The National Institutes of Health (NIH) recently issued notice NOT-OD-26-032, which informs the research community that Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition. This will be effective with applications submitted to due dates on or after May 25, 2026.
BESH will not have to follow the requirements for clinical trials, including registration and reporting in ClinicalTrials.gov. BESH must continue to follow all other applicable clinical research laws, regulations, and policies, including, but not limited to, human subjects protections and the NIH Data Management and Sharing Policy.
NIH will provide further guidance and examples for how to assess if a study is BESH, a clinical trial, or an observational study involving humans in a forthcoming Guide Notice.
Please direct all inquiries to the NIH Office of Policy for Extramural Research Administration (OPERA), Division of Grants Policy. They can be contacted via email at grantspolicy@nih.gov.