02/24/2011: New FDA requirement for Informed Consent forms effective immediately!

Under Federal law, studies that utilize any drug or device must include the following statement at the end of section 5 in the Informed Consent form starting March 7, 2011:

A description of this clinical trial will be available on https://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.

This requirement extends to:

  • All drugs, whether they are previously approved by the FDA or investigational, except for Phase I studies.
  • All devices, except those used in small feasibility studies

Investigators must immediately start including the above statement in the Informed Consent forms for all new studies and continuing reviews for research that involves drugs or devices.

The final rule for this requirement was published in the Federal Register on January 4th, 2011 and just came to our attention this week. Due to the late discovery and notification of the requirement, IRB staff will assist investigators with implementing this requirement throughout the next month.

Please contact the IRB at UFIRB-L@lists.ufl.edu or (352) 273-9600 if you have any questions.