CASRAI Dictionary

Category: Policy & Funding News

Reporting and briefings on external policy, regulatory, and funder developments affecting the research community worldwide.

  • AI in Grant Peer Review: How ERC, NIH, UKRI and NHMRC Draw the Line

    Four major funders have now published, or are actively revising, formal rules on AI in grant peer review, and the details differ enough that a reviewer moving between panels could unknowingly breach one funder’s terms while complying with another’s. In March 2026 the European Research Council (ERC) issued new guidelines on AI use in evaluation; the US National Institutes of Health (NIH) tightened its stance on AI-drafted applications from September 2025; UK Research and Innovation (UKRI) maintains a stricter blanket ban that peers expect to loosen; and Australia’s National Health and Medical Research Council (NHMRC) introduces a revised generative-AI policy from 28 April 2026. Research offices drafting or updating reviewer agreements need to track all four.

    How ERC, NIH, UKRI and NHMRC draw the line

    Each funder separates permitted “AI-assisted” support from prohibited “AI-generated” evaluation, but the exact boundary — and the effective date — varies.

    Funder Rule effective AI-assisted (permitted) AI-generated (prohibited)
    ERC 24 March 2026 Language polishing of a reviewer’s own report; general (non-proposal) information searches Summarising proposals, assessing scientific merit, drafting evaluations, uploading any proposal content to external AI systems
    NIH Applications submitted from 25 September 2025 Limited administrative tasks in application preparation Reviewers using generative AI to analyse applications or formulate critiques; applications “substantially developed by AI” are treated as non-original and not reviewed
    UKRI Current policy; Research Funding Policy Group review pending None yet formally sanctioned for reviewers — even AI-assisted grammar checks are currently disallowed Any generative AI use by reviewers or panellists in assessing applications
    NHMRC 28 April 2026 Generative AI to refine clarity or grammar of a reviewer’s own comments Using AI to evaluate, critique or score applications

    A fifth data point is worth noting: the US-based Foundation for Food & Agriculture Research (FFAR) went further still in November 2025, prohibiting reviewers from using AI tools in any capacity during peer review — including refinement of their own comments — on confidentiality grounds. That makes FFAR the strictest outlier against which UKRI’s current position, and NHMRC’s narrower allowance, can be benchmarked.

    • Confidentiality is the universal red line. Every policy reviewed prohibits uploading proposal text, applicant data or reviewer notes into public or third-party AI tools.
    • Non-delegation is the second constant. Scientific merit assessment must remain a human judgement in all four jurisdictions, regardless of how permissive the language-polishing allowance is.
    • UKRI is currently the most conservative of the four, with a sector-wide Research Funding Policy Group review expected to permit limited generative AI use in processing (not scoring) applications while keeping final decisions human-made.

    AI-assisted vs AI-generated: common questions

    Research offices repeatedly ask the same handful of questions when briefing reviewers. The answers below are grounded in the funder documents referenced above.

    What is the difference between AI-assisted and AI-generated peer review?

    AI-assisted review means a human reviewer uses a tool only for mechanical tasks — grammar, clarity, formatting of their own text — while retaining full intellectual authorship of the assessment. AI-generated review means the AI performs part of the evaluative task itself, such as summarising a proposal, scoring merit, or drafting critique content, which every funder surveyed here prohibits.

    Has NIH banned AI in grant peer review?

    Yes. NIH prohibits scientific peer reviewers from using generative AI tools to analyse applications or formulate critiques, a position it has held since June 2023. From 25 September 2025, NIH also treats applications substantially developed by AI as non-original, removing them from review rather than scoring them on merit.

    Can UKRI reviewers use AI to check grammar in their assessments?

    Not currently. UKRI’s existing policy forbids reviewers and panellists from using generative AI for any part of assessment, including language or grammar correction — a stricter line than ERC or NHMRC. A sector-wide funder policy group is expected to revisit this, but any change would still require human-made final decisions.

    When does the NHMRC generative AI policy take effect?

    NHMRC’s revised Policy on Use of Generative Artificial Intelligence in Grant Review takes effect from 28 April 2026. It permits peer reviewers to use generative AI to refine the clarity or grammar of their own comments, but explicitly prohibits using AI to evaluate, critique or score applications.

    Practical reviewer-agreement language for research offices

    Research offices administering panels — whether for an internal seed-fund competition, a co-funded international call, or as a delegated peer-review manager for an external funder — need reviewer agreements that anticipate divergence between funder rules. Three drafting principles reduce risk:

    • Name the prohibited actions explicitly, not just the tool category. A clause banning “AI tools” is weaker than one banning “uploading proposal content, applicant identifiers, or draft scores to any AI system, whether or not the funder’s own policy names that system.”
    • State the confidentiality obligation independently of the AI-use clause. General-purpose AI (GPAI) providers regulated under the EU AI Act’s GPAI obligations, in force since August 2025, may process submitted inputs for model improvement unless expressly excluded, so agreements should require reviewers to confirm no proposal content has been shared with any third-party system, GPAI-regulated or not.
    • Require disclosure, not just prohibition. A short attestation line — “I have not used generative AI to draft, summarise or score any part of this review, and any AI assistance used was limited to language editing of my own original text” — gives research integrity offices an auditable record if a dispute arises.

    Where a funder (such as NHMRC from April 2026) permits limited AI-assisted editing, research offices should still require reviewers to disclose which tool was used and confirm no proposal content was entered into it. This keeps institutional practice defensible even where funder rules differ from one call to the next.

    Implications and outlook

    For institutions running multi-funder portfolios, the practical challenge is less about any single funder’s rule and more about reviewer confusion across simultaneous panels. A reviewer serving both an ERC panel and a UKRI-funded call in the same month operates under materially different AI permissions for the same underlying task. Research offices should treat funder AI policies as living documents — ERC’s and NHMRC’s 2026 updates both followed roughly a year or more after their organisations’ initial public positions on AI, suggesting further revision is likely as reviewer behaviour and AI capability both evolve.

    The direction of travel across all four funders is convergence on two non-negotiables — confidentiality of proposal content and non-delegation of scientific judgement — even as the permitted margin for administrative AI assistance slowly widens. Research offices that build reviewer agreements around those two constants, rather than around any single funder’s current wording, will need fewer rewrites as UKRI’s pending policy shift and any subsequent NIH or ERC revisions land through 2026 and beyond.

    For related terminology used across funder and publisher AI-governance documents, see the CASRAI research dictionary, and for broader institutional process guidance visit the research administration resource hub.

  • 2 CFR 200 Cost Principles: What Changes Under the 2026 OMB Rule

    On 29 May 2026, the US Office of Management and Budget (OMB), joined by federal award-making agencies, published a proposed rule in the Federal Register substantially rewriting 2 CFR Part 200 — the government-wide Uniform Guidance governing federal grants and cooperative agreements. Inside that broader overhaul sits a narrower, technical change: a rewrite of the 2 CFR 200 cost principles in Subpart E, the section that decides which costs a university, hospital, non-profit, or state agency may lawfully charge to a federal award. For research administrators, the operative question is not whether reporting formats change — it is whether costs an institution has always treated as allowable will still be allowable after the proposed effective date of 1 October 2026.

    What the 2 CFR 200 Cost Principles Actually Require

    Subpart E of 2 CFR Part 200 sets out the framework recipients must apply when deciding whether a cost can be charged — directly or indirectly — to a federal award. Under §200.403 and related sections, a cost is only allowable if it is:

    • Reasonable — it does not exceed what a prudent person would incur under the same circumstances, judged against market prices, sound business practice, and award terms.
    • Allocable — it is incurred specifically for the award, or benefits the award and other work in proportions that can be reasonably estimated.
    • Consistently treated — like costs must be treated alike across federally and non-federally funded activities.
    • Conforming — the cost must comply with limitations in Subpart E itself, in agency-specific implementations such as 2 CFR Part 300 (HHS’s codification of the Uniform Guidance), or in the award’s terms.

    Subpart E also lists over 50 “selected items of cost” — from advertising to travel, equipment, and compensation — each with its own rule. This is the list the 2026 proposed rule edits most directly.

