NIH Basic Experimental Studies Involving Humans No Longer Classified as Clinical Trials
NIH Basic Experimental Studies Involving Humans No Longer Classified as Clinical Trials
 
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NIH Proposes New Requirements for Clinical Trials; Public Comment Period Closes November 12

February 2026

On January 29, the National Institutes of Health (NIH) issued a notice announcing that Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements of the NIH clinical trial definition. This update applies to proposals with due dates on or after May 25, 2026, including education research and social and behavioral science studies currently classified as BESH.

NIH had required BESH projects to be classified as clinical trials following its 2014 revision to the definition of “clinical trial.” AERA joined 45 scientific associations and universities on a letter, led by the Council on Governmental Relations and the Federation of Associations in Behavioral & Brain Sciences, to the National Institutes of Health opposing the classification of basic research studies involving human participants as clinical trials. In addition, Brett Miller at the Eunice Kennedy Shriver National Institute of Child Health and Human Development discussed the impact of including BESH under the NIH clinical trial policy for education researchers in a January 2018 Highlights Q&A.

As stated in the January 29 NIH notice:

“In the context of the definition of clinical trials, the NIH now considers a health-related biomedical or behavioral outcome as having the potential for direct advancement of health. 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.”

Current BESH projects will continue to adhere to registration and reporting requirements in clinicaltrials.gov. NIH also indicated that it will provide updated guidance to help investigators determine whether a study qualifies as BESH, a clinical trial, or an observational study involving humans.