1. Overview of AAHRPP Accreditation Process for NYU SoM (August 2007) Elan Czeisler IRB Director NYU School of Medicine INSTITUTIONAL REVIEW BOARD www.med.nyu.edu/irb

2. Founders of AAHRPP Association of American Medical Colleges Association of American Medical Colleges Association of American Universities Association of American Universities Consortium of Social Science Associations Consortium of Social Science Associations Federation of American Societies for Experimental Biology Federation of American Societies for Experimental Biology National Association of State Universities and Land-Grant Colleges National Association of State Universities and Land-Grant Colleges National Health Council National Health Council Public Responsibility in Medicine and Research Public Responsibility in Medicine and Research

3. What is AAHRPP? Accreditation conducted by Association for Accreditation of Human Research Protection Programs (AAHRPP) Accreditation conducted by Association for Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP is a non-profit organization founded in 2001 to ensure research compliance and promote uniform standards for the protection of human research subjects AAHRPP is a non-profit organization founded in 2001 to ensure research compliance and promote uniform standards for the protection of human research subjects

4. Why Pursue Accreditation NYU SoM and affiliates: aspire to the highest level of research conduct aspire to the highest level of research conduct proud of program and recent history proud of program and recent history want to demonstrate to the public and sponsors that the program meets or exceeds national standards want to demonstrate to the public and sponsors that the program meets or exceeds national standards

5. Why Do We Need Accreditation ? Human Subject Protections Programs are currently under intense scrutiny—legislative attention, media attention Numerous evaluations of IRBs reveal lack of investigator, IRB member, and administrative staff understanding Loss of public confidence in research

6. Benefits of accreditation to organizations Improves human research protection program Improves human research protection program Assists in achieving compliance Assists in achieving compliance Improves research quality Improves research quality Facilitates research and recruitment of subjects Facilitates research and recruitment of subjects Builds public trust Builds public trust Instills confidence in sponsors Instills confidence in sponsors

7. Benefits of accreditation to organizations Elevates human research protection operations from a single review unit to a program Elevates human research protection operations from a single review unit to a program Validates the strengths and highlights the weaknesses Validates the strengths and highlights the weaknesses Focuses accountability within the human research protection program Focuses accountability within the human research protection program Provides opportunity to develop mechanisms to address related issues Provides opportunity to develop mechanisms to address related issues

8. Benefits of Accreditation to the Research Community Congressional interest in legislating is still high Congressional interest in legislating is still high Seeking accreditation will clearly demonstrate the research community’s commitment to do the right thing – conduct ethically sound and safe research Seeking accreditation will clearly demonstrate the research community’s commitment to do the right thing – conduct ethically sound and safe research Government action may be averted if the research community responds Government action may be averted if the research community responds

9. Focus on the WHOLE Human Research Protection Program: Organization IRB (s) Investigators Sponsors Participants …all parts of the “whole” (NOT accreditation of the IRB)

10. AAHRPP Accreditation “Domains” Program description divided into: Program description divided into: Domain I: Organization Domain I: Organization Domain II: Research Review Unit Domain II: Research Review Unit Domain III: Investigator Domain III: Investigator Domain IV: Sponsor Domain IV: Sponsor Domain V: Participant Domain V: Participant

11. What do the Standards evaluate? Structure Structure What we have What we have Process Process What we do What we do Outcome Outcome What we achieve What we achieve

12. How Does Accreditation Work? On-site evaluation Expert site visitors Tailored to organizational setting Self-assessment Self Evaluation Program Description Council on Accreditation Determines accreditation category

13. What AAHRPP doesn’t do: “ Audit” decisions made by the IRB not a “second guessing” exercise Critique researcher’s proposals Report “findings” to regulatory agencies

14. Where we are now: Completed initial self assessment Completed initial self assessment (18 month process of review,evaluation, surveys, improvements, reallocation of resources, etc.) (18 month process of review,evaluation, surveys, improvements, reallocation of resources, etc.) Continue to make improvements Continue to make improvements -Upgraded Policies, Forms, Review Process Submitted written application to AAHRPP Submitted written application to AAHRPP (April 2007) Completed revisions to application suggested by AAHRPP (May 2007) Completed revisions to application suggested by AAHRPP (May 2007) Site Visit: August 7, 8 and 9, 2007 Site Visit: August 7, 8 and 9, 2007

15. What happens next? Site visit (week long/system wide) Site visit (week long/system wide) Interviews with: Interviews with: Officials-Dean, Vice-Deans, CMO Officials-Dean, Vice-Deans, CMO Administrators—OCT, SPA, BHC, Compliance Administrators—OCT, SPA, BHC, Compliance Staff Staff IRB members IRB members Researchers Researchers

16. SITE VISIT DAYS 3 days August 7th – 9th

17. The Site Visitors John M. Falletta, M.D. Professor of Pediatrics Senior IRB Chairman Duke University Medical Center John M. Falletta, M.D. Professor of Pediatrics Senior IRB Chairman Duke University Medical Center Karen Blackwell, MS Director, Human Research Protection Program - Privacy Official University of Kansas Medical Center Karen Blackwell, MS Director, Human Research Protection Program - Privacy Official University of Kansas Medical Center Eugene A. Gallagher, MSPH IRB Compliance Officer Vanderbilt University Eugene A. Gallagher, MSPH IRB Compliance Officer Vanderbilt University Bruce Gordon, M.D. IRB Co-Chairman, Professor Pediatrics and Preventive and Societal Medicine University of Nebraska Medical Center Bruce Gordon, M.D. IRB Co-Chairman, Professor Pediatrics and Preventive and Societal Medicine University of Nebraska Medical Center

18. Key concepts: Accreditation is voluntary Accreditation is voluntary NYU SoM wants accreditation NYU SoM wants accreditation AAHRPP wants NYU SoM to be accredited AAHRPP wants NYU SoM to be accredited Compliance and achievement as an integrated organization Compliance and achievement as an integrated organization Not accreditation of the IRB Not accreditation of the IRB Protection, not Perfection is the focus Protection, not Perfection is the focus Institutional Support for the HRPP must be demonstrated, not personal commitment of a few people Institutional Support for the HRPP must be demonstrated, not personal commitment of a few people

19. What happens after that ? Exit Interview with Officials (written report) Exit Interview with Officials (written report) Thirty day response period to address questions or gaps-September Thirty day response period to address questions or gaps-September Site Visit Team Report and NYU SoM response submitted to AAHRPP Council on Accreditation Site Visit Team Report and NYU SoM response submitted to AAHRPP Council on Accreditation AAHRPP Council renders a decision-December AAHRPP Council renders a decision-December

20. How does this affect how we operate NOW? Upgraded Submission Forms Upgraded Submission Forms Enhanced Education & Training Program Enhanced Education & Training Program Pooled Resources-QA/QI Consortium Pooled Resources-QA/QI Consortium Administrative Efficiencies-Electronic Submissions-Elimination of Paper (finally!) Administrative Efficiencies-Electronic Submissions-Elimination of Paper (finally!) Growth of Research Program-Funding Growth of Research Program-Funding

21. NIH Awards to All Institutions by Rank - Fiscal Year 2004 RankOrganization # awards Award amt 1 Johns Hopkins 1,306$555,875,515 2 University of Washington 1,002$440,877.371 3 University of Pennsylvania 1,166$434,456,754 4 University of California San Francisco 926$420,731,695 5 Science Applications International Corp 3$417,351,396 6 Washington University 834$383,225,085 7 University of Michigan 920$362,149,790 8 University of Pittsburgh 864$348,225,811

22. Where to get More Information: http://aahrpp.org/index.html