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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.

ESS logo
Federalwide Assurance (FWA) for the Protection of Human Subjects
  1. Create a Submission #
  2. Complete FWA Info
  3. Review Summary & Submit
  4. Check Status of Submitted FWA

Filing a New/Initial FWA

A new/initial FWA application may be submitted to OHRP when your institution has never filed an FWA with OHRP in the past. You will need to create a submission number to start this process.

Create a New FWA Submission Number

In order to create a new Submission Number, you must first provide your email and create a new password. Once submitted, the new Submission Number will be emailed to the email address provided. Please remember your password as you will need both the new Submission Number and Password to start the new FWA application.

Important Reminders for this Process:

  • Remember your new password. You will need it to for the new FWA application.
  • You will receive an email to the email address provided that contains the new Submission Number
  • After receiving the email with the new Submission Number, return to this application to use the Submission Number and Password to start the new FWA application.
  • A submission number will be sent to you immediately by e-mail.

Step 1:

Please make sure you can receive emails from OHRPElectronicSubmissionSystem@mail.nih.gov
Contains at least 1 uppercase letter
Contains at least 1 lowercase letter
Contains at least 1 number or special character
Contains a minimum of 7 characters, and maximum of 15
Passwords match
NOTE: If you do not use the submission number within 30 days, it will be withdrawn from the system. You will have to request a new submission number to begin a new FWA application.
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