Federalwide Assurance (FWA)

The Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is requesting a revision of the currently approved collection for the OMB No. 0990-0278, Federalwide Assurance (FWA) Form. The form is currently approved through October 31, 2026. The purpose of the FWA form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act) (42 U.S.C. 289); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this information collection are institutions engaged in HHS-conducted or –supported research involving human subjects. With this revision, OHRP is seeking to remove information from the FWA form to adopt the changes at 45 CFR 46.103 of the 2018 Requirements and reduce burden on respondents. The proposed changes to the FWA form include: 1) removing the Pre-2018 Common Rule requirement that institutions provide a statement of ethical principles; 2) removing the Pre-2018 Common Rule requirement that an institution designate one or more IRBs to review the research to which the FWA applies; 3) removing “check the box”, or the option for U.S. institutions to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46, to all of an institution’s nonexempt human subjects research regardless of the source of support; and 4) eliminating the requirement for institutions outside the U.S. to provide procedural standards they apply for human subjects research when assuring compliance with the Terms of the Federalwide Assurance. Updates to the software applications OHRP uses to manage the FWA application process will be deployed to enable such changes.

The latest form for Federalwide Assurance (FWA) expires 2029-02-28 and can be found here.