Research funded by the Department of Defense must be reviewed by the IRB under an additional set of federal regulations 32CFR219. This set of regulations is similar to 45CFR46 Part A. DoD does follow protections in 45CFR46 Subparts B-D. In addition to the regulations, the DoD distributes guidance documents called “Directives”. Additional information regarding review for a DoD funded study may be found in the Directives.
How do I know if my research involves the DoD?
Research involves the DoD when any of the following apply:
- The research is funded by a component of DoD. (Example: Department of Defense direct grant, the Office of Naval Research, Department of the Army, etc.)
- The research involves cooperation, collaboration, or other type of agreement with a component of DoD.
- The research uses property, facilities, or assets of a component of DoD.
- The subject population will intentionally include personnel (military or civilian) from a component of DoD.
Department of Defense components include, but may not be limited to:
- Department of Defense
- Office of Naval Research
- Naval Academy
- U.S. Naval Observatory
- U.S. Army Corps of Engineers
- Military Academy (West Point)
- Air Force
- Air Force Academy
- Coast Guard
- Coast Guard Academy
- National Guard
- Missile Defense Agency
- Defense Advanced Research Projects Agency (DARPA)
- Pentagon Force Protection Agency
- Defense Intelligence Agency
- National Geospatial-Intelligence Agency
- National Security Agency
- National War College
- Other DoD facilities
Office of Naval Research Website
The web site above lists additional DoD references, which includes the following:
- Title 32, Code of Federal Regulations, Part 219, “Protection of Human Subjects”.
- DoD Directive 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD–Supported Research”
- DoD Directive 6200.2, “Use of Investigational New Drugs for Force Health Protection,”
- Section 980 of title 10, United States Code - PDF