Key Dates

Related Announcements

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Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

In 2014, the NIH revised its definition of a clinical trial (NOT-OD-15-015) to increase transparency and accountability and enhance the precision of the information NIH collects, tracks, and reports on clinical trials. In the context of the NIH clinical trial definition, the NIH also defined an intervention as:

A manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.

These efforts preceded the 2018 Common Rule (45 CFR 46, Subpart A [Protection of Human Subjects]), which defined an intervention as:

Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

NIH adopted an implementation approach that operationalized these definitions in a similar manner. However, to ensure consistency and harmonize implementation of the Common Rule across federal agencies, effective with the publication of this Notice, NIH is adopting the definition of an intervention as defined in 45 CFR 46, Subpart A, above. The NIH will make revisions to its websites and forms, as needed, to reflect this change.

Guidance on determining whether a research study with human subjects is considered by the NIH to be a clinical trial, a basic experimental study involving humans (BESH), or an observational study can be found on the Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving humans webpage.

Inquiries

Please direct all inquiries to:

The Office of Policy for Extramural Research Administration, OER
Division of Grants Policy
Email: [email protected]