Fred Hutch Cancer Center
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Fred Hutch Cancer Center
Institutional Review Office
1100 Fairview Ave. N.
Mail Stop J2-100
Seattle, WA 98109

Contact Information

Last Modified: 10-15-24

Research Involving Department of Defense (DoD) Components

Relevant IRB policies/procedures:

Requirements for Research Involving the DoD

  • Research involving the DoD requires additional compliance activities, documentation, and subject protections.  
  • These requirements apply to all Expedited (minimal risk) and Full IRB review of human subjects research "involving" a DoD component.

NOTE: A DoD Supplement is not required for studies requesting either an Exempt or a Not Human Research determination.

 

FAQ

Research involves the DoD when any of the following apply:

  • The research is funded by a component of DoD (example: Department of Defense direct grant, the Office of Naval Research, Department of the Army, etc.).
  • The research involves cooperation, collaboration, or other type of agreement with a component of DoD (example: An Army Medical Laboratory will conduct tests on the blood samples you collect in your study).
  • The research uses property, facilities, or assets of a component of DoD (example: Madigan Hospital, or the military setting up tents for vaccination during a public emergency).
  • The subject population will intentionally include personnel (military or civilian) from a component of DoD, or intentionally include data or specimens from DoD personnel.

DoD components include, but may not be limited to:

  • Department of Defense
  • Navy
  • Office of Naval Research
  • Naval Academy
  • U.S. Naval Observatory
  • Army
  • U.S. Army Corps of Engineers
  • Military Academy (West Point)
  • Air Force
  • Air Force Academy
  • Marines
  • Coast Guard
  • Coast Guard Academy
  • National Guard
  • Missile Defense Agency
  • Defense Advanced Research Projects Agency (DARPA)
  • Pentagon Force Protection Agency
  • Defense Intelligence Agency
  • National Geospatial-Intelligence Agency
  • National Security Agency
  • National War College
  • Under Secretary of Defense (Personnel and Readiness)
  • Other DoD facilities

An IRB supplement form called the Department of Defense (DoD) Supplement assists researchers in planning to meet the additional DoD requirements.

For New Applications involving DoD: The New Application submission (for expedited or full review) must include the completed DoD Supplement.  (A DoD Supplement is not required for studies requesting either an Exempt or a Not Human Research determination.)

When adding DoD to an existing IRB-approved project (expedited or full review study): The Modification must include the DoD Supplement.

You also must follow all requirements of the DoD entity, including any IRB review needed by the component entity (if applicable). 

Researchers are not allowed to expend DoD funds on human subjects projects until all of the following conditions are met:

  • The IRB has reviewed and approved the research.
  • The DoD component that is funding the research has been provided documentation of IRB approval.
  • When required, the appropriate DoD IRB has also reviewed and approved (dual review).
  • Office of Sponsored Research has received notice from the DoD component that the IRB approval has been received and accepted.

Please contact IRO@fredhutch.org with questions about this information.