Addendum and Assurance Information

For Non-DoD Institutions: Navy Addendum to Federalwide Assurance (FWA)

Effective February 1st, 2016, DoN will no longer require or issue the Navy Addendum to the FWA.

The Department of the Navy (DoN) continues to support research involving human subjects conducted by a non-DoD institution by way of contracts, grants, assistance agreements, cooperative agreements, cooperative research and development agreements and other partnering agreements. DoN implements human research protection requirements through the Common Rule (32 CFR 219), Department of Defense Instructions (DoDI 3216.02) and directives, and DoN instructions (SECNAVINST 3900.39D). The DoD and DoN also have additional requirements for research involving human subjects, including the requirement for review by a Human Research Protection Official (HRPO).

For Navy Institutions: DoD Navy Assurance)

DON institutions are required to obtain an “assurance” from the Surgeon General of the Navy if they are conducting, supporting, reviewing, approving or managing research with human subjects. According to the SECNAVINST 3900.39D, para 6.a(4)(b), a DoD Navy Assurance is “a document originated by the institution engaged in human subject research that states that it will comply with federal, DoD and DoN requirements for human subject protections.”

The assurance applies to research involving human subjects and activities that involve such research even in part, regardless of whether the research is otherwise subject to federal regulation. The requirements of the assurance apply to all programs within the institution and are not restricted by funding source, funding appropriation, nature of support, program budget activity, program title, or security classification.

To see a list of current DoD-Navy assurances, please visit:
http://www.med.navy.mil/bumed/humanresearch/resource/AssuranceInformation/Pages/NavyAssurances.aspx

If you need help obtaining a DoD-Navy Assurance, please contact the DoN Human Research Protection Program at 703-696-2092 or DONHRPP.info@navy.mil.

* Some pages on this website provide links which require a plug in to view.