Assurance Information

For Non-DoD Institutions: Federalwide Assurance (FWA)

NOTE: Effective February 1st, 2016, DON no longer requires or issues 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 series). The DoD and DON have additional requirements for research involving human subjects, including the requirement for review by a Human Research Protection Official (HRPO).

For Department of the Navy Institutions: DoD-DON 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.

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.

A list of current DoD-DON assurances is available on the DON Human Research Protection Program (HRPP) milSuite site. To create a milSuite account (DoD Common Access Card required) follow the link below and subsequent prompts to request access.

https://www.milsuite.mil/book/groups/don-hrpp

If you need help obtaining a DoD-DON Assurance, please contact DON HRPP at ONR343@navy.mil.

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