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The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.

Last Reviewed: 06/17/2011

• What research does the Federalwide Assurance (FWA) cover?
• What time period does the Federalwide Assurance (FWA) cover and when does it have to be updated?
• What are the key features of the Federalwide Assurance (FWA)?
• Do international institutions have a separate FWA form or Terms of Assurance?
• Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?

• Assurance Process