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Human Subjects Division (HSD)

Announcements

July 1 Separation of the UW IRB and the VA

Apr 28, 2009 at 8:12am

As of July 1, the UW IRB will no longer provide IRB review and oversight for research at the VA Puget Sound Health Care System (VAPSHCS) or the Boise VA Medical Center.  VAPSHCS is forming its own independent IRB, which will begin operations on July 1, 2009 and which will provide IRB oversight of all research at VAPSHCS and Boise VA.

1.  What is the reason for the separation?

This action is required by the VA Office of Research Oversight in response to its audit last fall.

2.  What does this mean for research that involves both institutions (UW and VA)?

As of July 1, all research in which the UW and the VA are both engaged (as defined by federal regulations; http://www.hhs.gov/ohrp/policy/engage08.html  ) must be reviewed by both the UW and the VA IRBs.   This is called dual review.

 3.  Why is dual IRB review necessary?

The VA central research office will not allow its IRBs to rely on the IRBs of other institutions, nor will it allow other IRBs to rely on the reviews of VA IRBs.

 4.  What  does this mean for my research study that is reviewed by UW IRB Committee V, V2, EV, or EV2?

If you are a VA researcher and your research does not involve the UW:  As of July 1, you should use the forms and procedures that will be provided on the VAPSHCS website.  

If you are a VA researcher and your research involves the UW (for example, the research funding is administered through the UW Office of Sponsored Programs, or you or the research staff are UW employees), OR if you are a UW researcher and your research involves the VA (for example, you are recruiting from a VA patient population or a VA colleague is doing assays for you):  your research will be reviewed by the new VA IRB andyour research will be reviewed by UW IRB Committee A, B, C, D, G, J or a Minimal Risk team.  You will need to submit all future paperwork to both IRBs, using each IRB's specific form (modifications, annual Status Reports, adverse event reports, etc.)

 5.  What does this mean when I want to start a new study that involves both the UW and VAPSHCS?

You will need to submit an application to both the UW IRB and the VA IRB.  Our two institutions are currently designing procedures to minimize the extra paperwork and effort required.  These procedures will be widely publicized, and will be prominently posted on the UW and VA websites.

 6.  How can I find out more?

There will be a Research Town Hall meeting to discuss the transition from the University of Washington IRB to a newly constituted VA IRB.

Date:    Thursday, May 14, 2009

Time:    1:30-3:00 PM

Presenters/moderators
Dr. Steven Kahn, ACOS for Research & Development, VAPSHCS
Dr. Karen Moe, Director, UW Human Subjects Division

VA location
Seattle Division, Building 100, Room BB108

Other VA locations
VTEL videoconferencing will be set up at American Lake, Met Park, and the Boise VAMC

UW location
A live video broadcast of the meeting will be provided in Health Sciences T239.  Representatives of the UW Human Subjects Division will be present.