CASRAI Dictionary

Tag: NIH public access policy

  • NIH Grants Policy Statement 2026: 5 Key Changes for Award Administration

    NIH reissued its Grants Policy Statement in March 2026, superseding the April 2024 edition via Guide Notice NOT-OD-26-057. The revision consolidates every NIH Guide Notice in effect as of 17 March 2026, adds a new prior-approval requirement for domestic subawards, harmonises NIH’s definition of “intervention” with the Common Rule, and folds in the zero-embargo public access requirement that took effect on 1 July 2025. For institutions managing NIH awards, the practical effect is a single, current reference document — but several of its changes carry hard compliance deadlines that pre- and post-award offices need to act on now.

    The NIH Grants Policy Statement (NIHGPS) is NIH’s primary vehicle for setting standard terms and conditions on grants and cooperative agreements, applied by incorporation into every Notice of Award. The March 2026 revision (rev. 03/2026) applies to all NIH grants and cooperative agreements with budget periods beginning on or after 1 October 2025, and formally supersedes the April 2024 version.

    Contents

    What changed in the March 2026 NIHGPS revision

    NIH announced the revised NIHGPS through Guide Notice NOT-OD-26-057, published 25 March 2026. The notice states the update “incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies” made since April 2024. Institutional summaries from Northeastern University and Washington University in St. Louis flag further administrative shifts folded into this edition: expanded research-security disclosure across the award lifecycle, new guidance restricting generative AI use in applications and peer review, tighter limits on concurrent applications per principal investigator, and confirmation that childcare costs are allowable for full-time NRSA trainees and that dependent-care resources are allowable for conference-grant participants.

    The table below summarises the notices anchoring the update, each with its own effective date — a distinction institutions often miss when treating the NIHGPS as a single-date change.

    Guide Notice Change Effective date
    NOT-OD-26-057 Publishes revised NIHGPS (rev. March 2026), supersedes the April 2024 edition Awards with budget periods starting on/after 1 October 2025
    NOT-OD-26-062 New prior-approval requirement for post-award domestic subawards 1 June 2026
    NOT-OD-26-063 Harmonises the NIH definition of “intervention” with the Common Rule (45 CFR 46, Subpart A) 27 March 2026
    NIH foreign-subaward policy NIH no longer recognises foreign subawards; new PF5/UF5 application structure required for international collaborations 1 May 2025
    2024 NIH Public Access Policy (accelerated by NOT-OD-25-101) Zero-embargo deposit of peer-reviewed manuscripts in PubMed Central 1 July 2025

    New prior-approval requirement for domestic subawards

    Effective 1 June 2026 under NOT-OD-26-062, prime recipients must obtain NIH prior approval before adding a new domestic subaward to a project post-award, whenever that subaward arrangement was not part of the originally peer-reviewed and approved application. NIH states the requirement exists so it “is aware of all subaward activities for each NIH project,” supporting monitoring and reporting compliance further down the award chain.

    Requests must be submitted through the eRA Commons Prior Approval Module, using the “Other Request” type. For Small Business Innovation Research and Small Business Technology Transfer awards, the March 2026 NIHGPS goes further: recipients must seek prior approval for any new subaward and include a foreign risk assessment of the proposed subrecipient.

    This sits alongside a harder line already in force: since 1 May 2025, NIH has not recognised foreign subawards. International collaborations must instead use NIH’s PF5/UF5 application format.

    Terminology shifts and Common Rule alignment

    Two changes in the March 2026 NIHGPS are easy to miss because they read as drafting cleanup rather than policy change, but both affect how compliance offices should tag and search award documents.

    • “Facilities and Administration (F&A) Costs” is now “Indirect Costs” throughout the NIHGPS, aligning NIH’s terminology with 2 CFR 200 (the Uniform Guidance).
    • “Non-Federal entity” has been replaced with “recipients and subrecipients” — a distinction that matters for institutions cross-referencing older award language against the current document.

    Separately, under NOT-OD-26-063, effective 27 March 2026, NIH adopted the Common Rule’s definition of “intervention” — “both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes” (45 CFR 46, Subpart A) — replacing its own prior operational definition. NIH frames this as harmonising human-subjects implementation “across federal agencies,” reducing ambiguity when institutions classify a study as a clinical trial, a basic experimental study involving humans, or an observational study.

