1. VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs

2. 2 Human Research Has Changed New opportunities Electronic age Larger, more complex studies Faster translation to clinical care New risks Database Research (e.g., Medicare, PTSD, TBI) Genomics Research Health Services Research

3. 3 VA Central IRB Purpose Improving veterans lives Enhancing the quality of human research protection in VA-funded multi-site studies by ensuring Expert ethical & scientific review Local issues are addressed Enhancing efficiency of IRB reviews

4. 4 VA Central IRB Logistics Office of Research & Development (ORD)-funded studies only ORD funding Service will determine if a study should be reviewed by the VA Central IRB No charge to the field for using the VA Central IRB Staffed by PRIDE in ORD IRB members from all over the country Expert ad hoc advisors Monthly meetings VA Central IRB Web site

5. 5 VA Central IRB Reviews Full Expedited Exempt Continuing Waiver of HIPAA-compliant authorization

6. 6 IRB Composition @ 18 members 2 Co-chairs Mostly VA appointments Without compensation (WOC) appointments for non-affiliated members Compensation @ 1/8 for members @ 2/8 for co-chairs

7. 7 Nonvoting Members Regulatory affairs Legal Privacy & HIPAA Information security

8. 8 VA Central IRB Process PI enlists sites PI submits protocol to VA Central IRB, including list of participating VA facilities Each participating VA facility submits a local site application VA Central IRB performs review Local VA facilities provide comments

9. 9 VA Central IRB Process VA Central IRB is final arbiter Local VA facilities decide whether or not to participate Local R&D Committee must approve before research is initiated at that facility Other sites may be added later

10. 10 Federalwide Assurance (FWA) VHA Central Office (VHACO) will seek an FWA for the VHACO Human Research Protection Program (HRPP) Institutional Official (IO) – PDUSH Human Protections Administrator (HPA) – CRADO Local VA facilities that plan to use the VA Central IRB will amend their FWAs to include it as one of their IRBs of record

11. 11 MOU Between Local Facility & VHACO HRPP Memoranda of Understanding (MOUs) will be “crisp” agreements with clear delineation of respective Roles Responsibilities Authorities

12. 12 VA Central IRB Local Accountability Concept of Human Research Protection Program (HRPP) vs. IRB Every VA facility that performs human research has ultimate responsibility for its HRPP, even if it uses an external IRB (e.g., affiliate’s, another VA’s or the VA Central IRB)

13. 13 Local Accountability Who is Responsible? The local Institutional Official (IO) is the medical center director (MCD) MCD & ACOS/R&D have ultimate responsibility

14. 14 Local Accountability Who is Responsible? Who should be designated to provide local accountability & to provide local comments to the VA Central IRB? IRB or designee R&D Committee or designee Other IO designee Combination of the above

15. 15 Local Accountability Local Roles & Responsibilities Knowledge of local research context Community culture & attitudes (e.g., ethnicity, race, language, etc.) Needs of differing subject populations Research culture (e.g., depth & breadth of local research program) Professional & community standards Research infrastructure (e.g., space, equipment, etc.) State & local laws (e.g., who can be legally authorized representative)

16. 16 Local Accountability Local Roles & Responsibilities Resources for local Research Office & HRPP Investigator oversight Investigator responsibilities (e.g., hiring qualified research personnel) Research misconduct/impropriety (e.g., investigations of misconduct) Local R&D Committee Review

17. 17 Local Accountability Local Roles & Responsibilities Training & credentialing (must keep documentation on file) Monitoring & auditing of projects Local handling of adverse events & unanticipated problems Other reviews (e.g., local R&D Committee, IACUC, Radiation Safety, etc.)

18. 18 VA Central IRB Measures to Ensure High Quality Well-trained staff Qualified IRB chair & members Expert ad hoc advisors Formal peer-reviewed evaluation Routine ORO auditing & monitoring AAHRPP accreditation

19. 19 VA Central IRB Measures to Ensure High Quality Work closely with 4 ORD Services ORO OGC Ethics Privacy OI&T Input from other Federal agencies (e.g., OHRP)

20. 20 VA Central IRB Advantages Consistent expert ethical & scientific review More training & experience for IRB in reviewing multi-site studies Centralized investigator accountability Earlier identification of trends in adverse events Eliminates local conflict of interest Model for local VA IRBs More efficient IRB review of multi-site studies Gets research results to veterans faster

21. 21 VA Central IRB Challenges Ownership by local IRBs Assurance of review quality Expectations that it will solve everyone’s problems Affiliate relationships Conflict of interest Communication

22. 22 Contact Information Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE 202-254-0282; lynn.cates@va.govlynn.cates@va.gov Marisue Cody, PhD Director, COACH 202-254-0271; marisue.cody@va.govmarisue.cody@va.gov Annette Anderson VA Central IRB Administrator 202-254-0204; annette.anderson3@va.govannette.anderson3@va.gov Lorna Kamber VA Central IRB Coordinator 202-254-0291; lorna.kamber@va.govlorna.kamber@va.gov