Registration with FDA
OSU’s Institutional Review Boards (IRBs) are now registered with the Food and Drug Administration (FDA) in compliance with the new FDA rule issued on July 14, 2009. The rule requires all U.S. IRBs reviewing clinical investigations involving FDA-regulated products to register with FDA. IRBs have until September 14, 2009 to register.
FDA’s new requirement operates in coordination with the Office for Human Research Protections (OHRP), which already requires registration for IRBs reviewing federally-supported research. A single database of all U.S. IRBs, regardless of whether they review research regulated by FDA or other federal agencies, has been established.
IRBs are required to renew registration every three years, or sooner if contact information changes. IRBs do not provide specific protocol numbers as part of the registration process or routinely update registration information with the current number of active protocols under review. IRB registration does not represent accreditation or certification by FDA or OHRP. The agencies do not provide certificates confirming an IRB’s registration.
Registration information can be accessed via OHRP’s online database.
- IRB Organization number (IORG)
- OSU’s IORG is 0000181.
- IRB registration number
- 00000294 – OSU Biomedical Sciences IRB
- 00003096 – OSU Cancer IRB
- 00000295 – OSU Behavioral & Social Sciences IRB (OHRP only)
Please note that these numbers are linked to both FDA and OHRP registrations (as applicable).
For additional information, view the Federal Register and FDA’s FAQs Regarding IRB Registration.
