Basic Experimental Studies In Humans: Recent NIH Changes and What They Mean for Researchers

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This message was approved by Phillip Worts, Director of the Clinical Research Hub and Health Research Connections, for distribution to faculty and staff.

For NIH grant applications due on or after May 25, 2026, Basic Experimental Studies with Humans (BESH) are no longer classified as clinical trials.

NIH now interprets a "health-related biomedical or behavioral outcome" as one with the potential for direct advancement of health. Many prospective experimental studies of fundamental biology or behavior therefore fall outside the clinical trial category.

The changes may also impact clinicaltrials.gov registration and results reporting. Join us and learn how BESH applies to your research.

Date: October 28th

Time: 12:00 p.m. - 1:00 p.m.

Location: Microsoft Teams via https://bit.ly/4ycB1MR 

Article Date
October 07, 2026