Federalwide Assurance (FWA) is a required institutional commitment filed with the U.S. Department of Health and Human Services to comply with federal human subject protection regulations (45 CFR 46).
An FWA is the assurance mechanism accepted by the Office for Human Research Protections (OHRP) for institutions engaged in non-exempt human subjects research. It establishes that an institution will maintain an IRB and follow federally required ethical standards. FWAs are foundational for federally supported research and are commonly referenced in compliance governance. Maintaining an active FWA supports lawful conduct of regulated human research and reinforces institutional accountability.