Rule Amends Trials Consent Procedures

The Food and Drug Administration has published a final rule that requires patients in clinical trials be informed that trials information will be entered into a national database.

The rule, published Jan. 4 in the Federal Register, amends existing informed consent regulations governing clinical trials. The Food and Drug Administration Amendments Act of 2007 requires submission of trials information to the Clinical Trial Registry Databank of the National Institutes of Health and National Library of Medicine.

For text of the rule, click here.

--Joseph Goedert