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.
If you started an FWA update/renewal application and need to finish and submit:
Enter the submission number you received in your email, along with the password you created.
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