Planned changes outlined in the U.S. federal government’s 2026 Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) could reshape the clinical research process from regulatory authorization through to site activation.
Published online on July 3, 2026, at reginfo.gov, the Unified Agenda includes the proposed and final rules that federal agencies currently plan to advance within the next 12 months.
Several 2026 Department of Health and Human Services (DHHS) Agenda actions could affect multiple aspects of study startup. Of particular note for clinical operations (clin ops) and study startup teams are proposed changes involving single institutional review board (sIRB) review, sponsor and investigator responsibilities, and first-in-human (FIH)/Phase 1 development, among others.
Many of the planned actions seek to reduce burden, remove barriers to improve efficiency, and bolster innovation.
This article discusses the 2026 Unified Agenda items that may be most impactful to clin ops and study startup teams across sponsors, contract research organizations (CROs), sites, and institutions. DHHS does not use these categories or segmentation in its Agenda entries. (For information on the 2026 Agenda’s broader impacts on the clinical research community, read our blog.)
(Note: The Unified Agenda is forward-looking. The proposed rules described in this article are at different stages of development, and an Agenda entry does not itself change any existing requirements.)
sIRB requirements could change study startup
FDA 0910-AI08: Institutional Review Boards; Cooperative Research
Agenda date for final rule: December 2026
This final-stage action would require U.S. institutions participating in Food and Drug Administration (FDA)-regulated, multisite cooperative research to rely on an sIRB for the U.S. portion of the research, with certain exceptions. The planned final rule would also include a recordkeeping requirement when the reviewing institutional review board (IRB) is not operated by the institution. FDA issued the associated notice of proposed rulemaking (NPRM) in September 2022.
The agency intends this planned regulation to reduce duplicative review, support earlier study activation, and lessen the need to reconcile multiple varying IRB decisions. Federally funded research has followed similar sIRB requirements for several years under the revised Common Rule and National Institutes of Health (NIH) policy. This would be the first time an sIRB has been mandated for FDA-regulated research.
This final rule may require enhanced collaboration among site, sponsor, and CRO stakeholders. It could also necessitate unique process changes for each of these groups to realize the intended startup efficiencies. (For more on this planned rule, read our blog.)
Updated sponsor and investigator responsibilities could reshape the operating model
FDA 0910-AJ13: Responsibilities of Sponsors and Investigators for Clinical Investigations of Human Drugs and Biological Products
Agenda date for NPRM: December 2026
FDA says it plans to revise sponsor and investigator requirements at 21 Code of Federal Regulations (CFR) 312 subpart D to reflect the modern trial ecosystem, with a focus on clinical trial quality. The agency intends the changes to improve FDA’s ability to help ensure research participants are protected, support the reliability of study results, and encourage innovation and efficiency.
Little additional information is currently available regarding the proposed rule. However, the action appears to have the potential to affect, for example, study startup and the conduct and oversight of research areas. The actual NPRM, when available, will determine the scope.
Streamlined requirements and new flexibilities could transform Phase 1 conduct
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*
This planned action would amend portions of 21 CFR 56 and 312 and contemplates changes to the investigational new drug application (IND) process, content, format, and sponsor responsibilities for FIH/Phase 1 clinical investigations. FDA expects the proposed rule would reduce development delays that can adversely affect patient health outcomes. It would also address regulatory risks perceived as disproportionate to the risks typical of many early phase studies.
Separately, DHHS has released additional information related to this proposed rule. Operation TrialBlazer includes FDA’s proposed expedited IND pilot program, which would pair sponsors with qualified research institutions providing regulatory advisory services, IRB review, and study conduct capabilities. The pilot program also suggests implementing rolling IND submissions to shorten the path to FIH studies. While these activities are separate from Agenda item 0910-AJ30, when viewed together, they highlight the agency’s interest in making early phase and FIH research more efficient, effective, and competitive globally.
Some rules could change which startup pathway a study follows
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) says it plans to propose expanded exemptions for certain low-risk research, flexibility for regulatory review of de minimis protocol changes, and clarified definitions for key terms. The revised regulation is expected to reduce ambiguity and administrative burden for sites and institutions and help IRBs and human research protection programs (HRPPs) focus on activities posing the greatest potential risk to participants. In the Agenda entry, OHRP acknowledges a risk of reduced oversight and/or inconsistent institutional implementation. This proposed change in regulatory classification could affect a variety of study startup workflows.
