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The HHS regulations at 45 CFR part 46, subpart E, require all IRBs to register with HHS if they will review human subjects research conducted or supported by HHS and are to be designated under an assurance of compliance approved for federalwide use (i.e, an FWA) by OHRP.

Last Reviewed: 12/02/2010

• When must an IRB be registered?
• How must an IRB be registered?
• Where can I find the IRB registration instructions and registration form?
• Who can I contact with questions about an IRB registration?
• How can I track receipt of my IRB registration submission?

• IRB Registration Process