Initial IRB Registration

An institution or organization that has not registered an Institutional Review Board (IRB) or been assigned an IORG number must complete a new, initial IRB registration application online using the Electronic Submission System at https://ohrp.cit.nih.gov/efile/IrbHome.aspx.

[If your institution or organization has previously registered an IRB(s), or been assigned an IORG number, it generally should complete an IRB registration update/renewal application. (For instructions on how to update or renew an existing IRB registration, please go to https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/update-renew-registration/index.html.)]

Obtaining a submission number is the first step to access a new, initial IRB registration application. Please follow the instructions below:

1. Go to: https://ohrp.cit.nih.gov/efile/IrbStart.aspx
2. Click “I need a submission number”
3. Enter the following in the appropriate fields:
   1. Your e-mail address
   2. Create a password with a mix of upper- and lower-case letters and numbers or special character; and
   3. Confirm the password.
4. Click 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
6. Enter the following in the appropriate fields:
   1. Enter the submission number
   2. Enter the password you created
7. Click the “Submit” button. The IRB registration application 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, contact OHRP by telephone at (240) 453-6900, or by email at IRBorFWA@hhs.gov.

A short tutorial on the IRB-Registration process is located at: https://www.youtube.com/watch?v=57EQt8xtwsc

Frequently Asked Questions (FAQs) on the IRB Registration Process are found at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/irb-registration-faq/index.html

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

An IRB registration accepted by OHRP is effective for 3 years.

Each IRB must renew its registration every 3 years. However, an IRB-operating institution or organization (IORG) must update its IRB registration if either of the following circumstances apply:

1. Within 90 days after changes regarding the contact person who provided the IRB registration information or the IRB chairperson.
2. For IRBs registered with FDA, within 30 days after an IRB decides to review additional types of FDA-regulated products (e.g., to review device studies if it only reviewed drug studies previously) or to discontinue reviewing clinical investigations regulated by FDA

An IORG must also notify OHRP in writing at IRBorFWA@hhs.gov of its decision to disband a registered IRB that it is operating within 30 days after permanent cessation of the IRB's review of HHS-conducted or –supported research.

OHRP generally recommends that an institution or organization should also update its IRB registration within 90 days of a change in the membership roster if that IRB reviews research conducted or supported by HHS. Whenever an IRB registration is updated or renewed, the IORG should ensure that all information on the application is current and accurate.