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Human Subjects Division (HSD)

Announcements

Faster WIRB Review Time

Jan 11, 2011 at 10:12am

UW clinical trials that are industry-sponsored and industry-initiated are reviewed for the UW by Western IRB (WIRB).

Two changes implemented in December will result in significantly faster IRB review by WIRB.

  1. The three-day "hold" requirement has been lifted.   This means that study documents approved by WIRB will no longer be held for HSD inspection before being released to the research team and the study sponsor.   The hold is no longer necessary because of the changes in the WIRB submission process that were implemented in August.
  2. The reading level requirement for consent forms has been changed.  Until now, consent forms were required to be written at no more than an 8th grade reading level.   WIRB's standard policy is that consent forms should be written at an 8th- 10thgrade reading level.   WIRB's procedures to address this specific UW requirement added a minimum of 5 days to review time, and sometimes as much as a couple of weeks.   The UW has now changed its reading level requirement for WIRB-reviewed studies to make WIRB's standard policy.