What is Quorum Review’s Federal Wide Assurance (FWA) number?
An independent IRB does not need to obtain a Federalwide Assurance (FWA). An FWA is required for institutions that are engaged in research conducted or supported by a federal agency (such as HHS.) An IRB itself is not engaged in the research nor is it a direct recipient of federal funds. However, an FWA requires the institution to designate one or more IRBs that review research for the institution. If the institution does not have an internal IRB designated on its FWA, then it must designate an external IRB that reviews the largest percentage of the research covered by the FWA. All IRBs must be registered with OHRP before they can be listed on an institution’s FWA. If an institution wishes to add an external IRB to its FWA as an IRB of Record, it must use the IRB’s OHRP registration number. More information is available at http://answers.hhs.gov/ohrp/categories/1563 .