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62. Additional DoD Review Requirements

NOTE: Non-exempt human subject research involving classified information requires approval by the Secretary of Defense after IRB approval.

Requirements for Non-DoD Institutional Review

  • As with all research, the University IRB will consider the scientific merit of the research and may rely on outside experts to provide an evaluation of same.
  • Substantive changes to approved DoD-sponsored research, including modifications to research reviewed by expedited procedures, must undergo scientific review prior to IRB review.

Requirements for Administrative Review by DoD Component

The HRPO must concur with all RIO or IRB determinations of "not human subject research" before project activities may be initiated.

If the University determines an activity is non-exempt research involving human participants, the HRPO must administratively review and approve the research before the activities that involve human participants can begin. The purpose of this approval is to confirm the research is compliant with DoD regulations and directives; and laws and requirements, and cultural sensitivities of a foreign country, as applicable.

The HRPO must administratively review and approve surveys developed for administration to DoD personnel, after IRB review and approval.

The following conditions require administrative review and approval by the DoD component:

  • DoD-supported research that will be conducted in a foreign country by University or affiliate investigators.
  • Collaborative research in which a DoD institution will rely on a University IRB.
  • NOTE: Requires a written agreement defining the responsibilities and authorities of both organizations, use of the University's FWA, and that the involvement of DoD personnel is secondary to that of the University.
  • DoD-supported research permitting a waiver of informed consent.

NOTE: University and affiliate investigators have never and are not expected to engage in DoD-supported fetal research, making requirements for DoD administrative review of fetal research moot.

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