60. Department of Defense (DoD) Regulations for Human Subject Research (32 CFR 219)
Involvement of DoD personnel in research requires compliance with the Common Rule, Subparts B, C, and D and the additional directives itemized below. DoD regulations apply to and may vary for the separate components: Army, Navy, Air Force and Marine Corps.
Additional DoD requirements involve the following:
- ethics training
- IRB review and approval
- use of research monitors
- recruitment and informed consent
- special or vulnerable populations
- compensation in research
- multi-site or transnational research
- reporting requirements
The IRB requires an additional investigator form to verify that investigators address IRB-relevant elements specific to DoD regulations.
In presenting the protocol to the IRB, the primary reviewer will address the additional DoD regulatory requirements.