HHS Seeks Comments on IRB Registration Form Update
Published Date: 7/20/2026
Notice
Summary
The Department of Health and Human Services wants your thoughts on updating a form that Institutional Review Boards use to register. This update aims to make the process clearer and easier, with a 30-day window to share your ideas before August 19, 2026. If you’re involved in research oversight, this could affect how you submit info, but no new fees are involved.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
IRB Registration Requirement Affirmed
If your institution does nonexempt human subjects research supported by HHS, or reviews FDA-regulated clinical investigations, you must rely on IRBs registered with OHRP to meet Federalwide Assurance and FDA registration requirements (45 CFR part 46, subpart E; 21 CFR 56.106). The notice restates these registration obligations for institutions and IRBs.
IRB Form Drops Member Roster
If you run or work for an organization that operates an Institutional Review Board (IRB), the IRB registration form will no longer ask for the IRB membership roster. This change aligns the form with the 2018 requirement at 45 CFR 46.103 and is intended to shorten and simplify registration, reducing the estimated time to complete the form to about 0.5 hours per submission.
No New Fees for IRB Registration
If your organization files IRB registration, this notice states there are no new fees associated with the updated IRB registration form. You can expect the change to be implemented without adding a fee for registration.
Estimated Time Burden and Volume
The agency projects up to 5,350 IRB respondents, with each registration or renewal taking about 0.5 hours on average. The total annual burden is estimated at 2,675 hours, assuming about 350 new registrations and about 5,000 annual updates or renewals.
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