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Summarize with:
Five federal developments require attention from IACUC programs in 2026. Two updates were issued in 2025 and take effect in the current reporting cycle. One restates a requirement that has been in place for years. One is a proposal that has not been finalized. Only one is revised federal guidance issued in 2026 itself.
Each raises a question a program should answer in 2026. They fall into three groups: developments that require action now, developments that apply only to certain institutions, and developments to monitor. The table below will help you compare them based on: what happened, current status, who is affected, what it means, and what to monitor.
This article covers what changed in each case and what did not, since several of this year's items clarify existing requirements rather than create new ones.
The 2026 developments at a glance
1. OLAW revised its guidance on prompt reporting
What happened. On January 20, 2026, OLAW issued NOT-OD-25-148, Update to Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. It rescinds and replaces NOT-OD-05-034, issued in February 2005.
The review behind it was directed by the 21st Century Cures Act. That Act asked the National Institutes of Health (NIH), working with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), to reduce administrative burden while maintaining the protection of research animals.
Current status. In effect. OLAW determined that the reporting guidance in NOT-OD-05-034 (2005) remains applicable and carried it into the new notice. Alongside general edits for clarity, OLAW identified six substantive content revisions:
- Clarification of how reporting requirements apply based on the scope of the institution's Animal Welfare Assurance.
- Clarification of situations that may affect activities subject to the PHS Policy, added as the final example of reportable situations.
- Three additional examples of situations that are not normally required to be reported.
- Updated guidance on including award numbers and funding sources in reports.
- Clarification of how reporting requirements apply to federal entities holding a memorandum of understanding (MOU) with OLAW.
- Clarification that the signature of the Institutional Official (IO) on the final report verifies compliance with PHS Policy section IV.F.3.
None of the six creates a new category of reportable event. Each clarifies how an existing obligation is applied, described, or documented.
Who is affected. Every institution holding an Animal Welfare Assurance. Under PHS Policy section IV.F.3, the IACUC reports through the IO, and the IO who signs the Assurance is responsible for that reporting in concert with the committee.
What it means. The point that matters most for committee practice is what the notice states directly. Because a comprehensive list of definitive examples is impractical, the examples given demonstrate the threshold at which OLAW expects to receive a report rather than defining the complete set. Situations not listed may still qualify, and OLAW asks institutions to use rational judgment and to consult OLAW when in doubt.
Two related points sit alongside it. If an institution's Assurance states that incidents will be reported regardless of funding source, the incident must be reported. And situations identified by outside parties, including USDA, AAALAC International, or individuals outside the institution, are not exempt.
The examples of situations not normally reportable work the same way. OLAW recognizes that some level of illness and death occurs in virtually any animal-related activity, but before electing not to report, the IACUC is to consider the specific circumstances, the intent, and the actual effect on animal welfare. The examples added in this revision cover:
- Injury by conspecifics during social housing, where proper introduction and subsequent monitoring occurred
- Expired medications identified after the expiration date but not administered to animals
- Brief and infrequent fluctuations in temperature and humidity, where daily monitoring was in place and no animal health or welfare issue resulted
On the IO signature, the clarification states what the signature verifies rather than adding a step, since section IV.F.3 already required final reports to be submitted by the IACUC through the IO. On mechanics, OLAW recommends a preliminary report from an authorized institutional representative as soon as possible, followed by a thorough report once action has been taken. Reports go to OLAW's Division of Compliance Oversight and should be submitted as situations occur, not grouped or held for the Annual Report. Award numbers are required for National Science Foundation (NSF) funded activities; others are not, unless OLAW requests them or the institution determines they apply. The funding source must be identified for all PHS-supported activities, including those of agencies holding an MOU with OLAW.
What to review
- Whether written procedures, training materials, and report templates still cite the rescinded NOT-OD-05-034.
- Whether the committee's working threshold for reportability matches the notice, including the three added examples.
- Whether the committee has a consistent way of recording its reasoning when it decides not to report an event. The notice does not require this, but it asks the committee to weigh circumstances, intent, and actual effect on animal welfare, and a record of that assessment is a sound institutional practice.
