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Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
When working with certain governmental entities, there are additional steps and protections that PIs and IRBs must be aware of and execute, or risk complications with their funding.
In addition to the Federalwide Assurance (FWA) agreement approved by the Department of Health and Human Services (DHHS), the University of Wisconsin-Madison (UW) has signed an addendum with the United States Air Force that adds special requirements to conducting any human subjects research for DOD-supported studies. Researchers and their staff must be aware of these additional requirements when planning a study, as they may add a significant amount of time to the regulatory review and approval process.
These additional requirements are summarized in this guidance. It is highly recommended researchers work with the granting agency/DOD component to verify compliance with these requirements, as well as to determine if there are any agency-specific requirements not noted here that will affect their study.
Human subject research is a systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or about whom identifiable private information is obtained. For purposes of DOD-supported research, this individual is known as an experimental subject, meaning “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.” (3216.02, 2. Applicability (2); 32 CFR 219; 10 USC 980).
Human subject research involves the DOD when any of the following apply:
- The research is funded by a component of the DOD (e.g.; Navy, Army, Air Force)
- The research involves cooperation, collaboration, or other type of agreement with a component of DOD
- The research uses property, facilities, or assets of a component of DOD
- The subject population will intentionally include personnel (military or civilian) from a component of DOD. (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.)
DoD Components include but are not limited to:
- Air Force
- Air Force Academy
- Coast Guard
- Coast Guard Academy
- Defense Advanced Research Projects Agency (DARPA)
- Defense Commissary Agency
- Defense Contract Audit Agency
- Defense Finance and Accounting Service
- Defense Information Systems Agency
- Defense Intelligence Agency
- Defense Legal Services Agency
- Defense Logistics Agency
- Defense Security Cooperation Agency
- Defense Security Service
- Defense Threat Reduction Agency
- Military Academy (West Point)
- Missile Defense Agency
- National Geospatial-Intelligence Agency
- National Guard
- National Reconnaissance Office
- National Security Agency
- National War College
- Naval Academy
- Office of Naval Research
- Pentagon Force Protection Agency
- Tricare Health System
- U.S. Army Corps of Engineers
- U.S. Naval Observatory
Exemptions: listed 32 CFR 219.101 (b)
- Independent scientific review prior to IRB review.
Components of the Navy (including Marine Corps) and the Army may require independent scientific review and approval prior to IRB review of new applications and substantive modifications.
The scientific review conducted by a funding agency (including DOD) or by an established internal review mechanism in the researcher’s school or department will satisfy this requirement.
- For oncology studies: all cancer trials must be evaluated by the UWCCC Protocol Review & Monitoring Committee prior to IRB review.
- For non-oncology studies: federally funded projects that have received peer-review will not be reviewed again by the ICTR Scientific Review Committees.
UW IRBs do not offer any additional guidance or checklists for DOD sponsored studies, however they will refer to many of the documents listed in “Other Resources: Department of Defense”, found below, when reviewing and approving these studies. Of note, an IRB initial review must contain:
Evidence of scientific review: While this is done before the IRB would initially review a DOD sponsored study at UW, the results of this review must be included in the IRB report.
Level of risk: The level of risk to potential subjects participating in the study must be clearly established in the IRB’s minutes. If a study is determined to contain more than minimal risk (the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests), additional safeguards will be required to conduct the trial, such as continuous review by an independent Research Monitor. (See: 32 CFR 219.102(i), reference (c).)
Necessity of Research Monitor: If warranted by the level of risk, a research monitor will be appointed to the study. This person will be mentioned by name in the IRB application, will be independent of the study team, and will possess sufficient education and professional experience to serve as the subject/patient advocate. This means if the monitor would require specific medical knowledge to perform their duties, then this person should be a physician, psychologist, dentist, nurse, or other appropriate healthcare professional.
