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Initial IRB Registration

An institution or organization that has not registered an Institutional Review Board (IRB) or been assigned an IORG number must complete an initial IRB registration application on-line using the Electronic Submission System (ESS). Please be aware that the following instructions should ONLY be used if your institution or organization has never been assigned an IORG number by OHRP. For instructions on how to update or renew an existing IORG please CLICK HERE.

Obtaining a submission number is the first step. Please follow the instructions below:

1.            Go to:  https://ohrp.cit.nih.gov/efile/IrbStart.aspx

2.            Scroll down to the bottom of the webpage and select:  “I need a submission number

3.            Enter the following in the appropriate fields  

               -  Your e-mail address

               -  A password with a mix of upper and lower case letters and numbers or special characters

               -  A password hint that cannot be the same as the password

4.            Click on the “Submit” button. Your assigned submission number should be delivered to the email address you entered within 24-48 hours.

5.            Once you receive the submission number, return to the Electronic Submission System by clicking  the following link: https://ohrp.cit.nih.gov/efile/IrbEnter.aspx?typ=hav

               - Enter the submission number

               - Enter the password you created and select “Submit

6.            The IRB registration fields will be presented for you to complete and submit to OHRP.

OHRP does not accept hard-copy IRB registration submissions. If an Institution lacks the ability to register an IRB electronically using the Web page, contact OHRP by telephone at (240) 453-6900, or by email at the following address: irborfwa@hhs.gov

Frequently Asked Questions (FAQs) on the IRB Registration Process are located at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/index.html

FDA’s “Guidance for Institutional Review Boards (IRBs) - Frequently Asked Questions - IRB Registration” is available (PDF). - PDF

If an institution lacks the ability to register an IRB electronically using the Electronic Submission System, after consulting with OHRP, it must send the IRB registration information in writing.

               - If the IRB reviews research regulated by OHRP only or reviews research regulated by FDA and OHRP, send the IRB registration information to OHRP by:

FAX: (240) 453-6909
By email as a pdf scanned document
or mail it to
Division of Policy and Assurances
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

               - If the IRB reviews research regulated by FDA only, send the IRB registration information to FDA to:

Office of Good Clinical Practice
 Special Medical Programs, Office of Medical Products and Tobacco
Food and Drug Administration
10903 New Hampshire Avenue
WO32-5103
Silver Spring, MD 20993-0002

Content created by Office for Human Research Protections
Content last reviewed on March 15, 2016