    The 2026 OMB Proposed Rule: What Changes for Allowability

    OMB frames the May 2026 proposal around three objectives: improving transparency, accountability, and oversight of federal funds; clarifying the regulatory status of the 2 CFR text as an OMB rule; and reducing recipient burden. In Subpart E, these goals pull in different directions — some provisions loosen documentation, others tighten what can be charged at all. Comments are due 13 July 2026, ahead of a proposed effective date of 1 October 2026, the start of federal fiscal year 2027.

    The most consequential Subpart E changes in the current draft include:

    • Publication costs would become unallowable unless required by statute or approved in advance by the awarding agency case-by-case.
    • Advertising and public relations costs would become presumptively unallowable, narrowing existing exceptions for recruitment and procurement.
    • Conference attendance costs would only be allowable where expressly approved by the agency and written into award terms.
    • Fundraising and investment management costs would require prior written agency approval rather than the current general prohibition with narrow carve-outs.
    • Fixed-amount awards and subawards would be eliminated; OMB argues they “limit transparency and hinder effective oversight” versus cost-reimbursement structures.
    • A related change to §200.300 (Statutory and National Policy Requirements) would bar federal funds from being used to “fund, promote, encourage, subsidize, or facilitate” DEI or DEIA policies found to violate federal anti-discrimination law — adjacent to, but legally distinct from, the Subpart E allowability tests.

    Despite Executive Order 14332 directing OMB to curb indirect cost recovery on discretionary grants, the proposal does not alter the indirect-cost-rate negotiation system: FY2026 appropriations riders required specified agencies to keep applying negotiated rates as they stood in FY2024. That leaves the 15% de minimis indirect cost rate — raised from 10% in the October 2024 revision, alongside a $10,000 equipment threshold (up from $5,000) and a $1,000,000 Single Audit threshold (up from $750,000) — unchanged for now.

    Allowable vs Unallowable Costs: Current Guidance vs the 2026 Proposal

    The table below summarises how treatment shifts for the categories most affected by the 2026 draft. Treat this as directional, not final — the rule remains open for comment and can change before any effective date.

    Cost category Current treatment (2024 Uniform Guidance) Proposed treatment (2026 draft rule)
    Publication costs Generally allowable as a direct or indirect cost Unallowable unless statute-required or agency pre-approved
    Advertising / public relations Allowable for specified purposes (recruitment, procurement, outreach) Presumptively unallowable; narrow exceptions only
    Conference attendance Allowable if reasonable, necessary, and documented Allowable only with express prior agency approval in award terms
    Fundraising / investment management Generally unallowable, with limited carve-outs Requires prior written agency approval
    Fixed-amount awards Available as alternative to cost-reimbursement awards Eliminated on transparency grounds
    Indirect cost (de minimis) rate 15%; agencies barred from imposing a lower rate absent statute Unchanged pending FY2026 appropriations riders

    Cost Principles: Direct Answers to Common Questions

    What are the 4 cost principles?

    The four cost principles applicable to sponsored awards under 2 CFR 200 are that costs must be reasonable, allocable, allowable, and consistently treated. These tests apply not only to federal funds but also to any cost share or in-kind contribution tied to the award.

    What are the three elements of 2 CFR Part 200?

    2 CFR Part 200 combines three components in one regulation: Uniform Administrative Requirements for pre- and post-award management, Cost Principles in Subpart E governing allowability, and Audit Requirements in Subpart F, which sets the Single Audit threshold and reporting obligations.

    What is the 2 CFR 200 standard?

    2 CFR Part 200, commonly called the Uniform Guidance, is the OMB-issued, government-wide rulebook for federal financial assistance. It prescribes how awards are made, how recipients must account for funds, how costs must be treated, and when audits are required — applied across nearly all federal grant-making agencies.

    Under what circumstances does 2 CFR 200 consider a cost reasonable?

    A cost is reasonable if it does not exceed what a prudent person would incur under the same circumstances at the time the spending decision was made. Reviewers weigh market prices, sound business practice, award terms, and deviation from established institutional policy.

    Implications for Research Administrators and Institutions

    Institutions should not wait for a final rule to begin preparing:

    • Audit PI-facing guidance. Flag any internal policy or budget template that assumes automatic allowability of conference travel, publication charges, or advertising spend before 1 October 2026.
    • Submit comments by 13 July 2026. The 45-day comment period is the main channel through which universities, hospitals, and non-profits — often via associations such as COGR, NCURA, or SRAI — can flag unintended compliance burdens before finalisation.
    • Distinguish Subpart E from §200.300. The DEI/DEIA restriction sits in statutory and national policy requirements, not the cost-allowability tests in Subpart E, and follows a different legal standard and appeal pathway.

    These distinctions matter for the broader research administration compliance function, where allowability determinations increasingly intersect with award terms, indirect cost negotiation, and audit preparation. Grant-compliance terminology used throughout this analysis — allowability, allocability, de minimis rate — is catalogued alongside related research-integrity and funding terms in the CASRAI Dictionary.

    What Happens Next

    The 2 CFR 200 cost principles have changed before — the October 2024 revision raised the de minimis indirect cost rate and equipment threshold — and they are set to change again. What distinguishes the 2026 proposal is its narrower target: rather than adjusting thresholds, it tightens the allowability tests themselves for specific cost categories, shifting several from “generally allowable” to “allowable only with prior written agency approval.” Until the comment period closes and OMB issues a final rule, institutions should treat the current Subpart E text as controlling while building the internal review processes the proposal will likely require. For most research offices, the practical impact will be measured in how many budget lines now need agency sign-off before they can be spent.

  • University Research Funding Cuts: What the Court Cases Mean for Grant Recipients

    University research funding cuts have moved from budget-line disputes into federal courtrooms. Since April 2025, Harvard, Columbia and coalitions of state attorneys general have filed parallel legal challenges against the National Institutes of Health (NIH) and National Science Foundation (NSF) over grant terminations, funding freezes and new indirect-cost caps. The cases differ in posture — one produced a court ruling, one produced a settlement, others remain active — but together they are setting the procedural rules that will govern how frozen, denied or withdrawn grants get reviewed for years to come.

    For research offices, the practical question is no longer whether litigation is happening but what it is actually requiring agencies and institutions to do while cases proceed. This analysis sets out the pattern, compares the major tracks, and lists what sponsored-programs and general counsel offices should be monitoring now.

    The pattern: why universities are suing over federal funding

    Beginning in early 2025, the administration froze, terminated or delayed thousands of federal research awards to universities, citing diversity, equity and inclusion (DEI) content, alleged civil-rights failures, or new indirect-cost policy. According to a mapping analysis by the Center for American Progress, more than 4,000 grants across over 600 institutions were targeted for termination, with claimed award values between roughly $6.9 billion and $8.2 billion.

    Universities and state attorneys general responded with a consistent legal theory: that agencies violated the Administrative Procedure Act (APA) by acting in an “arbitrary and capricious” manner, skipping required notice-and-comment procedures, or exceeding authority Congress had granted them. In several cases, plaintiffs also raised First Amendment retaliation claims, arguing that funding was cut in response to institutional speech or governance decisions rather than for programmatic reasons.

    • Institutional suits — Harvard sued the federal government directly over a frozen $2.2 billion in grants and contracts.
    • Negotiated settlements — Columbia resolved its dispute through a financial and compliance agreement rather than litigating to judgment.
    • Multi-state actions — coalitions of state attorneys general sued NIH and NSF separately, challenging both DEI-related terminations and the NSF’s 15% indirect-cost cap.

    Harvard, Columbia and the multi-state track record

    The three tracks have produced different outcomes, which matters for institutions trying to predict what a given legal strategy is likely to achieve.

    Track Funding at stake Legal basis Outcome so far
    Harvard v. federal government ~$2.2 billion frozen (April 2025) APA “arbitrary and capricious”; First Amendment retaliation District court ruled the cuts unlawful (September 2025); the Department of Justice subsequently sued Harvard (March 2026) seeking to recoup funds and contest the ruling
    Columbia University ~$400 million cut (March 2025) Civil-rights compliance dispute; no APA suit litigated to judgment Settled for $221 million (July 2025) — $200 million civil-rights, $21 million employment claims; ~$400 million in research funding reinstated; increased federal oversight and reporting requirements
    Multi-state AGs v. NIH Hundreds of grants (DEI, transgender health, vaccine-hesitancy research) APA violations; exceeded statutory authority Settlement committed NIH to its “usual process” for grant review; a court separately ruled roughly 900 terminated grants unlawful and ordered reinstatement, though the administration has appealed
    Multi-state AGs (16 states) v. NSF STEM diversity programmes; 15% indirect-cost cap APA and constitutional claims regarding congressional intent Litigation ongoing; plaintiffs are seeking to block the indirect-cost cap and reverse related terminations

    Harvard’s case is the clearest judicial precedent to date: a U.S. District Court in Boston found the government’s cancellation unlawful and ordered funding restored, only for the Department of Justice to open a separate recoupment suit months later — a reminder that a favourable ruling does not end the underlying dispute. Columbia’s settlement, by contrast, traded a fixed financial payment and expanded oversight for the reinstatement of frozen funds without a court ruling on the merits.

