Chapter 9: Department of Defense (DOD) Research
Human subjects research is subject to Department of Defense (DoD) oversight when one or more
of the following applies:
- the research is funded by the DoD,
- the research involves cooperation, collaboration or other type of agreement with the DoD (including subawards),
- the research uses property, facilities, or assets of the DoD, and/or
- the subject population will intentionally include military personnel and/or civilian personnel employed by the DoD.
These regulations do not apply when DoD personnel incidentally participate as research subjects where they are not the intended research population.
Involving a detainee as a human subject is prohibited in DoD-regulated research.
In addition to its Common Rule regulations at 32 CFR 219, DoD provides specific instructions for human subjects research in DoD Instruction 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.” Investigators are encouraged to consult the granting agency with questions about additional requirements for specific DoD-regulated projects. DoD agencies may provide additional guidance about regulations specific to each agency. After the IRB has approved a research project, the project may also be subject to additional review or approval by the Secretary of Defense.
Investigators intending to survey or interview military or civilian DoD personnel should note that the survey or interview instrument(s) may require specific review and approval by the DoD.
For research conducted in an international setting, all applicable national laws and requirements of the foreign country must be met. The IRB may request documentation to this effect from the research team. During its review, the IRB must also consider the cultural sensitivities in the setting where the research will take place.
For multisite research, the research involving human subjects must be approved by all required organizations before human subjects research activities begin. The IRB may approve a protocol contingent upon approval by other organizations.
1. Training Requirements
DoD requires continuing research ethics training for research personnel involved in the design, conduct, or approval of humans subjects research. For certain DoD-sponsored research, UM training requirements meet the DoD requirements. However, for research specifically sponsored by the Under Secretary of Defense for Personnel and Readiness, training is required on an annual basis. For research specifically sponsored by the Department of Navy, training specific to Department of Navy-Supported Extramural Performers is required. For other military branches, researchers are advised to consult the appropriate program officer for any applicable training requirements. The IRB may require documentation of appropriate training for personnel, as applicable.
2. IRB Review Requirements
DoD regulations place certain limitations on IRB review of certain research, including that DoD research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review procedure.
When evaluating risk to subjects, the IRB must consider the risk to the average person, and not the specific risks of the everyday life of a person inherent in the work environment (e.g., emergency responder, pilot, soldier in a combat zone) or associated with a medical condition (e.g., frequent medical tests or constant pain).
Recruitment and Enrollment
Officers are not permitted to influence the decision of their subordinates.
- Officers and senior non-commissioned officers may not be present at the time of recruitment.
- Officers and senior non-commissioned officers have a separate opportunity to participate.
- When recruitment involves a percentage of a unit, an independent ombudsman is present.
For greater than minimal risk research involving DoD-personnel, when recruitment and consent occur in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
- Must not have a conflict of interest with the research or be a part of the research team.
- Must be present during the HSR recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.
- Should be available to address DoD-affiliated personnel’s concerns about participation.
Consent
If the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, the IRB or component HRPO must confirm that the consent documents must include:
- If the research involves risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.
- If applicable, a statement of potential risks for the revocation of clearance, credentials, or other privileged access or duty.
- A statement that the DoD or a DoD organization is funding the study.
- A statement that representatives of the DoD are authorized to review research records.
For greater than minimal risk research:
- Consent documents must include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended.
- Written materials must document how organizations will care for participants with research-related injuries, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.
Unless specifically agreed to by the DoD, the IRB cannot approve a waiver of consent for research where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Informed consent must be obtained in advance from the experimental subject or the subject's legal representative.
If consent is to be obtained from the experimental subject's legal representative rather than the subject, the research must intend to benefit the individual subject. The determination that research is intended to be beneficial to the individual experimental subject must be made by the IRB.
