FDA: Guidance for Sponsors, Investigators, and Institutional Review Boards

Policymed: March 09, 2012.

Earlier this month, the Food and Drug Administration (FDA) released a new Clinical Trials Guidance Document.  The guidance addresses questions on informed consent elements for clinical trials, regulated under 21 CFR §50.25(c).  The new regulation is on page 256, volume 76 of the Federal Register and was published on January 4, 2011.

All applicable clinical trials initiated on or after March 7, 2012, must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.  For the purposes of this rule only, FDA considers “initiation” of a clinical trial to be the clearance or approval of any informed consent documents by an IRB or other ethics review committee. Read More