and approval of her own proposal.
University researcher who conducts research using a gene therapy agent jointly owned by his university and his biotech company.
Doctor who recruits research participants and conducts research on drug H for a capitation fee after receiving research training at a course paid for by company J which manufactures drug H.
Public sector agency that has funded a research project manages the investigation of a complaint about the conduct of the project.

3. What are conflicting interests in human research?
Should any of the following be regarded as having a conflicting interest?
a dedicated animal rights activist who is a member of an advisory committee on xenotransplantation
a researcher with an incentive to undertake, complete and publish research for professional advancement, or
a member of fetal tissue advisory body who is a member of a conservative religious organisation.
Or are these simply necessary elements to achieve the purposes of these social processes?
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4. What are conflicting interests in human research?
What makes an interest conflicting?
Malign motivation:
a promotion panel member who seeks revenge against a colleague who is an applicant
Structural:
an investigator in a narrow field of expertise who reviews a competitor’s proposal
In contemporary academic and professional life, impossible to eliminate structural conflicts
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5. Conflicting interests or confidentiality obligations in human research
A researcher who conducts a peer review of a research proposal will have information subject to the duty of confidentiality not to use that information for any purpose other than that peer review
If that researcher is a member of a panel to rank the eligibility of competing proposals for funding, including the proposal on which she has given advice, she has an obligation not to use the information acquired as a peer reviewer
It will be practically impossible to perform funding panel role without breaching the confidentiality
Often referred to as a conflict of interest, this is a situation in which a confidentiality obligation overrides, and renders practically impossible, performance of the panel responsibility.
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6. What is the objectionable effect of a conflicting interest?
Is it that it undermines judgement because of
bias
unreliability, or
corruption of will?
However,
these effects will vary according to personal strength,
factors other than conflicting interests can have these effects
illness
family stress
these would not usually be referred to as conflicting interests.
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7. What is the objectionable effect of a conflicting interest?
Individually -
being in a situation of conflicting interests
may offend personal morality
may damage personal/professional reputation
Institutionally
decisions and decision processes in which a person with a conflicting interest has participated are open to challenge & rescission because
the conflict has distorted the individual’s role,
that distortion prevents the individual fulfilling her responsibilities in the decision process
as a result the decision process may not achieve its aim, and
institutional goals served by that process may not be realised.
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8. What is the objectionable effect of a conflicting interest - example
Where a researcher participates in the competitive funding review or research ethics review of her own proposal.
Roles
individual
personal/professional morality is to apply expertise honestly & impartially.
institutional
researcher’s role, as committee member, is as an impartial expert
responsibility is to apply expertise,
to achieve the purpose of selecting the best proposal and
to realise institutional goal that best proposals are identified and seen to be identified and funded.
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9. What is the objectionable effect of a conflicting interest - example
The effect of acting with a conflicting interest:
Individually
offends personal or professional morality, and
damages personal or professional reputation
Institutionally
distorts the role of impartial expert - self-interest not expertise
makes achievement of decision process unlikely, and
makes unlikely realisation of institutional goal to identify and be seen to identify and fund the best proposals.
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10. What interests conflict?
Those that
distort an individual’s role in an institutional process
deform/impair performance of individual role responsibilities
render fulfilment of aims of institutional process unlikely
render unlikely realisation of institutional goals to which process was directed.
May also be interests that
offend chosen standards of personal morality, and/or
damage personal/professional reputation.
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11. The Code on conflicting interests and research – the Code Ch 7
Defines conflict as “a divergence between the individual interests of a person and their professional responsibilities such that an independent observer might reasonably conclude that the professional actions of that person are unduly influenced by their own interests.”
Institutional obligations
to have clear policies
encourage full disclosure
person with conflict not to in decision making processes
maintain records of management of conflicts of interest
Researchers
be aware of institutional policy
keep records of possibly conflicting activities
disclose conflicts
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12. Conflicting interests and research – the National Statement chapter 5
“A conflict of interest in the context of research exists where:
a person’s individual interests or responsibilities have the potential to influence the carrying out of his or her institutional role or professional obligations in research; or
an institution’s interests or responsibilities have the potential to influence the carrying out of its research obligations.”
Institutions to
establish transparent processes to identify & manage actual & potential conflicts of institution, researchers, HRECs, members or advisers
notify ethical review bodies of institutional conflicts.
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13. Conflicting interests and research – the National Statement chapter 5
HRECs to see measures taken to manage researcher conflicts, e.g.
require disclosure to participants
initial approach to participants not by researchers
use another researcher
disclosure in research report
don’t conduct the research
HRECs also
may manage researcher conflict while allowing researcher to conceal source
should notify institution if become aware of institutional conflict
HREC members to
disclose conflicts, e.g. personal involvement in research or competing research, financial interest or affiliation
adopt measures to manage conflict e.g. exclusion from discussion/decision
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14. Identifying conflicting interests - HRECs
What are relevant institutional processes?
Who are participants in those processes?
What our roles and responsibilities of participants?
What are the aims of those processes?
What goals of the institution do those processes serve?
ethical review of proposed human research
researchers, HREC members and establishing institutions
Researchers: describe & explain project,
HREC member: apply ethics review criteria;
Institution: oversight conformity with standards
identification of ethically good human research
institution quality and reliability of review; ethically good human research
A conflicting interest is one that would or could distort the role of any of the participants.
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15. Defining roles
Roles of members of research funding or peer review panels are relatively clear –
relevant expertise,
impartiality,
rational assessment,
reliance on criteria agreed to be relevant
A conflicting interest is one that could or would distort that role
Roles of HREC members less clear –
experience – of community, pastoral care, research, counselling,
knowledge of & capacity to apply review criteria.
Can be more difficult to define interests that could or would distort any of those roles
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16. An embedded conflict?
Is the institutional establishment of an HREC to review the ethical acceptability of human research for which that institution has responsibility an embedded and irreconcilable conflict of interests?
Is requirement for one third external committee membership adequate to counter the institution’s interest?
What course of action should an HREC take when
institutional financial interests are likely to be affected by an HREC approval or suspension decision about research funded by an institutional donor? (see Olivieri Symposium, Journal of Medical Ethics, Feb 2004, Vol 30:1)
institutional researchers fail to distinguish consultancy from research and risk institution’s research reputation?
remediation of unethical research practice delays completion of research funded by the institution & timely completion is of reputational importance?
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17. Managing conflicts of interest
Clear, transparent and regularly applied polices
Training of all staff – academic and professional
As important as equal opportunity – use similar compulsory courses?
Annual disclosures and registers of interests
Refresher training at commencement of involvement in any process that would fail to achieve its aims if affected by a conflicting interest – especially chairs
Regular agenda items on all meetings of relevant processes
Established committee procedures for dealing with conflict situations.
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