New NIH FAQ for Basic Experimental Studies with Humans (BESH)

NIH has developed a Frequently Asked Question (FAQ) for investigators planning applications with Basic Experimental Studies with Humans (BESH) on or after May 25, 2026 to clarify that the information in NOT-OD-26-032 only applies to basic science studies/BESH. It does not apply to other types of NIH funded clinical trials.

For due dates on or after May 25, 2026, NIH will no longer consider BESH to be clinical trials. However, BESH must continue to comply with all other applicable laws and regulations applicable to human subjects protections and the NIH Data Management and Sharing Policy.

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