    Where the update meets the zero-embargo public access rule

    The March 2026 NIHGPS does not introduce a new public access policy — it consolidates the one that already reshaped NIH-funded publishing. The 2024 NIH Public Access Policy took effect on 1 July 2025, after NIH accelerated its original 31 December 2025 target date. Under the policy, any peer-reviewed manuscript arising from NIH funding and accepted for publication on or after 1 July 2025 must be deposited in PubMed Central for immediate public availability, with no embargo period permitted.

    For award administrators, the intersection matters because the same Notice of Award terms and conditions that reference the NIHGPS now also carry the zero-embargo requirement as a standing condition of every applicable award — not a separate library-services matter. Institutions that track compliance by Notice of Award language, rather than by publication date alone, should confirm their research-output tracking systems flag manuscripts by acceptance date against the 1 July 2025 threshold, since the obligation attaches at acceptance, not at final publication.

    What institutions should do now

    Sponsored-programs offices should treat the March 2026 NIHGPS as a trigger for three concrete actions. First, update subaward-change checklists to route any new domestic subaward through the eRA Commons Prior Approval Module before 1 June 2026. Second, audit standard operating procedures for the terminology shift from “F&A Costs” to “Indirect Costs” and from “non-Federal entity” to “recipients and subrecipients,” since document searches keyed to the old terms will miss current guidance. Third, confirm research-output compliance tracking distinguishes manuscripts accepted before and after 1 July 2025, given the zero-embargo requirement now sits inside the same consolidated policy document as the award terms.

    The stakes are not abstract. NIH’s total FY2026 budget for extramural grants and contracts is approximately $38 billion, yet the overall number of grants awarded is running roughly 25% below levels typical for a comparable date in 2021–2024, according to reporting in Science. Against that backdrop, missteps on prior approval or subaward compliance carry a higher relative cost: fewer awards means less institutional tolerance for a stalled or non-compliant action.

    Answer-first Q&A

    What is the NIH Grants Policy Statement?

    The NIH Grants Policy Statement is NIH’s standard terms-and-conditions document for grants and cooperative agreements, incorporated by reference into every Notice of Award. NIH reissues it periodically — most recently in March 2026, superseding the April 2024 version — to consolidate Guide Notices and reflect statutory, regulatory, and policy changes.

    What is the NIH salary cap for 2026?

    Effective 1 January 2026, the NIH salary cap increased to $228,000, up from $225,700 in 2025. This is a 12-month cap; institutions with 9-month faculty appointments must prorate the figure accordingly for budgeting and rebudgeting purposes on active awards.

    When does the March 2026 NIHGPS take effect?

    The revised NIHGPS applies to all NIH grants and cooperative agreements with budget periods beginning on or after 1 October 2025. It consolidates NIH Guide Notices in effect as of 17 March 2026 and supersedes the prior, April 2024 edition of the document.

    Does the NIH Grants Policy Statement cover public access requirements?

    Yes. The NIHGPS incorporates the 2024 NIH Public Access Policy, which took effect 1 July 2025 and requires zero-embargo deposit of peer-reviewed manuscripts in PubMed Central for any paper accepted for publication on or after that date.

    The bottom line for award administration

    The March 2026 NIHGPS is best read as a consolidation exercise with two genuinely new compliance obligations — the domestic subaward prior-approval rule taking effect 1 June 2026, and the Common Rule-aligned “intervention” definition already in force since 27 March 2026 — layered onto a document that now also carries the zero-embargo public access requirement as standing award language. Institutions that update subaward workflows, terminology-dependent search tools, and publication-tracking systems ahead of the June deadline will avoid the compliance gaps that a document reissue of this scope typically exposes.

    For related context on how research-administration offices track compliance obligations across funders, see CASRAI’s research administration resources.

  • OMB Publication Cost Ban vs the Nelson Memo: What to Negotiate Before October 2026

    The OMB publication cost ban is a proposed revision to 2 CFR 200.461, published in the Federal Register on 29 May 2026, that would make article processing charges (APCs), page charges and colour-figure fees categorically unallowable on federal research awards unless a project specifically budgets and pre-approves them. It arrives while the Nelson Memo’s zero-embargo mandate still requires the same federally funded researchers to make their papers immediately, freely available — a collision research offices need to plan for now, not after the 1 October 2026 effective date.

    In plain terms, the OMB publication cost ban is a default-flip: where 2 CFR 200.461 today allows publication costs as “necessary for the performance of the Federal award,” OMB’s proposed rule presumes them unallowable unless a federal statute requires otherwise or the awarding agency approves them case by case.

    What does the proposed 2 CFR 200.461 rule actually change?

