Department of Defense Research Requirements

Background

The Department of Defense (DOD) IS a signatory to the Revised Common Rule, which took effect January 21, 2019.   To determine additional applicability and requirements when conducting DoD supported research, view the DoD Instruction 3216.02. The IRB Application in Kuali Research Protocols addresses DoD requirements.

Specific branches of the military may have their own additional requirements.  In addition to following the  DoD Instruction 3216.02, it is critical to work with your Program Officer on specific requirements for your research.

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.

Post-Approval Instructions

Documentation

Lead Researhers (LRs) and the UCI HRP are responsible for maintaining certain documentation in their files. LRs are also responsible for submitting documentation to DoD prior to starting an IRB-approved study and upon subsequent reviews by the IRB (amendments and renewals, etc.). DoD uses such documentation to conduct a "headquarters-level administrative review." DoD HRPP requires certain IRB documentation that is not maintained by the LR (such as IRB meeting minutes). These items will be sent directly from the UCI HRP to DoD as requested. UCI HRP will notify the PI when these documents are sent.

IRB Reporting Requirements

The IRB may be required to notify the DoD and the sponsor of serious adverse events, non-compliance, unanticipated problems involving risks to subjects or other and protocol deviations and actions taken regarding the reports.

Amendments to Approved Research

When submitting amendments to previously approved research, review your Defense Supplement to ensure that it still accurately reflects the research. Submit a revised supplement (and any additional documentation) if necessary.

If the amendment involves substantive changes (e.g., new procedures, a new subject population), also submit documentation of scientific review and approval of the changes with the amendment request.