The U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), released the federal government’s 2026 Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) on July 3, 2026. Available at reginfo.gov, the Unified Agenda includes the proposed and final rules federal agencies currently plan to advance within the next 12 months.
Several Department of Health and Human Services (DHHS) Agenda entries could materially change how clinical research is designed, authorized, overseen, documented, and supported after approval.
For human research protection program (HRPP) and institutional review board (IRB) leaders, planned changes to Common Rule exemptions, Food and Drug Administration (FDA) single institutional review board (sIRB) requirements, and early phase research could alter how institutions allocate oversight.
(Note: None of the planned changes described in the 2026 Unified Agenda should be treated as requirements until the relevant notice of proposed rulemaking (NPRM) or final action (e.g., final rule, final guidance) is published, opened for comment, and/or takes effect. Agenda dates sometimes shift, and listing a planned action in the Unified Agenda does not oblige an agency to complete the action.)
This article focuses on the planned actions most likely to be impactful to HRPP and IRB leaders. DHHS does not apply the same lens or categories in its Agenda entries. (For information on the 2026 Agenda’s broader anticipated impacts on the clinical research community, read our blog[SP1] .)
Here are four areas HRPP, IRB, and institutional research leaders should consider monitoring in the 2026 Unified Agenda.
DHHS might redraw the boundaries of IRB oversight
OHRP 0937-AA16: Human Research Protections: Exemptions and Clarifying Provisions Related to Institutional Review Board Oversight
Agenda date for NPRM: July 2026*
The Office for Human Research Protections (OHRP) states it plans to propose revisions to 45 Code of Federal Regulations (CFR) 46 that could expand exemptions for certain additional types of low-risk research and provide flexibility for regulatory review of de minimis protocol changes. With these planned changes, the agency seeks to help IRBs and HRPPs focus more attention on activities presenting greater risk.
The proposed rule changes would also clarify terminology, including the meaning of “undue influence,” and reduce ambiguity for investigators, IRBs, and institutions. Additionally, the changes may address burdens affecting research integrated into clinical care.
Because the NPRM text is not yet available, many questions remain unanswered. For example, it’s not yet known which research activities OHRP proposes to make exempt, and it’s unclear how these changes might interact with FDA-regulated research.
In the Agenda entry, OHRP acknowledges concerns that expanded exemptions and additional flexibility could reduce oversight or produce inconsistent implementation. The agency anticipates relying on continued oversight of higher-risk activities, existing protections, interagency coordination, and public comment to mitigate those risks.
FDA’s sIRB rule could shift the reliance baseline
FDA 0910-AI08: Institutional Review Boards; Cooperative Research
Agenda date for final rule: December 2026
This final rule would require U.S. institutions participating in FDA-regulated multisite cooperative research to rely on one IRB for the U.S. portion of the research, with exceptions. It would also add a recordkeeping requirement when an institution relies on an IRB it does not operate. FDA issued the associated NPRM in September 2022.
Under existing FDA guidance, institutions may use cooperative review arrangements and should document the respective responsibilities of the reviewing IRB and participating institutions in writing. The delegating institution remains responsible for ensuring that research conducted at the institution follows the reviewing IRB’s determinations.
The planned rule would change the baseline for covered cooperative research from a permitted arrangement to a mandated sIRB model, subject to the final exceptions and transition provisions.
FDA’s regulatory impact analysis identifies reduced duplicative review, earlier study initiation, and less need to reconcile varying IRB decisions as anticipated benefits of the regulation. (For more information on the planned rule, read our blog.)
FDA–Common Rule harmonization is likely to happen further in the future
FDA 0910-AI07: Protection of Human Subjects and Institutional Review Boards
Agenda date for final rule: July 2027
This action appears in a separate list of long-term actions but is included here because of its relationship to another Agenda item. The NPRM for this proposed regulatory harmonization action was published simultaneously with the above NPRM regarding cooperative research and sIRB review in September 2022.
Because of this timing, some may have overlooked that these are in fact two separate proposed rules: one to require sIRB review, and the other to harmonize FDA’s human subject protection regulations (21 CFR 50 and 56) with the Common Rule (45 CFR 46).
We suggest HRPP and IRB leaders should continue monitoring this planned rule change while prioritizing preparatory efforts for other, more urgent planned actions in the 2026 Unified Agenda.