    What the settlements and court orders have required so far

    Three concrete procedural requirements have emerged from this litigation, and they matter more to research administrators than the headline dollar figures:

    • NIH’s court-ordered grant review. Following the ruling that roughly 900 terminated grants were unlawfully cancelled, NIH was ordered to reinstate them and, in a related settlement, committed to returning to its “usual process” for reviewing applications rather than applying ad hoc political criteria.
    • Reinstatement is not automatic. Reporting has repeatedly noted that court-ordered reinstatements are not occurring uniformly across all affected grants or states, and that the administration has filed appeals that keep some awards in limbo even after a favourable ruling.
    • Settlements bundle funding with oversight. Columbia’s agreement did not simply restore money; it added federal reporting obligations on admissions and international-student data and required adoption of the IHRA definition of antisemitism — a template that later negotiations may echo.

    None of this activity has produced a single, uniform national standard. Each institution’s relief depends on its specific docket, its circuit, and whether it litigated to judgment or settled.

    Frequently asked questions

    Why did Harvard get its research funding cut?

    The administration froze roughly $2.2 billion in Harvard grants and contracts in April 2025, citing the university’s response to campus antisemitism concerns and its refusal to comply with a set of governance demands. Harvard sued, arguing the freeze violated the Administrative Procedure Act and the First Amendment.

    Why is Columbia University losing funding?

    Columbia had roughly $400 million in federal grants terminated in March 2025 over alleged civil-rights compliance failures related to campus antisemitism. Rather than litigate, Columbia negotiated a $221 million settlement in July 2025 that restored most of the frozen research funding in exchange for expanded federal oversight.

    Was terminated NIH research funding actually reinstated?

    Partially. A court ordered roughly 900 NIH grants reinstated after finding their termination unlawful, but subsequent reporting found reinstatement was inconsistent across institutions and states, and the administration has appealed the underlying ruling, leaving some awards unresolved.

    What should a research office track during active litigation?

    Research offices should track award status changes, agency guidance updates, court docket entries affecting their sponsors, and internal expenditure and indirect-cost documentation — the same records needed both for compliance and for supporting institutional legal counsel if a grant is challenged.

    What research offices should track while litigation is pending

    Regardless of whether an institution is a named party, sponsored-programs and research-administration offices with active NIH or NSF awards should maintain contemporaneous records across five areas:

    • Correspondence with program officers — emails, termination or stop-work notices, and summaries of calls, since these documents establish the factual record if an award is later challenged.
    • Award terms and modifications — particularly termination, suspension and indirect-cost clauses, which vary by grant vintage and mechanism.
    • Expenditure and indirect-cost documentation — detailed enough to substantiate negotiated facilities-and-administrative rates if a cap or clawback is contested.
    • Docket activity relevant to the sponsoring agency — court orders, appeals and settlement terms that could reinstate, further freeze, or attach new conditions to an award.
    • Contingency and bridge-funding plans — since even a favourable ruling can take months to translate into disbursed funds, as Harvard and NIH grantees have both experienced.

    Institutions should also coordinate closely with general counsel before responding to any new agency demand tied to a settlement template, since Columbia’s agreement shows that funding restoration can come bundled with reporting and governance conditions extending well beyond the original grants at issue.

    Implications and what comes next

    The litigation pattern suggests two durable lessons for institutional research offices. First, a court ruling in an institution’s favour does not guarantee funds will flow on the original schedule — reinstatement has proven uneven, and follow-on actions such as the Department of Justice’s suit against Harvard show that disputes can continue well after an initial win. Second, settlement and litigation are not mutually exclusive strategies within a single funding relationship: an institution can win a ruling on one set of terminated NIH awards while separately negotiating conditions with another agency, or facing new litigation over the same funds.

    For offices managing sponsored research and research administration more broadly, the operational takeaway is procedural discipline rather than prediction. Consult the CASRAI Dictionary for definitions of the compliance and funding terms surfacing in this litigation, and treat every termination notice, court order and settlement condition as part of a single evidentiary record — because in this funding environment, that record is what any given grant’s outcome will ultimately turn on.

  • mRNA Research Funding Cuts: Tracking the Institutional Fallout

    The 2026 research-funding landscape has a new, narrower fault line: mRNA research funding cuts tied specifically to the messenger-RNA vaccine platform, distinct from the broader reductions affecting cancer and biomedical research generally. On 5 August 2025, the US Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., announced it was winding down mRNA vaccine development activities administered through the Biomedical Advanced Research and Development Authority (BARDA), terminating or restructuring 22 contracts worth nearly $500 million. Nearly a year on, the institutional fallout is now measurable, and research offices are adjusting their portfolios in response.

    What changed: HHS and BARDA’s mRNA wind-down

    The August 2025 announcement marked a deliberate shift in federal biomedical strategy: HHS stated it would move BARDA’s pandemic-preparedness investment away from mRNA platforms for respiratory viruses and toward what officials described as “safer, broader vaccine platforms.” The decision followed an earlier, separate cancellation of a roughly $600 million Moderna contract for a pandemic influenza mRNA vaccine in May 2025 — a move HHS and Moderna both describe as distinct from the August action, though the two together set the tone for the year’s mRNA-specific retrenchment.

    The August wind-down did not apply uniformly. According to contract-level reporting from HHS and trade press, the 22 affected awards fell into four categories:

    • Terminated contracts — awards cancelled outright, ending federal support for the specific project.
    • De-scoped work — existing contracts kept alive but with mRNA-specific tasks removed or reduced.
    • Rejected or withdrawn solicitations — proposals for new mRNA work that were declined before an award was made.
    • Restructured collaborations — joint projects renegotiated to change or remove the RNA component.

    Nature’s editorial board called the cancellations “the highest irresponsibility,” noting that a related executive order gives political appointees expanded authority over federal research-grant decisions — a governance change research offices should track independently of the funding total itself, since it affects how future awards in adjacent fields may be reviewed.

    Which institutions and companies have reported losses

    Public reporting to date identifies a specific set of universities, biotechs and pharmaceutical partners affected by the BARDA wind-down, each experiencing a different type of impact:

    Organisation Type of impact Project area
    Emory University Contract terminated Inhaled dry-powder mRNA antiviral platform
    Tiba Biotech Contract terminated RNA interference (RNAi) therapeutic — company disputes classification as an mRNA vaccine project
    Luminary Labs, ModeX, Seqirus Scope reduced mRNA-related tasks removed from existing BARDA agreements
    Pfizer, Sanofi Pasteur, CSL Seqirus, Gritstone Proposal rejected New mRNA-related solicitations declined pre-award
    AAHI, AstraZeneca, HDT Bio, Moderna/UTMB Collaboration restructured Nucleic-acid vaccine partnerships renegotiated

    Emory’s public statement was measured — a spokesperson said the university would “adjust as needed to pursue our research goals and ambitions” — but a lead researcher on the inhaled-platform project told local press the cuts risk signalling that mRNA is no longer a viable federal research priority, a concern echoed across the affected cohort.

    The scale of what is at stake extends well beyond the 22 terminated awards. A cross-sectional study published in JAMA Network Open, led by a team including researchers at Northwestern University and the University of Virginia, catalogued 178 active NIH grants related to RNA vaccines awarded between 1997 and 2025, representing $1.65 billion in cumulative federal investment. Those grants produced 2,342 publications and nearly 150,000 citations; 35% were cited in clinical trials or practice guidelines, and 18 were awarded through the Small Business Innovation Research and Small Business Technology Transfer programmes — the mechanism many university spinouts rely on to commercialise federally funded research. An accompanying commentary from researchers at the University of Calgary and University of Saskatchewan warned that excising RNA vaccine research from the NIH portfolio “is antithetical to current goals of making America healthy,” and separately noted that current-season flu vaccines are poorly matched to circulating strains — an argument for, not against, continued RNA platform investment.

