Department of Defense
- Purpose and Applicability
- Definition of DoD-involved Research
- Planning DoD-involved Research
- Financial Considerations
- FDA Regulated Research
- Classified Human Subjects Research
- Scientific Review
- Additional Required Approvals
- Education and Training Requirement
- Protected Populations
- Definition of Minimal Risk
- Participants Who Are DoD-affiliated Personnel
- “Experimental Subjects”
- International Research
- Subject Protection from Medical Expenses
- Reporting Requirements
- Applying for IRB Approval
- Related Materials
- Regulatory References
- Version Information
Purpose and Applicability
This web page provides guidance to UW researchers who are planning, setting up, or conducting human subjects research that involves any component of the U.S. Department of Defense (DoD). This guidance applies to research reviewed by the UW IRB as well as UW research reviewed by a non-UW (“external”) IRB.
Definition of DoD-involved Research
Two criteria define “DoD-involved” research.
Criterion 1. A component of the DoD is involved. The DoD is made of many branches, agencies, and other components in addition to the seven armed forces (e.g., Army, Navy). A complete list of the components other than the seven armed forces is available at this website: https://pentagontours.osd.mil/Tours/DoD-components.html.
For convenience, here is a partial list of DoD components that are often involved in human subjects research.
- The seven armed forces (Army, Navy, Air Force, Marines, Coast Guard, National Guard, Space Force)
- The military academies (e.g., West Point; Air Force Academy)
- Office of Naval Research
- U.S. Army Corps of Engineers
- Tricare Health System
- National War College
- Several intelligence agencies (e.g., National Security Agency)
- Defense Advance Research Projects Agency (DARPA)
Criterion 2. The DoD involvement consists of one or more of the following:
- Any of the research funding comes from any component of DoD; or
- The research involves cooperation, collaboration, or other type of agreement with a component of DoD; or
- The research uses property, facilities, or assets of a component of DoD; or
- The subject population will intentionally include personnel (military and/or civilian) from a component of DoD. DoD policies and requirements do not apply when DoD personnel incidentally participate as subjects in research that does not otherwise involve DoD and when DoD personnel are not an intended population of the research.
Planning DoD-involved Research
DoD regulations and requirements include some unique subject protections, compliance activities, training, and additional documentation (see sections below). Researchers should anticipate and plan for these requirements, which may require significant coordination of timing and activities among offices and institutions. This also means that study start-up may take longer and research costs may be higher.
Budgeting. Meeting DoD requirements may increase the costs of conducting the research. DoD has provided the following guidance:
“Most costs associated with Human Research Protections are expected to be included in an Institution’s indirect overhead rates. However, if an Institution has identified a specific cost directly associated with performance of a particular effort and thinks the cost should be direct [sic] charged to an award, they should approach the awarding agency Contracting Officer for further consideration. The awarding agency Contracting Officer would normally make a determination as to whether this type of cost is reasonable as a direct cost to their award”. Guidance provided to the UCLA Office for the Protection of Research Subjects, as posted in the 5/31/2007 version of the document, “Guidance: Department of the Navy Human Subject Protections”.
Use of DoD research funding. DoD does not allow researchers to expend DoD funds for human subjects research until all of the following requirements have been met (as specified in the DoD’s DFARS clause attached to grants and contracts). Researchers should plan ahead to avoid unexpected delays in accessing DoD funding.
- The IRB has reviewed and approved the research (or HSD has granted exempt status). If the IRB will be an external (non-UW) IRB, the researcher must first obtain HSD’s authorization to use the external IRB before applying for that IRB’s approval.
- The UW Office of Sponsored Programs has furnished the DoD component that is funding the research with:
- Documentation of the IRB approval
- Assurance (and possibly documentation) that relevant study team members have met the DoD training requirements. (see Education and Training Requirements)
- If the research qualifies for exempt status from HSD: Documentation of the exempt determination, including citation of the exempt category and a rationale statement.
- The UW Office of Sponsored Programs has received notice from the Contracting Officer at the DoD component that its Human Research Protection Program has reviewed the research protocol and accepted the IRB approval or exempt determination. (see Additional Required Approvals)
Additional terms in the DoD Notice of Award or contract. Researchers should carefully read these official communications about DoD funding. They may describe additional requirements that are specific to the grant, contract, or study. Example: specific data security protections.
