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

March 16, 2026

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.

Resources

Categories: You Ask, We Answer

Related News

Reminder of Requirement for Certification of IRB Approval

NIH would like to remind the extramural research community that NIH requires recipients to submit a certification to NIH that all nonexempt research involving human subjects has been reviewed and approved by an appropriate Institutional Review Board (IRB).

Tips Before You Submit

Planning an NIH Application involving Basic Experimental Studies with Humans (BESH)?

NIH announced that Basic Experimental Studies with Humans (BESH) will no longer be considered clinical trials by the NIH. 

Top Stories
For technical issues E-mail OER Webmaster