1. VISN 20 Multi-Site IRB

2. VISN 20 Institutional Review Board Who we are: VISN 20 includes the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county each in Montana and California. VISN 20 covers approximately 23% of the United States land mass.

4. VISN 20 IRB There are 8 facilities in VISN 20: – VA Puget Sound Healthcare System – Portland VAMC – Boise VAMC – Alaska VA Healthcare System – VA Roseburg Healthcare System – Spokane VAMC – Walla Walla VAMC – VA Southern Oregon Rehabilitation Center & Clinics

5. VISN 20 IRB Portland VAMC has its own facility based IRBs Puget Sound and Boise use their affiliate, University of Washington, IRB

6. VISN 20 IRB The 5 remaining VA facilities had no IRB options open to them for staff who wished to participate and/or conduct research studies because: – The cost and administrative overhead – Clinicians did not have faculty appointments at a university affiliate – Prohibition to use community/commercial IRBs

7. VISN 20 IRB VISN 20 leadership proposed several variations to ORD and then ORCA over a two year period.

8. VISN 20 IRB Benefits Allows veterans at small sites to participate in research Allows small facilities to conduct research Large, multi-site, minimal risk studies can be conducted Areas of Concern Governance Accountability Administrative Oversight Communication IRB Membership

9. VISN 20 IRB Benefits Patients have more participation opportunities Small facilities gain (more) experience in research conduct Large, multi-site, minimal risk studies can be conducted

10. VISN 20 IRB Concerns & Solutions: Governance – Directors are ultimately responsible as Institutional Official – Director provides adequate resources, space, & administrative support – Each facility signs and submits FWA – Each facility signs a Memo of Understanding with Portland VAMC – Chief of Staff is delegated to be Coordinator for R&D – COS sits on the IRB but is a non-voting member

11. VISN 20 IRB Governance continued… – COS manages policies and procedures – All 5 sites adopted the same policies and procedures – All studies must receive approval from the Portland R&D Committee – Final issue resolution is at the facility and network director level

12. VISN 20 IRB Structure and Process of Accountability – COS conducts pre-review of proposals – COS is the primary point of contact – COS provides oversight Active onsite protocols Training Compliance Conflict of Interest

13. VISN 20 IRB Structure and Process continued… – IRB administrator directs support functions and operation of the IRB – IRB administrator maintains documentation – IRB members participate in reviews – PIs & COS ensure compliance with regs and protocols – PIs meet education & credentialing requirements

14. VISN 20 IRB Administrative Oversight – COS has primary administrative oversight responsibilities – VISN Compliance Officer provides onsite review of policies, procedures and applicable audits – All 5 sites will undergo NCQA accreditation

15. VISN 20 IRB Communication – Committee minutes flow thru’ the COS to the facility Director – IRB meetings are held by video teleconferencing. (Roll call is taken periodically) – Non-compliance issues have reciprocal reporting requirements – Annual evaluation of performance and effectiveness – IRB correspondence sent to PI and cc’d to Co-I(s)

16. VISN 20 IRB IRB Membership (each site provides) – VA employee – Non-scientific – Non-affiliated member (Community member) If the selected facility members are not present, applications from that facility cannot be approved

17. VISN 20 IRB Lessons Learned Minimal Risk Research Only Carefully consider oversight Carefully consider lines of communication Many reminders of meeting times/places (Quorum requirements are more difficult to meet when membership is geographically diverse!)