Ethical Issues for Institutional Review Boards: Conflicts of Interest Alan Sanders, PhD(c)

1. Ethical Issues for Institutional Review Boards:Conflicts of Interest Alan Sanders, PhD(c) Director, Center for Ethics Saint Joseph’s Health System, Atlanta, GA System Ethicist Catholic Health East WWW.CHE.ORG/ETHICS

2. Etiquette • Press * 6 to mute; • Press # 6 to unmute • Keep your phone on mute unless you are dialoging with the presenter • Never place phone on hold • If you do not want to be called on please check the red mood button on the lower left of screen

3. Conflict of Interest • A conflict of interest is a situation in which someone has competing professional, personal, social, etc., obligations. A conflict of interest arises when anyone has competing obligations within one area of concern or between different areas of concern. • These competing obligations can make it difficult for the person to fulfill his or her role. The conflict may involve no unethical or improper acts, but it can create an appearance of impropriety that may undermine confidence and trust in the person or system in which the person operates.

4. General Examples* • A For-Profit Health System • A Working Parent • Self Appointed Congressional pay raises • A Pharmaceutical Company • Knowledge of impropriety of a trusted friend • Marriage * Some of these examples are intended for humor, but also to demonstrate that not all conflicts of interest are substantial ethical issues.

5. Conflicts of Interest in Research • Therapy versus Research • Payment for Recruitment • Ownership and Financial Interest • Notoriety, Professional Advancement • Academic Institutions and Private Industry

6. Examples • Tobacco – The Classic Example • The Gelsinger Case • Nancy Olivieri • David Healy • Vioxx and Celebrex • Antidepressants – Suicide & Adolescents • Synthroid

7. Conflicts of Interest on the Large Scale • Politics • Profit • Prestige • Career Advancement • Integrity • Selective suppression or emphasis • Debated interpretations • Questionable protocols • Harm • Human Subjects • Adverse Events • Investigators • Undermine Confidence

8. Resources • Sismondo, S. “Ghost Management: How Much of the Medical Literature is Shaped Behind the Scenes by the Pharmaceutical Industry?” PLoS Medicine: www.plosmedicine.org Sept. 2007, Volume 4, Issue 9, e286. • Trotter, G. "Interpreting Scientific Data Ethically: A Frontier for Research Ethics." In Research Ethics, Ana Iltis (Ed). Routledge, New York: 2006.

9. NIH • Maintain a written, enforced policy on financial conflict of interests • Inform research investigators of that policy, the associated reporting responsibilities, and related federal regulations • Report to awarding offices the existence of any conflicts of interests and assure that interests have been managed, reduced, or eliminated

10. NIH • Ask investigators to complete a short questionnaire in which they are asked “whether they or any other person responsible for the design, conduct, or reporting of this research has an economic interest in, or acts as an officer or a director of any outside entity whose financial interests would reasonably appear to be affected by, the research.” • Provide instruction to IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest.

11. Conflicts of Interests IN the IRB? • Who is on the IRB? • What other positions do they hold? • What is their political/financial power within the organization? • What importance does research play to the organization?

12. Case #1 • The IRB at a local hospital is getting ready to examine a new Cancer protocol. The principal investigator of this particular protocol, who is on the IRB, is asked to leave for the discussion, she returns when the discussion is over.

13. Case #2 • Saint Under Pressure has a large financial leg in its research organization. Other portions of the system, such as the hospital, are suffering financially and really depend on the success of their research program. They are currently reviewing the protocol of an investigator who is a high performer and brings in a large portion of money to the organization.

14. Case #3 • The IRB at Saint Small Community needs another scientifically trained person on their IRB. The VP of the Oncology Services at the institution volunteers. A large portion of the protocols at this institution are cancer trials.

15. Case #4 • Doctor M. submits a new protocol. The IRB recommends numerous changes before approval and has serious concerns about the protocol. Doctor M. is good friends with the chair of the IRB. Doctor M. asks the chair during a game of golf why the IRB is taking so long and giving him so much trouble over his protocol.

16. Case #5 • The IRB is currently reviewing a protocol testing for a new cardiac drug to be tested in conjunction with the current standard of care. Doctor C, who is on the IRB, is not an investigator on this protocol, but she practices in the same cardiac group as the principal investigator.

17. Case #6 • A nurse believes that a protocol involving children should have a separate assent form for children over the age of 14 as well as an informed consent form for parents. The chair of the IRB, a physician, disagrees because he believes that the informed consent form is enough, and doctors have enough forms to deal with anyway.

18. Conflicts of Interest In the IRB? • Politics • Profit • Prestige • Career Advancement • Integrity • Selective suppression or emphasis • Debated interpretations • Questionable protocols • Harm • Human Subjects • Adverse Events • Investigators • Undermine Confidence

19. Conflicts of Interest on the Large Scale • Politics • Profit • Prestige • Career Advancement • Integrity • Selective suppression or emphasis • Debated interpretations • Questionable protocols • Harm • Human Subjects • Adverse Events • Investigators • Undermine Confidence

20. Discussion