    A Yale School of Public Health report has separately warned of downstream health consequences from the funding cancellation, and the American Lung Association and Harvard T.H. Chan School of Public Health have both published concern statements specifically about the loss of mRNA vaccine development capacity for respiratory disease.

    Common questions on the mRNA funding rollback

    Is the Moderna contract cancelled?

    Two separate Moderna contracts were affected. HHS cancelled a roughly $600 million bird-flu mRNA vaccine contract in May 2025, and Moderna’s collaboration with the University of Texas Medical Branch was restructured — not fully terminated — as part of the August 2025 BARDA wind-down.

    Why did the FDA reject Moderna’s mRNA flu vaccine application?

    The FDA said it refused to review Moderna’s mRNA flu vaccine filing because the company had not tested the product against a CDC-recommended comparator vaccine in a head-to-head clinical trial, as agency guidance issued in 2024 required — a regulatory, not funding, decision that compounds the platform’s commercial headwinds.

    How research offices are hedging portfolio risk

    Institutional research offices with active or pending mRNA-related awards are responding in broadly consistent ways, even where individual contract outcomes differ:

    • Diversifying platform exposure — reframing single-platform mRNA proposals as multi-modal nucleic-acid or protein-subunit programmes to reduce reliance on one federal funding line.
    • Pursuing non-federal co-funding — several affected groups, including Tiba Biotech, have publicly stated intent to pursue philanthropic, state-level, or industry funding to continue work federal contracts previously covered.
    • Auditing award language for termination clauses — sponsored-programmes offices are reviewing existing BARDA and NIH awards for early-termination-for-convenience language, which was the operative mechanism in several August 2025 cancellations.
    • Separating cancer-mRNA and infectious-disease-mRNA portfolios — because the HHS wind-down targeted respiratory-virus vaccine platforms specifically, institutions with mRNA cancer-vaccine work are treating that portfolio as distinct in risk profile, even though it uses overlapping delivery technology.

    For research administration offices, this is a live case study in sponsor-concentration risk — the same principle that underpins diversified grant portfolios more broadly. Institutions tracking these developments alongside broader shifts in research administration practice are better positioned to model exposure across single-sponsor dependencies before the next policy shift, rather than after.

    Outlook: what research administrators should track next

    The mRNA-specific rollback is narrower than the broader federal research-funding contraction affecting NIH and cancer research overall, but its concentration in a single platform and a single agency relationship (HHS/BARDA) makes it a useful, contained case study in how quickly a funding line can be repriced on policy grounds rather than scientific merit. Three signals are worth monitoring going into the next budget cycle: whether the executive order expanding political appointee authority over grant decisions is applied beyond mRNA to other platforms; whether the $1.65 billion NIH RNA-vaccine grant base identified in the JAMA Network Open study sees further reductions at renewal; and whether affected institutions successfully replace lost BARDA funding with non-federal sources, which would signal a durable shift in how pandemic-preparedness research is financed. Research offices with mRNA-adjacent portfolios should treat this episode as a template for stress-testing single-sponsor concentration risk across all federally funded platforms, not just this one.

  • Cancer Research Funding Cuts: What the 2026 NIH Data Shows

    Search interest in cancer research funding cuts has spiked through the first half of 2026, tracking a wave of NIH award terminations, a proposed 37% cut to the National Cancer Institute’s budget, and a roughly $500 million rollback of federal mRNA vaccine research contracts. For research administrators, the practical question is no longer whether the funding landscape has shifted — it clearly has — but how exposed a given portfolio is, and what a grants office can do about it before the next termination notice arrives.

    What the 2026 NIH Funding-Cut Data Shows

    HHS reporting released in April 2026 puts the cumulative tally of terminated National Institutes of Health awards at 1,392, with $539 million in unliquidated obligations still outstanding — funds that were committed but not yet disbursed when the terminations took effect. That figure sits alongside an earlier, broader accounting: a PubMed Central analysis found that by June 2025, roughly 2,300 NIH grants worth nearly $3.8 billion had already been cancelled agency-wide, including more than 160 cancer-related clinical trials.

    The cuts are not evenly distributed across the calendar. A May 2025 US Senate HELP Committee Minority Staff report found the administration cut approximately $2.7 billion in NIH funding during the first three months of 2025 alone, with cancer-specific research funding down 31% for that quarter compared with the same period in 2024. On the budget side, the National Cancer Institute’s own FY2026 congressional justification requested $4.53 billion — a $2.69 billion, or 37.3%, reduction from its FY2025 level of $7.22 billion.

    • Indirect cost cap: facilities-and-administrative (F&A) reimbursement rates on NIH grants have been capped at 15%, cutting into the overhead that funds shared cores, compliance staff, and research infrastructure at host institutions.
    • mRNA-specific rollback: HHS cancelled roughly $500 million in mRNA vaccine and therapeutics research contracts during 2025, with direct knock-on effects for mRNA-based cancer immunotherapy pipelines.
    • Review bottlenecks: reporting in early 2026 described new layers of administrative review delaying disbursement of already-approved grants, with some applications flagged for specific terminology before release.

    Which Disease Areas and Grant Types Are Most Exposed

    Exposure is not uniform across tumour types. A 2025 analysis of NIH and Congressionally Directed Medical Research Programs (CDMRP) funding from 2013 to 2022, presented at the Journal of Clinical Oncology, found that funding levels correlate strongly with disease incidence (Pearson coefficient 0.85) but only weakly with mortality (Pearson coefficient 0.36) — meaning historically under-funded, high-mortality cancers have the least financial cushion to absorb further cuts.

    Cancer type Combined NIH + CDMRP funding, 2013–2022 Relative funding position
    Breast $8.36 billion Highest-funded
    Lung $3.83 billion Well-funded
    Prostate $3.61 billion Well-funded
    Hepatobiliary $1.13 billion Under-funded vs. mortality burden
    Cervical $1.12 billion Under-funded vs. mortality burden
    Uterine $435 million Lowest-funded

    Grant type matters as much as disease area. Early-stage-investigator R01s, K-series career development awards, and T32 institutional training grants have been disproportionately represented among terminations, largely because diversity, equity, and inclusion-linked language in aims or personnel sections triggered policy-based review flags. Multi-year, non-competing renewals and diversity supplement awards have also recurred repeatedly in termination letters reviewed by health-policy reporters. Large P30 cancer-centre support grants are separately exposed through the F&A cap, since their budgets rely heavily on indirect-cost recovery to fund shared facilities.

    Answer-First Q&A: Cancer Research Funding Cuts

    Why is NIH cutting cancer research funding?

    The terminations stem from a mix of executive-branch policy priorities — including the rollback of diversity, equity, and inclusion-linked research — and proposed budget reductions for FY2026 and FY2027. Congress has historically restored some NIH funding after similar proposals, but administrative terminations of already-awarded grants have proceeded independently of the appropriations process.

    How much cancer research funding has been cut?

    By April 2026, HHS reporting recorded 1,392 terminated NIH awards with $539 million in unliquidated obligations. Separately, cancer-specific funding fell 31% in the first quarter of 2025 versus the prior year, and the National Cancer Institute’s FY2026 budget request represents a 37.3% reduction from its FY2025 level.

    Which cancer types are most affected by funding cuts?

    Historically under-funded cancers with high mortality — including uterine, cervical, and hepatobiliary cancers — have the least buffer to absorb cuts, since funding has tracked incidence rather than mortality. Early-career researchers and training-grant recipients across all disease areas are also disproportionately exposed.

    What Grants Offices Can Do Now

    None of this is speculative risk anymore — it is portfolio management. Institutions with active NIH-funded cancer research should treat funding volatility as a standing operational condition rather than a one-off shock, and research administration offices should build response capacity accordingly.