2. NIH confirmed that animal disposition, adoption, and retirement costs are allowable
What happened. NOT-OD-25-163, issued September 25, 2025, updated NIH Grants Policy Statement section 7.9.1, Selected Items of Cost. Effective October 1, 2025, recipients may charge costs for the rehoming and retirement of experimental animals. On February 19, 2026, OLAW revised its frequently asked questions on charging these costs after an IACUC-approved activity ends to incorporate that guidance.
Current status. In effect and carried into the March 2026 revision of the NIH Grants Policy Statement.
Who is affected. Institutions with NIH awards that operate, or are considering, an adoption, rehoming, or retirement program. OLAW identifies the Attending Veterinarian as the person who determines whether pre-transfer procedures such as diagnostic testing, vaccination, and surgical sterilization are necessary. NIH also reminds institutions that their policies must clarify the disposition of animals acquired for research once the research has ended. It does not assign the IACUC a defined role in adoption or disposition decisions, so where that responsibility sits is an institutional choice.
What it means. Costs are allowable for the acquisition, care, use, and rehoming or retirement of experimental animals, contingent on compliance with the PHS Policy. Adoption itself remains optional and is a decision for the institution. The allowable costs are those incurred to prepare for transfer. OLAW describes health certificates, transfer of ownership agreements, and pre-transfer veterinary work including diagnostic testing, vaccination, and surgical sterilization where the Attending Veterinarian considers it necessary. Costs do not extend beyond transfer to support the ongoing care of the animal.
What to review. Whether institutional policy states clearly what happens to animals once an approved activity ends. Whether the Attending Veterinarian's criteria for suitability are documented. And whether investigators and departmental administrators know these costs may now be charged.
3. The NIH Grants Policy Statement was reissued, and the Assurance requirement it carries is not new
What happened. NOT-OD-26-057, issued March 25, 2026, published the NIH Grants Policy Statement revised March 2026. It supersedes the April 2024 version in its entirety and applies to awards with budget periods beginning on or after October 1, 2025.
Current status. In effect. NIH states that the revision does not introduce new material for the first time. It consolidates Guide Notices in effect as of March 17, 2026, and clarifies existing policies.
Who is affected. Award recipients and any organization serving as a performance site where animal activities will be conducted.
What it means. Section 4.1.1, Animal Welfare Requirements, restates a long-standing PHS Policy requirement rather than introducing a new IACUC obligation. An approved Animal Welfare Assurance must be on file with OLAW at the time of award for all organizations involved in PHS-conducted or supported activities involving live vertebrate animals. That includes both award recipients and organizations serving as performance sites.
The requirement appears here because the March 2026 revision is the version now incorporated into award terms, and because it carries a practical deadline. NIH will delay an award for research involving live vertebrate animals until the recipient and all performance sites are operating under approved Assurances, and until verification of IACUC approval has been provided for the sections of the application involving animals. Related provisions address verification of IACUC approval, consortium arrangements, and foreign performance sites.
What to review. Whether the pre-award process confirms Assurance status for every performance site where animal work will occur, including new collaborating sites and subawards. The second question is timing: whether that confirmation happens early enough for a gap to be resolved before the award date rather than identified after it.
4. The fall 2025 funding lapse produced temporary administrative guidance
What happened. The lapse in appropriations ran from October 1, 2025 to November 11, 2025, and OLAW closed for that period. The guidance that followed came in two parts, issued on different dates and applying to different institutions.
NOT-OD-26-003 set the routine reporting position. Annual Reports covering October 1, 2024 through September 30, 2025 were due to OLAW by December 1, 2025, and the reporting period was unchanged by the lapse.
OLAW issued guidance on November 19, 2025, once the lapse had ended, addressing the effect on IACUC business. Federal institutions with an approved Domestic Assurance that were unable to conduct official IACUC business as scheduled were given a 30-day extension to complete those activities, and federal institutions had a 30-day extension to submit the fiscal year 2025 Annual Report, no later than January 1, 2026. The extension did not apply to non-federal institutions that were not impacted by the shutdown. Where the shutdown caused the interval between semiannual program reviews or facility inspections to exceed six months plus the 30-day grace period, it should be noted as the reason for the delay on the 2026 Domestic Annual Report.
