Harmonizing NIH Intervention Definition with Common Rule

NIH Guide Weekly Index

Published March 27th, 2026

Detected March 27th, 2026

Summary

The National Institutes of Health (NIH) has updated its definition of 'intervention' to align with the 2018 Common Rule (45 CFR 46, Subpart A). This change aims to harmonize implementation across federal agencies and will be reflected in NIH websites and forms. The notice was released on March 27, 2026.

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What changed

The NIH has officially adopted the definition of 'intervention' as provided in the 2018 Common Rule (45 CFR 46, Subpart A), replacing its previous 2014 definition. This harmonization aims to ensure consistency in how research involving human subjects is classified and regulated across federal agencies. The NIH will update its relevant websites and forms to reflect this change.

Compliance officers and researchers should review the updated definition to ensure accurate classification of studies. While this is a harmonization of definitions and not a new compliance deadline, it is crucial to understand how this change might affect the categorization of research projects, particularly those involving physical procedures or manipulations for research purposes. The NIH has provided guidance on distinguishing clinical trials, basic experimental studies involving humans (BESH), and observational studies.

What to do next

Review the updated NIH definition of 'intervention' to ensure accurate study classification.
Update internal documentation and processes as needed to reflect the harmonized definition.

Source document (simplified)

Harmonizing the NIH Definition of Intervention with the Common Rule Notice Number: NOT-OD-26-063

Key Dates

Release Date: March 27, 2026

Related Announcements

None

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 subjects 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.