The federal rules that govern most human subjects research in the United States are heading for another revision. HHS has told the public it plans to revise the Common Rule (45 CFR part 46, subpart A) to expand exemptions for certain low-risk research and add flexibility for minor protocol changes. As Science reported on October 1, 2026, the plan focuses on easing regulatory burden for lower-risk studies, and it has some research ethicists worried about what might be lost.
Separately, the Office for Human Research Protections (OHRP) is moving to remove IRB membership rosters from the IRB registration form. That change is going through federal paperwork review, not the Common Rule rulemaking.
One point matters more than any other: as of this writing, no proposed rule has been published. Nothing in the regulations has changed yet. This post explains what has been announced, what is still unknown, and how IRB offices can prepare without getting ahead of the regulatory text.
In This Article
- What HHS Has Announced
- The IRB Roster Change
- Proposed vs. Final: Where Things Stand
- How IRB Offices Can Prepare Now
- How Fibi IRB Helps
- Key Takeaways
What HHS Has Announced
The Unified Agenda entry
The plan appears in the federal regulatory agenda as RIN 0937-AA16, “Human Research Protections: Exemptions and Clarifying Provisions Related to Institutional Review Board Oversight.” HHS says the revisions are meant to “modernize and simplify” subpart A while upholding protections for human subjects and reducing burden and ambiguity for investigators, IRBs, and institutions. The entry is at the Proposed Rule Stage and is designated deregulatory. HHS says it will work with the other Common Rule departments and agencies.
The changes HHS has described
According to the agenda entry, examples of planned changes include:
- Expanded exemptions: new exemptions for certain additional types of low-risk research activities.
- De minimis protocol changes: flexibility in how IRBs review very small changes to approved protocols.
- Clearer terminology: clarifying key terms, including the definition of “undue influence.”
- Research in clinical care: HHS cites feedback that the Common Rule remains cumbersome for research within learning healthcare systems and other research integrated into clinical care settings.
HHS says the goal is to let IRBs and human research protection programs (HRPPs) focus on activities that pose the greatest risk to participants.
Why ethicists are watching closely
The agenda entry itself acknowledges the concern: some stakeholders worry that expanded exemptions and added flexibility could reduce oversight for certain research or lead to inconsistent implementation across institutions. HHS expects to address those risks through continued IRB oversight of higher-risk activities, existing protections, interagency coordination, and public comment. That tension is the focus of the Science coverage.
The IRB Roster Change
In a July 2026 Federal Register notice (FR Doc. 2026-14537), HHS asked the Office of Management and Budget to reinstate, with changes, the IRB Registration Form (OMB No. 0990-0279). OHRP is seeking to remove the IRB membership roster information collection from the form, to align it with the 2018 Requirements at 45 CFR 46.103. HHS says the change, when implemented, should mean a shorter, simpler registration process, and that OHRP’s registration software will be updated to support it. Public comments on that request were due by August 19, 2026.
Until the change is implemented, current guidance still applies. OHRP’s registration update page still says it generally recommends updating an IRB registration within 90 days of a membership roster change for IRBs that review HHS-conducted or HHS-supported research.
Proposed vs. Final: Where Things Stand
A Unified Agenda entry announces what an agency plans to do. It is not proposed regulatory text. The agenda had targeted a notice of proposed rulemaking (NPRM) for July 2026, but as Advarra noted, the NPRM text is not yet available, so it is still unknown which research activities would become exempt or how the changes would interact with FDA-regulated research.
| Item | Status |
|---|---|
| Common Rule revision (RIN 0937-AA16) | Planned; Proposed Rule Stage; no NPRM published yet |
| Expanded exemptions and de minimis flexibility | Described in the agenda only; no regulatory text |
| IRB roster removal from registration form | Paperwork change submitted to OMB; comments closed Aug 19, 2026; not yet implemented |
| Current Common Rule (2018 Requirements) | Still fully in effect |
Once an NPRM is published, there will normally be a public comment period before any final rule, and then an effective date. IRB offices will have time to respond, but only if they are ready to read the proposal quickly.
How IRB Offices Can Prepare Now
Implementation should wait for the actual regulatory text. Preparation, however, can start now, and most of it pays off regardless of what the final rule says.
1. Inventory your exempt and minimal-risk portfolio
Know how many of your studies are exempt today, which exemption categories they use, and how many minimal-risk studies get expedited review. When the NPRM appears, you will be able to estimate quickly how much of your workload the new exemptions could affect.
2. Measure how you handle minor amendments
Track how many amendments are administrative or very small, how they are routed, and how long they take. This data will help you assess the de minimis flexibility and build a faster pathway if the rule allows one.
3. Review your use of “undue influence” and related terms
Collect how your SOPs, consent templates, and reviewer guidance currently describe undue influence and compensation. If HHS clarifies the definition, you will know exactly which documents to update.
4. Map research embedded in clinical care
If your institution supports learning health system or quality-improvement-adjacent research, document how those projects are currently classified and reviewed. HHS has specifically named this area as a source of burden.
5. Plan your roster process for the transition
Keep updating rosters as current guidance recommends, but note where roster data lives and who maintains it. Membership records still matter internally for quorum, expertise, and conflict-of-interest checks even if registration stops asking for them.
6. Set up monitoring and a comment plan
Assign someone to watch the Federal Register and reginfo.gov for RIN 0937-AA16. Decide in advance who will draft your institution’s comments and how you will gather input from IRB members, investigators, and participant advocates.
How Fibi IRB Helps
Regulatory change is easier to absorb when your IRB data is structured and in one place. The Fibi Research Admin System IRB module supports that preparation:
- Portfolio reporting: pull counts of exempt, expedited, and full-board studies by category to estimate the impact of new exemptions.
- Configurable workflows: adjust routing and review pathways for amendments and exemption determinations when the rules change, without rebuilding your process.
- Amendment tracking: see the volume, type, and turnaround of protocol changes to support a de minimis review pathway.
- Membership and committee records: maintain IRB member information internally for quorum and expertise checks, whatever registration requires.
- Audit-ready history: keep a full record of determinations and approvals so you can show consistent, risk-based oversight.
Key Takeaways
- HHS plans to revise the Common Rule (RIN 0937-AA16) to expand exemptions for certain low-risk research, allow flexibility for de minimis protocol changes, and clarify terms such as “undue influence.”
- No proposed rule has been published yet. The current Common Rule remains fully in effect.
- OHRP is separately seeking to remove IRB membership rosters from the IRB registration form; until that is implemented, follow current OHRP guidance.
- Ethicists and HHS itself recognize the risk of reduced oversight and inconsistent implementation, so expect an active comment period.
- Start now with data: inventory exempt and minimal-risk studies, measure minor amendments, review key definitions, and plan your comment process.
