# Presentation: 659618

## VISN 20 Multi-Site IRB

## 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. *

## 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

## VISN 20 IRB

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

## 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

## VISN 20 IRB

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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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)

## 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

## 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!)