New FDA Consent Requirement Becomes Mandatory on March 7, 2012

The US Food and Drug Administration has issued a guidance document explaining a new requirement to include language about in consent forms for drug and device studies.

Consent forms for covered studies that begin on or after the implementation deadline of March 7, 2012, must include the following statement:

A description of this clinical trial will be available on, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

There is no requirement to revise existing consent forms or to re-consent previously enrolled participants. The new guidance, “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”, explains in more detail which trials are covered and how to comply.

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