Requirements for Research Involving the Department of Defense

Purpose and Background

This page provides guidance for researchers and IRBs about special requirements for conducting and reviewing human subjects research involving any component of the Department of Defense (DoD).

In 2006, the DoD enhanced its human subject protection requirements. UCSF has signed an Addendum to its Federalwide Assurance (FWA) that it will apply Department of Defense (DoD) regulations and policies for the protection of human research subjects when conducting, reviewing, approving, overseeing, supporting or managing human subjects research involving the DoD. A copy of the DoD/DoN Addendum to UCSF’s Federalwide Assurance is available for you to provide as needed.

Responsibility for upholding DoD requirements for human subjects research is shared between researchers and their teams, the University administration and the DoD.

You will be asked to complete the "Department of Defense (DoD) Supplement" in IRB Application in iRIS if your research involves the DoD.

What Qualifies as DoD Research

Research is considered to involve the DoD when:

  • Funding: The research is funded by a component of DoD. Example: A grant from the Office of Naval Research.
  • Collaboration: The research involves cooperation, collaboration or other type of agreement with a component of DoD. Example: An Army Medical Laboratory will conduct malaria antigen detection tests for study.
  • Facilities: The research uses property, facilities or assets of a component of DoD.
  • Personnel: The subject population will intentionally include personnel (military and/or civilian) from a component of DoD. Note: 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.

For research sponsored by the DoD, “experimental subject” is defined as an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32CFR.210.102). 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.

    Instructions for all DoD Research

    DoD-related research typically requires additional compliance activities, documentation and subject protections. You should anticipate and plan for these requirements, which may require significant coordination of timing and activities among offices and institutions.

    This information and guidance applies to all human subjects research involving the DoD, with the following exception: for human subjects research that qualifies for exemption, the only part of this guidance that applies is the requirements for DoD Funding Release described below.

    DoD Funding Release

    Researchers are not allowed to expend DoD funds for human subjects research until all of the following requirements have been met:

    • The IRB has reviewed and approved the research (or granted an exemption).
    • Office of Sponsored Research (OSR) has provided any materials requested by the DOD funding agency.
    • OSR has been authorized by DoD to activate the award.

    Researchers have the following responsibilities for non-exempt research involving the DoD:

          Post-Approval Instructions

                Review these instructions before submitting the types of submissions listed below.

                IRB and OVPR Responsibilities

                    Additional Information and Regulatory Citations

                          32 CFR 219, “Protection of Human Subjects”

                          Department of Defense (DoD) Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research”

                          Department of Defense Directive 5500.7-R, Joint Ethics Regulation, “Standards of Conduct”

                          Department of Defense (DoD) Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs, February 27, 2008.

                          Under Secretary of Defense Memorandum, HA Policy 05-003, March 28, 2005; “Policy for Protection of Human Subjects in Department of Defense Sponsored Research” Department of Defense Instruction 1100.13, November 21, 1996, “Surveys of DoD Personnel” Section 980 of Title 10, United States Code

                          Section 209 of Title 18, United States Code 48 CFR 207, “Acquisition Planning” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 207.172

                          48 CFR 235, “Research and Development Contracting” part of Defense Federal Acquisition Regulations

                          Supplement (DFARS). Specifically: 48 CFR 235.072 48 CFR 252, “Solicitation Provisions and Contract Clauses” part of Defense Federal Acquisition Regulations Supplement (DFARS). Specifically: 48 CFR 252.235-7004

                          Secretary of the Navy, SECNAV INSTRUCTION 3900.39D, “Human Research Protection Program”. National Naval Medical Center Scientific Review Template, revision 12-15-06.

                          Naval Operations, OPNAV INSTRUCTION 5300.8B Army Human Research Protections Office Institutional Policies and Procedures, Version 1, April 2005, Section V.A., “Scientific Peer Review of Research”

                          Army Regulation 70-25, January 25, 1990; “Use of Volunteers as Subjects of Research” Air Force Instruction 40-402, “Protection of Human Subjects in Biomedical and Behavioral Research”, May 5, 2005

                           

                          Last updated: June 17, 2022