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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

Filing a New Registration for an Institutional Review Board (IRB) by an Institution or Organization (IORG)

Alert: Before continuing on this page, please be aware that this area should ONLY be used if your institution or organization has never been assigned an IORG number by OHRP and never registered an IRB.

Submission of an Institutional Review Board (IRB) registration application to the Office for Human Research Protections (OHRP) must be done using this electronic submission system, unless your institution lacks the ability to do so electronically. If your institution believes it lacks the ability to submit its IRB registration application electronically, it must contact OHRP by email at IRBorFWA@hhs.gov or by telephone at (866) 447-4777 (see https://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html) and explain why it is unable to submit its IRB registration electronically.

An IRB registration is effective for 3 years. However, when there are information changes regarding the contact person that provided the IRB registration information or the IRB chairperson, an update/renewal must be submitted to OHRP within 90 days after the changes occur. After processing the initial registration, any update/renewal to the registration information on your institution's or organization's IRB also must be done electronically through the electronic submission system, unless your institution or organization lacks the ability to register an IRB electronically.

Using this web page, your institution or organization can register an IRB if your institution or organization has never been assigned an IORG number by OHRP and never registered an IRB. We recommend that you print out and have available the instructions for registering an IRB(s) at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/irb-registration-instructions/index.html.

What are you looking for?

Additional instructions for an electronic submission of a new IRB registration are provided below:

  1. You must have an email address to use the electronic submission system. You will start the electronic submission process by clicking on the “Start a new IRB registration application” button above.
  2. After obtaining your submission number, you will be able to access the new IRB registration application.
  3. Please provide accurate information for your institution or organization and each registered IRB before you "Submit" the new IRB registration.
  4. Please complete all required (*) application fields.
  5. 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.
  6. 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.
  7. 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.
  8. Once you "Submit" the new IRB registration 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, it is assigned to OHRP staff for review.
  9. 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. 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.
  10. Please do not attempt another IRB registration when there is already an electronic application being processed by OHRP.
  11. 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.
  12. 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 new IRB registration application.
  13. The submission number used for the IRB registration application closes out when OHRP processes and accepts your IRB registration.
  14. 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.

With the electronic submission process, the submitter, the IRB Chairperson(s), and the Institution or Organization (IORG) Head Official/Senior Officer who is responsible for overseeing activities performed by the IRB will be notified automatically by e-mail as soon as OHRP has processed your submission. Please review that the correct e-mail addresses are provided for each of these individuals.

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