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Institutional Review Board (IRB) Registration

Registration of your Institutional Review Board (IRB)/Independent Ethics Committee (IEC) with the Office for Human Research Protections (OHRP) is voluntary.  However, IRB/IEC Registration is required for any IRB/IEC designated on a Federalwide Assurance.  IRB registration is not currently required by the Food and Drug Administration.

Electronic submission of a new IRB/IEC is now available (see link below).  The electronic form may not be used at this time by institutions that have already submitted IRB Registrations or have been assigned an IORG Number (e.g., all MPA institutions).  These institutions must update or renew their IRB/IEC Registrations by faxing or mailing a hard copy.  The IRB organization must have an e-mail address to register an IRB electronically.

Registering your IRB/IEC will facilitate OHRP's effort to establish effective communication with IRBs/IECs working to protect human subjects, especially those responsible for research supported or conducted by the Department of Health and Human Services (DHHS).


Background
    Why Register an IRB or IEC?
    IRB Knowledge of Local Research Context

IRB/IEC Registration & Related Information
    Instructions for Registering IRBs or IECs
         Sample IRB Registration Form - RTF Format
         Sample IRB Registration Form - HTML Format

Electronic Registration of an IRB/IEC 



Organizations with Registered Institutional Review Boards

IRB Registrations/Updates Received in Past 60 days

Procedures for Updating/Renewing of IRB Registrations

Related Forms
    IRB Authorization Agreement - RTF Format (Sample)
    Protection of Human Subjects: Assurance Identification/Certification/Declaration
of Exemption (formerly called the Optional Form 310) - RTF Format (Sample)

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If you have questions about human subject research, click   ohrp@osophs.dhhs.gov
If you have questions/suggestions about this web page, click  lniemoeller@osophs.dhhs.gov



Last revised: June 18, 2004

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