As described in DOD Instruction 3216.02 section 8(2), the research monitor shall have authority to stop a research protocol in progress, remove individual human subjects from a research protocol, and take whatever steps are necessary to protect the safety and well-being of human subjects until the IRB can assess the monitor’s report. Research monitors shall have the responsibility to promptly report their observations and findings to the IRB or other designated official. The duties, authority, and responsibilities for the research monitor will be approved by the IRB in a written summary.
The Institutional Official of the DOD Component may waive the requirement for the monitor.
Assurance that protocols involving exposure to ionizing radiation, radiopharmaceuticals, or biologically hazardous materials are approved by the appropriate committee prior to IRB approval.
If the non-DOD institution determines the activity is non-exempt research involving human subjects, the granting agency must perform an administrative review of the research before the activities that involve human subjects can begin.
Results of the Continuing Review must be reported to the funding agency.
Modifications that significantly change the original protocol (i.e., new primary or secondary aim(s), elimination of safety procedures or addition of new procedures, the addition or removal of protected subject populations) will require that a new scientific review be performed and filed with the IRB before the study can be reapproved.
A DOD-supported trial does not alter the criteria UW IRB will use in determining the type of review they will perform (i.e., full vs. expedited) at any of the given time points.
As referenced in section B.3 above, for research involving more than minimal risk to subjects, an independent medical monitor shall be appointed by name. Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
Depending on the nature of the study, the medical monitor may be assigned to oversee and/or assess one or more of the following phases of a research project: subject recruitment, subject enrollment, data collection, or data storage and analysis.
At the discretion of the IRB, the medical monitor may be assigned to discuss research progress with the principal investigator, interview subjects, consult on individual cases, or evaluate adverse event reports. Medical monitors shall promptly report discrepancies or problems to the IRB. They shall have the authority to stop a research study in progress, remove individual subjects from a study, and take whatever steps are necessary to protect the safety and well-being of research subjects until the IRB can assess the medical monitor's report.
Research involving the administration of surveys to, or interviews of, DOD personnel (military or civilian) may require DOD approval as well as IRB approval.
Captured or detained personnel: any persons deemed to be civilian internees, retained persons, or lawful/unlawful enemy combatants are prohibited from participating in DOD research, except research with investigational new drugs or devices 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.
- Enemy prisoners of war: the involvement of prisoners of war (as defined by DOD and the Third Geneva Convention) as human subjects of research is prohibited
Military personnel: Command approval may be required for military personnel to participate in human subjects research as some types of research could impact a soldier’s readiness in the field. Investigators may be asked to provide documentation of Command approval. DOD requires the following protections for military personnel being recruited for research that involves greater-than-minimal risk.
- 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.
- During recruitment briefings to a unit where part of the unit is being recruited, an independent ombudsman is present.
- Limitations on dual compensation prohibit an individual from receiving pay from more than one position for more than 40 hours of work in one calendar week, which includes temporary, part-time, and intermittent appointments.
Compensation for US military personnel: On-duty federal personnel including military members may receive up to $50 for blood draws, but no compensation for general research participation. Off-duty federal personnel including military members may receive up to $50 for blood draws and compensation for general research participation. Stipends cannot be paid directly from a federal source (payment from a federal contractor or non-federal source is permissible). Non-federal personnel may receive up to $50 for blood draws and compensation for general research participation. Stipend funds may come from a federal or non-federal source.
Additional DOD protections 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.
International populations: studies conducted outside of the United States that involve subjects that are not US citizens or DOD personnel must be conducted in compliance with local laws, regulations, customs, and practices and provide documentation indicating the following.
- Permission of the host country
- Ethics review and approval by the host country or a local Naval IRB with host country representation
Pregnant women, prisoners, and children: the typical exemptions granted to research being done on pregnant women, prisoners, and children under DHHS 45 CFR 46 are not recognized for DOD-supported research, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
Consent form language related to injury and adverse events: the IRB will ensure any specific DOD component language concerning research-related injury will be disclosed in the consent form.
Waiver of consent: the IRB is not allowed to approve a waiver of informed consent for any DOD-supported trial that meets the definition of human subjects research without prior approval from the Secretary of Defense, with the following exceptions:
- If the research participant does not meet the definition of experimental subject.
