INVESTIGATORS’ CONFLICTS OF INTEREST AFFECTING RESEARCH

1. INVESTIGATORS’ CONFLICTS OF INTEREST AFFECTING RESEARCH Avoiding Adverse Consequences by Disclosing, and then Reducing, Eliminating or Managing Conflicts Susan H. Frey, J.D. Assistant Provost for Research Compliance and Health Information Privacy Boston University 617-414-4736 January 2010

2. Imaginary Headline:“DHHS/NIH and NSF Require Scientists to Disclose Significant Financial Interests” 1995 (and since) • Government regulations responded to the increasing role of industry in funding academic research and obtaining licenses to academic inventions (technology transfer) • Institutions must review investigators’ relationships with industry and determine • Appearance of potential to bias research? • Need to eliminate or manage conflicts of interest? • To protect objectivity and credibility of research • To protect academic integrity of training programs • To ensure informed consent of human subjects

3. Heightened Concerns (after 1995) about Conflicts of Interest affecting Clinical Research • DHHS issued guidance • Gelsinger Case • Gene therapy experimental treatment • Jesse Gelsinger,18, died • University of Pennsylvania and the PI owned stock in company to which the experimental therapy had been licensed and which hoped to put the therapy on the market • Allegations included disregard of eligibility requirements in order to increase number of human subjects

4. Scientific professional societies & Institutions Step Up to the Problem • FASEB, AAMC and many institutions are now taking the lead in developing standards and procedures for • managing the relationship between industry and academia • institutional review and management of conflicts of interest • See: http://www.faseb.org/ public affairs and http://www.aamc.org/

5. Federal policy and the phrase “conflict of interest” • Federal policy requires institutions to review disclosures from scientists to determine whether a “conflict of interest” exists that could affect objectivity of research • Having a “conflict of interest” is not wrong, per se; this is often poorly understood • Some institutions prefer to avoid using this phrase, while still regulating the relationships with industry

6. Boston University policy BU Policy on Investigators’ Conflicts of Interesthttp://www.bu.edu/faculty/handbook/policies/policies-conflict.htm (BMC has a virtually identical policy) Website of BUMC & CRC Advisory Committees on Investigators’ Conflicts of Interest http://www.bu.edu/research/compliance/financial-conflict/index.shtml

7. What is a conflict of interest? • A conflict of interest is a situation that arises when an individual acquires interests or duties that • Appear to be in conflict with each other, and, • Appear to have the potential to bias his or her decisions, when such decisions should be made objectively, without bias, on behalf of an employer, organization or community of professionals

8. Investigator’s Conflict of interest The next slide depicts the situation in which a researcher for Boston University has a conflict of interest based upon his private financial relationship with a company

9. Should I make decisions for my University about its research in which my company has a commercial interest? UNIVERSITY RESEARCH PROGRAM INVESTIGATOR COMMERCIAL INTEREST Professor X COMPANY STOCK HOLDER PAID CONSULTANT

10. Investigator’s Conflict of Interest In the previous slide, • there is a company in which the researcher has a financial interest; and • the company is potentially financially interested in his/her BU research because, for example, the company either • Sponsors the research; or • Has, or is developing, a product or technology that will be used in or evaluated in the research.

11. Conflicts of Interest are not wrong, but failure to disclose is wrong. • Federal policy does NOT say that conflicts of interest are wrong, per se • Boston University policy requires the investigator to • Disclose his/her significant financial interests to the Advisory Committee on Investigators’ Conflicts of Interest • Manage (or eliminate) the conflict as determined by the Committee

12. Research Decisions • Conflicts of interest affecting objectivity of research involve decisions investigators make for the University about: Research results Research goals Research training Research oversight These are research decisions, not business, decisions.

13. What is the traditional antidote to bias in decisions affected by conflicts of interest? DISCLOSURE

14. Why disclosure? • When Prof. X discloses his conflict of interest to both the University and Company, he • He reminds himself of the importance of avoiding bias because of his conflict of interest and • He allows others to take his conflict of interest into account, including the University’s Conflict of Interest Committee • University or company may assign someone who does not have a conflict of interest to make decisions about or monitor the matter

15. When must disclosure be made? At time of: • Funding applications • IRB applications, if unfunded • Addition of new Investigator to project • Material change not previously disclosed

16. Disclosure Protects You!! • Inevitable human errors occur in the management of science in this complex environment. • When an error occurs, you want to be “squeaky clean” • “My conflict of interest was fully disclosed and has been monitored and managed in accordance with federal and University policies.”

17. Investigator’s DISCLOSURE OSP Conflict of Interest Committee Provost Investigator IRB if human subjects

18. Committee Review The CRC or BUMC Advisory Committee on Investigators’ Conflicts of Interest will review each affirmative disclosure to : 1. Determine if conflict of interest exists: Could SFI directly and significantly affect University research? And if so… 2. How can we eliminate, reduce or manage the conflict of interest?

19. Conditions or Restrictions May be Imposed by Committee Reduction or elimination is most likely to be necessary in the case of human subjects research. Management has typically included: 1. Disclosure to chairman 2. Disclosure to all co-workers on the project (“Dear Colleague letter”) including students 3. Disclosure in publications 4. Submission of an annual report to Committee 5. Additional oversight, particularly of human subjects research or of a program for students and trainees that could be affected by the conflict.

20. Conditions where students/trainees are involved • Investigator sends a disclosure letter to all members of research team, including students/trainees • Committee member contacts students/trainees and informs them that COI Committee is monitoring for any adverse effects on • their training experience and • the openness of research in the laboratory/department

21. To sum up:Institutions are increasingly developing policies and procedures to manage the relationshipbetween academia and industry • So as to protect scientists and key academic values: • Credibility and objectivity of research results • Openness of research –sharing & publication • Academic integrity of training programs for students and post docs • Welfare and informed consent of human subjects of research