By Karla Damus, PhD, MSPH, MN, RN, FAAN
Administrator, BMC/BUMC ClinicalTrials.gov and MCSR Licensure
NIH has Refined the Definition of an ‘Intervention’
On March 27, 2026, NIH released NOT-OD-26-063 entitled, Harmonizing the NIH Definition of “Intervention” with the Common Rule. Effective with its publication, NIH has adopted the definition of an intervention from the 2018 Common Rule (45 CFR 46, Subpart A [Protection of Human Subjects]), which is:
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 reflects a change from the intervention definition NIH has used since 2014, when it revised its definition of a clinical trial in (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 2014 notice NIH 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.
Therefore, moving forward, NIH will use the harmonized definition of an intervention provided above from the 2018 Common rule. NIH is revising its websites and forms as needed to reflect this change in the definition of an intervention.
If you have questions about this topic or if you need assistance with registering, updating, or posting results and documents on CTgov, contact the BMC/BUMC CTgov Administrator [Karla Damus, damusk@bu.edu, 617 358 5337]