Ethical Challenges Related to Financial Conflicts of Interest in Research

1. Ethical Challenges Related to Financial Conflicts of Interest in Research Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University Baltimore, Maryland USA Will focus on the ethical issues in clinical researchWill focus on the ethical issues in clinical research

2. At the Newsstand �Safeguards Get Trampled in Rush for Research Cash� Chicago Tribune, 9/5/99 �Senators Ask Drug Giant to Explain Grants to Doctors� New York Times, 7/06/05 �How Tightly Do Ties Between Doctor and Drug Company Bind� New York Times, 7/27/05

3. At the Bookstore Science in the Private Interest : Has the Lure of Profits Corrupted Biomedical Research? Krimsky, 2003 The Truth About the Drug Companies: How They Deceive Us and What to Do About It Angell, 2004 On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health Kassirer, 2004

4. At the Medical Library �Handling conflicts of interest between industry and academia� JAMA 2003; 3240-1 "Regulating academic-industrial research relationships--solving problems or stifling progress?" NEJM 2005; 1060-5 "Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies" JAMA 2005; 110-111

5. In the Beltway Institutional Review Boards: A Time for Reform OIG, June 1998 Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research OIG, June 2000

6. Conflict of Interest Timeline

7. Ethical Foundations Scandals, codes, regulations and principles Fiduciary obligations Reservoir of trust

8. Fiduciary �a person holding the character of trustee, in respect of the trust and confidence involved in it and scrupulous good faith and candor which it requires.� a �person having duty, created by his undertaking, to act primarily for another�s benefit in matters connected with such understanding.� Black�s Law Dictionary

9. Fiduciary Obligations Put aside self-interest Focus primarily on the interests of the person for whom he or she serves as fiduciary Act to promote that individual�s interest and so earn the trust of that individual McCullough, et al 1998

10. Reservoir of Trust Individual physicians and investigators Specific institutions The research enterprise as a whole

11. Trust and Trustworthiness �Not all things that thrive when there is trust between people�are things that should be encouraged to thrive�There are immoral as well as moral trust relationships.� Baier A, 1986

12. Spectrum of Conflicts Initial considerations Research design Prospective review In process Recruitment Informed consent Integrity of the data Reporting

13. Selected Types of Financial Interests Per capita payments Money received outside the study Investigator holds equity Institution holds equity

14. Potential Solutions Divest Minimize Disclose

15. Important Empirical Questions Regarding Disclosures of COI Who, What, When, Where, and How? How will these data be used? What are the effects on trust? What are the effects on the research enterprise?

16. COINSConflict of Interest Notification Study Johns Hopkins Jeremy Sugarman Duke Kevin Weinfurt Rob Califf Kevin Schulman Joelle Friedman Jennifer Allsbrook Michaela Dinan Wake Forest Mark Hall NHLBI Grant: 1 R01 HL075538-01

17. COINS Overview