Updates Related to Recent Executive Orders

Basic Experimental Studies Involving Humans (BESH) Classification Change

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March 25, 2026

For NIH grant submissions on or after May 25, 2026, Basic Experimental Studies involving Humans (BESH) will no longer be considered clinical trials per NOT-OD-26-032. BESH are studies in humans that have the purpose of understanding fundamental aspects of phenomena without a direct application towards clinical processes or products. “Process or products” are used to define the application of biomedical or behavioral research to affect a health-related outcome. After this change takes effect, BESH studies will no longer need to register or report results on ClinicalTrials.gov. 

There are four key questions to determine whether a study qualifies as BESH or is considered a clinical trial: 

  1. Does the study involve human participants (per 45CFR46)?  
  2. Are participants prospectively assigned to an intervention?   
  3. Is the study designed to evaluate the effect of the intervention on the participants?  
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?  

For more information, visit "Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving Humans?"