Announcement: The National Institutes of Health (NIH) has issued new guidance under Notice NOT-OD-26-032 regarding Basic Experimental Studies Involving Humans (BESH).
What Has Changed?
NIH has announced that Basic Experimental Studies Involving Humans (BESH) will no longer fall under the NIH Clinical Trial Definition.
Effective for applications submitted to due dates on or after May 25, 2026, BESH studies:
- Will no longer be considered clinical trials by NIH.
- Will not be subject to NIH clinical trial requirements.
- Will not require registration or results reporting in ClinicalTrials.gov.
What Still Applies?
Although BESH will no longer be treated as clinical trials, these studies must continue to comply with:
- Human subjects protections.
- All applicable clinical research laws and regulations.
- The NIH Data Management and Sharing Policy.
- Any other relevant NIH policies.
Currently funded BESH projects must continue to follow their existing Terms and Conditions of Award, as well as prior guidance under NOT-OD-25-134 regarding flexibilities for registration and results reporting.
Why This Matters
This update reduces administrative burden for investigators conducting basic experimental studies involving human participants, while maintaining critical compliance requirements related to human subjects protections and data management.
Departments supporting NIH-funded research should review proposal development and compliance workflows to ensure alignment with this updated classification beginning May 25, 2026.
For full details, please review NIH Notice NOT-OD-26-032 on the NIH website.
Questions?
If you have any questions, please feel free to contact your DCG Officer.