- UW Research - https://www.washington.edu/research -

Department of Defense

Posted By Amanda Guyton On In | Comments Disabled

GUIDANCE Contents

 

Key take-away. There are significant additional researcher responsibilities and issues to consider when planning and conducting research involving any component of the U.S. Department of Defense. The additional time required to fulfill these means that study start-up will take longer.

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.

Back to Table of Contents [21]

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 [22].

For convenience, here is a partial list of DoD components that are often involved in human subjects research.

Criterion 2. The DoD involvement consists of one or more of the following:

Back to Table of Contents [21]

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.

Back to Table of Contents [21]

Financial Considerations

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.

  1. 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 [23] before applying for that IRB’s approval.
  2. 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. (Education and Training Requirements [9])
    • If the research qualifies for exempt status from HSD: Documentation of the exempt determination, including citation of the exempt category and a rationale statement.
  3. 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. (Additional Required Approvals [8])

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.

Back to Table of Contents [21]

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.

Back to Table of Contents [21]

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 hsdinfo@uw.edu [24] when planning classified human subjects research.

Research is considered to be classified human subjects research when:

Human subjects research is NOT considered to be classified when:

Back to Table of Contents [21]

Scientific Review

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:

Back to Table of Contents [21]

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:

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:

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.

Back to Table of Contents [21]

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 [27] 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 [28]) 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.

Back to Table of Contents [21]

Protected Populations

DoD-involved research must comply with the requirements of the federal Common Rule for these protected populations (HSD webpage on Protected and Vulnerable Populations [29]), except as noted here.

Pregnant women, fetuses, and neonates.

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.

Back to Table of Contents [21]

Definition of Minimal Risk

DoD applies the definition of “minimal risk [30]” 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:

Back to Table of Contents [21]

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:

  1. Specific written approval for recruiting must be obtained from the personnel’s command or specific DoD component. Review the Additional Approvals [8] section.
  2. Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in the research.
  3. 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.
  4. 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 [31]. 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:

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.

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.

Back to Table of Contents [21]

“Experimental Subjects”

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:

Back to Table of Contents [21]

International Research

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.

Back to Table of Contents [21]

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.

Back to Table of Contents [21]

Reporting Requirements

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:

Additional Army reporting requirements are outlined in the document entitled “Information for Investigators” available at this direct link [32].

Back to Table of Contents [21]

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 [33] as other federally-involved research.

Which IRB? See this HSD guidance [34] for assistance in determining which IRB should review the research.

Using an external (non-UW) IRB. Follow the standard instructions [23] for requesting HSD authorization to use an external IRB.

UW IRB review. The SUPPLEMENT Department of Defense [31] must be completed and submitted through Zipline [35] 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 [36].

Back to Table of Contents [21]

Related Material

SUPPLEMENT Department of Defense [31]
WORKSHEET Department of Defense [36]

Information for Investigators [37]
DoD Human Research Protections website [38]
Army Human Research Protections Office [39]
Navy Human Research Protection Program [40]
Air Force Human Research Information [41]

Back to Table of Contents [21]

Regulatory References

Back to Table of Contents [21]

Version Information

Open the accordion below for version changes to this guidance.

Version History

Version Number Posted Date Implementation Date Change Notes
1.1 08.04.2022 08.04.2022 Clarify DoD definition of FDA-regulated
1.0 12.28.2021 12.28.2021 New guidance

Keywords: Federal agencies