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1.

2. What will be discussed Why accreditation programs were developed. The AAHRPP accreditation process. Status of UW-Madison’s accreditation efforts. The up-coming accreditation site visit and your involvement. Opportunity for questions.

3. Why were accreditation programs developed? In the late 1990s and in early 2000, non-compliance with federal regulations for the protection of human subjects became front page news through stories such as the suspension of research at Duke University, John Hopkins and University of Pennsylvania. The most influential case that prompted changes in human subjects research was the death of Jesse Gelsinger at the University of Pennsylvania.

4. Who will accredit? Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) AAHRPP is a non-profit organization founded in 2001 to promote uniform standards for the protection of human research subjects and enhance research compliance.

5. Founders of AAHRPP Association of American Medical Colleges Association of American Universities National Association of State Land Grant Colleges (NASULGC) Federation of American Societies for Experimental Biology (FASEB) Consortium of Social Science Associations (COSSA) National Health Council (NHC) Public Responsibility in Medicine and Research (PRIM&R)

6. Benefits of accreditation Improves human research protection program (HRPP) Assists in achieving compliance Facilitates research integrity Improves research quality Instills confidence in sponsors Builds public trust

7. What organizations have been accredited to date? As of March 16, 2007, 52 organizations have been accredited, including 25 universities and numerous hospitals and VA medical centers. Examples of accredited institutions include: University of Iowa University of Minnesota Pennsylvania State University Michigan State University Johns Hopkins Stanford University Washington University in St. Louis

8. AAHRPP Accreditation Model Voluntary – UW-Madison elected to achieve accreditation of its Human Research Protection Program Peer-driven Educational model – interactive, emphasis on learning and improvement

9. Ethical principles – Belmont Report Federal Common Rule and its Subparts – 45 CFR 46 Food and Drug Administration Regulations – 21 CFC 50 & 56 [and Parts 11, 312 & 812, as appropriate] International Conference on Harmonization – Good Clinical Practice Guidelines Best practices among top research institutions

10. AAHRPP accreditation process Submission of written accreditation application Site visit by AAHRPP to review program operations Determination of accreditation status by Accreditation Council

11. AAHRPP Site Visit Philosophy Accreditation, not auditing – no penalties attached to participation Outcomes-based Driven by peer standards Validation of UW-Madison’s programs Confidential and voluntary

12. Who are the site visitors? AAHRPP retains a pool of more than 80 expert site visitors Site visit teams are assembled based on expertise and the research setting Efforts are undertaken to tailor the site visit team to the needs of the organization. Site visitors generally represent four perspectives: Experience advocating for public and participants Experience with human research protection programs Experience conducting human subjects research Experience in institutional administration A site visitor may represent more than one perspective.

13. Who is on the AAHRPP Accreditation Council? AAHRPP’s Accreditation Council includes representatives from: Academic medical centers Accounting firms Central IRBs Pharmaceutical companies Research consultants Universities The public

14. What are the categories of accreditation? Full AAHRPP accreditation Qualified AAHRPP accreditation Accreditation-pending Accreditation withheld

15. At UW-Madison Human Subjects Protection is a Shared Responsibility

16. UW-Madison’s Human Research Protection Program William Mellon, Associate Dean for Research Policy, is the Institutional Official in charge of the Human Research Protection Program. The HRPP Organizational Chart.

18. UW-Madison’s Office of Research Policy UW-Madison’s Human Research Protection Program is located in the Graduate School’s Office of Research Policy. The ORP Organizational Chart.

20. UW-Madison’s Accreditation Process Self-assessment – UW-Madison conducted self-assessment from December 2004 until May 2006. Application – UW-Madison submitted its final accreditation application in December 2006. Site Visit – Scheduled for September 24-27, 2007. Site Visitors’ Report – Draft report will be submitted to UW-Madison 30 days after the site visit. Response – UW-Madison will have opportunity to respond to draft report within 30 days. Accreditation Council will make determination of accreditation status in December 2007.

21. What materials were included with the AAHRPP application? The AAHRPP application included: Application form Overview of the UW-Madison’s Human Research Protection Program Index of the 80 AAHRPP accreditation elements and associated UW-Madison documents 525 UW-Madison documents List of active protocols, IRB rosters, recent audit reports and IRB meeting minutes, correspondence with federal agencies The entire document was over 3,500 pages. Seven copies of the document weighed 142#The entire document was over 3,500 pages. Seven copies of the document weighed 142#

22. UW-Madison site visit The dates of the UW-Madison site visit are September 24 through 27, 2007. 4 site visitors will becoming to the UW-Madison.

23. What happens during the site visit? The site visit will begin with a 30 minute introduction by AAHRPP, which will describe the site visit process and the goals of the visit. Following the introduction, HRPP program personnel will give AAHRPP a one hour overview of the UW-Madison’s HRPP.

24. What happens during the site visit? Site visitors will interview: Institutional Official Deans of Graduate School, College of Letters & Science, School of Medicine and Public Health and School of Education Associate Deans of Research from L&S, Education and Medicine IRB staff and members Principal investigators, research staff, students doing research Research support personnel (e.g., Pharmacy, OCT) Legal counsel Office of Research Policy personnel

25. What happens during the site visit? Site visitors will review: the operations of the HRPP and the IRBs documentation including policies and procedures, investigator guidance and forms and selected research protocols.

