FDA Amends Consent for Trials

The Food and Drug Administration recently issued a proposed rule to amend informed consent regulations pertaining to clinical trials.

The amendment would "require that informed consent documents and processes for applicable drug, biologic and device clinical investigations include a statement that clinical trial information for such clinical trial investigations has been or will be submitted to the National Institutes of Health/National Library for inclusion in the clinical trial registry databank," according to the proposed rule.

The proposed rule is part of FDA initiatives to expand the clinical trial registry databank and make it publicly available through the Internet, as mandated under the Food and Drug Administration Amendments Act of 2007. The change called for under the proposed rule will increase public awareness of the databank, enable consumers to make informed decisions, and increase the transparency of clinical trials, according to the FDA.

The proposed rule was published in the Dec. 28 Federal Register, available at gpoaccess.gov/fr/index.html.

--Joseph Goedert