Human Subject Research Documentation Requirements

Research involving human subjects requires submission of the following documents:

1. Documentation of approval from an Institutional Review Board (IRB) or other determination (e.g., exemption or not research involving human subjects)
2. IRB-approved informed consent
3. IRB-approved research protocol
4. All other documentation submitted to the IRB (e.g., recruitment materials, questionnaires, surveys)
5. Proof of completed human research ethics and human subjects training (e.g., training certificate, institutional verification of training)

These documents must be submitted concurrently with the research proposal. For assistance with submission of documentation, contact the Human Research Protection Official (HRPO), Ms. Sevgi Bullock, via e-mail at sevgi.bullock@navy.mil.

Note: In accordance with DoDI 3216.02, for research greater than minimal risk, administrative procedures to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in a research project must be addressed. Documentation describing those procedures may be requested.

Additional documentation which may be needed:

1. Federalwide Assurance (FWA) for non-DoD Institutions/Performers: Non-DoD institutions engaged in non-exempt research involving human subjects that is supported by the Department of Defense shall have a federal assurance (e.g, FWA) consistent with 32 CFR 219.103 and acceptable to the HRPO.
2. Institutional Agreement for IRB Review: If an engaged institution does not have an IRB appropriate for review of DoN-sponsored research, the institution may designate IRB(s) outside of the institution. The institutional agreement for IRB review is signed by both the engaged institution as well as the institution supplying IRB review services, and outlines the roles and responsibilities of the institution and the IRB.
3. Individual Investigator Agreement: Any individual who is engaged in human subject research and is not an employee of an assured institution can enter into an agreement with an assured institution by means of an Individual Investigator Agreement.
4. Command Permission: When targeting DoD personnel (military and civilian) for research, provide documentation of Commanding Officer permission from military facilities or units in which recruitment will occur or the study will be conducted.
5. Research Monitor: If the research is determined to be greater than minimal risk, provide documentation of the name and contact information for the IRB-approved independent research monitor, as well as a written summary of the monitors’ duties, authorities and responsibilities.