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Human Subjects Division (HSD)

Topics

Clinical Trials

IRB Review:


Clinical trials conducted by UW researchers are usually reviewed by one of the following Institutional Review Boards (IRBs):

 

  • Western Institutional Review Board (WIRB) reviews most industry-sponsored and industry-initiated trials conducted by UW faculty. Industry-initiated means that the sponsor writes and owns the protocol for the study.
  • The Cancer Consortium IRB (CC-IRB) reviews most oncology trials conducted by UW faculty who are members of the Cancer Consortium.
  • The UW IRBs review clinical trials which are federally-funded and/or investigator-initiated. "Investigator-initiated" includes any clinical trial whose protocol was developed or idea was initiated by a UW investigator regardless of funding. Investigator-initiated trials can be partially funded by an industry-sponsor.

 

ClinicalTrials.gov

The UW HSD office also facilitates all registrations (e.g., initial registration, results postings) with Clinical Trials.gov for UW researchers.

 

Contract (Clinical Trials Agreements) and the Consent Form

The UW Office of Sponsored Programs (OSP) negotiates a contract (Clinical Trials Agreement) with an industry sponsor on behalf of the UW. However, the UW HSD office bears the responsibility of comparing the research consent form with the budget summary and the contract for UW studies reviewed by WIRB.

 

For more information, please see the links to these pages under "Related Topics."