VISN 20 MultiSite IRB VISN 20 Institutional Review

VISN 20 Multi-Site IRB

VISN 20 Institutional Review Board l 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.

VISN 20 IRB l 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 VAMC – VA Southern Oregon Rehabilitation Center & Clinics

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

VISN 20 IRB l 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

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

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

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

VISN 20 IRB l 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

VISN 20 IRB l 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

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

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

VISN 20 IRB l 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

VISN 20 IRB l 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)

VISN 20 IRB l 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

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