Proposed changes to Federalwide Assurance (FWA) for human research
06/13/2025 – Information Collection Request
The Federalwide Assurance (FWA) is how our research enterprise (VCU and VCU Health System) identifies our compliance strategy for human research protections. In doing so, we apply the highest relevant ethical and regulatory standards for research and privacy protections, specific to each individual human research protocol. 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.
Read the draft guidance. Comments due by July 14, 2025.