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*
FDA’s final-stage action regarding IND exemptions would broaden and clarify criteria for when certain studies involving lawfully marketed conventional foods, dietary supplements, or cosmetics may proceed without an IND. The planned final rule may have a broad impact on organizations specializing in this type of research. The associated NPRM was published in December 2022.
Specialized programs may soon need different startup readiness models
These Unified Agenda items could potentially impact a narrower segment of the clinical trial startup and clin ops communities.
CDC 0920-AA85: Import Regulations for Infectious Biological Agents, Infectious Substances, Vectors, and Nucleic Acids Capable of Producing Infectious Viruses
Agenda date for NPRM: November 2026
The Centers for Disease Control and Prevention (CDC) proposes this action to clarify import permit requirements for infectious biological agents, infectious substances, vectors, and nucleic acids capable of producing infectious viruses. The action could have international implications, given its mention of strengthening “border security.”
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) seeks to modernize CLIA requirements to address virtual access, cytology proficiency testing, personnel qualifications, and other laboratory requirements.
FDA 0910-AI57: Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies
Agenda date for NPRM: September 2026
FDA plans to update study conduct requirements for clinical pharmacology and clinical and analytical bioavailability/bioequivalence (BA/BE) studies, including revisions to 21 CFR 320 and the new 21 CFR 321. The agency states this change would help provide FDA with the necessary information to ensure studies are conducted appropriately and the resulting data are reliable.
Postapproval-related actions could impact clin ops
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’s planned pharmacovigilance action could affect how postmarketing safety information is generated and transmitted.
FDA 0910-AH55: Supplemental Applications and Certain Postapproval Reporting Requirements for Drug and Biological Products
Agenda date for NPRM: November 2026
This proposed postapproval reporting action may affect certain postmarketing requirements and commitments.
FDA 0910-AH68: Medication Guide; Patient Medication Information
Agenda date for final rule: December 2026
This patient medication information (PMI) action may change product labeling requirements for approved drugs.
FDA 0910-AJ17: Electronic Labeling for Medical Devices
Agenda date for NPRM: November 2026
This device labeling action may change product labeling requirements for approved devices.
These planned regulatory changes have the potential to alter how clin ops teams handle protocol amendments, consent changes, and other aspects of study conduct. To understand actual organizational impacts, however, we recommend waiting to review the NPRMs or final rules when available.
The same change may create different work for sponsors, CROs, and sites
The items above are the 2026 Unified Agenda items most likely to affect those who work in clinical trial startup and operations. However, a given change may affect a sponsor, CRO, site, or institution differently.
These groups should review the full text of relevant Agenda items to assess how meaningful the potential changes may be for their organizations. For example, sponsors and CROs may be paying specific attention to actions potentially affecting their responsibilities and governance, as well as overall planning for study timelines and workflows. Sites and institutions, on the other hand, may be more interested in the actions with the greatest potential impact on their workflows, policies, systems, and existing partnerships.
Signals clin ops leaders should watch for next
Because the actions and dates listed in the 2026 Unified Agenda may change, clin ops and study startup leaders should take an active monitoring approach in the near term. Places to watch include:
- Activities under review with the Office of Information and Regulatory Affairs (OIRA).
- Federal Register publications.
- Proposed regulatory text, when available.
- Related docket questions and associated public comment deadlines.
- Effective and compliance dates for final rules, when issued.
- New or updated agency guidance, FAQs, templates, and/or decision tools.
- Litigation or statutory developments.
- Future changes to the Unified Agenda.
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Turning regulatory flexibility into operational efficiency for clin ops and study startup
The 2026 Agenda could make portions of clinical research faster, more centralized, and more flexible. For clin ops and study startup teams, the opportunity is to convert that regulatory flexibility into operational efficiency.
Teams that want to start preparing before complete regulatory text is available could assess current workflows to map who owns each regulatory and operational dependency. It may also be helpful to consider the full study startup and site activation process to identify how timelines and bottlenecks might shift if one step in the process became faster.
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.
