FDA details compliance for informed consent
April 1, 2012
FDA details compliance for informed consent
The FDA issued a guidance detailing how to comply with the new regulation that informed consent documents include a specific statement that clinical trial information will be or has been submitted for inclusion in ClinicalTrials.gov's trial registry. The statement must be included in informed consent documents for "applicable" trials started on or after March 7, 2012.
"Applicable" trials "generally include controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE). Trial sponsors and investigators have the responsibility of determining whether or not a trial is an 'applicable clinical trial,'" guidance said.
The agency noted that the rule "does not prevent investigators from voluntarily reporting data from clinical trials that do not meet the definition of an applicable clinical trial to ClinicalTrials.gov and sharing that information with participants."
The guidance answers 27 questions on the new requirement and "is intended to help sponsors, investigators and institutional review boards better understand" the new requirement in 21 C.F.R. §50.25(c).
Although "applicable" trials conducted outside the United States must comply with the notification regulation, the agency noted that "the mere fact that we accept data from a foreign clinical trial in connection with a marketing application does not make it an applicable clinical trial." In addition, the rule "does not preclude the inclusion of mandatory or recommended language from non-U.S. governments, and it does not preclude reference to other clinical trial registries or regulatory bodies."
The FDA issued a guidance detailing how to comply with the new regulation that informed consent documents include a specific statement that clinical trial information will be or has been submitted for inclusion in ClinicalTrials.gov's trial registry.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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