Human Subjects

FDA ramps up enforcement of clinical trials

On August 14, the FDA released new guidance detailing increased penalties for identified cases of noncompliance with the requirement to register their studies and post results on This motion arises out of recent findings that compliance with these requirements remains low, and more so within academia than industry. Further, it is believed that poor compliance is likely reflective of a lack of enforcement by regulators, and stepping up enforcement efforts would be a useful remedy for the issue.

Currently, federal requirements mandate the use of this service in order to monitor clinical trial information for potential concerns as specified in 42 CFR 11.10(a). Specifically, researchers must register within 21 days of the first study subject enrollment, and the results must be posted within one year of completion. This applies to any studies that fall under FDA’s regulatory thumb, or studies receiving funding from the NIH. Failure to comply with this policy could result in penalties up to $10 thousand for each day until the violation is corrected, as well as civil or criminal proceedings.

To identify such violations, evidence is typically collected either during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO) or based on the evaluation of complaints received at the agency. Once discovered, the FDA said it’s continuing to send what it calls “pre-send notice letters,” which alert a company of potential violations and gives it 30 days to fix it. During a pilot enforcement project before the issuance of the rule, the FDA said it sent 15 such letters out and all the companies subsequently complied – further evidence that a more active stance would be beneficial for bolstered compliance.

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