Association for the Accreditation of Human Research Protection Program

1. Association for the Accreditation of Human Research Protection Program www.aahrpp.org

2. AAHRPP • Founding Members 2002 • Association of American Medical College • 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. External Benefits • NIH Intramural/Clinical Center seeking accreditation • Future Requirement-NIH Subcontracts at accredited institutions • Current Animal Research Contracts – AAALAC accredited institutions • AAHRPP – VA, DoD, DoE, HHS facilities

4. Five Domains of Responsibility • I. Organization – 5 standards, 26 elements • II. Research Review Unit including IRBs – 8 standards, 31 elements • III. Investigator – 2 standards, 11 elements • IV. Sponsored Research – 3 standards, 5 elements • V. Participant Outreach – 2 standards, 4 elements • Total 20 Standards, 77 Elements • New Evaluation Tool and Tip Sheets – see attachment

5. Human Research Protection Program Education Programs Investigators and Research Staff Conflict of Interest Organizational Plan Compliance Oversight Pharmacy Services Communications Systems Contracts and Grants Institutional Review Board

6. Records Review • Minutes last 12 meetings of each IRB • Protocols – Cross Section of Research Portfolio • Other Records which could be requested • IRB files • Training Records • Affiliation/MOU Agreements • COI Minutes • Clinical Trial Agreements • Scientific Review Committee Minutes • Radiation Safety, Radioactive Drug Use, IBC • Reports to Regulatory Agencies (does not include research misconduct)

7. Accreditation Process Overview • Packet Submission – UTHSCSA due 10/01/2008 VA submitted 5/28/2008 • Site Visit: Interviews, Records Review • VA Site Visit Scheduled for 9/8/2008 and 9/9/2008 • Draft Site Visit Report – 30d • Institution Response – 30d • Corrections/describe new changes implemented

8. Who is seeking accreditation • 100% of VA medical centers • 85% of research intensive universities • 80% of independent IRBs • 75% of academic medical centers • 50% of NCI-funded cancer centers • 30% independent teaching hospitals • 27% independent children’s hospitals • 13% research institutions • 12% universities with only behavioral/social science programs • First applications from research sites and contract research organizations

9. Accreditation Standards • Does the organization have policies and procedures that meet accreditation standards? • Is the organization following their policies and procedures? • Do staff know the policies and procedures? • Outcome based versus Process Based

10. How does accreditation work? Self-assessment On-site evaluation Council of Accreditation Self-study that leads to application Tailored to setting Expert Site Visitors Determines accreditation category

11. Interviews • Executives • UTHSCSA Dept Chairs or VA Section Chiefs • IRB and R&D Committee Chairs, Members • Principal Investigators • Research RN/Coordinators • AVP Sponsored Program/Contracts • AVP Regulatory Affairs & Complianceor STVHCS Compliance Office • Investigational Pharmacy • Others Possible – Legal, Environmental Health, IIMS

12. Department Chairs or Section Chiefs / Center Director • Department Chair or Section Chief /Center Director - Verification • Soundness of the Research Design - Ability to achieve Goals of Protocol • Competency of the Principal Investigator • Sufficient Resources (Participant Study) - Personnel, Funding - Lab/Equipment - Potential Subjects

13. PI Interviews • Background • Training to do Research - CITI on-line course - Clinical Research Course • Role in Research - Role of Staff – Scope of Practice Policy • Choice of Studies - Design - ?Turn Down

14. Research Staff Interviews • What is your role as - research nurse research coordinator • What role does your PI play Possible Additions – Research Scope of Practice Education, Licensure, Training

15. Is PI available when you need him or her? Co-Investigators/Back Up Call Plan

16. Recruitment IRB, R&D, and STVHCS Public Affairs Office required to approve advertisement How to identify possible subjects How to recruit/approach VA Policy regarding recruitment of veterans in non-VA research Who has initial contact? Subsequent contact Do sponsors offer bonuses? Bonuses – Prohibited by HSC and STVHCS Finder’s Fees – Prohibited

17. Consent – Factors of Importance Appropriate Language; Level Process – Non-coercive Time to Consider Documentation Non-English Speakers Consent and Legally Authorized Representatives

18. Contact Information for Research Team Questions Concerns Complaints How do participants receive contact information?

19. Contact Information – Non Research Team IRB Office Compliance Hotline/Office UTHSCSA AVPRO and VPR, STVHCSACOS/R and Assistant Chief for Clinical Research – open door

20. Conflict of Interest Research Team or Immediate Family Any financial; Board Positions Conflict of Interest Policy – UTHSCSAHOP 7.7.1 and STVHCS SOP 08-22 Level of Interest Management Plans IRB and R&D – Final Approval

21. Records Where do you keep regulatory files? Where do you keep consent documents? What do you keep and what do you give to subject?

22. UPIRSOs What is the IRB policy on reporting UPIRSOs? How would you define a UPIRSO? What do you have to report to the IRB? In what time frame?

23. Safety Monitoring What plans do you have for monitoring the data to ensure safety of participants? Discuss a safety monitoring plan for your study (not just DSMB)

24. Interview QuestionsIRB and R&D Committee Chairs & Members • Do you think the IRB and R&D Committee has scientific and disciplinary expertise to review protocols for the type of research conducted by UTHSCSA and STVHCS? • Yes – Large Multidisciplinary (Note: Our application says IRB provides both scientific and ethical review.) (Otherwise IRB could not review until after a scientific review/approval occurred) • The R&D Committee is responsible for evaluating scientific quality, relevance to the VA mission, and ability to conduct and complete the research.

25. Processes other Groups, Committees that ensure/conduct Scientific Review GCRC Committee Protocol Review Committee CTRC Departmental Review and Approval Note: If for a particular protocol, we need additional expertise, we request appropriate • Consultant Review (Consultants do not vote)

26. How does IRB decide it needs a consultant? - IRB pre-review determines Can recognize need and determine at IRB meeting that need to call in consultant • How is this done? • What training do new IRB members receive? • Have you received any other training? - Attended PRIMR - Education provided by IRB Office at IRB meetings - IRB Forums - Monthly VA Research Study Members Training - Clinical Research Course - Fall-2007 UT System planning to offer PRIMR Advance IRB Training in Houston

27. Do you have sufficient time to review IRB or R&D Committee materials? - What is in the agenda packet? - When do you get your packet? - How many days prior to IRB meeting? - What do YOU review? Could explain your approach (read consent first, then go back to review protocol) - If primary or secondary reviewer? - If not reviewer?