1. Financial Conflict of Interest Local Accountability for Research Protections VHA Office of Research & Development Baltimore, February 2008

3. It is not necessary to change. Survival is not mandatory. W. Edwards Deming, Statistician & Father of Post-war industrial revival

4. The History of this Effort 2002-2003 ORD began drafting FCOI policy. 2003-2004 NIH’s conflict of interest misadventures –OMB and Congress required NIH to publish stringent financial conflict of interest regulations –Final regulations published in August 2005 –Secretary VA, USH asked ORD to follow suit December 2004 VHA Handbook 1200.13 published.

5. History (Continued) February 2005 FCOI Handbook rescinded –Reason: OMB felt that it represented supplementation of existing Office of Government Ethics regulations –Supplemental regulations must go through the rule making process Office of Government Ethics approval required prior to publishing a proposed rule VA received approval from OGE Early 2006 Fall 2006 National Center for Ethics charged with developing conflict of interest policy for VHA

6. History (Continued) ORD collaborated with the National Center for Ethics to explore the possibility of one policy that would also address both clinical needs and research needs. –Spring of 2007 ORD determined this would not be possible Summer 2007: ORD working with OGC to publish new regulations for research

7. Definition of FCOI FCOI (real or perceived) occurs when any financial arrangement, situation or action affects or is perceived to exert inappropriate influence on the design, review, conduct, results, or reporting of research activities or findings

8. 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

9. Purpose of the Draft FCOI Policy Allow all VA facilities to develop a comprehensive FCOI program for research To enable investigators to comply with applicable VA and other Federal regulations To publish agency supplemental regulations as required by Office of Government Ethics

10. Focus of the FCOI Draft Policy Primary focus: –The integrity of each research project Secondary focus: –The investigator and the research team Note: A conflict may only affect one part of a project or one project within an individual’s overall research program

11. Scope of FCOI Draft Policy All VA investigators –Compensated (full or part time) –WOC VA investigator’s spouse & dependent children Collaborators contributing ≥ 5% effort on a research project

12. FCOI Committee MCD must appoint the committee Majority of members may not serve on research committees, e.g.: IRB, IACUC, R&D committee Responsibilities: –Review FCOI disclosure forms –Determining if a FCOI may exist –Make referrals to Regional Counsel –Assist in determining actions required to manage, reduce, or eliminate a FCOI

13. Investigators’ Responsibilities Submit FCOI disclosure form prior to first submission of a research proposal Update the disclosure only when: –There is a new FCOI –A current FCOI is eliminated or has changed Ensure all investigators associated with his/her protocol have submitted FCOI disclosures

14. Disclosures Disclosures relate to the investigator’s area of research only Requests information regarding the: –Investigator –Investigator’s spouse –Investigator’s dependent children

15. Required Disclosures Income & compensation Patents & copyrights Royalties Business concerns –Research results my reasonably be expected to affect the development or marketing of the organization Own or have equity interest in any non- publicly or publicly traded company

16. FCOI & Review of Research Research review committees must take into account the findings of the FCOI committee and Regional Counsel –May determine there is no impact on the research or –May add additional requirements to manage, reduce, or eliminate the FCOI

17. Examples of Safeguards to Ensure the Integrity of Research Not allow the research to be conducted Require that the investigator: –Disclose the FCOI to the research subject –Not consent research subjects –Functions only as an advisor –Not serve as the Principal Investigator

18. Failure to Comply Non-compliance may result in: –Termination of the research –Removal of the investigator from the research team –Revocation of the privilege to conduct research –Sanctions by other Federal Agencies Violation of Standards of Ethical Conduct for Employees of the Executive Branch: –Disciplinary actions –Civil and criminal penalties

19. End Result Preserve the integrity and quality of research carried out by VHA

20. The Next Steps in Developing VHA’s Research FCOI Policy Work with OGC on the submission to OMB Obtain OMB approval for the disclosure form and publication of a proposed rule Based on the proposed rule, and suggestions from the other offices and the field: redraft the FCOI handbook.

21. Where Does That Leave Research? VHA FCOI policy – none, it’s back to being a draft PHS Policy (42 CFR Part 50): Does not apply to Federal Agencies VHA will need to use a disclosure form approved by: OGE & OMB Does anything apply to VA research? Yes

22. Federal Regulations Established general principles that apply to all 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)

23. 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

24. Federal Regulations 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

25. What Should Each Facility Do? Be aware of the current Federal regulations on standards of conduct Educate all investigators & research staff –Base it on the current ethics rules & OHRP’s guidance, and “draft” Handbook 1200.13 Prior to submitting proposals ask: –Do they have any conflicts that will influence any aspect of the research Significant conflicts should be reported to Regional Counsel

26. What Should Be In VHA’s Draft Policy? Should there be a FCOI committee? –Who should be members? –Should it be a medical center committee or a research committee? Should there be a FCOI administrator? How should either interface with Regional Counsel? Should there be an appeal process? –To whom should it be appealed?

27. Science cannot resolve moral conflicts, but it can help to more accurately frame the debates about those conflicts. The Dreams of Reason, 1988 Heinz Pagels, American physicist

28. Comments, questions, and suggestions?