    The Office of Management and Budget’s Notice of Proposed Rulemaking, “Regulation for Federal Financial Assistance” (Federal Register, 29 May 2026, docket 2026-10817), rewrites large sections of the Uniform Guidance in 2 CFR Part 200, including a reversal of §200.461’s default treatment of publication costs.

    Today, publication and printing costs — including APCs at open-access journals and page or colour-figure charges at hybrid titles — are allowable when they report on federally supported work and are levied impartially. Under the proposed text, APCs and “similar fees such as open access fees for professional journal publications” become unallowable except where federal law compels payment or the agency grants case-by-case approval. Comments were due 13 July 2026, though the Council on Governmental Relations has requested an extension; the rule, if finalised as drafted, takes effect 1 October 2026.

    Two consequences follow directly. First, publication spending long absorbed informally into supplies budgets must become an explicit, pre-approved line item at award time. Second, the same NPRM proposes restricting §200.454, which today makes “subscriptions to business, professional, and technical periodicals” allowable; the revised text adds academic periodicals to the unallowable list, though Authors Alliance’s analysis of the NPRM notes it remains genuinely unclear whether OMB intends this to reach institutional library budgets or only project-specific subscriptions.

    How does the ban collide with the Nelson Memo’s zero-embargo mandate?

    The Nelson Memo is the August 2022 Office of Science and Technology Policy directive, “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research,” which instructed every federal agency funding at least $100 million in research and development to eliminate the optional 12-month embargo on peer-reviewed manuscripts and data. Agency policies implementing that directive — including NIH’s revised Public Access Policy (NOT-OD-25-047) and NSF’s public access policy update (PRPD-25-001) — took effect largely across 2024 and 2025, and now require immediate deposit of the accepted manuscript with no embargo period.

    The Nelson Memo did not treat compliance as costless. It explicitly directed agencies to allow researchers to include reasonable publication costs as allowable expenses in research budgets — the same cost category §200.461 would now presume unallowable. Immediate open access is typically achieved one of three ways: paying an APC for gold open access, depositing the manuscript under green open access, or paying through an institutional transformative (read-and-publish) agreement. The proposed rule directly restricts the first route, is largely neutral toward the second, and creates real ambiguity for the third, since indirect-cost-funded transformative agreements do not fit naturally into case-by-case, award-level pre-approval.

    One provision is conspicuously untouched: the federal purpose licence at 2 CFR 200.315(b) — the legal mechanism agencies use to deposit grant-funded manuscripts in public-access repositories — remains in the proposed text as drafted. The legal basis for zero-embargo repository deposit survives even as the funding route for paid open access narrows. Institutions cannot assume the mandate will soften just because the money is harder to find.

    What happens to subscriptions, transformative deals and the international picture?

    Read-and-publish agreements sit awkwardly across both proposed changes. Universities that have negotiated these deals typically bundle subscription access and OA publishing rights into a single institutional payment, usually drawn from the indirect cost pool rather than itemised per article. If §200.454’s subscription restriction is read to include institutional library subscriptions, and §200.461’s APC restriction is read to include the OA-publishing component of transformative deals, the combined effect could touch both halves of a single contract — without either provision naming transformative agreements directly.

    The US retreat looks unusual against comparable funder policy elsewhere. UKRI and Horizon Europe’s cOAlition S signatories already fund publication costs directly through block grants or eligible-cost provisions, because their zero-embargo mandates presuppose a funding route. For a collaboration with a US subrecipient and non-US lead institution, that divergence determines which partner’s budget can legally absorb the APC.

    Funder / jurisdiction Zero-embargo OA requirement Publication cost funding stance
    US federal agencies (NIH, NSF, DOE, USDA) under the Nelson Memo Yes — immediate deposit, no embargo Proposed 2 CFR 200.461 would make APCs presumptively unallowable absent pre-approval
    UKRI (UK) Yes — immediate OA required for most outputs Block grants and in-scope grant costs explicitly fund APCs
    Horizon Europe / cOAlition S signatories Yes — Plan S zero-embargo principle APCs treated as eligible project costs where OA is mandated

    Offices administering joint US–UK or US–EU awards should treat this as a live compliance risk: the same paper may need immediate deposit under one funder’s rules while its lead US institution can no longer legally pay the APC that made deposit unnecessary.

    What should research offices negotiate before October 2026?

