Federal Wide Assurance

The Federal Wide Assurance (FWA) is the only type of new assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR, part 46 as well as the Terms of Assurance. FWAs also are approved by OHRP for federal wide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support.

Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question. There are two versions of the FWA and the Terms of Assurance, one of each for domestic (U.S.) institutions and for international (non-U.S.) institutions. http://www.hhs.gov/ohrp/assurances/index.html

The St. John Hospital and Medical Center numbers are:

  • Federal Wide Assurance (OHRP): FWA 00003217
  • IRB Registration Number (OHRP): IRB 00002596