NIH Policy Update: Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH

NIH has issued a new policy titled Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH (NOT-OD-26-032). This policy will impact human subjects research projects moving forward and will result in some decreased burden on these types of projects. The clinical trial definition meant that many projects which don’t seem like traditional clinical trials met the definition of a clinical trial and, as such, had additional regulatory requirements imposed upon them.  The NIH guidance explains that:

“Although BESH research, which produces fundamental information about biology or behavior, might eventually inform advances in health, it is not conducted with the express intent of changing clinical practice or health but rather aims to understand fundamental aspects of phenomena without immediate clinical applications. Therefore, BESH research is no longer considered to meet the NIH definition of a clinical trial….

Effective with applications submitted to due dates on or after May 25, 2026, BESH will no longer be considered clinical trials by the NIH. Going forward, BESH will not have to follow the requirements for clinical trials, including registration and reporting in ClinicalTrials.gov.”

NIH has indicated that additional guidance will be released to help investigators determine whether their study qualifies as BESH versus a clinical trial or other type of human subjects research. Find that here: Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving Humans?

Please read the full NIH guidance here and reference it before making any compliance decisions regarding HSR:

Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH (NOT-OD-26-032)