NOT-OD-26-063
NIH Announces that it has updated its definition of “intervention” to align with the Common Rule (45 CFR 46, Subpart A).
Key Update
Effective immediately, NIH will adopt the Common Rule definition of an intervention:
“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.”
This replaces NIH’s previous definition used in its clinical trial framework.
Background
- NIH previously established its own definition of “intervention” as part of its clinical trial policy (2014)
- The 2018 Common Rule introduced a slightly different definition
- NIH has now aligned its definition to ensure consistency across federal agencies
Going Forward
- The updated definition may affect how studies are classified as
- Clinical trials
- Basic Experimental Studies Involving Humans (BESH)
- Observational studies
- Investigators should
- Review study designs involving human subjects
- Ensure correct classification under NIH policies
- NIH will update forms, systems, and guidance to reflect this change