Addendum and Assurance Information
For Non-Navy Institutions: Addendum to Federalwide Assurance (FWA)
Non-Navy institutions are required to obtain an “addendum” which identifies and covers the unique Department of Defense (DoD) and Department of Navy (DoN) requirements that are not specifically included in the institution’s Federalwide Assurance (FWA). DoN supports research with human subjects conducted by extramural performers through contracts, grants, cooperative agreements or other arrangement and by collaborators with DoN. The Navy 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 mandate additional requirements for research with human subjects.
To see a list of current DoD-Navy addendums to FWAs, please visit: http://www.med.navy.mil/bumed/humanresearch/resource/AssuranceInformation/Pages/DoD-NavyFWA%20Addendums.aspx.
For Navy Intramural Institutions: DoD Navy Assurance
Navy institutions are required to obtain an “assurance” from the DoN Human Research Protection Program if they are conducting, supporting, reviewing, approving or managing research with human subjects. According to the SECNAVINST 3900.39D, 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 DoN and are not restricted by funding source (intramural or extramural), 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.
How Do I Obtain an Addendum or Assurance?
The DoN Human Research Protection Program will assist you in completing the necessary documentation in order to receive an addendum or assurance. For more information, please contact 703-588-0612 or ONR_343_contact@navy.mil.