CASRAI Dictionary

Tag: nih grant funding policy change

  • NIH Grant Termination Study: What the Data Show

    Independent tracking studies of the National Institutes of Health’s 2025 grant terminations show the cuts did not fall evenly across the biomedical research portfolio. This NIH grant termination study review of four separate tracking efforts finds early-career investigators, women-led projects, infectious-disease and health-equity research, and a small cluster of NIH institutes and institutions absorbed a disproportionate share of the losses.

    An NIH grant termination study, in this context, is an independent, data-driven analysis — built from crowd-sourced trackers such as Grant Witness and NIH’s own Research Portfolio Online Reporting Tools (RePORTER) — that quantifies which grants the agency cancelled and who held them, because NIH has not published a single consolidated breakdown of its own.

    How independent studies measured the terminations

    NIH has not released an official, comprehensive tally of terminated awards, so researchers and journalists have relied on independent trackers to reconstruct the picture. Four efforts now anchor most public analysis:

    • Fregolent et al. (2026), published in PNAS, matched the crowd-sourced Grant Witness database against NIH RePORTER records for grants cancelled between February and August 2025.
    • Patel, Liu and Jena (2025), published in JAMA Internal Medicine, linked NIH ExPORTER data with the HHS Tracking Accountability in Government Grants System for a narrower 28 February–8 April 2025 window.
    • The Association of American Medical Colleges (AAMC) published a running snapshot of terminations as of 5 May 2025.
    • A PubMed Central review (Faiman et al., 2025) tracked cumulative losses across the calendar year, including clinical-trial detail by disease area.

    Because each study samples a different date range and data source, the headline totals diverge — but the pattern of who was affected is remarkably consistent across all four.

    Which career stages absorbed the deepest cuts

    Training and early-career funding took a disproportionate hit. Under the PNAS analysis, women held 60% of the 530 cancelled grants among assistant professors and doctoral students, while men lost 59% of the 1,410 cancelled grants held by professors and associate professors — meaning losses skewed toward more junior investigators even as senior researchers lost more total dollars.

    Predoctoral and undergraduate pipeline awards were hit hardest of all: women held 58% of cancelled F31 and F30 predoctoral fellowships and 66% of cancelled T34 undergraduate research awards. NIH terminated $56.8 million across these early-career programmes and a further $329.6 million in T32 institutional training grants. Separately, the AAMC tracker found 29% of all terminated grants were research training or career-development awards, versus 61% classified as standard research-and-development grants — a training-pipeline share roughly double what its overall funding weight would predict.

    Which fields and institutes were hit hardest

    By institute, the National Institute of Mental Health recorded the highest number of terminations (128 grants), followed by the National Institute on Minority Health and Health Disparities (77 grants), according to the JAMA Internal Medicine analysis. By dollar value, the National Institute of Allergy and Infectious Diseases lost the most funding ($505.9 million), with NIMHD second ($223.6 million).

    Clinical-trial data tell a parallel story: infectious-disease trials were the most affected topic area, at 14.4% of active trials disrupted, compared with 2.2% for neurologic and reproductive-health trials. Prevention-focused trials lost funding at more than four times the rate of basic-science trials (8.4% versus 2.0%). A separate PubMed Central review tallied at least 160 disrupted clinical trials spanning cancer and HIV/AIDS research, within a cumulative $3.8 billion in terminated NIH funding tracked across 2025.

    Which institutions and regions felt the impact

    Terminations touched 210 recipient institutions, but concentration was high: Columbia University recorded the most terminations of any single institution (157 grants) in the JAMA Internal Medicine sample. Geographically, trials based in the Northeast US were terminated at 6.3%, the highest of any US region, while multiregional US trials saw none. International trials lost funding at a higher rate than domestic ones (5.8% versus 3.4%), suggesting non-US collaborators carried a heavier share of the disruption than US-only projects.

    How the four tracking studies compare

    Reading the totals side by side clarifies why headline figures vary so widely in news coverage — each study samples a different window and a different data source, not a different underlying event.

