A Federalwide Assurance (FWA) is a way that institutions can let federal agencies know that they intend to comply with the regulations for the protection of human research participants. An FWA is required of institutions engaged in nonexempt research with human participants that is conducted or supported by the DHHS. Because it is federalwide, it is accepted by other federal agencies and departments that have adopted the Common Rule and that support research with human participants.
What this means in practice is that, if you have a current FWA, a federal agency that is providing funding for research at your institution will not have to request information from the institution concerning the makeup, policies, or procedures of the IRB. They will already have all the information they need in the FWA. It can streamline the process of obtaining grant money for research. The downside of an FWA is the amount of documentation required. Filing the paperwork and maintaining the FWA may require more work than choosing not to have an FWA.
You can compose an IRB that meets the federal guidelines described in 45 CFR 46 without an FWA. You can also, if you choose, use an IRB from another institution that has an FWA if you need it because of your request for funding from the DHHS (which requires an FWA). An FWA is not currently required for funding from other federal sources; however, other agencies may require their own assurance in the absence of an FWA.
There are significant advantages to having an FWA, but institutions need to be aware of both the requirements and the terms of such an assurance. For additional information, your IRB and/or your institution’s legal department should review the materials in the Assurances section of the OHRP website (https://www.hhs.gov/ohrp/assurancesopens in new window).