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Human Subjects Division (HSD)

Regulatory Updates

FDA: Guidance Regarding IRB Continuing Review

Jan 29, 2010 at 5:56am

On January 13, the FDA announced in the Federal Register the availability of a draft guidance entitled, "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval."

See: http://edocket.access.gpo.gov/2010/2010-426.htm, or http://edocket.access.gpo.gov/2010/pdf/2010-426.pdf

The draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.

The document may be obtained at: http://www.regulations.gov, or at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

Written or electronic comments on the draft guidance should be submitted by March 15, 2010.