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The UW Human Subjects Division compares the research consent form and the research budget with the Clinical Trial Agreement (CTA) or contract between the sponsor funding the research and the UW.  HSD's Clinical Trials Administrator does this comparison for WIRB-reviewed and UW IRB-reviewed studies.

For clinical trials reviewed by Western IRB (WIRB):

HSD must 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 is part of the HSD screening process for studies which will be reviewed by WIRB. The industry Clinical Trial Agreement must be final before HSD will sign the UW/WIRB Cover Sheet that authorizes submission to WIRB.  "Final" means at least partially executed by either the sponsor ot the UW Office of Sponsored Programs (OSP). Note that HSD can sign the UW/WIRB Cover Sheet if the UW has a Master Clinical Trial Agreement (MCTA) with the sponsor.  The OSP maintains a list of MCTAs on their website, linked at right.

For clinical trials reviewed by the Fred Hutchinson Cancer Research Center (FHCRC) IRB or the Cancer Consortium IRB (CC-IRB). The associate General Counsel performs this comparison among contract, budget and consent form.

For clinical trials reviewed by the UW IRB:

HSD does this comparison for UW IRB reviewed studies. The UW IRBs will review your application while the contract is pending. However, complete IRB approval will not be granted until the contract is final.

Document 1079, "Contract and Consent Form Comparison" describes in detail the new contract and consent form comparison process implemented on 8/16/10.