Topics

Operational Definition:

Clinical trials are biomedical or behavioral research studies in which the safety or therapeutic effect of an intervention, pharmacokinetics, or the effectiveness of a diagnostic procedure is being evaluated in human beings.

IRB Review:

Clinical trials conducted by UW researchers are 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 means that the investigator writes and owns the protocol for the study. Investigator-initiated trials can be partially funded by an industry-sponsor.

ClinicalTrials.gov

The UW HSD office also facilitates the initial and results registrations with Clinical Trials.gov for UW researchers.

Contract (Clinical Trials Agreements) and the Consent Form

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

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