DOD Requirements

The focus of this guidance page is on the requirements outlined in DoD Instruction 3216.02 (DoDI 3216.02), Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (April 15, 2020). Each DoD Component (e.g., Army, Navy, Air Force) may have additional requirements beyond those included in this guidance document. Principal investigators are advised to check with their DoD sponsoring Component about any additional requirements.

Human research must comply with DoD requirements when:

• Funding: The research is funded by a component of DoD. Example: A grant from the Office of Naval Research.
• Collaboration: The research involves cooperation, collaboration or other type of agreement with a component of DoD.
• Facilities: The research uses property, facilities or assets of a component of DoD.
• Personnel: The subject population will intentionally include personnel (military and/or civilian) from a component of DoD. Note: DoD policies and requirements do not apply when DoD personnel incidentally participate as subjects in research that is not supported by DoD, and DoD personnel are not an intended population of the research.

For research sponsored by the DoD, “experimental subject” is defined as an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32CFR.210.102). Research involving “experimental subjects” is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of 32 CFR 219.

Upon completion of review and approval by Indiana University HRPP, including a determination of exempt or not human subject research, the HRPO for the sponsoring component must perform an administrative review of the research before activities with research participants may begin. The review involves confirmation that the University and the proposed research comply with DoD requirements for the protection of research participants. While the HRPO review is not an IRB review, the HRPO may require changes to the research before the start of the research. It is the Principal Investigator’s responsibility to request this review. IU HRPP does not have any role in this process.

Additionally, before beginning human subject research, the DoD Component must also conduct a CLAR when any of the following conditions occur:

• Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.
• The involvement of DoD personnel in the conduct of the research is secondary to that of the non-DoD institution.
• The research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).
• The research is fetal research, as described in 42 USC 289g-289g-2.
• Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSDG includes data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc.
• The research constitutes classified research involving human participants
• The research is required to be approved by the DoD Office of Human Research Protections (DOHRP) (in addition to the DoD component's Office of Human Research Protections (COHRP) in accordance with DoDI 3216.02.

It is the Principal Investigator’s responsibility to request this review. IU HRPP does not have any role in this process.

There may be additional requirements that are specific to the grant, contract, or study. Researchers should carefully read the official communications (Notice of Award, Contract, etc.) about DoD funding requirements.

DoD does not allow researchers to expend DoD funds for human subjects research until all of the applicable requirements have been met (as specified in the DoD’s DFARS clause attached to grants and contracts). The Indiana University Office of Research Administration (ORA) will not process the NOA until the restrictions have been lifted by DoD.

DoD-involved research that involves more than one institution or collaborator must comply with the same federal requirement for a Single IRB as other federally-funded research. When conducting multi-site research, a formal agreement between institutions is required to specify the roles and responsibilities of each party.

The DoD requires the use of a Single IRB in accordance with Section 219.114 of Title 32, CFR. If a DoD institution believes that the research is not subject to the provision listed in Section 219.114(b) of Title 32, CFR, the applicable DoD Component Office of Human Research Protections (COHRP) may determine and document, in accordance with Section 219.114(b)(2)(ii) of Title 32, CFR, that use of a single IRB is not appropriate for the particular context of the proposed research.

Any DoD institutions collaborating in human subjects research with non-DoD institutions may rely on the collaborating non-DoD institution’s IRB if all of the following conditions are met: 

• The DoD institution determines the non-DoD institution has an appropriate federal assurance or that a federal assurance is not required.
• The non-DoD institution’s IRB is registered in accordance with Subpart E of Part 46 of Title 45, CFR.
• The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.
• The DoD institution, non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining the responsibilities and authorities of each institution in complying with all legal requirements. This agreement must specify that the non-DoD IRB will apply the DoD requirements specified in DoDI 3216.02, including but not limited to non-DoD institutional responsibilities defined under DoDI 3216.02 section 3.6(b).
• If the research constitutes classified human participant research, the COHRP must approve the agreement to rely on the non-DoD institution’s IRB.

DoD applies the definition of “minimal risk” that is specified in the Common Rule (45 CFR 46). DoD regulations explicitly add that minimal risk does not include the inherent risks that some subjects face in their everyday life, such as those:

• Encountered by Service members, law enforcement, or first responders while on duty
• Resulting from or associated with high-risk behaviors or pursuits
• Experienced by individuals whose medical conditions involve frequent tests or constant pain

Additional or more frequent education or certifications may be required for researchers conducting research subject to DOD regulations than currently required by IU. Researchers should contact their Program Officer at the DOD, or DOD component, to ensure adherence to any unique requirements.  It is the PI’s responsibility to ensure that research staff has completed all appropriate educational requirements as mandated by DOD policy.

