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How to file an FWA and Related Resources

In March of 2026, OHRP updated the Federalwide Assurance (FWA) to implement burden-reducing provisions in the revised Common Rule at 45 CFR part 46.103 and adopt other non-regulatory changes to decrease unnecessary burden and clarify the applicability of 45 CFR 46 to HHS-supported or conducted nonexempt human subjects research. The videos on this webpage are being revised to incorporate the FWA updates. In the meantime, please be aware that these videos do not fully reflect OHRP’s current FWA form (https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-form-2017/index.html). Details about the revisions to the FWA form, OMB No. 0990-0278, can be found at https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=202501-0990-001. OHRP is available to provide consultative support for FWA process related questions at IRBorFWA@hhs.gov.

How to obtain an electronic submission number for FWAs

Review of the FWA form and how to complete it

Find out when institutions need to file an FWA

  • Watch our mini-tutorial Institutional Engagement in Human Subjects Research

  • Review Lesson 5 of the Human Research Protection Foundational Training

Review OHRP guidance on Institutional Engagement

  • Engagement of Institutions in Human Subjects Research (2008)
  • Determining when Institutions are Engaged in Research (2009)
  • OHRP Correspondence on “Non-Engaged” Scenarios (2011)
Content last reviewed March 17, 2026
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