Topics
Related Documents
- HIPAA Authorization Template
- UW/WIRB Clinical Pharmacology Unit (CPU) Consent Template
- UW/WIRB Consent Template
- UW/WIRB Cover Sheet
- WIRB - Background on WIRB
- WIRB - Cancer Consortium Members
- WIRB - Conflict of Interest
- WIRB - Criteria for Review by WIRB
- WIRB - Documentation of Human Subjects Training
- WIRB - Final contract between the UW and the sponsor
- WIRB - HSD screening before applying to WIRB
- WIRB - IRB fees for review
- WIRB - Modifications
- WIRB - Other regulatory and compliance approvals
- WIRB - Partial Waiver of Authorization for Recruitment
- WIRB - UW Confidentiality Agreement
- WIRB - UW Consent Form
- WIRB - UW HIPAA Authorization Form
- WIRB - Western IRB's Review Process
Related Links
Western IRB (WIRB)
Western Institutional Review Board (WIRB) reviews industry-sponsored and industry-initiated trials conducted by UW faculty. Industry-sponsored means the trial is paid for by a private company which has contracted with UW faculty to conduct a study of the safety and/or efficacy of drugs, devices, diagnostics, treatments or preventative measures in humans. Industry-initiated means the company or sponsor writes and owns the protocol for the study.
The UW Human Subjects Division must screen your study prior to your submission to WIRB. To apply to WIRB for IRB review, complete the UW/WIRB Cover Sheet and send the cover sheet with attachments to hsdinfo@uw.edu.
The UW Office of Sponsored Programs negotiates the contract or Clinical Trials Agreement (CTA) with the industry sponsor. As of 8/16/10, the CTA must be final before HSD will sign off on the UW/WIRB Cover Sheet. However, we strongly encourage you to submit your UW/WIRB Cover Sheet and required attachments to HSD during Clinical Trial Agreement or contract negotiations.
Note that HSD can sign the UW/WIRB Cover Sheet if the UW has a Master Clinical Trial Agreement (MCTA) with the sponsor. The UW Office of Sponsored Programs (OSP) maintains a list of MCTAs on their website (see link at right).
The UW/WIRB Cover Sheet, the UW/WIRB Consent Form Template, UW HIPAA Authorization Form and a variety of policies and procedures specific to WIRB are listed in the "Related Documents" section of this page.
Send submissions or contact the Clinical Trials Administrator with questions at hsdinfo@uw.edu.
Change Notes
- Noted 09/08/2010 @ 02:19pmKeyword newly added.- sherrye

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