An independent IRB does not need to obtain a separate Federal Wide Assurance (FWA). It is generally accepted that the IRB is not actively engaged in the research nor is it a direct recipient of federal funds. Consequently, the IRB can be considered a sub-contractor and as such should be listed on the Sponsor’s FWA form as the IRB of record.
To designate Quorum as an IRB of Record on the FWA, simply include “Quorum Review IRB” and Quorum’s IRB registration number IRB00003226 on the FWA.
For more information on Federal Wide Assurances, visit the U.S. Department of Health and Human Services website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html. Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.
Posted in: Federally Funded Studies: FAQs