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Important Announcement about Office for Human Research Protections Electronic Submission System and Federalwide Assurance Updates

Changes to the Federalwide Assurance (FWA) are coming soon and will temporarily impact access to OHRP’s electronic submission system for both FWAs and institutional review board (IRB) registration. OHRP is updating the FWA to implement burden-reducing provisions in the revised Common Rule (the “2018 Requirements”) at 45 CFR 46.103 and to adopt other non-regulatory changes to decrease unnecessary burden and clarify the applicability of 45 CFR part 46 to HHS-supported or conducted nonexempt human subjects research. Details about the revisions to the FWA form, OMB No. 0990-0278, can be found online.

Implementing these changes requires system updates to the software applications that OHRP uses to manage FWA and IRB registration applications. The Electronic Submission System (ESS) for OHRP’s IRB registration and FWA registries will undergo system upgrades that require scheduled downtime on March 12, 2026, beginning at 7:30 PM EST. Please note that FWA and IRB registration applications cannot be submitted or processed during the scheduled downtime. We expect to resume normal service on March 23, 2026. If you are planning an initial or renewal application for either an FWA or an IRB registration prior to March 23rd, we strongly encourage you to complete and submit as soon as possible, and no later than March 6, 2026. Thank you for your patience as we complete the ESS system upgrades. Please contact IRBorFWA@hhs.gov if you have questions or need assistance.

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Institutional Review Board (IRB) Registration

Update or Renew an IRB Registration

Alert: This area should ONLY be used to update or renew the registration of an IRB previously registered by your institution or organization.

You must use this electronic submission system to update/renew the registration of an IRB previously registered by your institution or organization, unless your institution or organization lacks the ability to update/renew its IRB registration electronically.

An IRB registration is effective for 3 years. However, when information changes regarding the contact person who provided the IRB registration information or the IRB chairperson, an update/renewal application must be submitted to OHRP within 90 days after the changes occur.

We recommend that you use the IRB registration instructions at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/irb-registration-instructions/index.html.

Instructions to access an IRB registration update/renewal application are found at the "What are you looking for?" click button boxes below and online at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/update-renew-registration/index.html.

What are you looking for?

Additional instructions for electronic submission of a Update/Renewal IRB registration are provided below:

  1. You must have an email address to use the electronic submission process. Additionally, you will need to obtain an electronic submission number to access an application to update/renew an IRB registration.
  2. To create a submission number, you must know the IORG (institution or organization) number, the most recent Senior Officer/Head Official last name on file with OHRP, and most recent IRB Chairperson last name on file with OHRP. If your institution or organization has registered more than one IRB, then the most recent last name of any registered IRB Chairperson will work. You can start the electronic submission process at the bottom of this screen.
  3. After obtaining your submission number, as outlined below, you will be able to make changes to the registration of your institution or organization’s IRB(s). All information currently on file with OHRP will appear in the various fields.
  4. In addition to the changes you are making, you must ensure that ALL information for your institution or organization and EACH registered IRB is accurate and complete before you "Submit" the update/renewal.
  5. You must ensure all required (*) application fields are completed.
  6. Once you have entered or changed information on each screen and reviewed all data fields for accuracy, click on the "Save and Continue" button to move to the next section.
  7. You can use the tab at the top of the page for moving from section to section of the application. However, please be aware that if you have not saved information on a page before going to another page, you will lose the information you entered on the last screen.
  8. Once all entries are made, please review all fields of the application to ensure the accuracy of the data and click "Submit." If you left any required fields blank, you will be prompted to correct those errors. If not, you will be prompted to print a copy of your submission for your record.
  9. Once you "Submit" the electronic update/renewal application, please verify that it has been submitted to OHRP for review. You can verify and check the status of an IORG-IRB registration submission online at https://ohrp.cit.nih.gov/search/docsearch.aspx. After you submit the application for update/renewal, it is assigned to OHRP staff for review.
  10. The persons listed on the IRB Registration including the Senior Officer/Head Official, the information provider/contact person, and the IRB Chairperson(s) will be notified by email when OHRP has accepted the IRB registration update/renewal application. Receipt of the automated email notification depends on whether the correct email addresses were provided on the application. Please check spam or junk email folders if email notification is not received.
  11. Please do not attempt to update/renew an IRB registration when there is already an electronic application being processed by OHRP.
  12. The status of the IRB Registration will be updated on OHRP’s public web database when OHRP accepts the IRB registration application and you have received email notification.
  13. Unsubmitted applications are automatically withdrawn from the electronic submission system 30 days after the submission number was created. In such cases, applicants must request a new submission number and start another update/renewal application.
  14. The submission number used for the update/renewal application closes out when OHRP processes and accepts your IRB registration.
  15. Your institution or organization must request a new submission number and create a password for any subsequent electronic IRB registration update/renewal applications.

You can track OHRP’s receipt of your application and the status of an IRB registration at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html.

You can find registered IRBs on the OHRP public web database at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html.

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