NIH Further Delays Clinical Trial Reporting Requirements for Basic Research Involving Humans until September 2021
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NIH Further Delays Clinical Trial Reporting Requirements for Basic Research Involving Humans until September 2021
 
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August 2019

On July 24, the National Institutes of Health (NIH) announced that it would be extending a delay for enforcing the clinical trial reporting requirements for NIH-funded “basic experimental studies with humans” (BESH) through September 24, 2021. The initial deadline for compliance with the revised clinical trials policy was September 24, 2019.

Under the revised NIH clinical trials policy, basic experimental studies involving humans are considered clinical trials, requiring grantees to register their studies on clinicaltrials.gov. In response to concerns from the basic science community, last year NIH delayed enforcement of the reporting requirements and made study-type-specific funding opportunities available.

The extension of the enforcement delay was necessary to address continued challenges with reporting research involving BESH on clinicaltrials.gov, according to a post on the NIH Open Mike blog. NIH expects studies supported through the BESH-specific funding opportunity to register and report findings, but will allow continued flexibility for grantees to report and register their studies on portals other than clinicaltrials.gov.

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