What is required by this regulatory change?
The final rule revises the current informed consent regulations to require a new element for informed consent documents and processes that will inform potential participants that information about the research has been, or will be, entered into a databank that is publicly accessible at http://www.ClinicalTrials.gov. The statement is as follows:
“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 citation for the new regulation is: 21 CFR 50.25(c).