The National Institutes of Health will no longer categorize basic experimental studies involving humans (BESH) as clinical trials, according to a Jan. 29 announcement from the agency.
BESH applications submitted on or after May 25, 2026, will not be subject to clinical trial requirements but must still comply with all other applicable clinical research laws, regulations and policies, the release said. The agency said the revision is part of ongoing efforts to reduce administrative burden.
Under the revised definition, clinical trial research produces “a health-related biomedical or behavioral outcome as having the potential for direct advancement of health.” BESH research may potentially inform future health advancements, but it is not conducted with the intent of changing clinical practice; therefore, the agency said, it does not fall under the definition of a clinical trial.
The NIH is reviewing current systems and will provide future guidance on how to assess whether a study falls under the definition of a clinical trial.
Read the full announcement here.
