What is Federal Wide Assurance?

The Federal Wide Assurance (FWA) is the only type of assurance of compliance accepted and approved by the Office of Human Research Protection (OHRP) for institutions engaged in non-exempt human subjects research conducted or supported by the United States Department of Health and Human Services (HHS). Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CRF part 46, as well as the Terms of Assurance. For more information on 45 CRF part 46, as well as the Terms of Assurance, please visit: http://answers.hhs.gov/ohrp/questions/7142

The College of Medicine’s Institutional Review Board, CoMREC, is registered with the HHS. This registration is used by institutions and organizations operating IRBs that review:

a) Research involving human subjects conducted and supported by the Department of Health and Human Services, or other federal departments or agencies that apply the Federal Policy for the Protection of Human Subjects to such research; and/or
b) Clinical investigations regulated by the Food and Drug Administration (FDA) of the Department of Health and Human Services

CoMREC’S Institutional Organization number is: IORG0000800

CoMREC is also required to have Federal Wide Assurance (FWA). CoMREC’s FWA number is: FWA00011868