    Study Snapshot window Grants terminated Value tracked Distinct focus
    Fregolent et al., PNAS (2026) Feb–Aug 2025 2,291 terminated; 1,534 frozen $2.45 billion Gender and career-stage breakdown
    Patel et al., JAMA Intern Med (2025) 28 Feb–8 Apr 2025 694 $1.81 billion Clinical-trial disruption by institute, topic, region
    AAMC tracker As of 5 May 2025 777 $1.9 billion Grant-type split (research vs training)
    Faiman et al., PubMed Central (2025) Cumulative, 2025 160+ clinical trials $3.8 billion Disease-area detail (cancer, HIV/AIDS)

    Answer-first Q&A

    Which universities get the most NIH funding?

    Johns Hopkins University has historically led all US institutions in total NIH support, with other top recipients including the University of Washington, Stanford and the University of Michigan. Institutions with large NIH portfolios are not automatically those hit hardest by terminations — Columbia University topped the termination count despite not leading in total funding received.

    How much did the Trump administration cut from the NIH budget?

    The administration’s fiscal year 2026 budget request proposed a roughly 40% reduction to NIH’s overall budget, alongside the direct termination of thousands of active awards earlier in 2025. Congress has not enacted a cut of that scale, and litigation over specific terminations remains ongoing into 2026.

    Who is considered the biggest funder of biomedical research?

    NIH is the largest single public funder of biomedical and behavioural research in the world, with an annual budget exceeding $47 billion. That scale is why even a partial termination round — a few thousand of the roughly 50,000 active awards — produced measurable, trackable disruption across the sector.

    What this means for institutions and funders

    For research administrators, the consistent finding across all four studies is that training and early-career awards carry outsized termination risk relative to their share of total NIH spending. Institutions with concentrated early-career or health-equity portfolios should treat independent trackers such as Grant Witness and NIH RePORTER as live risk-monitoring tools, not just retrospective journalism sources, when advising principal investigators on contingency funding and bridge support.

    The divergence between studies also carries a methodological lesson for anyone citing termination figures: always state the snapshot date and data source alongside any total, since “NIH grant terminations” without a date range can mean anywhere from 694 to over 2,291 awards depending on which tracking effort is cited.

    Outlook: restoration, litigation and ongoing tracking

    Not all terminations have proved final. Litigation challenging terminations tied to diversity, equity and gender-related research topics has led to court-ordered reinstatement of some awards during 2025, and appeals continue into 2026. Independent trackers, including Grant Witness and the Impact Project, are continuing to log both new terminations and restorations, meaning the totals in this piece are a snapshot, not an endpoint.

    Researchers and administrators should expect further peer-reviewed analyses through 2026 as tracking teams extend their datasets — particularly on downstream effects for publications, collaborations and workforce retention, which the PNAS authors flag as their next research target. For institutions building sponsored-research risk frameworks, this body of independent tracking work is now a more reliable source than any single news report of the terminations themselves.

  • NIH Grant Cancellation Legality Under 2 CFR 200

    NIH grant cancellation legality rests on 2 CFR 200.340: a grant may be terminated mid-cycle only if the recipient fails to comply with award terms, both parties consent, or the awarding agency determines the project no longer effectuates programme goals — and in every case NIH must issue written notice and preserve the recipient’s appeal rights before funding stops.

    A grant termination is the enforceable act of ending some or all of an active federal award before its approved project period expires, distinct from the routine non-renewal of a grant at the end of a competitive cycle. Understanding where that line sits — and what procedural protections apply on either side of it — is now a core competency for research administrators, not a hypothetical.

    Federal grant terminations are governed by the OMB Uniform Guidance codified at 2 CFR 200.340, which HHS incorporates into its own grants regulations and which NIH restates in Section 8.5.2 of the NIH Grants Policy Statement (“Suspension, Termination, and Withholding of Support”). This is an administrative-law standard, not a discretionary one: an awarding agency cannot terminate a grant for an unlisted reason, however compelling it finds that reason.

    NIH’s default posture, per its own policy statement, is to suspend a grant and give the recipient an opportunity for corrective action before proceeding to full termination — except where a serious deficiency or risk to health or safety justifies immediate termination.

    What grounds allow NIH to cancel a grant mid-cycle?

    2 CFR 200.340 recognises a closed, not open-ended, list of termination grounds. The Center for Science in the Public Interest’s litigation summary of APHA v. NIH describes these as “three limited circumstances” under the regulation.

