Skip Navigation Links

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.

ESS logo

Welcome to the Electronic Submission System for FWAs and IRB Registrations

The Office for Human Research Protections (OHRP) Electronic Submission System (ESS) provides an online portal for registering institutional review boards (IRBs) and obtaining Federalwide Assurances (FWAs).

See our online FAQs for information about FWA and IRB registration requirements at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/assurance-process-faq/index.html and https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/irb-registration-faq/index.html .

Institutions must submit applications for initial, renewal, or update applications for FWAs and IRB registrations electronically using this system, unless an institution lacks the ability to do so electronically.

Before applying for a new FWA or IRB registration, we encourage you to check whether your institution has previously held an FWA or registered an IRB. If so, we generally recommend renewing the existing record. You can check for existing records on our Search website here: https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc

If you have submitted an application recently, you can also view the status of your application on the Search website: https://ohrp.cit.nih.gov/search/docsearch.aspx

What are you looking for?

A new FWA application

A "new" FWA application may be submitted to OHRP when your institution has never had an active FWA with OHRP in the past. An institution that has previously had an active FWA with OHRP generally should submit a renewal application. If your institution has previously held an active FWA with OHRP, you should use the "update/renewal" feature through this electronic submission system to update or renew the existing FWA record.

A new IRB registration

A "new" IRB registration should be submitted to OHRP when your institution or organization has never been assigned an IORG number and never registered an IRB. If your institution or organization has previously registered an IRB through OHRP's system, you should use the "update/renewal" feature through this electronic submission system to update or renew an existing IRB registration or to register an additional IRB.

An update/renewal to an OHRP-approved FWA

An institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, to maintain an active FWA. Institutions submitting renewal or update applications should confirm all information is current and accurate. Any renewal or update that is submitted electronically, and approved by OHRP, begins a new-5-year effective period.

An update/renewal to an OHRP IRB Registration

An "update/renewal" to your institution’s or organization's registered IRB(s) must be submitted within 90 days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson. Also the "update/renewal" function must be used to register an additional IRB panel on an IORG before it is designated under an FWA as an IRB(s) that reviews research conducted or supported by HHS. At a minimum, an IRB registration must be renewed every 3 years. Institutions submitting renewal or update applications should confirm all information is current and accurate for each IRB registered by the IORG. Any renewal or update that is submitted electronically and accepted by OHRP begins a new 3-year effective period. To begin your electronic submission, please select the appropriate tab menu at the top of this page.

Note: Should you enter information for an electronic submission and find that you are not ready to submit it to OHRP for review, you may save the application and return to complete the submission later. Note that the submission number used to complete the unsubmitted application is accessible for 30 days from the date that it was created. After 30 days elapse, an unsubmitted application will be deleted automatically by the software system. Be sure to record your submission number and password to return to the application.

▲Back to Top