University of Washington
Human Subjects Division

Federalwide Assurances,
IRB Authorization Agreements, and
Individual Investigator Agreements

What is the Federal policy? - What does it mean to be "engaged in research"? -
What does this mean for researchers affiliated with the University of Washington? - How does one apply for an FWA? - Resource Links

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.

Institutions are engaged in research whenever their employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or access individually identifiable private information for research purposes.

What does this mean for University of Washington Researchers?

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 an 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.

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.

1. Assurances and IRB Registration (Applications for Domestic and International FWA, IRB Registration)
2. "Engaged in research" (definition of)
3. Federal agencies requiring an FWA (List of HHS agencies)
4. Institutions with assurances (OHRP list)
5. University of Washington affiliated sites and cooperative agreements  with other institutions
6. University of Washington IRB Registration (for registration numbers of UW's IRBs requested in Item 5 of the FWA Form)
7. Guidance, Individual Investigator Agreement  (1/31/2005, change of policy regarding unaffiliated investigator/individual investigator agreement)

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