Human Subject Documentation Requirements

Research involving human subjects requires submission of three copies of each of the following documents:

1. Documentation of approval from an institutional review board (IRB) signed by a member
2. IRB-approved consent form, stamp dated of approval
3. IRB-approved research protocol, stamp with date of approval
4. Proof of completed human research training (e.g., training certificate, institutional verification of training)

These documents must be submitted concurrent with the research proposal.  For assistance with submission of documentation, contact Ms. Sevgi Bullock via e-mail at sevgi.bullock@navy.mil.

If the research is determined to greater than minimal risk, also provide name and contact information for the independent medical monitor.

Note: In accordance with DoDD 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.

All performers must have an active DoD-Navy Addendum to the Federalwide Assurance (FWA). To see a list of current DoD-Navy Addendums to FWAs, visit the Navy Bureau of Medicine and Surgery.

Additional documentation which may be needed:

1. DoD-Navy Addendum to the FWA for non-DoD Institutions/Performers: Non-Navy institutions engaged in DoN-supported research with human subjects must have an FWA for the protection of human subjects in accordance with 32 Code of Federal Regulations, Part 219 approved by the Department of Health and Human Services’ Office for Human Research Protections. A DoD Navy Addendum covers the unique Department of Defense and DoN requirements that are not specifically included in the FWA.
2. Institutional Agreement for IRB Review (IAIR): If an engaged institution does not have an IRB appropriate for review of Navy-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 external IRB, and outlines the roles and responsibilities for 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 institution can enter into an agreement with an assured institution by means of a DoN Individual Investigator Agreement.

For assistance please contact the Research Protections Office at 703-696-2864.