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Human Subjects Division (HSD)

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Federalwide Assurance (FWA)

An institution that is engaged in human subjects research that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS) must have an assurance of compliance with the HHS regulations for the protection of human subjects. This assurance is called a Federalwide Assurance (FWA) and is approved by the Office of Human Research Protections (OHRP).

Each institution's FWA is identified by a number that is assigned by OHRP. This number may be requested as part of the IRB review process, especially when research is done collaboratively - involving multiple institutions.

UW Federalwide Assurance - FWA#: FWA00006878

(To view the FWA expiration date: click on the related link on the right hand side of this page. Search by IORG#0000143, then click on U of Washington.)

Department of Defense Addendum to the UW FWA: DoD N-F50320

Related Questions And Answers

  • How does one apply for an FWA?

    The OHRP website provides the information, and the application form, needed to apply for a Federalwide Assurance (FWA) including step-by-step instructions for domestic (U.S.) and international (non-U.S.) institutions. The FWA form is to be completed and signed by the collaborating institution. The FWA form does not need a signature by anyone at the University of Washington. Step-by-step instructions provided by the OHRP web site should be followed by the institution completing this form. The FWA form, Section 5, "Designation of Institution Review Boards IRBs," requests that the institution designate IRB(s) for review of research under their Assurance. The institution may list the University of Washington IRB(s), and other IRBs, if and as appropriate.

  • What if I am doing my research in another place or country?

    University of Washington researchers who are conducting research with human subjects that is funded by, or conducted by, the Department of Health and Human Services, and who are engaged in research at sites that are not UW-affiliated sites, must have an assurance of compliance with the HHS regulations for the protection of human subjects. Please see the topic: Federalwide Assurance for information on how to obtain this assurance.

  • What is a Federalwide Assurance (FWA)?

    Under the Department of Health and Human Services (DHHS) human subjects protection regulations (at 45 C.F.R. 46.103), every institution engaged in human subjects research that is funded or conducted by DHHS must obtain an Assurance Of Compliance approved by the Office for Human Research Protections (OHRP). This Assurance Of Compliance, when granted, is called a Federalwide Assurance. Both "awardee" institutions and collaborating "performance site" institutions must file Assurances.

    The "awardee" is responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research.