Effective with applications submitted for due dates on or after May 25, 2026 (NOT-OD-26-032), Basic Experimental Studies in Humans (BESH) will no longer be considered clinical trials by the National Institutes of Health (NIH).
Going forward, 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.
For BESH study NIH Grant applications submitted for due dates on or before May 24, 2026, and contract solicitations issued prior to that date, BESH will continue to be treated as a clinical trial and need to follow the clinical trial requirements.