FDA Amends Informed Consent Requirements for Drug and Device Clinical Trials


All stakeholders involved in U.S. Food and Drug Administration-regulated clinical trials should begin now to plan for transitioning to use of informed consents that meet the specific requirements of the new rule.

On January 4, 2011, the U.S. Food and Drug Administration (FDA) published its final rule amending current regulations governing the informed consent process for clinical research studies of products regulated by the FDA, at 21 C.F.R. § 50.25(c).

The final rule requires that all informed consent documents for “applicable” drug (including biological product) and device clinical trials initiated on or after March 7, 2012, include a statement to inform individual subjects in the trials that a description of the clinical trial will be made available on the National Institutes of Health/National Library of Medicine (NIH/NLM) website at clinicaltrials.gov. The statement must also indicate clinicaltrials.gov will not include individually identifiable information.

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