FDA Proposes New Language for Informed Consents

A rule proposed by the FDA requires that informed consent forms for clinical trials include specific language telling patients that registration, results and other information about the trial will be submitted to ClinicalTrials.gov, a publicly available trial registry database. The rule would apply to Phase II and III trials for drugs and biologics, as well as many trials for medical devices, according to the agency’s notice in the Federal Register.
Washington Drug Letter