Federal Wide Assurance (FWA) Frequently Asked Questions
(FAQs)
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.
The original will be filed with the approved Human Subjects Application.
Keep a copy of the agreement in your human subjects application file.
Individual unaffiliated investigators are not required to have a
Federalwide Assurance.
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