Federal Wide Assurance (FWA) Frequently Asked Questions (FAQs)

• What is a Federalwide Assurance (FWA)?
• How does one apply for an FWA?
• What if I'm doing my research in another place or country?

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.

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’m 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 do the following:

• Ask collaborating institutions to provide a Federal Wide Assurance Number. If an institution does not have an approved FWA, ask the institution to apply for an FWA immediately.
• Once the collaborating institution has provided an assurance number, or when it has applied for the FWA, you should help the collaborating institution prepare an “IRB Authorization Agreement.”
• Complete Section 3.A-F as the University of Washington researcher.
• Obtain the signature of the appropriate official at the collaborating institution.
• Submit the original signed document to the Human Subjects Division. The Director of the Human Subjects Division (or designee) will sign the document and return a copy to you.
• Forward a copy of the signed document to the collaborating institution. (This is the responsibility of the Principal Investigator.) The Human Subjects Division will file the original document with the approved Human Subjects Application. Keep a copy of the agreement in your human subjects application file.

If an individual (as opposed to an institution) at a non-UW-affiliated site is engaged in the research, that individual must submit an “Individual Investigator Agreement.”

• Assist the unaffiliated individual investigator by completing the information under "Specify Research Covered by this Agreement."
• Submit the original document, signed by the unaffiliated individual investigator, to the Human Subjects Division. After the document has been signed by the Director of the Human Subjects Division (or designee), a copy of the document will be returned to you.
• Forward a copy of the signed document to the unaffiliated individual investigator.