    Ground Regulatory basis Typical trigger
    Recipient non-compliance 2 CFR 200.340(a)(1) Failure to meet award terms and conditions, financial mismanagement, or research misconduct findings
    Mutual agreement 2 CFR 200.340(a)(2) Recipient and NIH jointly agree the project is no longer viable (e.g. PI departure)
    Agency priorities / “for cause” 2 CFR 200.340(a)(4) NIH determines the award “no longer effectuates the program goals or agency priorities”

    The third ground is the one currently under judicial scrutiny. It gives the agency real latitude to align funding with shifting priorities, but that latitude is not unlimited: agency reasoning must still satisfy the Administrative Procedure Act’s bar on “arbitrary and capricious” action, meaning NIH must show a reasoned, non-conclusory basis tied to the individual award rather than a blanket, category-wide directive.

    What notice and appeal rights does 2 CFR 200 guarantee?

    Termination is not self-executing. 2 CFR 200.341 requires NIH to provide written notice specifying the reason for termination, the effective date, and whether the termination is full or partial. Where non-compliance is the stated ground, the notice must also disclose that the termination will be reported in the federal System for Award Management (SAM.gov), a public record that can affect an institution’s future funding eligibility.

    Recipients then have a two-tier route to challenge the decision:

    Stage Forum Typical deadline Scope of review
    First-level appeal NIH official named in the termination notice Per notice instructions Procedural and factual objections to the stated grounds
    Formal appeal HHS Departmental Appeals Board 30 days from final NIH decision Whether NIH followed its own regulations and notice requirements

    Disagreement over scientific merit is generally not a valid appeal ground; DAB review focuses on whether NIH complied with its own procedural rules, not on re-litigating peer review.

    How did 2025–26 litigation test these limits?

    The clearest real-world stress test of this framework is American Public Health Association v. NIH (D. Mass., No. 1:25-cv-10787). Beginning in February 2025, NIH terminated a large volume of active grants tied to categories the administration disfavoured, without individualised, award-specific justification.

    On 16 June 2025, District Judge William Young ruled the underlying directives and the resulting terminations arbitrary and capricious under the APA, finding the stated reasons “conclusory and bereft of reasoning.” His 23 June 2025 Partial Final Judgment declared the directives and terminations “of no effect, void, illegal, set aside, and vacated.” The First Circuit unanimously denied the government’s request to stay that judgment on 18 July 2025.

    On 21 August 2025, the Supreme Court issued a narrower, 5–4 emergency-docket ruling: it left the vacatur of the NIH directives in place, but held that district courts likely lack jurisdiction to order restoration of the terminated grants themselves, because such claims sound in contract and belong before the Court of Federal Claims under the Tucker Act. That split — policy directives reviewable in district court, individual grant restoration routed to a separate contract forum — is now the operative jurisdictional map for any institution challenging a termination. As of the case’s most recent public docket update, First Circuit oral argument on the merits appeal was calendared for 6 January 2026, with the outcome not yet reflected in publicly available case summaries at the time of writing.

    Separately, the Government Accountability Office found in August 2025 that NIH’s cancellation of roughly 1,800 grants violated the Impoundment Control Act of 1974, which requires the executive branch to obligate congressionally appropriated funds absent a formal rescission request to Congress. Harvard’s T.H. Chan School of Public Health, tracking the terminations independently, put the broader 2025 total at roughly 2,100 grants worth approximately $9.5 billion.

    Answer-first Q&A: what administrators are asking

    Are NIH grant terminations illegal?

    Not inherently. A termination is lawful when NIH cites one of the three grounds in 2 CFR 200.340, issues proper written notice, and grounds its reasoning in the specific award. A federal court found a 2025 wave of terminations unlawful specifically because NIH skipped individualised justification and relied on blanket, category-based directives instead.

    Can the government cancel a federal grant?

    Yes — federal agencies retain statutory authority to terminate grants “to the extent authorized by law,” including when an award no longer serves programme goals. That authority is bounded by the Administrative Procedure Act, the Impoundment Control Act’s restrictions on withholding appropriated funds, and the agency’s own termination regulations.

    How could researchers get a cancelled NIH grant restored?

