July 1, 2009: FDA Requirements Regarding IRB Registration
July 1, 2009: FDA Requirements Regarding IRB Registration
In January, 2009, the Food and Drug Administration (FDA) posted a final rule (effective July 14, 2009) that will require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). This registration system is the same system utilized by the HHS Office of Human Research Protections (OHRP) to maintain a list of IRBs which review federally funded research. Any IRBs reviewing clinical investigations regulated by the FDA must be registered in this system by September 14, 2009. Please note that UHCMC IRB has two IRB committees, both of which are registered in this system. Anyone who requires documentation of this registration may search the OHRP website to confirm current registration status. The IRB registrations numbers (IRB00000684 and IRB00001691), as well as the HHS Federal Wide Assurance of Compliance number (FWA00003937) can be found on the IRB FAQ webpage, the IRB Statement of Compliance letter, the IRB rosters and the IRB protocol approval letter. |
Posted on Thursday, July 09, 2009 (Archive on Friday, October 09, 2009) |
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