    • Bridge funding: establish or expand an internal bridge-fund mechanism, paired with external bridge grants from bodies such as the American Association for Cancer Research and the American Cancer Society, to keep terminated projects and personnel intact for six to twelve months while alternative funding is secured.
    • Appeals and documentation: maintain a standing file of scientific-merit documentation for every active award so a formal reconsideration request — or, where warranted, legal challenge — can be filed quickly; several 2025 terminations were reversed after litigation established that cancellations lacked adequate scientific justification.
    • Diversified funder mix: reduce single-funder concentration risk by cultivating relationships with disease-specific foundations (for example, the V Foundation and Damon Runyon Cancer Research Foundation), state-level programmes such as Texas’s CPRIT, and international co-funding arrangements, rather than relying on NIH as the sole primary sponsor for a given research line.
    • F&A exposure modelling: run budget scenarios against the 15% indirect-cost cap now, before it applies at renewal, so cancer-centre and core-facility budgets are not caught unprepared.
    • Track funding-notice guidance: assign a named staff member to monitor NIH Notice of Funding Opportunity and Guide Notices for terminology or eligibility changes that could flag active or pending applications for review.

    Professional associations — including ARMA, NCURA, and INORMS — have begun circulating shared templates and peer intelligence on termination response, and grants offices that pool this knowledge across institutions are responding faster than those working in isolation. As the FY2027 budget cycle approaches, with a further proposed reduction to overall NIH funding under discussion in Congress, the institutions best placed to protect their cancer research portfolios will be those that treated 2025’s cuts as a stress test rather than a one-time event — and built the bridge-funding, appeals, and diversification infrastructure needed to withstand the next round.

  • Grant Peer Review Under OMB’s Proposed 2026 Uniform Grants Regulation

    The Office of Management and Budget (OMB) has proposed a rewrite of the federal government’s grant-making rulebook that would change how grant peer review functions across agencies including the National Institutes of Health (NIH), the National Science Foundation (NSF) and the Department of Energy. According to reporting from STAT News, Inside Higher Ed, Science and NPR, the draft rule would convert the long-standing “Uniform Guidance” (2 CFR Part 200) into a binding “Uniform Grants Regulation,” subordinating scientific merit review to a new layer of political sign-off and giving agency political appointees explicit authority to terminate awards that no longer track administration priorities.

    For research administrators, the proposal is not a routine compliance update. It touches the mechanism — independent expert review — that has underpinned federal research funding decisions for more than half a century.

    What OMB’s Proposed Grants Rule Changes

    Uniform Guidance governs financial assistance rules across virtually every federal grant-making agency, covering everything from allowable costs to audit requirements. OMB’s proposal would elevate that guidance to a binding regulation and layer several new mechanisms on top of it. The core changes reported by STAT, Inside Higher Ed, Science and NPR include:

    • A mandatory pre-issuance review of discretionary grant awards by senior political appointees before funds are released.
    • Reclassification of peer-review recommendations as advisory rather than binding or routinely deferred to.
    • An undefined “Gold Standard Science” criterion appointees may apply during sign-off.
    • Expanded termination authority for awards deemed misaligned with agency priorities, including multi-year awards already underway.
    • New pre-approval requirements for costs tied to publications, conference attendance and journal subscriptions.
    • A “domestic-first” preference framework for research and development awards.
    • Prohibitions on funding tied to diversity, equity and inclusion (DEI) activities, “gender ideology,” or research supporting disparate-impact liability theories.
    • Elimination of fixed-amount subawards.

    The public comment period is reported to close on 13 July 2026, with an anticipated effective date of 1 October 2026 if the rule is finalised largely as proposed.

    From Deference to “Advisory”: How Peer Review’s Role Shrinks

    Under current practice, agencies such as NIH route applications through scientific review groups or study sections, which score proposals on significance, approach, innovation and investigator qualifications. Program officials retain formal award authority, but in practice they defer heavily to review scores and percentile rankings to set paylines.

    The proposed rule text, as reported across multiple outlets, states that peer-review recommendations “are not ministerially ratified, routinely deferred to, or otherwise treated as de facto binding” by senior appointees. That is a structural change: a proposal that clears scientific review with a strong score could still be delayed, reprioritised or rejected at a political pre-issuance gate that sits above the merit-review process rather than alongside it.

    Research associations — including the Association of Public and Land-grant Universities (APLU), the American Association for Cancer Research (AACR) and the Computing Research Association (CRA) — have raised concerns that the change would insert non-scientific criteria into funding decisions that have historically been insulated from politics precisely to protect scientific rigour and public trust.

    Aspect Current practice Proposed rule
    Peer-review status De facto determinative for most competitive awards Explicitly advisory
    Final sign-off Program/agency officials, largely deferential to review scores Senior political appointees, mandatory pre-issuance review
    Termination grounds Non-compliance, budget, performance Adds “no longer aligned with agency priorities,” including mid-award
    Allowable costs Publications, conferences, subscriptions generally allowable Pre-approval required for these cost categories
    Subaward mechanism Fixed-amount subawards permitted Fixed-amount subawards eliminated

    Grant Peer Review: Common Questions Answered

    What is a peer-reviewed grant?

    A peer-reviewed grant is funding awarded after independent subject-matter experts assess a proposal’s scientific merit — its significance, approach, feasibility and investigator qualifications — typically through a scored study section or review panel. At NIH, review groups assign priority scores that traditionally shape funding decisions, though final award authority sits with the agency, not the reviewers.

    What is the peer review process for grant applications?

    The peer review process for grant applications routes each proposal to subject-matter reviewers, who score it against published criteria and then discuss and rank applications in a panel meeting. Agencies use these rankings to set paylines and prioritise funding. Under OMB’s proposed rule, that ranking becomes one advisory input rather than the determining factor in a funding decision.

    Do grant reviewers get paid?

    Yes. Federal agencies, including NIH, typically pay peer reviewers a daily honorarium plus travel expenses for study section service. Many reviewers describe the compensation as modest relative to the time required to read, score and discuss a full panel’s worth of competing applications ahead of each review cycle.

    Expanded Termination Authority and Award-Level Risk

    Beyond the review gate itself, the proposal reported by STAT, Science and Inside Higher Ed would broaden agencies’ authority to suspend or terminate grants — including multi-year awards already in progress — if they are deemed no longer aligned with agency priorities or the “national interest.” It would also widen risk assessment of applicants to consider an institution’s affiliation with organisations engaged in activities that “violate Federal law, undermine public safety or national security, or advocate for the overthrow of the United States Government,” a standard with considerable interpretive latitude.

    Paired with new pre-approval requirements for publication, conference and journal-subscription costs, and the removal of fixed-amount subawards, the combined effect is a research-funding environment where mid-project risk is materially higher than under the current framework, even for awards that passed scientific review cleanly.

    What This Means for Research Administrators

    For institutions managing portfolios that depend on merit-reviewed research funding, the proposal raises operational, not just scientific, questions. Recommended near-term actions include:

    • Model termination risk explicitly in multi-year budget and staffing plans, rather than treating a scored, funded award as a settled commitment.
    • Audit cost-approval workflows for publication, conference and subscription spending now, ahead of any pre-approval mandate taking effect.
    • Brief principal investigators on the distinction between a favourable peer-review score and a final funding decision under the proposed pre-issuance review.
    • Coordinate institutional comments through professional associations such as NCURA and ARMA before the docket closes.
    • Track subaward structures that rely on fixed-amount mechanisms, which the proposal would eliminate.

    Offices that have historically treated peer-review outcomes as the primary predictor of award stability will need a second, policy-alignment layer in their risk assessment — one that is harder to forecast because it depends on political judgement rather than published scoring criteria.

    What Happens Next

    The proposed rule remains open for public comment, with reporting placing the deadline at 13 July 2026 and a possible effective date of 1 October 2026 if OMB finalises it substantially as drafted. Scientific and higher-education associations are expected to submit extensive comments opposing the advisory reclassification of peer review, and legal challenges are plausible if the rule is finalised without significant revision, given its scope relative to existing statutory peer-review requirements at agencies such as NIH.

    Until the final text is published, research administrators should treat every provision summarised here as subject to change — but the direction of travel is unambiguous: less deference to scientific merit review, and more discretionary authority at the award-decision and award-termination stages. Institutions that update their risk models and compliance workflows now will be better placed to respond once the rule, in whatever form it takes, becomes binding.

  • OMB Uniform Guidance 2026 Overhaul: What Research Offices Should Flag Before the Comment Deadline

    OMB’s omb uniform guidance 2026 overhaul is now a formal proposed rule, not a rumour circulating through listservs. Published in the Federal Register on 29 May 2026 as document 2026-10817 (tracked under docket OMB-2026-0034), the proposal would rewrite 2 CFR Parts 200 and 300 — the framework governing the large majority of academic, non-profit and state federal awards — and rename it the “Uniform Grants Regulation.” The public comment window closes on 13 July 2026, days from now, with a targeted effective date of 1 October 2026, the start of federal fiscal year 2027. For sponsored-programmes offices, general counsel and research administrators, the compressed 45-day comment period means institutions that have not yet reviewed the text are already behind.

