Overview of AAHRPP Accreditation Process for NYU SoM (August 2007)

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

2. Founders of AAHRPP • Association of American Medical Colleges • Association of American Universities • Consortium of Social Science Associations • 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

3. What is 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

4. Why Pursue Accreditation NYU SoM and affiliates: • aspire to the highest level of research conduct • proud of program and recent history • 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 toorganizations • Improves human research protection program • Assists in achieving compliance • Improves research quality • Facilitates research and recruitment of subjects • Builds public trust • Instills confidence in sponsors

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

8. Benefits of Accreditation to the Research Community • 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 • Government action may be averted if the research community responds

9. Focus on the WHOLEHuman 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: • Domain I: Organization • Domain II: Research Review Unit • Domain III: Investigator • Domain IV: Sponsor • Domain V: Participant

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

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

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

15. What happens next? • Site visit (week long/system wide) • Interviews with: • Officials-Dean, Vice-Deans, CMO • Administrators—OCT, SPA, BHC, Compliance • Staff • IRB members • 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 • Karen Blackwell, MS Director, Human Research Protection Program - Privacy Official University of Kansas Medical Center • 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

18. Key concepts: • Accreditation is voluntary • NYU SoM wants accreditation • AAHRPP wants NYU SoM to be accredited • Compliance and achievement as an integrated organization • Not accreditation of the IRB • Protection, not Perfection is the focus • 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) • Thirty day response period to address questions or gaps-September • Site Visit Team Report and NYU SoM response submitted to AAHRPP Council on Accreditation • AAHRPP Council renders a decision-December

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

21. NIH Awards to All Institutions by Rank - Fiscal Year 2004

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