1. 6/7/041 Seeking To Improve Human Research Protections through Accreditation John H. Mather MD Director, ORCR, OVPR

2. 6/7/042 What will be discussed?  The University’s commitment to accreditation of its Human Research Participant Protection Program (HRPPP)  Present information on the current status of development and the present schedule.  Provide an opportunity for questions.

3. 6/7/043 What has been the impetus for accreditation of human subject (participant) protection programs?  Increased vigilance of adherence to regulatory compliance at OHRP and FDA since 1998.  “Shut-downs” of human subject research at several major academic institutions by OHRP through summer 2001. [e.g. University of Pennsylvania, Duke, Johns Hopkins etc.]  Development of a “Plan for Insuring Adequate Protection of Participants in Clinical Trials”. Issued Spring 2002. University of Michigan.

4. 6/7/044 What is the “Plan for Insuring Adequate Protection of Participants in Clinical Trials”?  Human Research Coordinating Council  Significant enhancements of IRBs  Optimization of CACR  Organization of PEERRS Program  Establishment of ORCR  Development of M-PRIME  Seek Accreditation for the HRPPP

5. 6/7/045 Who will accredit? Association for Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP works to protect the rights and welfare of research participants by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self assessment, peer review, and education.

6. 6/7/046 What are the origins of AAHRPP?  Initiated by Public Responsibility in Medicine and Research [PRIM&R]  PRIM&R and AAMC partner with five other Founding Members.  Founding and Incorporated April 2001  Number Accredited Institutions May 2004 For More Information: h ttp://aahrpp.org/index.html

7. 6/7/047 Who are the founding organizations?  Association of American Medical Colleges  Association of American Universities  Consortium of Social Science Organizations  Federation of American Societies for Experimental Biology  National Association of State Universities and Land-Grant Colleges  National Health Council  Public Responsibility in Medicine and Research

8. 6/7/048 What are some Accreditation Principles?  Research participants protection is foremost  Compliance is the minimum requirement  The whole institution, not just the IRBs  Coverage of all disciplines under FWA  Educational and collegial  Peer Driven: “Expert” Review  Performance based: Not an audit  Confidential and Voluntary  No reports to Regulatory Agencies (AAHRPP modeled on AAALAC)

9. Human Subjects Protection is a Shared Responsibility Investigator/ Researcher Institution IRB

10. 6/7/0410 What are the accreditation standards? Based on U.S. federal regulations for conducting human researchBased on U.S. federal regulations for conducting human research - Department of Health and Human Services 45 CFR 46 45 CFR 46 - Food and Drug Administration - Food and Drug Administration 21 CFR 50, 56 [and 11,312,812, as appropriate] 21 CFR 50, 56 [and 11,312,812, as appropriate] ICH Good Clinical Practice GuidelinesICH Good Clinical Practice Guidelines “Common Sense” and “Best Practices” “Common Sense” and “Best Practices”

11. 6/7/0411 What do the Standards evaluate? StructureStructure - What we have - What we have Process Process - What we do - What we do Outcome Outcome - What we achieve - What we achieve

12. 6/7/0412 What are the Five Domains for accreditation by AAHRPP?  Domain IThe Organization  Domain IIReview Bodies (not just the IRB)  Domain IIIInvestigators  Domain IVSponsors  Domain VParticipants

13. 6/7/0413 What is involved in Each Domain?  Domains Divided into STANDARDS STANDARDS Divided into ELEMENTS STANDARDS Divided into ELEMENTS For each STANDARD and each ELEMENT For each STANDARD and each ELEMENT AAHRPP needs a written statement attached AAHRPP needs a written statement attached to a policy/procedure/item to demonstrate to a policy/procedure/item to demonstrate HRPP meets standard/element. HRPP meets standard/element.

14. 6/7/0414 What is the process sequence? Self-assessment On-site evaluation Council on Accreditation Self Evaluation Self Evaluation Program Description Program Description Expert site visitors Tailored to organizational Tailored to organizational setting setting Determines Accreditation category Accreditation category

15. 6/7/0415 What is going on Now?  Complete initial Self Assessment in 2004 (18 month process of review, evaluation, surveys, improvements, reallocation of resources, etc.)  Continue to make HRPPP improvements  Submit written application to AAHRPP  Provide additional input and documents  AAHRPP Site visit

16. 6/7/0416 What happens on a Site Visit?  Site visit (week long/system wide)  Interviews with: - Officials - Administrators – various units - Staff: RSPP and allied units - IRB members - Researchers - Allied research support [e.g. Pharmacy] - and other committees [e.g. COI, IBC]

17. 6/7/0417 What do IRB members need to know? Examples  Basic principles of human subjects protection  Regulations/Policies/Assurance: what they mean, where to find them, how to apply them  Process of review: meeting protocol  How to read minutes/expedited review reports  Where to go for more information

18. 6/7/0418 How do investigators prepare? Examples  (Re-) Read Belmont Report  (Re-) Read UM Human Subjects Guide  Fully comprehend the IRB processes  Familiarity with M-PRIME system  Complete on-line training modules [ e.g. PEERRS] and document completion

19. 6/7/0419 What happens after that? Exit Interview with OfficialsExit Interview with Officials Receipt of written reportReceipt of written report Thirty day response period to addressThirty day response period to address questions or gaps questions or gaps Site Visit Team Report and UM response submitted to AAHRPP Council on AccreditationSite Visit Team Report and UM response submitted to AAHRPP Council on Accreditation AAHRPP Council renders a decisionAAHRPP Council renders a decision

20. 6/7/0420 Summary of Timetable for Initial Accreditation Self Assessment → UNDERWAY Necessary system adjustments → ONGOING Preparation of application and program description Submission of application → AIMING FOR JAN 2005 Preparation for on-site evaluation Hosting of on-site evaluation-preliminary feedback → (Est) MARCH 2005 Notification and “negotiation” on accreditation → (Est) JUNE 2005 Receipt of Accreditation → (Est) JULY 2005

21. 6/7/0421 What are the potential Benefits of accreditation?  Improves protection program (HRPPP)  Assists in achieving compliance  Facilitates research integrity  Improves research quality  Instills confidence in sponsors  Builds public trust “Protection not Perfection is the Focus”

22. 6/7/0422 Audience Question “You said that they are going to randomly select investigators to interview during this process. We’re off to a good start with you beginning to do these road shows and this session today. How do we get the word out and let our many hundreds of investigators on this campus know about the potential of them being interviewed during this process?”

23. 6/7/0423 Audience Question “Do you see a need to come back and give updates to faculty when you have a better idea of what they need to know? I think I share Erich’s concern that unless we have a very targeted message and we know exactly who to target to we are not going to get a lot of interest from the faculty.”