Harmonizing the NIH Definition of Intervention with the Common Rule
National Institutes of Health (NIH)
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- Posted
- Mar 28, 2026
- Closes
- No deadline published by the funder
Amount
Amount not published by the funder
About this opportunity
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 ...