NOT-OD-26-067

NIH released implementation guidance confirming that, effective for applications due on or after May 25, 2026, Basic Experimental Studies with Humans (BESH) will no longer be classified as clinical trials. As a result, BESH studies will no longer be subject to NIH clinical trial requirements such as registration and results reporting in ClinicalTrials.gov, though all other human subjects protections and data sharing requirements remain in effect. Applications proposing BESH without a separate NIH-defined clinical trial may be submitted to Clinical Trial Not Allowed funding opportunities, while applications to Clinical Trial Required mechanisms must include a true clinical trial; NIH submission systems will enforce these distinctions. 

For more from the Pre-Award team, click here.