    Institutions can pursue NIH’s internal appeal, then the HHS Departmental Appeals Board, or litigate under the APA in district court against the policy directive itself. Per the Supreme Court’s August 2025 ruling, restoration of the underlying funding obligation likely requires a separate contract claim at the Court of Federal Claims.

    How many NIH grants have been cancelled?

    Independent tracking by Harvard’s T.H. Chan School of Public Health documented roughly 2,100 grants worth approximately $9.5 billion terminated during 2025, a volume the litigation record describes as unprecedented against decades in which such terminations were “exceedingly rare.”

    What should research administrators do now?

    Three practical implications follow directly from the legal standard, independent of how any single case resolves:

    • Preserve every termination notice in full — the stated reason under 2 CFR 200.341 determines which appeal forum and deadline apply, and a vague or category-wide reason is itself a procedural defect worth flagging.
    • Track the SAM.gov disclosure trigger — a non-compliance-based termination notice generates a public record that can affect future eligibility, so institutions should confirm the correct ground was cited.
    • Route restoration claims correctly — the 2025 jurisdictional split means a policy challenge and a funds-restoration claim are no longer the same lawsuit, and misfiling in the wrong forum can cost months.

    The underlying legal standard has not changed: NIH still needs one of three grounds, still owes written notice, and recipients still retain a defined appeal path under 2 CFR 200. What 2025–26 litigation changed is the practical burden of proof NIH must meet to invoke the “agency priorities” ground, and the forum in which recipients must seek a remedy. Research administration offices that build both into their grant-monitoring workflow will be far better positioned than those relying on general awareness that “terminations are being challenged in court.”

  • NIH Indirect Cost Cap Lawsuit Ends: Final Ruling Explained

    The NIH indirect cost cap lawsuit is over. In early April 2026, the deadline for the Trump administration to petition the US Supreme Court over its blocked attempt to cap National Institutes of Health facilities-and-administrative (F&A) reimbursements at 15% passed without a filing, closing out fourteen months of litigation that began with a February 2025 policy notice and ended with a unanimous First Circuit Court of Appeals ruling in January 2026. For research administrators who have spent a year budgeting around uncertainty, the case is now legally settled — though, as this article explains, the underlying policy debate is not.

    Timeline: From 15% Cap Proposal to Final Ruling

    The dispute began on 7 February 2025, when NIH issued guidance capping reimbursement of indirect costs — overheads such as facility maintenance, laboratory utilities, and administrative support — at 15% for all new and existing grants, replacing rates individually negotiated with each institution that typically ranged from 30% to 70%. Twenty-two state attorneys general, along with universities and organisations including the Association of American Medical Colleges (AAMC), challenged the notice within days.

    Date Development
    7 February 2025 NIH issues Supplemental Guidance capping indirect cost reimbursement at 15%
    10 February 2025 State attorneys general and higher-education associations file suit
    7 April 2025 US District Court issues a permanent injunction blocking the cap nationwide
    6 January 2026 First Circuit Court of Appeals unanimously upholds the injunction
    Early April 2026 90-day Supreme Court appeal deadline lapses; administration formally drops the case

    NIH’s own public estimate, cited in the appeals court’s opinion, put the fiscal effect of the 15% rate at roughly $4 billion in annual reimbursement withheld from institutions; the AAMC separately estimated the cap would have disrupted $6.5 billion in previously committed research funding had it taken effect immediately.

    Why the Appeals Court Ruled the Cap Unlawful

    The First Circuit’s 6 January 2026 decision rested on two grounds. First, the panel found that a flat cap conflicts with Department of Health and Human Services regulations requiring indirect cost rates to be individually negotiated with each institution rather than imposed uniformly. Second, and more decisively, the court pointed to an appropriations rider that Congress has re-enacted every year since 2017 explicitly preventing NIH from altering how it reimburses indirect costs outside the negotiated-rate process.

    Jurisdiction was itself contested. The administration argued that funding disputes belonged before the Court of Federal Claims rather than a district court, drawing on a Supreme Court precedent from a separate case over NIH grant terminations. Writing for the panel, Judge Kermit V. Lipez distinguished that precedent using Justice Amy Coney Barrett’s concurrence in the earlier grant-termination case, which separated challenges to agency-wide policy (properly heard in district court) from disputes over the withholding of already-awarded contract funds. The proposed rate cap, the court reasoned, was exactly this kind of general policy — so the original district court injunction stood.

