What Conflicts of Interests Do HRECs need to Address?

1. What Conflicts of Interests Do HRECs need to Address? Professor Colin J. H. Thomson Professorial Fellow, Faculty of Law University of Wollongong Consultant in Health Ethics National Health and Medical Research Council

2. Conflict of interest Researcher participating in competitive funding review of research proposals including her own. NHMRC Conference May 2005

3. Why Are Conflicting Interests Objectionable? Some say undermining judgment by • bias • unreliability • corruption of will, but • illness, stress can have same effects but not conflicting interests, and • effects vary according to personal strength. NHMRC Conference May 2005

4. Result of Acting with Conflicting Interest At individual level - • may offend accepted standards of personal/ professional morality • may damage personal/professional reputation. NHMRC Conference May 2005

5. Effect of Conflicting Interest At institutional level - decision, decision processes cannot stand, because • institutional goals, to find most deserving proposal, not achieved, because • conflict distorts individual’s role in decision, and • prevents fulfilment of her responsibilities. NHMRC Conference May 2005

6. Effect of Conflicting Interest At institutional level:- • researcher’s role is impartial expert, • responsibility to apply expertise, • to fulfil institutional goal of funding best proposal NHMRC Conference May 2005

7. Effect of Conflicting Interest At institutional level (continued): Personal conflicting interest of researcher: • distorts role of expert to that of advocate, • applies greed not expertise, • prevents achievement of institution’s goal to identify and be seen to identify & fund most deserving proposal. NHMRC Conference May 2005

8. What Interests Conflict? Those that: • distort individual role in institutional process, • deform performance of individual role responsibilities, and • prevent fulfilment of institutional goals. May also be those that:- • offend accepted standards personal morality, and • damage personal/professional reputation. NHMRC Conference May 2005

9. What Interests Do HRECs Need to Address? What processes involve HRECs? What are the goals of those processes? Who are participants in those processes? What roles & responsibilities do those participants have in those processes? (Conflicting interests will be those that distort those roles and responsibilities & prevent achievement of those goals). NHMRC Conference May 2005

10. What are institutional processes that involve HRECs? What are the goals? Who are participants in those processes? What are roles & responsibilities of participants? Ethical review of proposed of research involving humans Sound review Researchers, HREC members, institution Research integrity HREC disinterest Quality institution Processes & roles of HRECs NHMRC Conference May 2005

11. Conflicting Interests for HRECs What interests would: • distort those roles or responsibilities and • prevent achievement of that goal? NHMRC Conference May 2005

12. Conflicting Interests for HRECs HREC member participates in the ethical review and approval of her own proposal Competing researcher advises HREC Distorts HREC member/expert roles Prevents achievement of sound review goal. NHMRC Conference May 2005

13. What are institutional processes that involve HRECs? What are the goals? Who are participants in those processes? What are roles & responsibilities of participants? Ethical review of proposed of research involving humans Protect participants Researchers, HREC members, institution Research integrity HREC responsibility Quality institution Processes & roles of HRECs NHMRC Conference May 2005

14. Conflicting Interests for HRECs What interests would: • distort those roles or responsibilities and • prevent achievement of that goal? NHMRC Conference May 2005

15. Conflicting Interests for HRECs Doctor recruiting own patients in competitive site establishment for research on drug H for capitation fee paid (or who has patent interest in outcome) • distorts researcher role. • prevents achievement of protection goal. • does it prevent achievement of sound review goal? NHMRC Conference May 2005

16. Conflicting Interests for HRECs • Conflicts that prevent achievement of sound review goal - for institutions • Conflicts that prevent achievement of protection goal - for HRECs • Sponsor contractual restraint on researcher disclosure? • of results to public/peers • of risks to participants NHMRC Conference May 2005

17. NHMRC Conference May 2005