1. Conflict of Interest in Human Subjects Research Bette-Jane Crigger, PhD

2. validity phenomenon/ disease/condition rigor designanalysis value Science institutional integrity viability of institution subject well-being compliance education IRB board profitability shareholders “trade secrets” quality safety reputation Sponsor patient welfare community welfare viability reputation/ prestige other stakeholders Institution care helping others hope treatment/ cure convenience Subject trust position, prestige livelihood publications scientific curiosity viability of research program enrolling subjects Investigator Diverging Interests Competing Responsibilities Trainees professional education mentor relationships

3. Defining conflict of interest Over and under interpreted: Not every financial interest is a conflict of interest, ethically or legally Not every conflict of interest involves financial interests

4. “Conflicts of interest are a ‘set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)’.” Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. A systematic review. JAMA 2003;289:454-65, 454 [emphasis added].

5. Conflict of interest—why worry? Potential adverse effects on Safety, well-being and rights of human research participants Integrity of research and quality of data Dissemination of data and scientific collaboration Public safety and well-being Public trust in the research enterprise

6. Types of conflict Conflicts involving benefits received (financial, professional, etc.)—which can be institutional as well as individual Conflicts involving dual roles—which again can be individual or institutional Conflicts involving institutional structures and processes

7. Benefit-driven conflicts “Significant financial interest” Consulting fees, honoraria, gifts, “in kind” compensation from a financially interested company Equity interests Royalty income Nonroyalty income not directly related to the costs of the research Service as an officer, director, or in another fiduciary role for a financially interested company

8. Role-driven conflicts Incommensurate responsibilities: Clinician-investigator Promote the health and welfare of the individual patient Promote the advancement of science in the public interest

9. IRB Protect human subjects of research Serve the interests of the research institution

10. “Structural” conflicts--IRBs Reporting relationships that can compromise independence Disproportionate representation among members –Institutional vs. noninstitutional –Professional vs. lay –Departmental/disciplinary diversity

11. Managing conflict Conflicts involving benefits received –Disclose competing interests –Monitor conduct of research –Divest –Forgo research in which there are significant conflicts that cannot be effectively managed

12. Conflicts involving multiple roles –Disclose research responsibilities –Prohibit recruitment by treating health care professional –Prohibit research involving investigator’s current/former patients

13. Structural conflicts –Maintain “structural distance” in reporting relationships –Separate responsibilities for financial decisions and research decisions –Assure diversity of perspectives and institutional relationships in IRB composition