Compensation
In general, federal personnel enrolled in DoD-supported research may be compensated up to $50 for a blood draw and may not be otherwise compensated while on duty. If the personnel are off duty, and if the research is not federally funded, the human subjects may be compensated for blood draws in a reasonable amount as approved by the IRB. Additionally Federal personnel while off duty may be compensated for research participation other than blood draws in the same way as human subjects who are not Federal personnel. However, payment to off-duty Federal personnel for general research participation must not be directly from a Federal source.
Non-Federal personnel may be compensated for participation in DoD-supported research in a reasonable amount as approved by the IRB. Payment for non-Federal personnel for research participation may come directly from a Federal or non-Federal source.
Scientific Merit Review
The UM IRB Chair is authorized to write a Scientific Merit Review letter on behalf the UM IRB.
3. Specific Subject Protections
Service Members
Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required, as follows (DoDI 3216.02 section 3.9 (f)):
- If the research involves DoD-affiliated personnel as participants and if the research includes any risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.
- If the research involves DoD-affiliated personnel, the researcher must receive command or component approval to execute the research.
- Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in research.
- Military and civilian supervisors, officers, and others in the chain of command must not be present at any participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.
- Service members and all Reserve component and National Guard members in a federal duty status are considered to be adults. If a Service member, Reserve component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.
Research with Prisoners
Research involving incarcerated persons cannot be reviewed by the expedited procedure.
When the IRB reviews research involving incarcerated persons, at least one incarcerated person representative must be present for quorum. In addition to allowable categories of research on incarcerated persons in Subpart C, epidemiological research is also allowable when:
- The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease.
- The research presents no more than minimal risk.
- The research presents no more than an inconvenience to the participant.
If a participant becomes an incarcerated person, and if the researcher asserts to the IRB that it is in the best interest of the incarcerated person-participant to continue to participate in the research while an incarcerated person, the IRB chair may determine that the incarcerated person-participant may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD Component office review the IRB’s approval to change the research protocol. Otherwise, the IRB chair shall require that all research interactions and interventions with the incarcerated person-participant (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol.
The convened IRB, upon receipt of notification that a previously enrolled human participant has become an incarcerated person, shall promptly re-review the research protocol to ensure that the rights and wellbeing of the human participant, now an incarcerated person, are not in jeopardy.
The IRB should consult with a participant matter expert having the expertise of an incarcerated person representative if the IRB reviewing the research protocol does not have an incarcerated person representative. If the incarcerated person-participant can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the incarcerated person-participant’s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human participants from continuing as approved, the convened IRB may approve a change in the study to allow this incarcerated person-participant to continue to participate in the research. This approval is limited to the individual incarcerated person-participant and does not allow recruitment of incarcerated persons as participants.
Research involving a detainee as a human participant is prohibited. This prohibition does not apply to research involving investigational drugs and devises when the same products would be offered to US military personnel in the same location for the same condition.
If consent is to be obtained from the experimental participants’ legal representative, the research must intend to benefit the individual participant. The determination that the research is intended to be beneficial to the individual experimental participant must be made by an IRB.
Research involving a prisoner of war is prohibited. A prisoner of war is a person captured in war; especially: a member of the armed forces of a nation who is taken by the enemy during combat.
4. Institutional Requirements
The 91次元 is required to notify the DoD Human Research Protection Official when significant changes to the research protocol are approved by the IRB, the results of the IRB continuing review, if the IRB used to review and approve the research changes to a different IRB, when the institution is notified by any Federal department or agency or national organization that any part of its human research program is under investigation for cause involving a DoD-supported research protocol, and all unanticipated problems, suspensions, terminations, and serious or continuing noncompliance regarding DoD-supported research involving human subjects.
Records maintained by the institution that document compliance or noncompliance are accessible for inspection and copying by authorized representatives of the Department of Defense. The DoD Components may rely on the institution to keep the required records that were generated by the institution, or the DoD Components may make arrangements to transfer the records.
There may be additional requirements that the institution must comply with when conducting DoD regulated research.