Research supported by the Department of Defense (DoD) must be reviewed by the IRB under an additional set of federal regulations (32 CFR 219) and requires compliance with additional directives and instructions.
WHAT QUALIFIES AS DEPARTMENT OF DEFENSE RESEARCH?
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 the DoD
- The research uses property, facilities, or assets of a component of the DoD
- The subject population will intentionally include personnel (military or civilian) from a component of the 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.
WHAT ARE THE COMPONENTS OF THE DEPARTMENT OF DEFENSE?
Department of Defense (DoD) components include, but may not be limited to:
- Office of Naval Research
- Naval Academy
- U.S. Naval Observatory
- U.S. Army Corps of Engineers
- Military Academy (e.g., West Point)
- Air Force
- Air Force Academy
- 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
- Other DoD facilities
INSTRUCTIONS FOR RESEARCHERS
DoD-related research activities typically involve additional compliance requirements before investigators may begin their research. Researchers are expected to adhere to the following requirements for research involving the DoD:
- Submit documentation of an independent scientific merit review along with the protocol for UCSB IRB review*;
- Provide additional language in the protocol and consent form**; and
- Submit the IRB approval and approved documents to the appropriate DoD Human Research Protection Program Officer (HRPPO) for final review.***
- Researchers may be required to complete the DoD CITI training requirements. Instructions for completing training can be found here;
- For studies in which continuing review is required, researchers should include whether their research has resulted in any publications and/or presentations.
*The Army and Navy require an independent scientific merit review and approval prior to IRB review. The scientific merit review is project specific and evidence of the review should be uploaded with the IRB application. For more information on research involving the DoD, including specifics on scientific merit review, see UCSB’s guidance here.
** Consent forms must include a statement indicating that the DoD is providing support for the research project and a DoD representative may access research records for the protection of human subjects. If researchers will be sharing data with other institutions, this must be described in the Procedures section of the protocol and must also be included in the consent forms.
***Once UCSB IRB approval has been obtained, a review by HRPPO is required for research involving the DoD prior to initiation of any research involving human subjects. It is the investigator’s responsibility to submit the applicable documents for review and approval by the appropriate HRPPO before starting any research activities that involve human subjects.