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Human Subjects Division (HSD)

Regulatory Updates

FDA Issues Guidance on New Informed Consent Requirements

Feb 9, 2012 at 4:29am

FDA has issued the guidance, "Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c)." This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials better understand the new informed consent requirement, including small businesses.

The document is now available using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf