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65. Additional DoD Requirements for Special or Vulnerable Populations

See informed consent (above) for DoD requirements for obtaining consent for individuals with impaired consent capacity.

DoD Prohibitions on Research Involving Prisoners of War or Detainees

  • Research with prisoners of war is prohibited. Investigators should refer to the definition of "prisoner of war" for the particular DoD component supporting the research.
  • Research involving a detainee is prohibited unless
    • an investigational new drug or investigational device is offered to detainees with the detainees' informed consent, and
    • the same product would be offered to members of the U.S. Military Services in the same location for the same medical condition.

DoD Requirements for Research Involving Prisoners

  • DoD research involving prisoners cannot be reviewed by the expedited procedure.
  • DoD allows epidemiological research involving prisoners when the following are true:
    • The research describes the prevalence or incidence of a disease by identifying all cases, or studies potential risk-factor associations for a disease.
    • The research presents no more than minimal risk and presents no more than an inconvenience to the participant.
  • When a research participant becomes a prisoner while enrolled in DoD research, the PI must notify the IRB of the change in participants' status to prisoner.
    • If the PI asserts it is in the incarcerated-participant's best interest to continue in the research, the IRB chair may determine that s/he may continue to participate until both of the following occur:

(1) The convened IRB reviews and approves a change in the research protocol to allow the participant to continue to continue in the study while a prisoner. (See below for the role of the prisoner representative for the review.)

(2) The University or affiliate IO, and the DoD component review and agree with the IRB's decision.

    • If the PI cannot assert it is in the prisoner-participant's best interest to continue in the research, the IRB chair shall require that all research interactions and interventions with the prisoner-participant cease until the convened IRB can review the change in the research protocol.
    • Upon receipt of notification that a previously enrolled human participant has become a prisoner, the prisoner representative at a convened IRB meeting

(1) shall re-review the research protocol to ensure that the rights and wellbeing of the human participant, now a prisoner, are not in jeopardy;

(2) shall review the request to modify the protocol; and

(3) may recommend approval of the modification if all of the following conditions are met:

      • The prisoner-participant can continue to participate voluntarily and fully-informed.
      • The prisoner participant is capable of meeting the research protocol requirements.
      • The terms of the prisoner-participant's confinement does not inhibit the ethical conduct of the research.
      • There are no other significant issues preventing the research involving human participants from continuing as approved.

NOTE: This review and approval is limited to the continued participation of the individual prisoner-participant and does not allow recruitment of prisoners as participants.

DoD Requirements for Research Involving Pregnant Women, Human Fetuses and Neonates

  • For purposes of these requirements, the phrase "biomedical knowledge" shall be replaced with "generalizable knowledge" and be interpreted to have the same meaning.
  • The applicability of 45 CFR 46 subpart B is limited to research
    • that is more than minimal risk and
    • includes interventions or invasive procedures to the woman or the fetus, or fetuses or neonates (i.e., newborns as defined in §46 subpart B).
  • Fetal research must comply with US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.

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