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Office for Human Research Protections (OHRP)

Registration of an Institutional Review Board (IRB)

Version Date 7/09/2009

Obtaining an approved assurance from OHRP is a two-step process. First, you must ensure that the IRB(s) you designate under the Assurance are registered with OHRP. If not, submit the registration. Second, you must complete the Assurance application.

Please note: the fact that an Institutional Review Board (IRB) is registered with the Office for Human Research Protections (OHRP) does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46, and does not mean that the IRB has the appropriate competence or expertise to review a particular research project. However, all IRBs that review human subjects research conducted or supported by HHS, and that are designated under assurances of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a), must be registered with OHRP.

FAQs on IRB Registration

LIST OF REGISTERED IRBs AND APPROVED ASSURANCES

Filing a New Registration for an IRB

Your institution or organization can register an IRB even if your institution or organization has never been assigned an IORG number by OHRP and never registered an IRB. You must register your institution's or organization's IRB using the electronic submission system unless your institution or organization lacks the ability to register its IRB electronically. We recommend that you print out and have available the instructions for registering an IRB at http://www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm

Tracking the Status of an IRB Registration

Once you have submitted an IRB registration, you may track the progress of your document until the IRB is registered. Once your institution's IRB registration has been processed, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/.

IRB Registration

Other Forms

IRB Authorization Agreement
Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption (Formerly Optional Form 310)

Who to Contact re: IRB Registration

Steps to Register a New IRB

Note: You must register your institution's or organization's IRB using the electronic submission system unless your institution or organization lacks the ability to registry its IRB electronically.

Paper-Based IRB Registration

Download or Print the Instructions and the Registration form and membership roster.
[HTML] [RTF - 361KB]
Read the Instructions.
Review and fill out the Registration form and membership roster.
Fax the completed Registration form and membership roster to OHRP at:

(240) 453-8202
or mail the registration form and membership roster to:

Office for Human Research Protections
U.S. Department of Health and Human Services
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Forms to download:
- Instructions
- Registration form and membership roster
  [HTML] [RTF - 361KB]

Electronic IRB Registration

Download or print the Instructions for registering an IRB.
Read the Instructions.
Go to the electronic submission system website to create electronic IRB Registration.
1. Click "Enter New IRB Registration."
2. Request electronic registration number, which will be e-mailed to you.
3. Return to website and enter data to complete registration. All areas marked with an "*" must be completed. You may work on the registration, exit, and return as many times as you would like.
4. Review your entries carefully before clicking the "Submit IRB Registration" button.
5. Print a copy of the IRB registration for your file.

Tracking the Status of an IRB Registration

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