    OMB’s three stated objectives for the rewrite

    OMB has organised the proposal around three explicit objectives, set out in the preamble to the Federal Register notice:

    • Transparency, accountability and oversight — expanding federal agencies’ visibility into recipient risk, subaward reporting, conflicts of interest and termination decisions.
    • Regulatory clarity — converting 2 CFR Subtitle A from non-binding “guidance” into a document with regulatory effect in its own right, so future OMB amendments apply government-wide without separate agency rulemakings.
    • Reduced recipient burden — measures such as encouraging multi-year awards, mandating that funding opportunities post to Grants.gov, and using pre-application statements of interest to screen out low-probability applicants before a full proposal is required.

    Much of the substantive detail traces back to Executive Order 14332, “Improving Oversight of Federal Grantmaking” (7 August 2025), which directed OMB to build termination-for-convenience authority and mandatory senior-appointee review into the Uniform Guidance. The 2026 proposal is OMB’s formal vehicle for codifying that order, together with several 2025 executive orders addressing DEI, gender ideology and merit-based opportunity.

    What changes for award recipients

    The proposed rule touches nearly every phase of the award lifecycle. Recipients should not assume that practices considered compliant under the current text will automatically satisfy the revised one — several provisions are new law, not restatements.

    Section Current position Proposed change
    §200.205 – merit review Agency-run scientific/programmatic merit review Senior political appointee conducts “pre-issuance review” of every discretionary award; peer review recommendations are advisory only
    §200.340 – termination Termination chiefly for noncompliance Broad discretionary termination if an award “does not effectuate…the national interest as they exist at the time of termination”; new 90-day suspension authority
    §200.202(e) – R&D awards No domestic-entity restriction “Domestic-first framework” generally limits research and development awards to US-organised entities
    §200.220 (new) – foreign collaboration No equivalent provision Prohibits using federal funds, including indirect cost allocations, for collaboration with “covered foreign countries or entities”
    §200.461 – publication costs Generally allowable Unallowable unless required by statute or approved in advance by the agency
    §200.432 – conference costs Allowable Allowable only if expressly pre-approved in the award’s terms and conditions
    §200.333 – fixed-amount awards Permitted with agency approval Eliminated entirely, in favour of cost-reimbursement structures

    Other proposed changes worth flagging: mandatory E-Verify participation (§200.303(f)); a new requirement that recipients disclose employees who worked at the awarding agency within the prior two years (§200.112–.113); an expanded risk-assessment framework at §200.206(b) that lets agencies weigh an applicant’s Section 117 foreign-gift-disclosure compliance and “questionable practices” history; and a new subrecipient clause (§200.332(i)) obliging pass-through entities to ensure subrecipients do not “significantly damage the reputation” of the funding agency. Notably, OMB has explicitly declined to reopen indirect cost rate methodology in this rulemaking, though the pre-issuance review principle favouring “institutions with lower indirect cost rates” applies indirect downward pressure regardless.

    This is the third revision to the framework since its 2013 consolidation: OMB made administrative updates in August 2020, then a substantive 2024 revision (effective 1 October 2024) that raised the single-audit threshold from $750,000 to $1,000,000. The 2026 proposal is materially broader in scope than either predecessor, extending well beyond audit and cost mechanics into award termination, political review and non-discrimination policy — territory the Uniform Guidance has not previously occupied.

    Common questions about the 2026 Uniform Guidance rewrite

    What is the uniform guidance of 2 CFR 200?

    2 CFR Part 200, informally the Uniform Guidance, is the government-wide framework setting administrative requirements, cost principles and audit requirements for federal grants, cooperative agreements and other financial assistance. Consolidated from eight separate OMB circulars in 2013, it governs how universities, non-profits, states and tribal governments manage federal award funds.

    When did the uniform guidance change?

    OMB has revised the Uniform Guidance three times since 2013: minor administrative updates in August 2020; a substantive revision effective 1 October 2024 that raised the single-audit threshold to $1,000,000; and the sweeping rewrite proposed on 29 May 2026, targeting an effective date of 1 October 2026.

    What is the purpose of Subpart F of the Uniform Guidance in 2 CFR Part 200?

    Subpart F sets the audit requirements for non-federal entities, including the single audit obligation triggered once an organisation spends federal award funds above the statutory threshold. It defines auditee and auditor responsibilities, reporting deadlines and the criteria agencies use to assess an institution’s financial management and internal controls.

    What is the new uniform guidance threshold?

    The most recent confirmed threshold change raised the single-audit trigger from $750,000 to $1,000,000 in annual federal expenditure, effective for fiscal years ending on or after 30 September 2025. The 2026 proposed rewrite does not revisit this figure; it concentrates instead on oversight, termination authority and cost-principle changes.

    How institutions can still comment, and what happens next

    The comment window is short by design: OMB set a 45-day period specifically so that, in its words, “only a single set of government-wide requirements” applies to awards made during fiscal year 2027. Comments may be filed through Regulations.gov against docket OMB-2026-0034 or attached directly to the Federal Register listing for document 2026-10817. As of mid-June 2026 the docket had already drawn more than 14,800 public comments, reflecting the scale of institutional concern.

    Two procedural points matter for anyone drafting a submission before 13 July:

    • Grant-related rulemakings are generally exempt from the Administrative Procedure Act’s requirement that agencies individually respond to every “significant comment,” so OMB may group responses thematically in the final rule’s preamble rather than address each submitter.
    • An agency’s obligation to consider comments in judicial review is limited to the issues those comments actually raise — a specific, well-evidenced submission on a provision an institution intends to challenge later is more likely to preserve that argument than a general objection.

    Research-administration associations, including NCURA and ARMA, are coordinating member briefings and template comment language, and institutions weighing individual versus coalition submissions should consider filing both: a joint comment through a sector body carries collective weight, while an institution-specific comment on provisions with unique operational impact (large multi-year awards, extensive international collaboration, heavy publication or conference spend charged to awards) creates its own record.

    Whether or not the rule is finalised as drafted by 1 October 2026, institutions should not wait for that date to begin preparing. The executive orders underlying most of the proposed provisions — on grantmaking oversight, DEI, and foreign collaboration — are already in effect and already shaping agency behaviour in individual award decisions. Convening a cross-functional review involving the office of research, general counsel, sponsored programmes and research administration compliance staff now, before the final rule lands, is the practical way to avoid a scramble in early October. Given the volume of comments already filed and the litigation risk flagged by multiple legal analyses of the proposal, a modified final rule — rather than the text exactly as proposed — is a realistic outcome, but the direction of travel toward tighter political oversight and narrower allowable costs is unlikely to reverse.

  • NIH’s 2026 Data Management and Sharing Plan Format: What Changed and Why It Matters

    The NIH data management and sharing policy, in force since January 2023, is getting its first substantial format revision. Under guide notice NOT-OD-26-046, the National Institutes of Health has updated the required structure of the Data Management and Sharing (DMS) Plan that accompanies most extramural applications, with the revised elements taking effect for applications submitted on or after May 2026. For grant administrators, the change is not cosmetic: reviewers and program staff will now expect more granular metadata detail at the point of submission, not left for post-award justification.

    The revision arrives as NIH data sharing policy compliance has moved from a novelty to an audited routine. Institutions have spent three years building DMS Plan templates, and many of those templates are now out of step with what NOT-OD-26-046 asks for. This article walks through what changed, what stayed the same, and how research administration offices should adjust their internal checklists ahead of the effective date.

    What NOT-OD-26-046 Changes in the NIH Data Management and Sharing Policy

    The original 2023 policy set out six required elements for a DMS Plan: data type, related tools and software, standards, preservation and access timelines, access and distribution considerations, and oversight. NOT-OD-26-046 keeps that six-element skeleton but sharpens what “sufficient detail” means within each one. The revision responds to two years of program-staff feedback that plans were frequently too vague to be enforceable — naming a repository without specifying a deposit timeline, or citing “standard formats” without naming which standard.

