FDA Final Rule Amends Current Regulations Governing Informed Consent of Potential Clinical Trial Participants

The Food and Drug Administration (FDA) issued a final rule on January 4, 2011 that amends 21 C.F.R. § 50.25 and the requirements for informed consent documentation and process in FDA-regulated clinical trials of drugs, biological products, and medical devices.

The final rule responds to Section 801 of the FDA Amendments Act of 2007 (FDAAA), which requires registration and results posting in the federal data bank, ClinicalTrials.gov, for “applicable clinical trials” of FDA-regulated drugs and medical devices. FDAAA mandated that FDA’s drug regulations be updated “to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigations has been or will be submitted for inclusion in the registry data bank.” The final rule requires the following statement to be included in the informed consent documents and process of “applicable clinical trials” for both drugs (including biological products) and medical devices...

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