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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

NIH is notifying the community that Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition.

Background

In 2014, the NIH revised its clinical trial definition to increase transparency, accountability, and precision in tracking research:

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

This new definition was part of a broader stewardship initiative to ensure all NIH-supported research involving human participants is subject to rigorous standards and that results are rapidly disseminated, even if not considered an Applicable Clinical Trial under Section 801 of the Food and Drug Administration Amendments Act. As part of this effort, the categories of research considered clinical trials were expanded to include Basic Experimental Studies Involving Humans (BESH).

Because policies related to results dissemination have changed since 2014, and as part of ongoing efforts to reduce administrative burden, effective for applications submitted to due dates on or after May 25, 2026, the NIH will no longer characterize BESH as clinical trials. 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 understandfundamental aspects of phenomena without immediate clinical applications. Therefore, BESH research is no longer considered to meet the NIH definition of a clinical trial.

Applicability

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. BESH must continue to follow all other applicable clinical research laws, regulations, and policies, including, but not limited to human subjects protections and the NIH Data Management and Sharing Policy. Currently funded BESH studies should follow their established Terms and Conditions of Award as well as NOT-OD-25-134 (Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants).

The NIH will provide further guidance and examples for how to assess if a study is BESH, a clinical trial, or an observational study involving humans. NIH is actively reviewing current instructions and system validations and will provide detailed guidance in a forthcoming Guide Notice on any instruction or system changes, as needed, to reflect the updated classification. NIH also anticipates expiring all BESH-specific NOFOs for due dates on or after May 25, 2026 because BESH research can now be accepted through the Clinical Trials Not Allowed companions of these NOFOs.

Inquiries

Please direct all inquiries to:

NIH Office of Policy for Extramural Research Administration (OPERA)
Division of Grants Policy
[email protected]