On July 24, the National Institutes of Health (NIH) released a notice announcing a further delay of enforcement of clinical trials reporting requirements for NIH-funded research designated as “basic experimental studies with humans.” The enforcement date, originally extended to September of this year, has been pushed to September 24, 2021. A blog post from the NIH Office of Science Policy describes the extension as necessary to address the challenges of reporting requirements for some researchers by continuing to search for common ground with the basic science community.
The notice is the latest iteration of NIH statements relating to changes to NIH’s clinical trial policy. As previously reported, NIH has established a new definition of “clinical trials” which includes some basic behavioral and social science research and mandates new reporting requirements. COSSA previously authored a Hot Topic piece detailing how the changes would affect basic research. Due to negative reactions from the basic science community on concerns of undue burden on the researchers, NIH announced a delay in the enforcement of the clinical trials policy and issued a Request for Information (RFI) to the community on best practices for implementing the policy. Read COSSA’s previous coverage for more details.