OLAW updated that guidance on February 4, 2026, extending deadlines for renewal Assurance documents with February submission dates by a further 30 days and confirming that the interval note goes on the 2026 Domestic Annual Report due December 1, 2026.
Current status. The Annual Report extension has expired. The instruction on recording a delayed semiannual interval is still live because it applies to a report not yet due.
Who is affected. The extensions applied to federal institutions. The instruction on recording the reason for a delayed interval applies to any institution preparing the 2026 Domestic Annual Report whose intervals were affected.
What it means. During the lapse, OLAW encouraged Assured institutions to delay submitting Assurance documents, Annual Reports, preliminary and final reports of noncompliance, and reports of IACUC suspensions, and extended deadlines to compensate. Assurance status remained in effect and unchanged, including for institutions in Assurance negotiation. Obligations under the Assurance continued throughout. The reporting timetable moved; institutional responsibility for oversight and for correcting situations affecting animal welfare and PHS Policy compliance did not.
What to review. Whether semiannual program review and facility inspection dates for this reporting period show an interval exceeding six months plus the 30-day grace period. If they do, whether the person preparing the Annual Report due December 1, 2026, knows to record the shutdown as the reason. Confirm also that any reports held during the lapse have since been submitted.
5. A draft NIH Biosafety Policy is open for comment
What happened. On August 19, 2026, NIH issued NOT-OD-26-112, a request for comment on a draft NIH Biosafety Policy for Research Involving Biohazards. If finalized, it would supersede the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
Current status. A proposal, not a requirement. Comments are accepted through October 19, 2026. The draft states that a final policy would take effect six months after publication. Nothing about an institution's current obligations changes because a draft has been published for comment.
Who is affected. Institutions conducting NIH-supported research involving biohazards, and in particular institutions where the same study requires approval from both the IACUC and the IBC.
What it means. The draft would widen the range of research subject to biosafety review, from recombinant or synthetic nucleic acid molecules to biohazards more broadly, while reducing requirements for lower-risk work. NIH describes an intention to strengthen the role of IBCs and to reinforce consistency with Institutional Review Boards and IACUCs, which it identifies as the three foundational pillars of institutional oversight.
Four elements would reach animal programs directly:
• Laboratory research is defined as research within Biosafety Level and Animal Biosafety Level 1 to 4 containment, and the draft states this includes spaces such as vivaria, core facilities, and clinical settings.
• An IBC voting member with expertise in animal containment principles would be required where an institution conducts covered research in animals whose size or growth requirements prevent housing in primary containment isolators.
• The IBC would review certain incidents involving animals housed at ABSL-1 or ABSL-2, such as a bite, scratch, escape, or improper disposition, even where they are not reportable to NIH.
• IBC meeting minutes and incident reports would be posted on a public-facing page on the institution's website.
NIH does not state what this would mean for IACUC and IBC coordination. Per our inference, the current NIH Guidelines reach research involving recombinant or synthetic nucleic acid molecules, so a study using genetically modified animals typically requires both IACUC and IBC approval already. The draft would additionally reach wild-type agents that cause human disease, toxins, prions and other self-aggregating proteins, and cells or organisms containing them.
An institution whose animal work already falls almost entirely within the current scope would see little change. An institution that also runs animal studies involving wild-type infectious agents, toxins, or prion models, and that currently reviews those through the IACUC alone, would see those studies move into shared review. Whether that produces meaningful additional coordination is therefore a question about a given institution's research portfolio, not a general consequence of the policy.
What to review. Whether the institution intends to submit comments before October 19, 2026, since the comment period is when institutional input is invited. Separately, how IACUC and IBC review are coordinated today for studies requiring both approvals, and how incidents involving animals in containment reach each committee.
What did not change
No Animal Welfare Act rulemaking altered the core obligations of an IACUC during 2026, verified against the eCFR through September 23, 2026. The following remain as they were:
• Semiannual review and inspection. Under 9 CFR 2.31(c), the IACUC reviews the facility's program for humane care and use of animals, and inspects all animal facilities, at least once every six months.
• Committee composition. Under 9 CFR 2.31(b), the committee comprises a chairperson and at least two additional members. It must include a doctor of veterinary medicine with training or experience in laboratory animal science and medicine who has direct or delegated program authority, and at least one member not affiliated with the facility. PHS Policy section IV.A.3 sets a separate requirement of at least five members, including a veterinarian, a practicing scientist experienced in research involving animals, a nonscientist, and a nonaffiliated member.
