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

February 12, 2026

On January 29, NIH announced that Basic Experimental Studies with Humans (BESH) will no longer be considered clinical trials by the NIH. See NOT-OD-26-032.

What’s changing?

  • Beginning with applications submitted for due dates on or after May 25, 2026, BESH will no longer be considered as clinical trials by NIH.
  • As a result, BESH studies will not be required to follow NIH clinical trial requirements, including registration and results reporting in ClinicalTrials.gov.
  • BESH must continue to follow all other applicable laws and regulations applicable to human subjects protections and the NIH Data Management and Sharing Policy. 

NIH anticipates expiring all BESH-specific NOFOs with due dates on or after May 25, 2026. After that time, BESH research can be accepted through the Clinical Trials Not Allowed companions of these NOFOs.

NIH will issue a forthcoming Guide Notice with detailed guidance on any necessary instruction or system updates to reflect this revised classification.

Resources

Editor's Note: After publication, we added the third bullet above for clarity.

Categories: Top Stories

Related News

You’re Invited: A Conversation on NIH’s Unified Funding Strategy

We invite you to join a conversation between NIH leadership on NIH’s Unified Funding Strategy. Our Unified Funding Strategy is designed to support NIH Institutes and Centers to make informed, transparent, and flexible funding decisions. During their conversation, NIH leadership will clarify the approach’s rationale, goals, and implementation across NIH; address misconceptions; and help foster communication between NIH staff and research community.

Top Stories

What Study Information Should Be Included on a ClinicalTrials.gov Entry?

A ClinicalTrials.gov study record is intended to summarize key information from a study’s protocol and the study’s findings. The study sponsor or investigator is responsible for ensuring that their studies follow all applicable laws and regulations and for submitting complete, accurate, and up-to-date information about their study.

You Ask, We Answer
For technical issues E-mail OER Webmaster