NIH Further Extends Registration, Reporting Enforcement Delay for Some Clinical Trials

On March 23, the National Institutes of Health (NIH) issued a notice (NOT-OD-21-088) further delaying enforcement of the NIH Policy on Dissemination of NIH-Funded Clinical Trials Information for basic experimental studies with human participants (BESH). As previously reported, NIH established a revised definition of “clinical trials” several years ago, which now includes some basic behavioral and social science research and mandates new reporting requirements. The new registration and reporting requirements—specifically requirements to register and report in ClinicalTrials.gov—have presented challenges for some types of behavioral and social science projects that now fall under the BESH category. In response, NIH delayed enforcement of these requirements for BESH projects through September 24, 2021. This latest move delays enforcement for two additional years, through September 24, 2023, allowing the agency additional time to “work with the BESH community to explore solutions that allow for the dissemination of information in ways that are useful to other researchers and members of the public, while also maintaining the NIH commitment to stewardship and increasing transparency.” In the interim, if not reported in ClinicalTrials.gov, BESH projects are expected to be registered and results reported on alternative publicly available platforms. See the Notice for full details.

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Posted in Issue 7 (March 30), Update, Volume 40 (2021)

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