1. 1 Human Subject Protection: Thoughts from OHRP Bernard A. Schwetz, D.V.M., Ph.D. Director, Office for Human Research Protections Department of Health and Human Services Bernard.Schwetz@hhs.gov VA IRB Chairs Meeting Washington, DC November 15, 2006

2. 2 Topics  The VA as a role model  Accreditation  Alternatives to local IRBs  Where are the greatest risks to subjects?

3. 3 The VA as a role model for human subject protection  best practices  accreditation – impact  learning from “near-misses”  mentoring investigators

4. 4 Accreditation of HRPPs  OHRP’s position  critical role of the VA  mandatory beyond the VA?  how much of the enterprise needs to be accredited to enhance protection of subjects?

5. 5 Alternatives to the local IRBs  Workshop, November, 2005 Barriers Barriers LiabilityLiability Shared responsibility agreementsShared responsibility agreements Timeliness, costsTimeliness, costs Loss of revenue – Local IRBLoss of revenue – Local IRB Local contentLocal content Quality of reviewQuality of review

6. 6 Alternative Model – No problem with FDA, OHRP  For your calendar: National IRB Conference – November 20, 21 National IRB Conference – November 20, 21 Marriott Wardman Park Hotel, Washington, D.C.  Who should attend? Institutional attorneys, officials; research deans, VP for research, IRB folks, investigators, others Institutional attorneys, officials; research deans, VP for research, IRB folks, investigators, others  Objective Convince IO’s and attorneys to consider the benefits of alternatives to local IRB Convince IO’s and attorneys to consider the benefits of alternatives to local IRB

7. 7 Where are the greatest risks to subjects? What can we do about it?

8. 8 Allocation of OHRP Resources vs. Risk to Human Subjects IRBs Investigators & Staff & Staff IOs Sponsors Subjects % of risk to subjects % of OHRP attention Source of estimates: “handful” of OHRP employees 194510188

9. 9 Allocation of OHRP Resources vs. Risk to Human Subjects IRBs Investigators & Staff & Staff IOs Sponsors Subjects % of risk to subjects % of OHRP attention Source of estimates: “handful” of OHRP employees 194510188 5717 6 119

10. Sponsor OHRP Investigators and Staff IRB Structure Institution’s Administration SO

11. Sponsor Institution’s Administration SO OHRP’s Education Link OHRP IRB Structure Investigators and Staff

12. Sponsor Institution’s Administration SO OHRP’s Education Link Where are the risks to subjects? OHRP IRB Structure Investigators and Staff

13. 13 In the absence of a regulation, how do we assure adequate training of physician investigators?  medical school curriculum (not likely)  on-line training (available)  short courses, continuing education  certification (very few so far)  mentoring (promising)

14. 14 For mentoring to work  Institutions must recognize value of mentoring  Mentors must be trained (certified ?)  Not everyone is a good mentor  Good mentors must be rewarded

15. 15 Why have I singled out institutional/signatory officials? Set the culture of the institution Set the culture of the institution Training of investigators Training of investigators

16. 16 Closing thoughts  the VA can serve as a role model in several ways  trust of research subjects is essential  training of investigators as investigators is critical for protection of subjects

17. 17 How to contact OHRP? Address: Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Phone: Toll-Free Telephone within the U.S. (866) 447-4777 Main Number (240) 453-6900 Fax: (240) 453-6909 Email: ohrp@osophs.dhhs.gov Website: http://www.hhs.gov/ohrp/