    The most consequential change is a new expectation that plans identify specific, named metadata standards and persistent identifier schemes rather than describing them generically. Plans that previously said data would be shared “using appropriate metadata” will now need to name the applicable schema — for example, a Dublin Core or DataCite metadata profile, or a domain-specific standard where one exists. This mirrors a broader trend across funders and publishers: DataCite, CrossRef, and ORCID have each pushed toward named, machine-actionable identifiers rather than free-text descriptions, and NIH’s revision brings its DMS Plan expectations closer into line with that norm.

    Section-by-Section Checklist for the Revised DMS Plan

    Administrators preparing applications for the May 2026 cycle should work through each element against the following practical checklist. This is not a substitute for the official NIH guidance, but it reflects where NOT-OD-26-046 tightens expectations relative to the 2023 baseline.

    1. Data type

    • Distinguish clearly between data that will be preserved and shared versus data generated but not intended for sharing, with a stated rationale for any exclusions.
    • Estimate approximate data volume and modality (imaging, sequencing, survey, sensor, etc.) rather than describing data in purely narrative terms.

    2. Related tools, software, and code

    • Name any custom code, pipelines, or proprietary software required to access or interpret the data.
    • State whether code will be deposited alongside the data (for example in a version-controlled repository) and under what licence.

    3. Standards

    • Name the specific metadata schema and, where applicable, community data standard (such as those maintained by domain repositories or standards bodies).
    • Confirm which persistent identifier scheme will be used for datasets — a DOI issued via DataCite is the default expectation in most disciplines.

    4. Data preservation, access, and timelines

    • Name the repository and confirm it meets NIH’s criteria for an established, sustainable repository, rather than describing repository characteristics generically.
    • State a concrete deposit timeline tied to publication or award milestones, not an open-ended commitment.

    5. Access, distribution, and reuse considerations

    • Address any human subjects, privacy, or controlled-access considerations explicitly, including how consent language supports secondary use.
    • State the reuse licence or terms under which shared data will be made available.

    6. Oversight

    • Name the institutional office or role responsible for monitoring compliance with the plan across the life of the award.
    • Confirm how deviations from the plan will be reported to NIH, consistent with the enforcement posture program staff have adopted since 2023.

    How the NIH Genomic Data Sharing Policy Interacts With the Revised Format

    Applications involving genomic data must continue to satisfy the NIH genomic data sharing policy (GDS Policy) in addition to the general DMS Plan requirements. NOT-OD-26-046 does not replace the GDS Policy’s separate requirements around Institutional Certifications, data use limitations, or submission to NIH-designated data repositories such as dbGaP. What changes is that the DMS Plan’s “standards” and “access” elements now need to explicitly reference the GDS-specific data use limitation categories and repository submission timelines, rather than treating GDS compliance as a parallel, loosely linked process. For research administration offices handling both genomic and non-genomic awards, this means the DMS Plan template can no longer be a single generic document — it needs a genomic-data branch that pulls in GDS-specific language by reference.

    This tightening reflects a pattern seen across major funders: as more institutions ask “what is a data management plan supposed to demonstrate”, the honest answer has shifted from “an articulated intention” to “a verifiable operational commitment.” Reviewers are increasingly trained to check whether named repositories, standards, and identifiers actually correspond to what the applicant’s field uses, rather than accepting boilerplate language.

    What This Means for Research Administrators

    The practical burden of NOT-OD-26-046 falls squarely on research administration offices, sponsored programs staff, and data librarians who support investigators through the DMS Plan drafting process. Three actions are worth prioritising before the May 2026 effective date:

    • Audit existing DMS Plan templates. Any institutional template built around the 2023 language should be checked against the sharpened standards and access-timeline expectations, particularly where templates currently rely on generic placeholder text.
    • Build a named-standards reference list. Rather than asking each investigator to independently identify the correct metadata schema, administration offices should maintain a discipline-by-discipline reference list of accepted standards and identifier schemes, updated as fields evolve.
    • Clarify oversight roles in writing. Because NOT-OD-26-046 expects a named office or role for monitoring compliance, institutions without a designated data-sharing oversight function should assign one now, rather than leaving it implicit.

    None of this is exotic. It is largely the same discipline that publishers, funders such as UKRI, and initiatives like cOAlition S have already been pushing through open-access and open-data mandates elsewhere in the research lifecycle. What is new is that NIH — as the single largest funder of extramural biomedical research — is applying the same rigour to its own plan format.

    A Standards-Originator Perspective

    Consistent, well-documented metadata practice is the connective tissue that makes data management plans auditable rather than aspirational — the same principle that underpins contributor attribution standards. CASRAI originated the CRediT contributor role taxonomy in 2014. The standard is now stewarded by NISO as ANSI/NISO Z39.104-2022. That history is a useful reference point here: a taxonomy or metadata convention only becomes durable once a neutral standards body maintains it beyond its originating organisation, and once funders and publishers build compliance checks around it rather than treating it as optional guidance. NOT-OD-26-046 is, in effect, NIH doing the same thing for dataset metadata that CRediT did for authorship — moving from generic description toward named, checkable categories.

    For grant administrators, the takeaway is not that the DMS Plan has become harder to write — it is that the plan must now say precisely what the institution intends to do, in terms that a reviewer, a repository, and an auditor can all verify independently. Offices that treat the May 2026 changes as an opportunity to formalise their metadata and oversight practices, rather than a compliance inconvenience, will be better positioned as NIH data sharing policy enforcement continues to mature through the remainder of the decade.

  • UKRI’s New Funding Model Explained: What Research Administrators Need to Know for 2026

    UK Research and Innovation (UKRI) is in the middle of the most significant overhaul of its application and grants-management infrastructure in a generation. The UKRI new funding model consolidates the disparate systems that research offices have used for years — most notably the ageing Je-S (Joint Electronic Submission) system — into a single, browser-based UKRI Funding Service, alongside a redesigned Funding Finder for discovering live opportunities. For institutions managing a share of UKRI’s more than £8 billion in annual research and innovation funding, this is not a cosmetic IT upgrade. It changes how proposals are drafted, how organisational data is captured, and how compliance is monitored across the grant lifecycle.

    For research administrators, the practical stakes are high. Application routes, data fields, and reporting obligations that have been stable — if clunky — for over a decade are being replaced council by council, scheme by scheme. Getting institutional processes aligned to the new platform, and doing so with consistent metadata practices, is now a live operational priority heading into the 2026 cycle.

    What the UKRI New Funding Model Actually Changes

    At its core, the transition moves application and post-award activity away from Je-S and onto the UKRI Funding Service, a modern, cloud-based platform intended to serve all seven research councils, Research England, and Innovate UK from a common front end. UKRI has been rolling this out incrementally: rather than a single cutover date, individual funding opportunities and schemes have migrated in phases, meaning many research offices are currently operating a hybrid environment — some calls still routed through Je-S, others exclusively through the new service.

    Alongside the application platform itself, UKRI has overhauled UKRI Funding Finder, the public search tool researchers and administrators use to identify open and forthcoming calls. The redesigned finder is intended to reduce the friction of tracking opportunities across nine constituent councils with historically inconsistent naming conventions, deadlines, and eligibility criteria. Institutions that previously relied on manually curated spreadsheets or council-specific alerts to track UKRI funding opportunities are being encouraged to migrate to the centralised finder and its associated notification tools.

    The stated ambition behind the wider UKRI funding portal consolidation is simplification: fewer bespoke application forms, a common set of reusable organisational and project data, and — eventually — a single sign-on and case-tracking experience regardless of which council is funding the work. UKRI has also continued to update its standard UKRI terms and conditions for research grants, clarifying obligations around data management, open access compliance, and financial reporting as part of the same modernisation effort.

    Why This Is a Governance-Standards Issue, Not Just an IT Migration

    Research offices tend to experience system migrations as a training and helpdesk problem. That framing understates what is actually at stake. Every time a funder changes its application architecture, it also changes — implicitly or explicitly — the data model institutions must feed into it: how principal investigators are identified, how organisational affiliations are recorded, how costings and terms are structured, and how outputs and outcomes are reported back.

