Department of Defense


Research supported by the Department of Defense (DoD), including the separate components, the Army, Navy, Air Force and Marine Corps, or recruitment of DoD personnel requires compliance with additional federal regulations, Directives and Instructions. This procedure applies to human subject research that is funded by any DOD component or that recruits participants from the DoD.


Continuing non-compliance: A pattern of noncompliance that suggests the likelihood that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply, or a persistent lack of knowledge of how to comply with the DoD Instructions 3216.02.

Minimal risk: When following Department of Defense regulations: The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in everyday life.  For example the risks imposed in certain work environments (emergency responder, pilot soldier in a combat zone) or with certain medical conditions (frequent medical tests or constant pain).

Non compliance: Failure of a person, group, or institution to act in accordance with DoD Instruction 3216.02

Research Involving a Human Being as an Experimental Subject: An activity, for research purposes, 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 (32 CFR 219.103(f) reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose. Research involving a human being as an experimental subject is a subset of research involving human subjects. The definition relates only to the application of Section 980 of Title 10, U.S.C. as implemented by DoDI 3216.02, paragraph 3.11.; it does not affect the application of Part 219 of Title 32 CFR.

Large Scale Genomic Data (LSGD): Data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. Research involving LSGD may or may not also constitute HSR. Examples of research involving LSGD includes, but is not limited to, projects that involve generating the whole genome sequence data for more than one gene from more than 1,000 individuals, or analyzing 100 or more genetic variants in more than 1,000 individuals.

Serious Non-Compliance: Failure of a person, group, or institution to act in a manner such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

Educational Requirements

Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support or manage human research supported by the DoD or its components. At the present time, the University of Pittsburgh HRP requires that individuals conducting human subjects research complete modules on Responsible Conduct of Research and Human Subjects Protection as described in Chapter 22.  Individual DoD components may have stricter or specific educational requirements and may require re-certifications more frequently than currently mandated by the University of Pittsburgh HRP.  Researchers should contact their Program Officer at the DoD, or DoD component, to ensure adherence to any unique requirements.  It is the Principal Investigator’s responsibility to ensure that research staff has completed all appropriate educational requirements as mandated by DoD policy.

Scientific Review

New research and substantive modifications to approved research must undergo scientific review prior to IRB review.  This requirement can be met by University departmental scientific review process and will be documented in PittPRO before a review can be conducted by the IRB.

Consent Issues

Research Related Injury

The Department of Defense components may have stricter requirements regarding research-related injury than those outlined in the policies of the University of Pittsburgh and federal regulations.  Investigators should work with their Program Officer within the DoD component to identify such requirements.  Additional language regarding specific requirements by the DoD should be incorporated into the informed consent document as appropriate.

Waiver of Consent

If the research subject of a study funded by the DoD or its components meets the definition of “experimental subject” then a waiver of consent [including an exception from informed consent in emergency medicine research] by the IRB is prohibited. The requirement for consent may be waived by the DoD Officer for Human Research Protections (DOHRP) or its delegate, if the following three conditions are met: 1) the research is necessary to advance the development of a medical product for the Military Services; 2) The research may directly benefit the individual experimental subjects; 3) The research is conducted in compliance with all other laws and regulations. However, if the research subject does not meet the definition of an “experimental subject,” then the IRB may waive the consent process. Waivers are prohibited for classified research.

Emergency Medicine Research

When conducting emergency medicine research, the DOHRP on behalf of the Secretary of Defense must approve a waiver of the advanced informed consent provision of 10 USC 980.

Consent from Legally Authorized Representative

Research involving consent by a legally authorized representative is only permissible if the research is intended to be beneficial to individual subjects. The determination that the research is intended to be beneficial to the experimental subject must be made by the IRB. The University of Pittsburgh has additional requirements for those who are decisionally impaired as outlined in Chapter 14. As a protocol at the University would need to meet both sets of requirements, the more restrictive policy would apply.

DoD Conducted/Supported Research

For DoD-conducted and DoD-supported research, the consent must include the following:

  • A statement that the DoD or a DoD organization is funding the study
  • A statement that representatives of the DoD are authorized to revie research records

Studies Involving Department of Defense Personnel

If the research involves DoD-affiliated personnel as subjects, the following is required:

If the research includes any risks to fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about the risks for the revocation of clearance, credentials, or other privileged access or duty, and that command or Component guidance should be sought before agreeing to participate.

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 human subject research.

Military and civilian supervisors, officers, and others in the chain of command must not be present at any HSR participant recruitment sessions or during the HSR consent process. Excluded supervisors or those in the chain of command may participate in separate HSR recruitment sessions, if applicable.

Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.

In a study determined to be greater than minimal risk where recruitment is in a group setting, the IRB must appoint an ombudsperson. For minimal risk studies, the IRB will consider whether a ombudsperson is necessary. The ombudsperson:

  • Must not have a conflict of interest with the research or be part of the research team.
  • Must be present during 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 the DoD-affiliated personnel’s concerns about 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. 

Vulnerable Populations

Research supported or conducted by the Department of Defense that affects vulnerable classes of subjects must meet the additional protections of 45 CFR Part 46, Subparts B, C, and D.  Determinations authorizing or requiring any action by an official of DHHS is under the authority of the DOHRP.

Research with Minors

The exemption at 45 CFR 46.104 (d) (2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed (See 32 CFR 219.101). 