Research involving surveys or interviews with DoD personnel (military or civilian) or their families may require DoD approval after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD Components, additional review is required. Consult with the Department of Defense funding component to coordinate this review.

Research that is conducted in non-U.S. locations must meet any requirements and restrictions of the specific nation. However, this does not apply to DOD-involved research whose subjects are DoD-affiliated personnel and not citizens of the host country. Consult with the DoD component’s human research protection official for assistance in identifying any host nation requirements that may apply.

The involved DoD components can advise researchers about whether their planned research is considered classified, although the definition is provided here for informational purposes.

Research is considered to be classified human subjects research when:

• Classified information is required for IRB review and oversight, or
• Classified information must be provided to human subjects, or their guardians, during the recruiting or consent process in order to achieve fully effective legal consent, or
• Classified information is provided to, or by, research subjects.

Human subjects research is NOT considered to be classified when:

• The research is part of a classified program but the research itself does not involve the three characteristics described immediately above for classified human subjects research, OR
• The research requires subjects to hold a clearance as a means of creating ease of entry or access to controlled spaces where the otherwise unclassified research will occur, OR
• The research is an authorized operational activity (which means it is not considered to be human subjects research).

Indiana University permits the conduct of classified human subject research in accordance with applicable federal regulations, including DoDI 3216.02 and the National Industrial Security Program Operating Manual (NISPOM, 32 CFR Part 117). All classified research activities must comply with institutional, federal, and sponsor requirements. Contact the University Director, IU HRPP, when planning classified human subjects research.

The Facility Security Officer (FSO), designated by Indiana University, is responsible for coordinating compliance with security requirements related to classified research, including Personnel Clearances (PCLs) and Facility Clearance (FCL) processes. Any proposal to conduct classified human subjects research must be submitted to the FSO for review. The FSO will determine eligibility for required clearances and coordinate with federal agencies as needed. IU’s Chief Research Security Officer and Director of National Defense R&D Relations serve as primary institutional points of contact for matters related to classified research.

The IRB is prohibited from approving the following research:

• Research with detainees or prisoners of war, except research with investigational new drugs or devices, when the purpose is for diagnosis or treatment of a medical condition in a patient, with their informed consent, and where such treatment would also be offered to US military service members at the same location and with the same medical condition consistent with established medical practice.
  • DoD Instruction 2310.01E defines a detainee as: “Any individual captured by, or transferred to the custody or control of, DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the United States is the occupying power. Detainees who are U.S. citizens or U.S. resident aliens will continue to enjoy all applicable rights and privileges under U.S. law and DoD regulations.”
• Human testing of chemical or biological agents, except for certain prophylactic, protective, or peaceful purposes. Before any excepted testing of chemical or biological agents involving human participant research can begin, the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP).

DoD requires that the protection of Common Rule Subpart B (Pregnant Women/Fetuses), C (Prisoners), and D (Children) be applied to the research it supports. The DoD (and the IRB) considers the need for similar safeguards for other vulnerable populations such as those with cognitive impairment, mental illness, physical disability or any other circumstance that might require special protections.

Pregnant women, fetuses, and neonates:

• For purposes of applying Subpart B, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.”
• The applicability of Common Rule Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
• Fetal research must be conducted in accordance with, and follow restrictions outlined in US Code Title 42, Chapter 6a, Sub-chapter 3, Part H, 289g.

Prisoners:

Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted, but must first be approved by the Indiana University IRB and meet the requirements of Subpart C and DoDI 3216.02.

Children:

Regardless of any state or federal definition of “minor”, DoD considers all of the following to be adults for the purposes of research. However, if any of the participants might be under 18 years of age, the IRB must carefully consider the recruiting process and the necessity of including these individuals.

• Service members
• Members in all Reserve components and National Guard who are in a federal duty status
• Students at a Service Academy (e.g., West Point, Air Force Academy)
• Military trainee

DoD-affiliated personnel are: Service members and trainees, Reserve Service members, National Guard members, DoD civilian employees, and DoD contractors.

Recruiting: If a service member, reserve component or National Guard member in federal duty status, a student at a Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the research recruitment process and the necessity of including such a member as a human subject.

If the research involves DoD-affiliated personnel as subjects and if the research includes any risks to their fitness for duty (e.g. health, availability to perform the 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 key investigator 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 research 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 HSR recruitment sessions, if applicable.

For greater than minimal risk research and where recruitment is conducted in a group setting, the IRB must appoint an ombudsman person. The IU HRPP expects the researcher to nominate the ombudsperson and, include contact information and credentials. 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 research 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.

