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 http://www.ClinicalTrials.gov, 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.