    This is precisely the territory that research information management standards exist to govern. Persistent identifiers such as ORCID for individual researchers and the Research Organization Registry (ROR) for institutions reduce the ambiguity that free-text name fields introduce into any funder’s database — ambiguity that becomes costly when a research office has to reconcile its internal systems (CRIS, HR, finance) against a funder’s records at renewal, reporting, or audit time. Where a new platform like the UKRI Funding Service standardises identifier capture at the point of application, it materially reduces downstream reconciliation work for research offices — provided institutions actually populate those fields consistently rather than treating them as optional.

    The same logic applies to reporting metadata more broadly. Bodies such as DataCite and CrossRef have spent over a decade demonstrating that consistent, machine-readable metadata at the point of creation is far cheaper than retrospective clean-up. A funder-level platform consolidation is an opportunity to embed that discipline institutionally — or, if handled poorly, an opportunity to multiply inconsistency across an even larger data set.

    Practical Steps for Institutional Research Offices

    Ahead of further rollout through 2026, research offices should treat the transition as a data-governance exercise as much as a systems one:

    • Audit current Je-S versus Funding Service coverage. Maintain an internal register of which schemes and councils have migrated, since guidance and support arrangements differ between the two systems during the transition period.
    • Standardise identifier capture now. Ensure ORCID iDs are mandatory in internal proposal-approval workflows for all named investigators, and confirm the institution’s ROR identifier is used consistently wherever organisational affiliation is recorded, rather than relying on free-text institution names.
    • Re-brief costing and contracts teams on updated terms and conditions. Changes to UKRI’s standard grant terms and conditions can affect audit obligations, data-sharing requirements, and financial reporting deadlines; contracts staff should not assume prior guidance still applies unchanged.
    • Update internal training materials and templates. Application forms, checklists, and costing templates built around Je-S field structures may no longer map cleanly onto the Funding Service’s data model.
    • Assign ownership for Funding Finder monitoring. As legacy alert mechanisms are retired, someone in the research office should own migration to the new finder’s notification tools to avoid missed deadlines during the changeover.

    What This Means for Research Administrators

    The immediate operational burden of the UKRI new funding model falls on research offices, not on principal investigators. Administrators are the ones reconciling which schemes sit on which platform, retraining academic staff on new interfaces, and absorbing the ambiguity of a multi-year, phased rollout rather than a single clean cutover. That burden is real, but it is also time-limited and manageable with the right internal governance discipline.

    The larger, more durable implication is about data quality. Institutions that use this transition as a forcing function to standardise identifier use, tidy internal CRIS records, and align local metadata practices with the fields the Funding Service expects will find themselves with cleaner, more defensible data for REF-related reporting, funder audits, and institutional benchmarking well beyond this migration. Those that treat it purely as a login-page change will likely recreate today’s reconciliation headaches inside tomorrow’s system.

    For sector bodies such as ARMA, NCURA, and EARMA, the consolidation also strengthens the case for shared guidance on identifier practice and metadata hygiene across UK and international funders — reducing the risk that every major funder’s platform change becomes a bespoke crisis for research offices to absorb alone.

    Looking Ahead

    UKRI’s platform consolidation will continue in phases through 2026 and beyond, and further schemes are expected to move from Je-S onto the Funding Service as confidence in the new platform grows. Research offices that get ahead of the transition — auditing coverage, enforcing identifier discipline, and refreshing internal guidance on the current terms and conditions — will be better placed to absorb whatever comes next, whether that is further UKRI consolidation or similar modernisation efforts from other national funders following the same trajectory.

  • Texas TRAIGA and the US State AI-Law Patchwork

    The Texas Responsible Artificial Intelligence Governance Act (TRAIGA), enacted as House Bill 149, took effect on 1 January 2026. It is one of the more comprehensive entries in a rapidly expanding patchwork of US state AI laws, in which different states regulate different aspects of AI in different ways. This article explains TRAIGA’s main features and how state approaches diverge. It is informational and not legal advice.

    What TRAIGA does

    TRAIGA establishes a framework governing the development and deployment of AI systems in Texas. Reported features include:

    • A broad definition of AI systems, covering machine-based systems that infer from inputs how to generate outputs such as content, decisions, predictions or recommendations — not only generative AI.
    • Prohibited uses, including AI developed or deployed for unlawful behavioural manipulation, certain forms of unlawful discrimination, and specified harmful content.
    • Obligations on government entities, such as disclosure to consumers that they are interacting with an AI system, and restrictions on social-scoring and certain biometric uses.
    • A duty for healthcare providers to disclose to patients where AI is used in their care.
    • A regulatory sandbox for testing AI systems and an AI advisory council to inform policy.

    Enforcement is reserved to the Texas Attorney General, with civil penalties and a cure period before action, and the law does not create a private right of action. The statute and analyses are summarised in published legal commentary; the bill itself is available through the Texas Legislature.

    Scope and reach

    TRAIGA is reported to apply broadly: to those conducting business in Texas, offering products or services to Texas residents, or developing or deploying AI systems in the state. That framing can pull in out-of-state organisations whose systems reach Texas residents, a common feature of state-level technology laws. As enacted, the law was described as a pared-back version of earlier, more expansive drafts, with some of the broadest proposed duties narrowed before passage. This trajectory — an ambitious initial proposal trimmed during the legislative process — is itself characteristic of how several state AI bills have moved from introduction to law.

    The patchwork problem

    TRAIGA’s significance is amplified by its context. In the absence of a single comprehensive federal AI statute, US states have moved at different speeds and along different conceptual lines. The result is a patchwork in which the same AI system can face materially different rules depending on where it is used. Broad themes include:

    • Comprehensive risk frameworks. The Colorado AI Act (SB24-205) pioneered a developer-and-deployer model centred on algorithmic discrimination in consequential decisions, though its effective date was repeatedly deferred.
    • Targeted use-case rules. NYC Local Law 144 regulates a single use — automated employment decision tools — through mandatory bias audits and disclosure.
    • Transparency and disclosure laws. Several states have enacted measures focused on disclosing AI-generated content, chatbots or deepfakes, themes we follow under generative-AI disclosure.
    • Broad governance statutes. TRAIGA itself blends prohibited-use rules, government-specific duties, sectoral disclosure and a sandbox.

    For a structured comparison of these regimes, see our overview of US AI laws by state.

    What differs state to state

    The divergence runs along several axes. States differ on who is regulated (developers, deployers, government, specific sectors), on what triggers obligations (consequential decisions, employment screening, content generation, biometric use), on core mechanisms (impact assessments, bias audits, consumer notices, prohibited-use lists), and on enforcement (attorney-general action versus, in some cases, other routes). Even shared concepts like “high-risk” or “consequential decision” can carry different statutory meanings. This variability is the defining operational challenge of the patchwork.

    The sandbox and advisory council

    Two features distinguish TRAIGA from purely prohibitive approaches. The regulatory sandbox is intended to let participants develop and test AI systems under a relaxed regulatory posture, with the aim of encouraging innovation while gathering information about emerging uses. The AI advisory council is positioned to inform the legislature and state agencies on AI policy, the use of AI within government, and improvements to the sandbox. Together these reflect a model that pairs enforcement with structured experimentation and ongoing policy review — an approach that contrasts with measures focused solely on prohibitions or audits.

    Federal-state tension

    The patchwork exists against a backdrop of debate about whether AI should be governed primarily at the federal or state level. Proposals to limit or pre-empt state AI regulation have surfaced in national policy discussions, and the outcome of that debate would directly affect how durable individual state laws prove to be. For organisations, this adds a layer of uncertainty: the rules in force today reflect a particular moment in an unsettled allocation of authority, and the balance between state initiative and federal coordination remains an open question that could reshape the landscape.

    How organisations respond

    Faced with multiple overlapping regimes, many organisations build a governance baseline using voluntary frameworks and then layer state-specific obligations on top. The NIST AI RMF is frequently used to structure risk management, and ISO/IEC 42001 to provide an auditable management system; international comparisons are also drawn with the EU AI Act. None of these substitutes for a given state’s legal requirements, but they offer common scaffolding across jurisdictions. Readers encountering terms such as deployer, consequential decision or regulatory sandbox may find our dictionary helpful.

    In summary

    TRAIGA, effective 1 January 2026, adds a broad governance statute to a US state AI-law patchwork that already spans comprehensive risk frameworks, targeted use-case rules and transparency measures. The practical consequence is divergence: scope, triggers, mechanisms and enforcement vary by state. This article is a neutral overview, not legal advice; organisations should consult qualified counsel and the relevant statutes for their own circumstances.