The FDA has recently issued guidance on the new statement that must be included as part of “informed consent” forms for clinical trial participants.  Sponsors, investigators, and review boards conducting an  “applicable clinical trial” of drugs, biological products, and devices involving human subjects must inform participants of the availability of clinical trial information at www.ClinicalTrials.gov in order to comply with new FDA regulation, 21 CFR § 50.24(c). 

The following statement, word for word, must be included in the participant consent or in the consent of parents/guardians of child participants:

“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.”

The requirement is not retroactive, so re-consents will not be needed for ongoing clinical trials as long as the IRB approved the consent form before March 7, 2012.  If the potential participants are non-English speaking, the statement should be translated. The statement must also be included in participant consents in FDA-regulated trials overseas.  The consequences for non-compliance are that the FDA may seek administrative, civil, and criminal penalties.