Status as Adults:

For purposes of legal capacity to participate in DoD-conducted or supported research involving human subjects, all Service members and all Reserve Component and National Guard members in a Federal duty status are considered for the purpose of DoD Instruction 3216.02 to be adults.   If a Service member, Reserve Component or National Guard member in a federal duty status, student at a Service Academy, or trainee is  under 18 years of age, the IRB shall carefully consider the recruitment process and the necessity to include such members as human subjects. 

Research with Prisoners

Captured or detained personnel: The DOD Directive 3216.02 (section 3.9) prohibits research involving prisoners of war.    This includes any person captured, detained, held, or otherwise under the control of DOD personnel (military and civilian or contractor employees).  Such persons include enemy prisoners of war, civilian internees, detained persons, lawful and unlawful enemy combatants.  Such persons do not include DOD personnel being held for law enforcement purposes. 

This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition. 

DoD funded research involving prisoners cannot be expedited. 

In addition to the allowable categories of research on prisoners in 45 CFR Part 46, Subpart C, two additional categories are permissible:

  1. Epidemiological research is allowable when:
  • The research describes the prevalence or incidence of a disease by identifying all cases or studies the potential risk factor associations for a disease.
  • The research presents no more than minimal risk.
  • The research presents no more than an inconvenience to the participant.
  • Prisoners are not a particular focus of the research. 
  1. Human subject research that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB and must meet the requirements in Subpart C of 45 CFR 46

If a participant becomes a prisoner, if the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, 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. 

Pregnant Women

For the purposes of applying 45 CFR Part 46, Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”

The applicability of Subpart B is limited to research involving pregnant women 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

Fetal research funded by the DOD must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.   Please refer to Chapter 14 of the IRB Policies and Procedures Manual, Considerations for Special Subject Populations, Research Involving Pregnant Women, Neonates, and Fetuses.    

Additional DoD Review Requirements

Required Approvals

Non-exempt classified research conducted or supported by DoD must receive final approval from the DoD Office of Human Protections (DOHRP), in accordance with the requirements of DoD Instruction (DoDI) 3216.02, paragraph 3.13.

Large Scale Genomic Data

When research involves large scale genomic data (LSGD) collected on DOD-affiliated personnel, additional protections are required:

  • Additional administrative, technical, and physical safeguards to prevent disclosure of DoD affiliated personnel’s genomic data commensurate with risk (including secondary use or sharing of de-identified data or specimens)
  • The study team will apply for an HHS Certificate of Confidentiality
  • The research is subject to DoD Component security review and DOHRP approval.

Formal Agreements

When conducting multi-site research, investigators should contact the University of Pittsburgh Office of Sponsored Programs to ensure that a formal agreement between organizations is implemented. The purpose of the agreement is to specify the roles and responsibilities of each party.

Single IRB

The use of a Single IRB will be required in accordance with 32 CFR 219.114. If a DoD Institution believes that the research is not subject to those provisions, the applicable DoD Component Office of Human Research Protections may determine and document, that use of a single IRB is not appropriate for the particular context of the proposed human subject research. Studies already in progress before January 20, 2020 are not required to transition to a single IRB, nor request an exception. Additional policy information related to use of a single IRB is in Chapter 24.

International Research

When DoD-sponsored research involves human subjects who are not U.S. citizens or DoD personnel and the research is conducted outside the United States, and its territories, the Principal Investigator must obtain permission from the host country.  The laws, customs, regulations and practices of the host country and those required by the University of Pittsburgh IRB will be followed.  An ethics review by the host country, or local DoD IRB with host country representation is required.  Evidence of permission to conduct the research in the host country by certification or local ethics review must be submitted to the University of Pittsburgh IRB prior to initiation of the project.

Records Review

Records maintained that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the supporting DoD Component.

Chemical or Biological Agents

Human participant research involving the testing of chemical or biological agents is prohibited, pursuant to Section 1520a of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic, protective, or other peaceful purposes apply. Before any excepted testing of chemical or biological agents involving HSR can begin, explicit written approval must be obtained from the DoD Office for Human Research Protections (DOHRP).


Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD IMCO after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD Components, additional review is required.

Additional Reporting Requirements for Investigators and the IRB


Investigators conducting DoD funded research must promptly report (within 5 business days of completion of report) to the Human Research Protection Officials (HRPO):

  • any unanticipated problem involving risks to subjects or others
  • suspension or termination of IRB approval
  • any serious or continuing noncompliance pertaining to DoD-supported human subjects research
  • substantiated allegations related to classified HSR

Investigators conducting DoD funded research must promptly report (within 30 days) to the DoD HRPO:

  • The results of the IRB continuing review
  • Change of reviewing IRB
  • Closure of a study
  • Changes to key investigators or institutions
  • Decreased benefit or increased risk to subjects in greater than minimal risk research
  • Transfer of human subject research oversight to a different IRB
  • Addition of vulnerable populations or DoD-affiliated personnel as subjects
  • Change in status when a previously enrolled subject meets the criteria for Subpart B or C and the protocol was not reviewed and approved by the IRB under those Subparts.


The IRB must promptly report (within 5 days) to the DoD research protection officer when they are notified by any Federal department, agency or national organization that any part of the human research protection program is under for cause investigation of a research protocol involving a DoD support.    

Audit Reports

Reports of audits of DoD-conducted or DoD-supported human participants research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government will be promptly reported (within 5 business days of discovering that such an audit report exists) to the DOHRP.


  • 32 CFR 219
  • 10 USC 980
  • DoD Directive 3216.02
  • SECNAVINST 3900.39D
  • OPNAVINST 5300.8B
  • DoD Dual Compensation Act, 24 U.S.C 301