1. 1 Financial Conflict of Interest Brenda Cuccherini, Ph.D., MPH VHA Office of Research & Development January 2007

2. 2 Morality, like art, means drawing a line someplace. Oscar Wilde

3. 3 Defining Conflict of Interest “A conflict of interest is 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).” Thompson DF: NEJM 1993;329(8): 573-576.

4. 4 Conflict: Real or Perceived Perceived COI: Perception may be because of misinterpretation of facts, incomplete information, poor communication, or past experiences Real COI: Must meet established criteria Both may have equal impact on the perceived validity of a study and the credibility of both the investigator and the institution

5. 5 Commitments & Divided Loyalties Financial Role –Employment –Professional –Personal Longstanding disagreements Other

6. 6 Situational Conflicts of Interest: Real or Perceived Functioning as an investigator/collaborator Membership on committees Roles –Health care provider –Supervisory –Administrative –Mentor/student Beneficiary of services

7. 7 Federal Regulations Established general principles that apply to Federal employees –Executive Order 12674 –5 CFR Part 2635 & others Defined 14 general principles Established penalties for failure to comply –Civil and criminal penalties –Employment related discipline (removal or suspension)

8. 8 Federal Regulations (Cont.) Established the Office of Government Ethics (OGE) Designated Agency Ethics Official (DAEO) –Requires agency to appoint a DAEO –DAEO: source of official advise –Location: DAEO is in OGC Allows Agencies to develop supplemental regulations with the concurrence and co- signature of OGE

9. 9 General Principles of Conduct Two core concepts underlying the 14 principles: –Employees shall not use public office for private gain –Employees shall act impartially and not give preferential treatment to any private organization or individual Additionally, employees must strive to avoid any action that would create the appearance that they are violating the law or ethical standards

10. 10 Why a VHA COI Policy Misadventures: real or perceived –Death of Jesse Gelsinger -- PI: founder of a biotechnology firm set up to take gene therapy from laboratory to marketplace –NIH scientists’ arrangements with outside interests COI negatively impacts research

11. 11 Why a VHA COI Policy (Cont.) To preserve trust –Public Service is a public trust –COIs undermine trust & prudent stewardship of public resources To define VHA’s minimal requirements To serve as basis for facility policies and SOPs

12. 12 Current Draft of FCOI Policy Type of Conflict: financial Scope: VA investigators and Collaborators with ≥ 5% effort FCOI disclosure: filed before 1 st protocol submission FCOI committee: reviews disclosure Possible significant FCOI: referral to Regional Counsel for review and action

13. 13 Current Draft of FCOI Policy (Cont.) If no significant FCOI: if additional safeguards needed FCOI committee communicates to: –IRB, IACUC, & R&D committee Who imposes safeguards: any of the committees Possible safeguards: –Informing subjects –Removing investigator –Disapproving the research Next disclosure filing: when FCOI changes –Additional FCOIs –Management of FCOIs –Elimination of FCOIs

14. 14 The Disclosure Requests information about the investigator, spouse and dependent children –Income other then Federal or university salaries that exceed an aggregate of $10,000 in the last 12 months –Patents, copyrights, royalties, business concerns related to the research being conducted –Position as an officer, director, trustee, general partner, or owner of an equity interest in publicly and/or non-publicly traded companies that do business in an area related to the investigator’s research

15. 15 The Disclosure Form Designed for ease of completion Defines who must fill it out Gives reminders: –Significant FCOI referred to Regional Counsel –Penalties for violating ethics rules or policy Section 1: –7 “yes” or “no” questions –Certification that the information is correct & complete Section 2: –Requests information for all “yes” questions

16. 16 Status of Draft Policy Policy published December 2005 Rescinded February 2006 –OGC: may need OMB approval of disclosure form OMB: may need to publish as a regulation –NIH had just published as a draft interim final regulation Multiple reasons behind OMB’s suggestion

17. 17 OMB Suggestions Strongly suggested VA proceed through notice and comment rulemaking –Publish in Federal Register –30-60 day comment period –Review comments & incorporate applicable suggestions –Publish final rule Reasons for OMB suggestion –Policy may have an impact on private sector entities –Collecting information on non-VA employees (spouses, children)

18. 18 But Then… OGE consulted: –Does collection of the information represent supplemental regulations? OGE approved disclosure form OGC (VA General Counsel) reviews necessity for publication as regulations

19. 19 “Surprise like misfortune, never comes alone” Oliver Twist Charles Dickens

20. 20 Another Player in the Arena Under Secretary for Health charged National Center for Clinical Ethics (NCCE) to develop a VHA COI policy To be based on NCCE recommendations –“Compensation to Health Care Professionals from the Pharmaceutical Industry” February 2006 Draft policy by Spring 2007

21. 21 Impact on Research FCOI Policy ORD invited to be member of NCCE’s task force Major questions on the scope of the VHA policy: –Address primarily compensated relationships –Separate policies for clinicians and researchers Possible goal: –One VHA policy encompassing clinical care and research

22. 22 What now? Work with NCCE’s new COI task force Remind all investigators and research staff that other Federal statutes & regulations still apply Identify web-based training programs Research review committees continue to be alert to situations that may violate the 14 ethics principles ORD continue process of “rule making”

23. 23 Remember… "There are many ways of going forward, but only one way of standing still." Franklin D. Roosevelt

24. 24 Reference & Educational Material Office of Government Ethics: www.usoge.gov

25. 25 A wise man's question contains half the answer. Solomon Iban Gabirol Poet & Philosopher 1021 to 1058

26. 26