1. For VA Facilities-Identifying and Managing Institutional Conflict of Interest Peter A. St. Arnold Administrative Officer and Director of Operations For Research and Development Human Subjects Protection Administrator Memphis VA Medical Center

2. Types of Conflicts of Interest Individual – AAHRPP Elements: I.1.D, I.3.G, I.3.G, I.5.A, II.1.C, III.1.A AAHRPP Tip sheet at: http://www.aahrpp.org/www.aspx?PageID=105$9http://www.aahrpp.org/www.aspx?PageID=105$9 (VHA Handbook 1200.13 due out soon) For Conflict of Interest s ee the ORD Pride website: http://www.research.va.gov/programs/pride/conferences/accountability.cfm http://www.research.va.gov/programs/pride/conferences/accountability.cfm Office of the General Counsel: http://vaww.gc.va.gov/law/employment/ethics/coi.htm Oversight Committee (IRB and R&D) - AAHRPP Elements: I.1.D, II.1.C, II.3.C AAHRPP Tip sheet at: http://www.aahrpp.org/www.aspx?PageID=105$9http://www.aahrpp.org/www.aspx?PageID=105$9 VHA Handbooks 1200.1 R&D Committee, and 1200.5 Requirements for the Protection of Human Research Subjects in Research. Institutional – AAHRPP Elements: I.3.H –suggestions and guidance only, not in the regulations

3. Identifying and Managing Institutional Conflict of Interest AAHRPP Element I.3.H. The organization is developing written policies and procedures for recognizing and managing institutional conflicts of interest.

4. Institutional Conflict of Interest (ICOI) – not a new concept New Engl J Med. 1995 Jan 26;332(4):262-7. Institutional conflict of interest. Emanuel EJ, Steiner D. Dana-Farber Cancer Institute, Boston, MA Emanuel EJSteiner D

5. AAU Report – October 2001 The Task Force concluded that a university’s institutional financial conflict of interest processes – for both financial holding- related conflicts and those involving senior officers – should follow a three-fold approach: 1) disclose always; 2) manage the conflict in most cases; 3) prohibit the activity when necessary to protect the public interest or the interest of the university. A key goal is to segregate the decision making about the financial activities and the research activities, so that they are separately and independently managed.

6. GAO Report – November 2001 Develop and communicate information on best practices for institutions to consider for identifying and managing investigator and institutional financial conflicts of interest in biomedical research. Develop specific guidance or regulations concerning institutional financial conflicts of interest.

7. AAMC Report – October 2002 Accreditation. The effectiveness of an institution's ICOI policies and a formal assessment of the institution's compliance with these policies should be examined as an element of any accreditation process for the institution's human subjects protection program.

8. OHRP Guidance – July 2004 Establishing criteria to determine what constitutes an institutional conflict of interest, including identifying leadership positions for which the individual's financial interests are such that they may need to be treated as institutional financial interests.

9. ICOI Regulation – not much VHA Handbook 1200.5 7 A (9) Conflict of Interest. The IRB must ensure that steps to manage, reduce or eliminate potential or real conflicts of interest (financial, role (investigator/patient relationships), and/or institutional) have been taken. All VA investigators must comply with VHA policies and procedures regarding conflict of interest.

10. Institutional Conflict of Interest “An institution may have a conflict of interest in human subjects research whenever the financial interests of the institution, or of an institutional official acting within his or her authority on behalf of the institution, might affect –- or reasonably appear to affect --institutional processes for the conduct, review, or oversight of human subjects research.” AAMC, Task Force on Financial Conflicts of Interest in Clinical Research, October 2002

11. Identify ICOI Financial – patents and royalties. Example: The royalty money sent to the Memphis VAMC (151) is as follows I. Director $2,705 ACOS for Research $6,770 Individual Research labs Investigator 1 $1,145 Investigator 2 $1,233 Investigator 3 $1,233 Investigator 4 $1,233 Investigator 5 $8,689 Total to be sent to Memphis (151) $23,008 II Technology Transfer admin fee $4,061 From the Technology Transfer Handbook: "Facilities may use royalty funds received for scientific research and development consistent with the VA research mission and objectives; to further scientific exchange among VA laboratories; for education and training of employees consistent with the VA research mission and objectives; to reward scientific, engineering, technical, and other employees of the laboratory with incentive awards; and other activities that increase the potential for enhancement of research within the VA. [15 USCS §3710c(a)(B)(i) – (v)] "

12. Identify ICOI Organizational / personal relationships Example: GTx, Inc. (http://www.gtxinc.com/) – Memphis Biotech Company started 1997 by a Department Chairman – many in the department were involved financially, personally, and by organizational structure. Began in two laboratories at the Memphis VA Medical Center on a Space Sharing Agreement (lease) and two employees, now with over a hundred employees and publicly traded on NASDAQ.http://www.gtxinc.com/ RxBio, Inc. (http://www.rxbio.com/) – New start-up Biotech Company with three employees in two leased laboratories at the Memphis VAMC. Company founded in 2002 by University Vice-Chancellor of Research and two Senior Faculty.http://www.rxbio.com/

13. Identify ICOI National multi-center clinical trial sponsored by National Institutes of Health (NIH) in which the Memphis VA holds the Interagency Agreement (IAA) for $3 million/year for ten years (including 18% indirect) to conduct this trial at 10 centers.

14. Identify ICOI OTHERS?

15. Identifying and Managing Institutional Conflict of Interest AAHRPP Element I.3.H. The organization is developing written policies and procedures for recognizing and managing institutional conflicts of interest.

16. Manage ICOI Remember the AAU report? 1) disclose always; 2) manage the conflict in most cases; 3) prohibit the activity when necessary to protect the public interest or the interest of the university.

17. Manage ICOI Disclosure by all parties involved - Investigators - Oversight Officials - Disclosure to subjects - Disclosure to the institution - Monitor “Keep it in the sunshine”

18. Manage ICOI Management Strategy - start a plan 1.Get info – call Office of Research Development (ORD) Program for Research Integrity Development and Education (PRIDE) or AAHRPP 2.Draft and formulate policy 3.Outside review if needed 4.Finalize

19. ICOI Template Courtesy of PRIDE and Columbia, MO

21. At what point does an ICOI become too great to manage? - Define criteria -Designate responsible individuals/ committees – Conflict of Interest Officer / Research and Development Committee -Set parameters - Alternatives? -Perhaps have another IRB review it!

23. “…St. Arnold, a former Air Force medic, said that he takes special pride in what accreditation means for VA research and the program’s volunteers: “We want to advance science and medical care, but at the same time protect our veterans to the fullest degree.” Peter A. St. Arnold VA Research Currents, Vol. 3, No. 11/Nov. 2003