    Institutions have a narrow window before the effective date:

    • Budget publication costs explicitly. Awards dated after 1 October 2026 should carry a named, pre-approved publication line item rather than relying on discretionary reallocation later.
    • Clarify transformative agreement language. Confirm with publishers, in writing, whether institutional payments are classified as subscription or publication costs, since §200.461 reaches the substance of a payment, not its label.
    • Document green open access workflows. Since the federal purpose licence under 2 CFR 200.315(b) is unaffected, manuscript deposit to agency repositories remains the most audit-resistant compliance path.
    • Submit substantive comments. Comments citing the Nelson Memo, NOT-OD-25-047 and PRPD-25-001 by name, documenting the operational conflict directly, carry more weight than generic objections.
    • Map multi-funder awards. Offices running US–UK or US–EU collaborations should flag which funder’s rules govern publication costs before submission, not at closeout.

    Answer-first: quick questions on publication costs

    Who pays for publication fees?

    Publication fees are typically paid by the author’s research funder, their institution, or the author directly. Under current US federal rules, grant funds routinely cover APCs; the proposed 2 CFR 200.461 revision would shift that burden onto institutions unless a project specifically budgets for it in advance.

    How much does it cost to publish in open access?

    Article processing charges vary widely by publisher and journal tier, from no charge at diamond open-access titles to several thousand dollars at flagship journals. The figure depends on venue, not funder — which is why offices need a pre-approved, venue-agnostic publication budget line rather than a fixed assumption.

    Why are article processing charges so high?

    Article processing charges reflect editorial, peer-review and production costs plus, at prestigious titles, a reputation premium. Because funders rather than competitive pricing pressure have historically absorbed these charges, journals have had limited incentive to reduce them.

    Implications and outlook

    The contradiction between a rule that bans paying for open access and a mandate that requires it will not resolve itself quietly. Litigation, a revised final rule, or an OMB clarification narrowing “case-by-case” to budget-level rather than publication-level approval are all plausible before 1 October 2026. What is not plausible is that either policy simply disappears: the Nelson Memo’s zero-embargo requirement is embedded in agency policy notices already in force, and the OMB rewrite proceeds under Congress’s grant of authority at 31 U.S.C. 503.

    For research administration offices, the safest posture treats the coming months as a negotiation window, not a waiting period: secure pre-approved publication lines, harden green open-access workflows under the still-intact federal purpose licence, and map which funder’s cost rules govern each collaborative output. Institutions doing that work now will keep publishing compliantly under both regimes; those waiting for the contradiction to resolve will inherit the audit findings meanwhile.

  • NIH Public Access Policy 2026: Zero-Embargo Mandate

    The NIH Public Access Policy in 2026 requires that final peer-reviewed manuscripts from NIH-funded research be deposited in PubMed Central and made publicly available on the same day the article is published, with no embargo period. One year after this zero-embargo mandate took effect on 1 July 2025, the US Government Accountability Office has warned that meeting it could push federal publishing costs toward $1 billion a year by 2030.

    The NIH Public Access Policy is the National Institutes of Health’s requirement that peer-reviewed manuscripts arising in whole or in part from NIH funding be archived in PubMed Central (PMC) and made freely available to the public, without a subscription paywall or embargo delay, from the official date of publication.

    What is the NIH Public Access Policy in 2026?

    The current policy traces to a 2022 memorandum from the White House Office of Science and Technology Policy (OSTP), commonly known as the Nelson Memo after then-OSTP Director Alondra Nelson, which directed federal agencies to remove embargoes on the results of taxpayer-funded research. NIH’s implementation — the 2024 NIH Public Access Policy — took effect for manuscripts accepted for publication on or after 1 July 2025.

    The policy applies to any journal-accepted manuscript resulting from NIH funding through a grant, cooperative agreement, contract, Other Transaction, or intramural research, regardless of whether the NIH-funded investigator is the corresponding author. Authors must retain the right to deposit their author accepted manuscript (AAM) in PMC by asserting the NIH Rights Statement in publication agreements, and NIH holds a nonexclusive Government Use License under 2 CFR 200.315 that survives any later exclusive-rights agreement signed with a publisher.

    What changed under the zero-embargo mandate?

    The defining change from the prior 2008 policy is timing, not scope. Under the 2008 rule, authors had up to twelve months after publication to make their manuscript public and up to 90 days to supply a PMCID. Under the 2024 policy, the manuscript must be publicly available in PMC on the official date of publication, with no embargo window at all.

