Success! NIH Changes Clinical Trials Policy

An APS advocacy goal has been securing a change to the National Institutes of Health policy related to Basic Experimental Studies involving Humans (BESH).

Several years ago, the NIH began classifying basic experimental studies involving humans, including many basic psychological and behavioral studies, as clinical trials under NIH’s clinical trials reporting and compliance requirements. This significantly complicated and added bureaucratic burdens to psychological and behavioral science research. APS actively opposed that policy change and has steadfastly advocated for NIH to reverse course.

APS opposes a series of NIH policy changes that classify basic experimental studies with humans as clinical trials. View the archive of APS coverage on this topic.

APS is pleased to share that the NIH has heard our calls. On 29 January 2026, NIH announced that basic experimental studies involving humans will no longer be subject to NIH Clinical Trials Requirements. Effective with applications submitted to due dates on or after 25 May 2026, BESH will no longer be considered clinical trials by the NIH.

We thank NIH for this change which makes important basic psychological and behavioral sciences research involving humans easier to conduct. This means science will move a little faster.

For examples of APS advocacy on this issue, please see:

• US Congress Cautions NIH on Clinical Trials Policies
• Make Your Voice Heard: Tell NIH You Oppose the Classification of Basic Human Subjects Research as Clinical Trials
• NIH Delays Some Clinical Trials Requirements Imposed Earlier on Basic Behavioral Research