FDA Regulated Research
The DoD applies the Food and Drug Administration regulations more broadly than HSD does. DoD applies FDA regulations to all research focused on a drug, biologic, or device that is investigational or that is already regulated by the FDA, even if there are no plans to submit the study data to the FDA. The UW IRB defers to the DoD’s opinion about the applicability of FDA regulations for all DoD-involved research.
Classified Human Subjects Research
The involved DoD components can advise researchers about whether their planned research is considered classified, although the definition is provided here for informational purposes. Consult with HSD through firstname.lastname@example.org when planning classified human subjects research.
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).
All research involving DoD must be evaluated for scientific merit prior to IRB approval. The review must consider the study’s significance, approach (conceptual framework, design, methods, analysis), researcher qualifications, and research environment. Feasibility of study completion must also be considered per DoD regulations. This requirement is met as described here:
- Research funded by the DoD meets this requirement because of the DoD review conducted as part of the decision to award a grant or contract.
- Research that involves the DoD but is funded by another government agency or by a non-profit organization that has a review process involving scientific experts independent of the study meets this requirement because of the funding review process.
- All other research (that will be reviewed by an external, non-UW IRB): The UW researcher should contact the external IRB or (for multi-institutional studies) the overall study coordinating group for information about any UW researcher responsibilities related to this requirement.
- All other research (that will be reviewed by the UW IRB): must meet this requirement through a mechanism initiated by the researcher. The UW IRB review process does not include a scientific review that fulfills this DoD requirement. Examples of some acceptable options: (1) a departmental, college, or school review committee; (2) review through the Institution for Translational Health Sciences (ITHS); (3) an ad hoc scientific review provided by the researchers department chair, division chief, or dean. Documentation of the review must be provided to the UW IRB, including a summary of the review, and the names and descriptions of the reviewers.
Additional Required Approvals
The terms of any DoD funding award may include DoD-specific requirements. Two of the most common are described here. Each service branch (e.g., Army, Navy) may have some additional requirements, which will likely be described in the funding communications or can be obtained from the relevant DoD human research protection office.
1. DoD Human Subjects Administrative Review.
Most studies supported by a grant, contract, or other award from any DoD component must be approved by a DoD Human Research Protection Official at specific points during the life of the study. This is an administrative review or concurrence, not an IRB review. If it is required, it will be mentioned in the grant or contract communications. It is the researcher’s responsibility to request this review. HSD does not have any role in this process.
Who performs the DoD administrative review. The relevant DoD Human Research Protection office or official will be identified in the official communications about the funding (e.g., notice of award, contract).
Timing of the DoD administrative review. The review must occur (1) before beginning the research AND (2) before implementing IRB-approved substantive changes to the study. “Substantive change” is defined as:
- Change in the lead researcher, key investigators, or involved institutions
- Elimination or alteration of the consent process
- Significant change in study design (i.e., that would prompt additional scientific review)
- Decreased benefit or increased risk to subjects in greater than minimal risk research
- Addition of vulnerable populations, or DoD-affiliated personnel as subjects
- Transfer of oversight from one IRB to another IRB
Requesting the DoD administrative review. The request process, and the purpose of the review varies with the DoD component and the study. Researchers should contact the Human Research Protection office or official (or review any website) identified in the grant award or contract communications, for information about the process and specific required forms and documents. At a minimum, these documents and information will be required:
- The IRB application and/or protocol (if available at the time)
- The IRB approval letter, including the IRB’s determination of Not Human Subjects Research status (if granted), exempt status (if granted, which may or may not have included a Limited IRB Review), or study risk level
- Consent forms and related documents
- For international research, confirmation that all applicable national laws and requirements of the foreign country have been met plus confirmation that the IRB considered the cultural sensitivities in the setting where the research will occur. Consult with HSD if you need assistance with this.
- Curriculum vitae (CV) or Biosketch of the lead researcher
- Documentation of completion of DoD-required human subjects protection training for the lead researcher and other key investigators participating in the study
- A letter of support from Commanders of military facilities or units in which any recruitment will occur or the study will be conducted (see next paragraph)
2. Approval from involved DoD facilities and units
DoD requires researchers to obtain these additional written approvals. The relevant DoD can be consulted for names, titles, and contact information. It is expected that researchers will have initiated this process when planning their research or preparing a grant/contract application. HSD has no role in this process.
