Office of Research Integrity 2009 Research Conference on Research Integrity

1. Conflicts of Interest and DisclosureA Critical Assessment of the Current COI Policyand the Value of IntegritySusan S. Night, JD, LLMhealth Policy and Ethics FellowBaylor College of MedicineHouston, Texas Office of Research Integrity 2009 Research Conference on Research Integrity

2. Overview Integrity History Disclosure

3. Defining Integrity

4. Current Perspective • Integrity in Research • Individual • Intellectual honesty • Objectivity • Personal responsibility • Transparency in conflicts of interest or potential conflicts of interest • Institutional • Promote responsible conduct and foster integrity • Anticipate, reveal and manage individual and institutional conflicts of interest

5. Revised Perspective What are my values and beliefs? What do I think is right and wrong? What are the standards of my profession? Do my personal beliefs conflict with my profession? Reflection of commitment to beliefs. Standing for something even at personal cost. Typically requires courage. Reevaluate beliefs of right and wrong. Correction or reevaluation of commitments given changing circumstances. Integrity as a continuous process. Say that one’s actions are consistent with what one believes is right. Forthright in explaining what one is doing.

6. Conflicts of Interest

7. Is it possible to promote and even accelerate the progress of research while maintaining public trust in research by having a balance in, but not eliminating industry-academia relationships? Prohibition Capitalism COIs are a prima facie wrong • Any interaction with drug industry presents fundamental COI • All interactions of physicians with Pharma unethical and serious cause of COI • Zero tolerance policy for IRB members to have financial interest in studies • No legitimate justification for institutional decision makers to have financial interest • Disclosure is only a warning flag to alert possibility of future problems, not a fix • Delicate balance has swung too far toward private profit at the expense of public trust • Unacceptable, faculty members makes decision not in institution’s interest • Financial COI of institution subject to oversight and management • COIs are ubiquitous and inevitable, learn to recognize and manage them • Don’t promulgate rules that prohibit conduct of reasonable corp. research Academic capitalism is the present and future of research in AMCs

8. What is a COI? • A conflict of interest may occur when a • clinician, researcher, public official, IRB member, university official, author, reviewer, editor • allows a secondary interest • financial gain, publication opportunity, career advancement, outside employment, personal considerations, relationships, investments, gifts • to interfere with a primary interest • patient welfare, research validity, publication of research, obligation to act in the best interest of another

9. History of Conflicts of Interest

10. History Prior to 1940 1940s • Foundations are primary funding source for research • Federal funding = threat to scientific freedom • Employment by industry • “domination by government” vs. “domination by industry” • Research on behalf of the country-partnership with industry • Beginning of federal funding for research • Merton’s objectivity • COI - meetings

11. History 1950s 1960s • Industry sponsors retain publication rights and restrictions • COI related to federal employees • Academia and industry address drug safety • COI related to defense of public interest • Federal funding now 60% • AAUP report on COI

12. History 1970s 1980s • Mandates on disclosing COIs – McCarthyism? • Disclosure more than required by federal statute • COIs – environmental and occupational exposure • Bayh-Dole • Pajaro Dunes – COIs managed according to “special circumstances and traditions”

13. History 1990s 2000s • NIH policy on COI withdrawn • AAMC, AAU, AAHC reports on COI • 8 reports on guidelines and/or recommendations for COI

14. This page intentionally left blank

15. Disclosure

16. Goal of Disclosure • Objectivity in research – reduce bias • Prevent harm • Increase public trust

17. Impact of Disclosure • Advantages • Consistent with policy approaches in other areas • Stock analysts • Sarbanes-Oxley • McCain-Finegold • Can help management govern better • Consistent with principle of autonomy • Reduces the need for other remedies e.g. regulation

18. Impact of Disclosure • Disadvantages • Shift responsibility away from one who discloses – caveat emptor • Does not achieve goal of Objectivity/Elimination of Bias • Implicit and unconscious bias • Banaji and Loewenstein • www.tolerance.org/hidden_bias • Does not meet the criteria for Integrity • Discernment = NO • Act = yes • Speak = yes

19. Disclosure in the Real World • Individual researcher disclosure • “In order to manage this conflict of interest, the Committee requires that you keep your consulting fees from XXX to an amount equal to or less than $10,000 on an annual basis….In doing so, you will eliminate your conflict of interest as defined by….policies and PHS regulations. • Institutional Conflict of Interest • Virginia Commonwealth University • Master Service agreement with Philip Morris

20. Final Thoughts • History tells the story of collaboration • Honesty and objectivity = disclosure • Integrity = encourages exploration of unconscious bias • What would Cicero say? • There are 3 questions when considering a course of action • What is honorable? • What is useful? • What is apparently useful conflicts with what is right • “for when the useful seems to pull them forward towards itself and rectitude seems to draw them back in its direction, the mind as it reflects is tugged in opposite directions, and this makes for troubled indecision”