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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.

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