Researchers should expect and plan for additional costs, actions, and documentation that may be associated with DoD-supported research. For example, when a scientific reviewer is required, costs for the reviewer should be included when developing the application. Consider the following when planning to do research with the DoD:
Requirements for Additional Training
The DoD requires training in human subjects research. In addition to the CITI course required by the UI, the Navy requires additional certification modules offered through the CITI program. For directions on how to access these modules, see Training Requirements on this page.
Check with the DoD representative to determine if other training is needed or if current training should be recertified. Rules and regulations specific to the Navy and the Marines may be found in SECNAVINST 3900.39D.
The Army and Navy require independent scientific review and approval of nonexempt research prior to IRB review of new applications and substantive modifications. The review may be conducted by the funding agency (including the DoD), through the use of an established internal review mechanism in the PI’s school or department, or via an ad hoc scientific review by the researcher’s chair or dean.
When scientific review is required, the PI must provide documentation to the IRB upon submission of the initial IRB application or substantive amendments. Scientific review must demonstrate that the research uses procedures consistent with sound research design and is likely to yield the expected results and should include an assessment of the following:
- Significance of the research question;
- Scientific approach;
- Research team qualifications;
- Facilities and resources available; and
- Adequate subject protections.
The name and qualifications of the reviewer(s) should be included as part of the review.
At the UI, the requirement for scientific review will be met by the Departmental Executive Officer’s (DEO’s) signature on the Assurance submitted by the PI as part of the IRB submission. The form for documenting scientific review is incorporated with the Assurances.
Approval of Surveys
Research involving surveys or interviews with DoD military or civilian personnel or their families may require DoD approval. Check with the DoD contact to determine if there are additional requirements and whether the approval is required before or after IRB review.
Navy Research and IND/IDEs
Investigators doing research with the Navy may not be designated as sponsors of an Investigational New Drug (IND) or Investigational Device Exemptions (IDE). Only the Surgeon General, Commanders, and Commanding Officers may be sponsors. (SECNAVINST 3900.39D(6)(h). Research Involving the Use of Investigational Test Articles.)