• PHS Policy program requirements. Semiannual program evaluation, facility inspection, reporting to the Institutional Official, and the Annual Report to OLAW all operate as before.
• Assurance obligations. OLAW stated during the funding lapse that obligations under Animal Welfare Assurances continued.
• Reference standards. The Guide for the Care and Use of Laboratory Animals, eighth edition, remains OLAW's primary reference for PHS Policy compliance and AAALAC International's primary accreditation standard. USDA inspection and enforcement continue to be based on the Animal Welfare Act and the Animal Welfare Regulations at 9 CFR Parts 1 to 3.
Sections of Title 9 of the Code of Federal Regulations are amended from time to time for reasons unrelated to research facilities. The provisions governing IACUC programs sit at 9 CFR Parts 1 to 3, and the eCFR displays the amendment history for each section, which is where the verification above was carried out and where a reader can confirm the current position at any later date.
What these updates mean for each role
IACUC Chairs
The examples in NOT-OD-25-148 illustrate a threshold rather than a closed list. Committees will therefore encounter events that the notice does not describe. In those cases, the notice directs the IACUC to weigh the specific circumstances, the intent, and the actual effect on animal welfare. The added examples of situations not normally reportable support a proportionate response where a deviation occurred but no welfare issue resulted. The notice does not require the committee's reasoning to be recorded, but keeping a record of that assessment is a good practice.
IACUC Administrators and Coordinators
This year's updates call for four specific actions from the IACUC administrative office: identifying procedures and training content that still cite NOT-OD-05-034; updating report templates to capture funding source and NSF award numbers; tracking semiannual intervals against the six-month plus 30-day window so the Annual Report explains any delay; and confirming that performance-site Assurance status is checked before award rather than after, wherever pre-award review sits.
Attending Veterinarians
Several clarified reportable situations turn on veterinary judgment, including post-procedural monitoring during recovery from anesthesia or recuperation from invasive procedures, failed euthanasia, and the failure of personnel to carry out veterinary orders. The position on morbidity and mortality also relies on a veterinary assessment of whether an outcome fell within the parameters described in the approved protocol. The allowable-cost update adds a second area of involvement, since pre-transfer diagnostic testing, vaccination, and surgical sterilization are carried out where the Attending Veterinarian considers them necessary.
Institutional Officials and compliance leadership
The IO signature on a final report verifies that the report was submitted by the IACUC through the IO, as PHS Policy section IV.F.3 requires. The IO therefore relies on the completeness and accuracy of the record behind the report at the point of signing. Corrective action remains the substance of a report: OLAW's stated role is to assess whether the corrective actions an institution reports are adequate, and it will assist in developing definitive corrective plans and schedules where necessary. The draft biosafety policy is the one item this year where institutional input is actively invited, through a comment period closing on October 19, 2026.
A review list for your next semiannual evaluation
Each item below is drawn from the sections above. Taken together, they cover the four confirmed updates and the one proposal.
Where this leaves your program
No new Animal Welfare Act rule has changed what an IACUC must do, verified against the eCFR through September 23, 2026. The changes sit in the guidance around it: how reporting decisions are made and documented, what an institution may charge when animals leave a study, and where Assurance status has to be confirmed before an award is issued. One proposal, on biosafety, remains open for comment and would reach institutions where animal research and biosafety review overlap.
Each update raises a question about how oversight operates in practice. The prompt reporting guidance asks a committee to exercise judgment against a stated threshold and to show how it reached its decision. The Assurance requirement asks an institution to confirm the standing of every site where animals will be used before the work is funded. The draft biosafety policy asks whether two committees reviewing the same study are working from a shared understanding of it.
Each is easier to answer when protocol history, semiannual findings, corrective actions, and committee decisions are maintained as part of the everyday workflow rather than assembled when a question arrives.
Key Solutions works with research institutions on the systems that support IACUC and multi-committee oversight. If you are reviewing how your program handles reporting decisions, semiannual documentation, or coordination between committees, that is a useful conversation to have.