Changes to existing drug regulations may require institutional policy updates
FDA 0910-AJ30: Amendments to 21 CFR Parts 56 and 312; Expedited Investigational New Drug Application for Phase 1 Clinical Trial Reform
Agenda date for NPRM: July 2026*
In 0910-AJ30, FDA says it plans to revise 21 CFR 56 and 312 to streamline Phase 1 investigational new drug application (IND) processes, content, format, and sponsor responsibilities through risk-based flexibility. The proposed changes seek to speed access to investigational drugs, decrease regulatory burden, and potentially accelerate the availability of transformative treatments, which may lead to improved health outcomes.
FDA acknowledges these changes could create risks, such as inconsistent sponsor interpretation, safety concerns, and data quality problems. The agency suggests IRB review, sponsor responsibilities, FDA monitoring, and sponsor education as possible ways to mitigate those concerns.
FDA 0910-AJ13: Responsibilities of Sponsors and Investigators for Clinical Investigations of Human Drugs and Biological Products
Agenda date for NPRM: December 2026
Agenda action 0910-AJ13 would revise 21 CFR 312 responsibilities for sponsors and investigators to reflect modern trial structures, improve quality and participant protection, and align more closely with global expectations. FDA notes that this revised regulation would bring FDA’s requirements closer to those of its global counterparts and seeks to help ensure study sponsors are not incentivized to conduct clinical trials outside of the U.S.
FDA 0910-AH07: Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic
Agenda date for final rule: July 2026*
This planned final rule would broaden regulatory criteria and clarify when certain clinical investigations of lawfully marketed conventional foods, dietary supplements, and cosmetics may proceed without an IND. The NPRM for this revised regulation was published in December 2022.
Other Agenda actions potentially impacting HRPPs and IRBs
In our opinion, the preceding Agenda actions are directly relevant to HRPP and IRB leaders. The items below are not specifically focused on HRPP and IRB priorities, but they could still change certain aspects of these workflows.
FDA 0910-AJ25: Amendment of Regulations on Electronic Records and Electronic Signatures
Agenda date for NPRM: September 2026
FDA plans to streamline and modernize 21 CFR 11 requirements for the reliability, authenticity, and integrity of electronic records and signatures.
FDA 0910-AI61: Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products
Agenda date for NPRM: July 2026*
FDA proposes this rule to modernize postmarketing safety reporting, improve the quality and utility of reports, enhance efficiency, and align with international reporting standards. It would also require covered application holders to maintain pharmacovigilance quality systems.
FDA 0910-AH68: Medication Guide; Patient Medication Information
Agenda date for final rule: December 2026
This final rule would establish standardized patient labeling for outpatient prescription drugs and certain blood products.
CMS 0938-AV89: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualification Requirements, and Other Changes (CMS-3478)
Agenda date for NPRM: September 2026
The Centers for Medicare & Medicaid Services (CMS) plans to update CLIA requirements involving virtual access, cytology PT, personnel qualifications, and other laboratory matters. The proposed rule revisions concern clinical laboratories, although there may also be research-related implications.
OCR 0945-AA28: HIPAA Privacy Rule to Promote Individuals’ Timely Access to their Protected Health Information
Agenda date for NPRM: November 2026
These changes, outlined by the Office for Civil Rights (OCR), would address the amount of time covered entities have to respond to requests for protected health information (PHI).
What to do with the information in the 2026 Unified Agenda
Many of these actions are intended to reduce burden, eliminate duplication, and/or accelerate research. Several actions could also directly or indirectly affect institutional determinations, IRB submissions, reliance workflows, ongoing safety review, and participant communications. If finalized, certain actions may also ask HRPPs to oversee less in some places and demonstrate more oversight in others, with the potential for directing IRB and HRPP resources more proportionately.
IRB and HRPP leaders should view the Unified Agenda as a planning and transparency tool. In the near term, consider focusing on monitoring the regulatory environment, since Agenda dates and agency priorities can shift.
Consider tracking:
- OIRA review activity.
- Federal Register publication.
- Proposed regulatory text.
- Docket questions and comment deadlines.
- Final rule effective and compliance dates.
- Agency guidance, FAQs, templates, and/or decision tools.
- Litigation or statutory developments.
- Later Agenda changes.
At this stage, we suggest only preliminary scenario planning and inventory work may be appropriate. Implementation activities should generally wait for the actual regulatory text.
Have questions about the Unified Agenda or another regulation? Contact us for support.
*As of September 8, 2026, no additional information has been published regarding this Agenda item.