- Research involving DoD-affiliated subjects: Approval from the DoD-affiliated personnel’s command or specific DoD component.
- Research that will take place on a DoD facility, even if the activity is limited to recruiting: Approval from the command or DoD component responsible for the facility.
Education and Training Requirement
The DoD education and training requirements exceed the requirements of the UW but may be different for different components of the DoD. The requirements are typically described in the terms of a DoD contract or a grant Notice of Award. HSD offers a variety of training options that are likely to fulfill most of these requirements. In addition, most DoD funding agencies require training refreshers every few years. Researchers are responsible for obtaining documentation of completed training (e.g., through the UW MyResearch Portal) and providing that documentation to the DoD agency (directly or through the UW Office of Sponsored Programs individual who is handling the initial award or contract). For additional information, contact the DoD human subjects protection official or office identified in the communications from the funding information.
DoD-involved research must comply with the requirements of the federal Common Rule for these protected populations (see the HSD webpage on Protected and Vulnerable Populations), except as noted here.
Pregnant women, fetuses, and neonates.
- The criterion for approval that the results will result in “biomedical knowledge” is replaced with “generalizable knowledge”.
- The Common Rule regulations about pregnant women is applied only to research:
- That is greater than minimal risk, or
- Includes invasive procedures involving the woman or the fetus, or fetuses or neonates (of uncertain or no viability) as human subjects.
Prisoners. Research involving a military detainee or prisoner of war as a human subject is prohibited. However, this prohibition does not apply to the use of investigational new drugs or investigational devices when the purpose is for diagnosis or treatment of a medical condition. Such treatments can be offered to detainees or prisoners of war with their informed consent when the use is regulated by the FDA and only when the same product(s) are available to DoD-affiliated personnel consistent with established medical practices.
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
Definition of Minimal Risk
DoD applies the definition of “minimal risk” that is specified in the federal Common Rule. 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
Participants Who Are DoD-affiliated Personnel
DoD-affiliated personnel are: Service members and trainees, Reserve Service members, National Guard members, DoD civilian employees, and DoD contractors.
Recruiting. Civilian investigators attempting to access military volunteer pools are advised to seek collaboration with a military investigator who will be familiar with service-specific requirements. Researchers should consider that service members are trained to act as a unit, so peer pressure should be considered and minimized if possible. There are several specific requirements:
- Specific written approval for recruiting must be obtained from the personnel’s command or specific DoD component. See the Additional Approvals section.
- Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in the research.
- Military and civilian supervisors must not be present at any participant recruitment sessions or during the consent process. Excluded supervisors or those in the chain of command may participate in separate recruiting and consent sessions, if applicable.
- If the research involves greater than minimal risk AND recruitment will occur in a group setting, the IRB must appoint an ombudsperson that meets the requirements listed in the SUPPLEMENT Department of Defense. The UW IRB expects the researcher to nominate the ombudsperson and, include contact information and credentials.
Payment for research participation. Payment for participation in research that occurs while the participants are on duty is limited to blood donation and may not exceed $50 per blood sample drawn. They cannot receive any other payment or non-monetary compensation for research participation unless they are off duty or on leave during the actual participation.
Risks. Risks unique to DoD-affiliated personnel must be identified, evaluated, managed, and described in the IRB application. These include:
- Risk to fitness for duty. Researchers and the IRB must consider the risks to fitness for duty that the study may create (e.g., health, availability to perform job, data breach) for DoD-affiliated subjects. The consent document must inform DoD-affiliated personnel about these risks and that they should seek command or DoD component guidance before participating.
- Risk of revocation of clearance, credentials, or other privileged access of duty. The consent document must include, if applicable, these potential risks.
- Risk to privacy and confidentiality. In addition to the typical data security protections that the IRB may expect and require, a DoD contract or grant award may require that a study meet specific information security policies and standards. These may also involve obtaining a federal Certificate of Confidentiality, providing a detailed written plan, and/or restrictions on personnel, access to facilities, or information sharing.
