Effective with applications submitted to due dates on or after May 25, 2026, Basic Experimental Studies in Humans (BESH) will no longer be considered clinical trials by the 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.
Currently funded BESH studies should follow their established Terms and Conditions of Award as well as NOT-OD-25-134 (Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants).
The 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. NIH is actively reviewing current instructions and system validations and will provide detailed guidance in a forthcoming Guide Notice on any instruction or system changes, as needed, to reflect the updated classification. NIH also anticipates expiring all BESH-specific NOFOs for due dates on or after May 25, 2026 because BESH research can now be accepted through the Clinical Trials Not Allowed companions of these NOFOs.
Full Notice
National Institutes of Health
NOT-OD-26-032
January 29, 2026