Are there options other than the Federalwide Assurance (FWA) for HHS-conducted or -supported research?
No. In January 2005, the Office of Management and Budget approved the Federalwide Assurance (FWA) forms and related documents and the IRB or independent ethics committee (IEC) registration form. At that time, OHRP announced that the FWA will be the only new type of assurance accepted for review and approval by OHRP. Institutions holding an OHRP-approved Multiple Project Assurance (MPA) or Cooperative Project Assurance (CPA) are required to submit an FWA to OHRP for approval by December 31, 2005, if the institution is required to have an OHRP-approved assurance of compliance. Any Inter-Institutional Amendment between an OHRP-approved MPA and an affiliate institution will be deactivated on January 1, 2006 if the affiliate institution has not obtained its own FWA. Single Project Assurances (SPA) currently approved by OHRP will remain in effect for the duration of the project and through all non-competitive award renewals.