Payment for research participation: Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with Title 5, U.S.C., with particular reference to Subparts G and H, with some exceptions for purposes consistent with Section 30 of Title 24, U.S.C. The following limitations on dual compensation for U.S. military personnel apply for DoD funded research:

• An individual may not receive pay from more than one position for more than 40 hours of work in one calendar week. This limitation on dual compensation includes temporary, part-time and intermittent appointments.
• Individuals may receive compensation for research activities if the research activities take place outside of scheduled work hours.
• Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.
• Non-Federal persons may be compensated for research participation other than blood draws in a reasonable amount approved by the IRB according to local prevailing rates and the nature of the research.

Large Scale Genomic Data (LSGD): The disclosure of genomic data may pose a risk to national security. DoD-conducted or DoD-supported research involving LSGD collected on DoD-affiliated personnel, or for which research the DoD provides assistance, is subject to additional requirements.

• Large scale genomic data are defined by DoD as data derived from genome-wide associate studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses, and gene expression data; etc. Examples include but are not limited to projects that involve generating the whole genome sequence for more than one gene from more than 1,000 individuals, or analyzing 100 or more genetic variants in more than 1,000 individuals.
• The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, such research requires administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of deidentified data or specimens. The DoD component(s) involved in the research must include in their administrative review a security review of the adequacy of the proposed administrative, technical, and physical safeguards.
• All research involving LSGD collected from DoD-affiliated personnel will apply an HHS Certificate of Confidentiality pursuant to Title 42, U.S.C., and Public Law 114-255.

The Common Rule identifies conditions under which an IRB may waive consent for research involving humans as research participants. However, the requirement to obtain consent cannot be waived for any research using DoD funds and meeting the definition of research involving a human being as an experimental subject. This places limitations on research involving deception, decisionally impaired individuals, or research being conducted under emergency conditions where the participant may not be able to provide consent.

When the research meets the 10 USC 980 definition of research involving a human being as an experimental subject, informed consent must be obtained in advance from the participant or the participant’s legal representative consistent with the Common Rule if the participant cannot consent. Informed consent may be provided by a legally authorized representative (LAR) only if: (1) the research participant lacks decision making capacity; AND (2) the IRB has determined that the research is intended to be beneficial to the individual research participants. 

The U.S. Secretary of Defense may waive this consent requirement for a specific project in order to advance the development of a medical product necessary to the Armed Forces, but only if the research may directly benefit the research participant and the research is carried out in accordance with all other applicable laws and regulations.

This statute applies only to certain intervention studies. It does not apply to retrospective research involving analysis of data or specimens, observational studies, blood draws, or tissue collection, and does NOT apply to screening of records to identify possible research participants. The IRB may grant a waiver of consent for such activities.

When conducting emergency medicine research (also known as Exception from Informed Consent “EFIC” research), the DoD component seeking to conduct such research must obtain explicit written approval from the DoD Office for Human Research Protections (DOHRP) on behalf of the U.S. Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980. Until this approval is obtained and submitted, IU HRPP may not approve such research.

Consent documents must include additional DoD elements of disclosure.

For all participants, the informed consent documents must include:

• A statement that the DoD or a DoD organization is funding the study, unless the research involves no more than minimal risk. The Secretary of Defense may grant an exception to this requirement on the grounds that providing this information could compromise intelligence sources or methods.
• 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. The disclosure for research-related injury must follow the requirements of the DOD component. Note that the DoD component may have stricter requirements for research-related injury than the Common Rule regulations (which apply to DoD research).

Additionally, if the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, 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 (ICD) 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.

The following must be reported by the Principal Investigator to the applicable DoD Component Office of Human Research Protections (generally within 30 days of the event):

• IRB-approved changes to research that involve changes to key investigators or institutions; decreased benefit or increased risk to subjects in greater than minimal risk research as defined in Part 219 of Title 32; addition of vulnerable populations, or DoD-affiliated personnel as subjects.
• Transfer of research oversight to a different IRB.
• Notification by any federal body, State agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that the non-DoD institution’s DoD-supported research is under investigation.
• Results of continuing review (if continuing review required). Sending the IRB approval letter should be sufficient.
• Change in status when a previously enrolled human subject becomes pregnant, or when the researcher learns that a previously enrolled human subject is pregnant, and the protocol was not reviewed and approved by the IRB in accordance with Subpart B of 45 CFR 46.
• Change in status when a previously enrolled human subject becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with Subpart C of 45 CFR 46.
• Closure of the study, for any reason.

NOTE 1: Reports of audits of DoD-conducted or DoD-supported human subjects research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government, within 5 business days of discovering that such audit reports exist.

NOTE 2: Substantiated allegations related to classified human subjects research must be reported immediately (less than five days).

NOTE 3: The following will be reported by IU HRPP as outlined in the HRPP Policy, “Reporting to Oversight Agencies:”

• Any unanticipated problems involving risks to subjects or others, suspension or termination of IRB approval, or any serious or continuing noncompliance pertaining to DoD-supported research.