    Requirement 2008 Policy 2024 Policy (effective 1 July 2025)
    Embargo before public availability Up to 12 months None — available on official date of publication
    Evidence of compliance PMCID within 90 days PMCID immediately, or a temporary NIHMSID for up to 3 months
    Deposit trigger Upon acceptance Upon acceptance (unchanged)
    Repository PubMed Central PubMed Central (unchanged)

    Compliance remains an institutional responsibility. Failure to demonstrate compliance in an application, proposal or progress report is a violation of NIH award terms and can delay non-competing continuation funding.

    What did GAO’s May 2026 report find?

    On 21 May 2026, the Government Accountability Office published GAO-26-107738, examining whether selected federal agencies’ public access plans are consistent with OSTP guidance and how much compliance is costing the government. As reported by MedPage Today, GAO estimated that combined federal publishing charges could climb to roughly $1 billion a year by 2030 — about triple the $295 million agencies were paying in the recent baseline year the report examined.

    GAO’s central finding is that zero-embargo compliance is increasingly routed through paid open-access publishing rather than free green open-access deposit, because many subscription journals will not grant immediate PMC deposit rights on standard terms. SPARC’s 22 May 2026 statement on the report pushed back on that framing, arguing that pay-to-publish models remain optional and that the underlying NIH policy itself imposes no fee — authors can comply at zero cost by depositing the author accepted manuscript directly.

    NIH has already begun responding to the cost pressure. Its December 2024 guidance, NOT-OD-25-048, set out what publication costs are allowable and reasonable under NIH awards, and the agency has signalled a cap on allowable publication costs starting in fiscal year 2026 — a direct answer to the “who pays for zero embargo” question GAO’s report puts back on the table.

    How should institutions adjust compliance workflows?

    For research offices, the practical burden of zero embargo has shifted from a single post-acceptance reminder to a submission-stage decision point. Institutions that have adapted their workflows are typically doing the following:

    • Requiring the NIH Rights Statement be inserted into every manuscript submitted for peer review before a publication agreement is signed.
    • Maintaining a tracked list of publishers’ zero-embargo green open-access terms, following the model of library-maintained trackers such as Northwestern’s Galter Health Sciences Library publisher guide.
    • Budgeting article processing charges into grant proposals where a subscription journal will not permit immediate deposit, rather than absorbing the cost after acceptance.
    • Negotiating or expanding “Read and Publish” agreements with major publishers to reduce per-article APC exposure.
    • Monitoring NIH’s allowable-cost guidance (NOT-OD-25-048) and the incoming FY2026 publication-cost cap for changes to what can be charged to an award.

    Institutions should treat the AAM-deposit route as the default compliance path and reserve APC-funded open access for cases where a publisher genuinely will not permit zero-embargo green deposit — this keeps compliance costs closest to the $0 the underlying policy actually requires, even as GAO’s figures show the system-wide trend running the other way.

    Common questions about the NIH Public Access Policy

    What is the NIH Public Access Policy?

    It is NIH’s requirement that peer-reviewed manuscripts resulting from NIH funding be deposited in PubMed Central and made publicly available without a paywall. The 2024 version, in force since 1 July 2025, removed the prior 12-month embargo entirely.

    When did the NIH zero-embargo policy take effect?

    The zero-embargo requirement applies to manuscripts accepted for publication on or after 1 July 2025. Manuscripts accepted before that date remain subject to the 2008 policy’s 12-month embargo and 90-day PMCID rule.

    Does the NIH Public Access Policy require paying an article processing charge?

    No. Authors can comply at zero cost by depositing the author accepted manuscript directly in PubMed Central. Costs arise only when a subscription publisher refuses immediate green deposit and pushes the author toward a paid open-access route.

    What did the GAO report say about NIH public access costs?

    GAO-26-107738, published 21 May 2026, found that federal publishing costs tied to public access compliance could approach $1 billion annually by 2030, and questioned whether agencies’ plans consistently follow OSTP guidance.

    What this means going into year two

    Year two of the mandate is less about awareness — most NIH-funded institutions now understand the mechanics — and more about cost governance. GAO’s report gives research administrators a federal-level evidence base for what many libraries had already observed anecdotally: that publishers control the compliance pathway, and default routing toward APCs is a policy design risk, not an inevitability. Institutions that formalise submission-stage checks and lean on the free AAM-deposit route, rather than treating open-access APCs as the default fix, are best placed to keep both their researchers compliant and their grant budgets intact as NIH’s own cost caps take shape through fiscal year 2026.

    Research administrators tracking related funder mandates and contributor standards can find further research administration compliance guidance on CASRAI’s site.