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Human Subjects Division (HSD)


Change in WIRB Process

Aug 3, 2010 at 8:53am

Affects:   Industry-initiated clinical trials reviewed by Western IRB (WIRB)

Effective date:   August 16, 2010

The industry contract or clinical trial agreement must be completed before HSD will sign the WIRB Cover Sheet that authorizes submission of the IRB application to WIRB.   This will allow HSD to ensure that the contract, consent form, and study budget are consistent in their descriptions of who pays for what procedures and adverse events.   This consistency comparison will be part of the WIRB Cover Sheet signing process.  By changing the timing of this process, HSD expects to eliminate many of the comparison iterations that currently occur for many WIRB-reviewed clinical trials.