FWAs

An FWA is an assurance of compliance submitted to the Office for Human Research Protections (OHRP) by an institution that is engaged in nonexempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) or another U.S. Department or Agency that uses OHRP’s FWA.

Through the FWA and the Terms of the FWA, an institution commits to HHS that it will comply with the requirements in the HHS regulations for the protection of human subjects at 45 CFR part 46. The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP.

Please note: The fact that the OHRP has approved an institution’s assurance does not mean that OHRP has determined that the institution is complying with the requirements of the HHS regulations for the protection of human subjects at 45 CFR part 46. It means that an institution has submitted all the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in nonexempt human subjects research conducted or supported by HHS or otherwise covered by the assurance. The Federalwide Assurance or FWA is the only type of assurance accepted and approved by OHRP.