- The research is intended to be beneficial to the subject, the subject lacks the capacity to provide consent, and a legally-authorized representative will provide consent.
- The Head of the DOD component involved in the research may waive the requirement for consent with respect to 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 subject and the research is carried out in accord with all other applicable laws and regulations (such as 21 CFR 50.24).
- The research is conducted in compliance with all other applicable laws and regulations.
This places limitations on research involving deception, decisionally-impaired individuals, or research being conducted under emergency conditions where the subject may not be able to provide consent. This rule does not apply to screening of records to identify possible subjects, and does not apply to retrospective research involving analysis of data or specimens, observational studies, blood draws, or tissue collection. The IRB may grant a waiver of consent for such activities.
Research in which legally-authorized representatives (LARs) provide consent: per military law and DOD directive, informed consent may be provided by a legally-authorized representatives of subjects if:
- The subject lacks capacity, due to age, condition, or other reason, to make a decision regarding consent to participate in the research; AND
- The IRB has determined that the research is intended to be beneficial to the individual subjects.
It should be noted that any additional costs associated with the use of a Research Monitor should be budgeted into and covered by your study’s indirect overhead.
There are no additional funding requirements for DOD studies. Refer to the UW department of Research and Sponsored Programs website for finding guidance: https://www.rsp.wisc.edu/
There are no additional human subjects training requirements for study staff engaged in DOD-supported research. (Study staff are expected to take human subjects research training as required by the UW, and maintain this certification while participating on a DOD trial.) However, agency-specific training, such as the Department of the Navy’s DON-Supported Extramural Performers (available through the CITI program) might be required. Investigators are strongly urged to contact their funding agency to determine if component specific training is necessary.
UW researchers are responsible for notifying their granting agency within 30 days of the following:
- 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
The institutional official is responsible for notifying the granting agency within 30 days of the following:
- Any unanticipated problems involving risks to subjects or others
- Suspensions, terminations, and serious or continuing noncompliance regarding DOD-supported research involving human subjects
- When the institution is notified by any Federal department or agency or national organization that any part of its HRPP is under investigation for cause involving a DOD-supported research protocol
- Other significant communication between the UW and other Federal departments and agencies regarding compliance and oversight
Researchers and their study staff are expected to follow UW policy on reporting adverse events, continuing reviews, etc.
Original copies of DOD-supported research documents may be required to be stored with the DOD component rather than kept on site or archived by the UW researcher.
Records maintained that document compliance or non-compliance with DOD regulations must 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.
Refer to UW IRB for recordkeeping guidance here:
Department of Defense
- 32 CFR 219
- DODD 3216.02 – “Protection of Human Subjects and Adherence to Ethical Standards in DOD-supported Research”
- 10 USC 980 – “Limitation on Use of Humans as Experimental Subjects”
- DODI 3210.7 – “Research Integrity and Misconduct”
- DODI 6200.02 – “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs”
- 48 CFR 252 - “Solicitation Provisions and Contract Clauses” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 252.235-7004 reference (n)
- DODD 5500.7-R, Joint Ethics Regulation - “Standards of Conduct”
- AR 70-25 – “Use of Volunteers as Subjects of Research”, 25 January 1990
- AR 40-38 – “Clinical Investigation Program”, 1 September 1989
- AR 40-7 – “Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances”, 4 January 1991
- SECNAVINST 3900.39D – “Human Research Protection Program”, 6 November 2006
- The Belmont Report
- Title 45 CFR 46: Protection of Human Subjects
- Policy guidance and documents
- OHRP Frequently Asked Questions
- 21 CFR Part 50 - Protection of Human Subjects
- 21 CFR Part 56 - Institutional Review Boards
- Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
- FDA Frequently Asked Questions
DOD Component Requirements: DOD Components may require that other research, not specifically identified by 32 CFR 219, also comply with the terms of this Addendum (32 CFR 219.101(d)).
Department of the Army
DHHS Office of Human Research Protections (OHRP)
Food and Drug Administration (FDA)