26. Daily Closeout Sessions Each day of site visit, AAHRPP will conduct a daily closeout session: We can present any problems and resolve issues regarding conduct of site visit. We can relay questions that have arisen and clarify site visit process. AAHRPP may request records to review.

27. Lead Contact Review AAHRPP will provide: detailed and specific observations and recommendations for each AAHRPP standard. guidance about what types of issues will be raised in the draft site visit report. Emphasis will be on that we will need to address We will be able to correct any erroneous observations. Key UW-Madison personnel, including top administration officials and those involved in policy development and day to day operations, will be present for this review.

28. Final Site Visit Closeout Final closeout by AAHRPP will occur at end of last day of site visit. Executive summary of the Lead Contact Review will be presented to the organization’s senior leadership. The site visitors will emphasize the major strengths and weaknesses of each domain of the organization.

29. Site Visitors for UW-Madison David Segal, Ph.D. Professor of Sociology and Director of the Center for Research on Military Organization University of Maryland Jennifer Ruocco, Ph.D. Director, Office of Research Compliance and Regulatory Affairs Cincinnati Children's Research Foundation John A. Bertolatus, MD Associate Professor Internal Medicine The University of Iowa College of Medicine Susan Z. Kornetsky, M.P.H., C.I.P. Director, Clinical Research Compliance Department of Clinical Investigation Boston Children's Hospital

30. How Interviewees were chosen? AAHRPP officials, not UW-Madison selected interviewees AAHRPP made its selections after reviewing the application UW-Madison submitted Site visitors want a representative sample of investigators, coordinators, IRB members, etc. Other interviewees were chosen because of their key positions, e.g., Legal Counsel

31. Interviewees’ Concerns Confidential – the site visit team operates under a confidentiality agreement with UW-Madison and cannot share information or findings. No penalty - PIs, Research Coordinators, IRB members and staff, etc. bear no risks (remember accreditation ? audit). Results have direct implications only for programs being reviewed (cannot trigger audit). Interview with site visitors is private.

32. Resources Web site for site visit participants at: http://info.gradsch.wisc.edu/research/compliance/humansubjects/1.accreditation.html How to Prepare for Accreditation UW-Madison IRB Policies and Procedures UW-Madison Investigator Guidance and Forms Contacts: Accreditation: Office of Research Policy: ED IRB: HS IRB MR IRB: SBS IRB

33. Tips for the Interview Be straightforward. A candid account of your knowledge and experience is all that is expected of you. It’s okay to say “I don’t know.” If you don’t know the answer, tell how you would find the right answer; who would you ask or where would you look?

34. Tips for the Interview (cont.) When discussing problems, also include ways that problems have been addressed (corrected). Note plans for improvement. Mention efforts at quality improvement.

35. Tips for the Interview (cont.) AAHRPP’s focus will be on: Your emphasis and dedication to ethics (related to human subject protection) Not on the perfect execution of rules and regulations

36. Tips for the Interview (cont.) Focus on philosophical aspects of your role first, then know the regulatory details (e.g. what you are reviewing/performing is sound, purposeful, and has value, before the nuts and bolts of compliance assessment)

37. Tips for the Interview (cont.) You may be asked idiosyncratic questions based on the background of the site visitors. Site visitors may ask for anecdotes or examples of situations that illustrate how you do things.

38. Final points to consider This is not an audit. Interviews are only a small portion of the overall assessment of the HRPP. AAHRPP recognizes that the HRPP at our institution is continuing to evolve and grow, and that we are committed to protecting human subjects.

39. Basic principles of human subjects protection. Federal Regulations – Common Rule and FDA regulations – Federalwide Assurance: what they mean, where to find them, how to apply them. UW-Madison HRPP Policies and Procedures. What interviewees need to know?

40. What interviewees need to know? Your role(s) in the Human Research Protection Program The roles of other members of the HRPP (e.g. IRBs, ORP) Where to obtain answers for ethical/regulatory behaviors expected of you in conducting research duties: policies, guidance and forms, IRB offices, Office of Administrative Legal Services, the HRPP website and the websites of the Education Research IRB, Health Sciences IRB, Minimal Risk IRB, and Social and Behavioral Sciences IRB. How to access HRPP Policies and Procedures.

41. What interviewees need to know? Do you have adequate resources to perform your duties? Do you have positive or negative feelings about the IRB? Is there any message that you would like us to relay to the University Officials?

42. What interviewees need to know? How to report trouble, non-compliance, adverse events, unanticipated problems, etc. How to handle participant complaints Where to go for advice (e.g. IRB Chair, IRB Director, IRB Staff, IRB Members). How to keep compliant research records and documentation and justify decisions

43. What interviewees need to know? Understand what constitutes a conflict of interest at all levels (e.g. IRB, investigator, institution, administration). How do you handle a conflict of interest? Describe the human subjects education you’ve had and how you use it in your research When was the first time you heard of the Belmont Report? What is the process for prior scientific review in your department? Know the ethics of recruitment and inclusion/exclusion criteria

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