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Human Subjects Division (HSD)

Announcements

All research involving the VA must be re-reviewed.

Dec 8, 2008 at 1:33pm

Certain restrictions and conditions have been imposed upon human subjects research at the VA Puget Sound Health Care System (VAPSHCS) and the Boise VA Medical Center (VAMC) as the result of a recent audit by the VA’s Office of Research Oversight.

 

One of those conditions is that all research already reviewed and approved by UW IRB Committee V or V2 must halt enrollment of new subjects at the VA, further acquisition of data and tissue at the VA, and analysis or publication of data housed at the VA until the research has been re-reviewed by the IRB.

 

The principal investigators (PIs) of these studies must provide the IRB with some specific materials required for the re-review.  These materials, and instructions on how to complete them, are provided on the HSD web site at:  

 

http://www.washington.edu/research/hsd/va

 

One required item is an Addendum to consent forms.  When an Addendum has been approved by the IRB, the PI will be required to provide the Addendum to all current subjects, and to obtain each subject’s signature and a witness signature on the Addendum.  This can be done the next time each subject comes for a clinic or research visit.

Please contact Amy Marsh at amy.marsh@va.gov or 206-764-2670 if you have any questions.