    With the ruling upheld and no Supreme Court petition filed inside the 90-day statutory window, the injunction is now final and nationwide. The administration also quietly withdrew parallel appeals over comparable rate-cap policies at the Department of Energy, the National Science Foundation, and the Department of Defense, effectively closing the entire family of indirect-cost-cap litigation at once.

    Answer-First Q&A

    What did the NIH’s proposed 15% indirect cost cap actually change?

    The NIH’s February 2025 policy would have replaced individually negotiated facilities-and-administrative rates, which typically ran between 30% and 70%, with a flat 15% cap on all new and existing grants. Institutions, state attorneys general, and higher-education associations argued this ignored real infrastructure costs and breached appropriations law protecting negotiated rates.

    Why did the appeals court say the cap was unlawful?

    The First Circuit Court of Appeals found the cap violated a Department of Health and Human Services regulation requiring individually negotiated indirect cost rates, plus an appropriations rider Congress has re-enacted since 2017 that bars NIH from unilaterally changing how indirect costs are reimbursed without new legislative authority.

    Is the NIH indirect cost cap litigation completely over?

    Yes. The Trump administration’s 90-day window to petition the Supreme Court after the January 2026 First Circuit ruling expired in early April 2026 without a filing. That deadline lapse permanently ends the case, leaving the nationwide permanent injunction against the 15% cap in place.

    Does the ruling mean indirect cost policy will never change again?

    No. The courts blocked only this specific capping mechanism, not future reform. A 2025 executive order still directs federal agencies to favour lower-overhead institutions in funding decisions, and groups such as AAMC continue advancing the FAIR model as a negotiated alternative to a flat cap.

    What the Ruling Means for Institutions

    For research administrators, the practical effect is restoration of the status quo ante: negotiated F&A rates on NIH awards remain enforceable exactly as they were before February 2025. There is no retroactive cap to reconcile, and no need to budget contingency reserves against a 15% ceiling that never took legal effect. That said, the ruling changes the litigation posture, not the political one — a distinction that matters for planning:

    • Negotiated rate agreements stand. Institutions’ existing Facilities and Administrative (F&A) rate agreements with their cognizant federal agency remain the operative basis for NIH indirect cost reimbursement.
    • Subaward flow-through is unaffected. The cap would have applied to NIH indirect costs on subawards as well as prime awards; with the injunction final, subrecipient reimbursement continues on negotiated terms.
    • Executive-order pressure persists. A separate August 2025 executive order instructing agencies to weight funding decisions toward lower-overhead institutions was not addressed by this litigation and remains in force as a policy lever.
    • Watch agency-specific rulemaking. Because the appeals court’s reasoning turned on the specific appropriations rider protecting NIH, institutions should not assume identical legal protection automatically extends to every other federal funder without agency-specific statutory analysis.
    • Transparency debate continues. AAMC’s Heather Pierce has been explicit that the litigation’s end does not resolve underlying questions about how explainable indirect cost rates are to Congress and taxpayers — a conversation research offices should expect to continue independent of any court order.

    What Comes Next for Indirect Cost Policy

    The NIH indirect cost cap lawsuit’s conclusion removes a year of acute legal uncertainty from institutional budgeting, but it does not close the broader policy conversation about how NIH direct and indirect costs are structured, negotiated, or explained. Two threads are worth tracking. First, the AAMC-backed Financial Accountability in Research (FAIR) model proposes a more granular, activity-based way of tracking indirect cost expenses — an alternative to both the old negotiated-rate system and the abandoned flat cap, and one that could shape future NIH grant funding policy change through negotiation rather than unilateral notice. Second, the administration’s remaining lever — the executive order favouring lower-overhead applicants in funding decisions — operates through discretionary award selection rather than rate-setting, so it sits outside what this ruling addressed and could still influence which institutions receive awards even as reimbursement rates themselves stay protected.

    For institutions tracking research administration standards and terminology more broadly, CASRAI’s research administration resources and open glossary of research-administration terms provide grounding definitions that sit alongside funder policy developments like this one.