Certificate of Confidentiality (CoC) for DoD-involved research. If the research has any funding from the federal department of Health & Human Services, it almost certainly has been automatically awarded a CoC. If not, then the DoD and/or the IRB may require the researcher to obtain a CoC from the DoD. Instructions can be obtained from the human subjects protection office/official at the DoD component.
- Risk to national security associated with the genomic data of DoD-affiliated personnel. The disclosure of genomic data may pose a risk to national security. Research involving large-scale genomic data (defined below) must provide data security protections that are appropriate for the specific data, including these mandatory requirements:
- A federal Certificate of Confidentiality (CoC) must be obtained for all research involving large-scale genomic data.
- 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.
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.
Experimental subjects are human subjects who are participating in non-exempt research that involves an intervention or interaction for the primary purpose of obtaining data regarding the effect of the intervention or interaction. This does not apply to records procedures or research screening activities.
Specific consent restrictions apply to experimental subjects in DoD-involved research:
- Consent cannot be waived except for records-related procedures, screening activities, and research that involves the planned “emergency exception to consent” (aka EFIC research). The exception to consent for EFIC research must be approved by the relevant DoD human research protections office in addition to the IRB.
- Although consent cannot be waived, the IRB may alter or waive specific required elements of consent for minimal risk research with experimental subjects as long as the consent process (1) indicates that the subject’s participation in the research is completely voluntary and (2) informs the subjects about the research risks.
- Consent can be obtained from a subject’s legally authorized representative ONLY if the intent of the research is for the research to be beneficial to the individual subjects.
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.
Subject Protection from Medical Expenses
There are DoD requirements for greater than minimal risk research, in addition to the Common Rule regulations (which apply to DoD research) about consent information describing compensation and any available medical treatments for research-related injuries. However, these may vary depending upon which DoD component is involved. Researchers are expected to consult with the relevant DoD human research protection office to find out what treatment and compensation is available for subjects, where, and how to describe it in the consent form.
There are additional reporting requirements for DoD-involved research. The following events or circumstances must be promptly reported by the researcher to the DOD component’s human research protection office:
- Research that does not involve human subjects or is exempt (which may or may not have involved a Limited IRB Review). The determination letter provided by HSD should be provided, together with the application materials provided to HSD for the determination.
- Documentation of IRB approval, unless the review is conducted by the DoD’s IRB. This should include the IRB’s approval letter and the IRB application materials.
- IRB-approved changes that involve changes to key investigators or institutions; decreased benefit or increased risk to subjects in greater than minimal risk research; addition of vulnerable populations or DoD-affiliated personnel as subjects.
- Transfer from one IRB to another IRB.
- Notification of investigation of the study by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government.
- Results of continuing review (if continuing review required). Sending the IRB approval letter should be sufficient.
- Unplanned involvement of prisoners or pregnant women in a study that wasn’t approved by the IRB for inclusion of prisoners or pregnant women.
- Closure of the study, for any reason.
Additional Army reporting requirements are outlined in the document entitled “Information for Investigators” available at this direct link.
Applying for IRB Approval
Single IRB requirement. 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-involved research.
Which IRB? See this HSD guidance for assistance in determining which IRB should review the research.
Using an external (non-UW) IRB. Follow the standard instructions for requesting HSD authorization to use an external IRB.
UW IRB review. The SUPPLEMENT Department of Defense must be completed and submitted through Zipline with the IRB Protocol form. This ensures that the IRB receives the information necessary to ensure that all DoD requirements have been met.
IRB review requirements. The specific DOD requirements that the UW IRB will consider are listed in the WORKSHEET Department of Defense.
- DoD Instruction 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research”, version April 15, 2020.
- United States Code, Title 10, Section 980, “Limitation on Use of Humans as Experimental Subjects”
- SECNAVINST 3900.39D, “Human Research Protection Program”, version May 29, 2018.
- DODI3216.02_AFI40-402_AFGM2021-01, “Air Force Guidance Memorandum to DODI3216.02_AFI40-402, Protection of Human Subjects and Adherence to Ethical Standards in air Force Supported Research”, version July 16, 2021.
Open the accordion below for version changes to this guidance.
|Version Number||Posted Date||Implementation Date||Change Notes|
|1.1||08.04.2022||08.04.2022||Clarify DoD definition of FDA-regulated|
Key Words: Federal agencies