OHRP Proposes Major Changes to Simplify FWA, TOA Forms

HHS’ Office for Human Research Protections (OHRP) is proposing key changes to the federal wide assurance (FWA) form and the terms of assurance (TOA), including a combined U.S. and non-U.S. FWA form. The combined form would have a shortened, simplified TOA. Sites engaged in HHS-supported research must hold an OHRP-approved FWA. The form ensures that the site has submitted all the documentation required by OHRP.
Clinical Trials Advisor