Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition.
grants.nih.gov/grants/guide...
NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH NOT-OD-26-032. NIH