U.S. Food and Drug Administration (FDA) Regulations and Guidance

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.

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