Department of Defense Research
Research conducted or supported by a DoD Component requires additional information to be submitted to the IRB with the research application. Investigators should complete and attach a completed DoD Supplement Form to the Documents and Attachments page of the ERICA application.
A Department of Defense (DoD) Component is the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities and all other organizational entities in the Department of Defense.
Additionally, investigators and IRB members need to be informed of the specific requirements for research that is conducted or supported by a DoD Component (e.g. through a contract, grant cooperative agreement or other arrangement). This web page is intended for use by both the investigator and IRB members in order to comply with any required regulations.
The University of Utah IRB follows IRB SOPs, IRB guidance, and DoD regulation when reviewing human subject research supported and regulated by the DoD. The University of Utah does not review a large number of studies involving the Department of Defense and those that have been reviewed by the University of Utah IRB have involved minimal risk. The following guidance describes the DoD regulations for reviewing studies that involve greater than minimal risk or has a special consideration(s) e.g., classified research, research with vulnerable populations, etc. that does not commonly occur at the University of Utah. The information below provides a brief overview of how the University of Utah IRB would review such studies. In conducting these reviews, the University of Utah IRB will refer to and follow the applicable Department of Defense regulations.
Human Subject Research Training
University of Utah investigators and study staff who conduct human subject research must complete training before the IRB will approve a project(s). Please visit Investigator & Research Staff Training for the current University of Utah training requirements and options. Training is valid for five (5) years. If research involving a DoD component requires more frequent or other training requirements in addition to those that the University of Utah requires, the investigator will be responsible for ensuring that the training is completed for those involved in the conduct of the research. Researchers should contact the human research protection officer of the DoD component for their education requirements and obtain documentation confirming the requirements.
Additional Protections for Military Research Personnel
When research involves U.S. military personnel as participants in research, the following guidelines apply:
Recruitment and Enrollment
- 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.
- When recruitment involves a percentage of a unit, an independent ombudsman is present.
- Participants may be compensated for research participation as long as the participant is involved in the research when not on duty. Enrolled individuals may not receive payment of compensation for research participation during duty hours.
- Federal employees while on duty and non-Federally employed individuals may be compensated for blood draws for research up to $50 for each blood draw.
- Non-Federally employed individuals may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB.
Waiver of Consent
In general, no Department of Defense component may conduct or use appropriated funds to support research involving a human being as an experimental subject without the prior informed consent of the subject. However, a waiver of consent may be granted for “research involving a human being as an experimental subject” if a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering. If the research participant does not meet the definition of an “experimental subject”, the IRB may waive the consent process as described in IRB SOP 703: Waiver or Alteration of Consent.
Research Subject to Department of Defense requirements is prohibited from using an exception from consent in emergency medicine research unless a waiver is obtained from the Secretary of Defense.
Informed Consent Process
The following are additional requirements regarding the informed consent process for DoD conducted or supported studies.
Disclosure of Research-Related Injury
- Any requirements for disclosure of research-related injury from a DoD component must be included in the informed consent process. See SOP 701 (2.3).
Consent from a Legally Authorized Representative
- If consent is to be obtained from the legally authorized representative of an experimental subject, the research must be intended to provide direct benefit to the individual participant. The determination that the research is beneficial to the individual experimental subject must first be made by the IRB.
Combined DoD and VA Research
- A Department of Defense (DoD) consent document may be employed for active duty military personnel participating in VA research at DoD sites when VA-specific language is not necessary.
Data and Safety Monitoring
If the research involves greater than minimal risk, an independent research monitor must be appointed for the study and approved by the IRB. Additionally, a research monitor may be required for research involving minimal risk as determined by the IRB. The monitor should be appointed based on expertise relative to the risks identified in the research protocol and the skills necessary to monitor the research.
Investigators should include the following information in the IRB application on the Safety Monitoring page:
- The monitor must be named.
- Duties, responsibilities, and authority of the research monitor should be outlined.
Investigators must specifically state that the monitor has the authority to perform
the following actions:
- Stop a research study in progress if the safety of participants is in question
- Remove participants from a study if the safety of the participant is in question
- Take any other appropriate steps to protect the safety and well-being of participants until the IRB can assess the study
The IRB confirms the monitor's responsibilities in the IRB approval letter. The investigator must provide a copy of the letter to the monitor.
Additional Department of Defense Investigator Responsibilities
Any surveys performed on Department of Defense personnel must be submitted, reviewed
and approved by the Department of Defense after the research protocol is reviewed
and approved by the IRB.
DoD supported researchers must report the following within 30 days to the DoD human research protection officer.
- When significant changes to the research protocol are approved by the IRB.
- The results of the IRB continuing review.
- Change of reviewing IRB.
- When the University of Utah is notified by any Federal department, agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol.
Vulnerable Populations in Department of Defense Research
Research involving pregnant women, prisoners and children that is conducted or supported by the Department of Defense is subject to DHHS Subparts B, C, and D. However, the DoD has supplemental guidance for these studies. Review the table below to determine the DoD requirements and IRB guidance for each vulnerable population.
|Population||DoD Requirement||University of Utah IRB Guidance|
|Pregnant Women, Fetuses, and Neonates||
Go to: Research Involving Neonates
See also: Transplantation of Fetal Tissues
||Go to: Research Involving Prisoners|
The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children except for research involving observations of public behavior when the investigators do not participate in the activities being observed. The University of Utah has the same stipulation.
|Go to: Children in Research|
For all Department of Defense conducted or supported non-exempt human subject research involving classified information (as defined in Executive Order 13526), additional requirements must be applied. The review of research involving classified information is rare and requires Secretary of Defense approval. Additional requirements are described in the Department of Defense Instruction 3216.02 13. It should be noted that VA conducted or supported non-exempt human subject research involving classified information is not permitted.
If you are the lead investigator/site for a multi-centered study, you have additional responsibilities for overseeing the activities at the University of Utah as well as the other sites participating in the study. To meet DoD requirements (SECNAVINST 3900.39D, section 6f), you must execute an agreement or statement of work with all collaborating sites that delineates each site's responsibilities. This document should include the following elements:
- A brief description of the research
- Specific roles and responsibilities of each site, including scientific and IRB review; recruitment of participants; and informed consent procedures
- Plan for ongoing data and safety monitoring, reporting requirements, documentation retention, and compliance for the entire research project
If you are not the lead investigator for a multi-centered DoD study, ensure that you request a copy and sign the study's agreement/statement of work prior to initiating study procedures at the University of Utah.
If the DoD research is conducted in a foreign country, the investigators must submit verification of the local ethics review (i.e. approval to conduct research). The investigator must abide by the local laws, regulations and customs as applicable. For more guidance, please see the Investigator Guidance Series: International Research.
Guidelines and Policies
Note: This is not a comprehensive list of guidelines and policies for DoD research, but represents guidelines and policies commonly referenced for research reviewed at the University of Utah.
- 32 CFR 219: Department of Defense Protection of Human Subjects
- Department of Defense Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported
(Version November 8, 2011)
- Department of Defense Directive 6200.2, Use of Investigational New Drugs for Force Health Protection (Version August 1, 2000)
- Title 10, United States Code, Section 980: Limitation on use of humans as experimental subjects
- Department of the Navy, SECNAV Instruction 3900.39D (November 6, 2006): DON Human Research Protection Program
- Department of the Navy, OPNAV Instruction 5300.8B (April 23, 1997): Coordination and Control of Personnel Surveys