1. CONFLICTS OF INTEREST AND DISCLOSURE A CRITICAL ASSESSMENT OF THE CURRENT COI POLICY AND THE VALUE OF INTEGRITY SUSAN S. NIGHT, JD, LLM HEALTH POLICY AND ETHICS FELLOW BAYLOR COLLEGE OF MEDICINE HOUSTON, TEXAS Office of Research Integrity 2009 Research Conference on Research Integrity

2. Integrity History Disclosure Overview

3. Defining Integrity

4. 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. 5 Revised Perspective Actions Based Upon Discernment Communicate Basis of Actions Moral Discernment 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. Say that one’s actions are consistent with what one believes is right. Forthright in explaining what one is doing. Reevaluate beliefs of right and wrong. Correction or reevaluation of commitments given changing circumstances. Integrity as a continuous process.

6. Conflicts of Interest

7. 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? ProhibitionCapitalism 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. 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  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 Prior to 19401940s

11. History  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 1950s1960s

12. History  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” 1970s1980s

13. History  NIH policy on COI withdrawn  AAMC, AAU, AAHC reports on COI  8 reports on guidelines and/or recommendations for COI 1990s2000s

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15. Disclosure

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

17. 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. 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. 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. 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”