CASRAI Dictionary

Tag: mnca template

  • Research Contract Template UK: 4 Types Compared

    A UK research contract template is a pre-negotiated model agreement — MTA, mCTA, MNCA or a Lambert/Brunswick collaboration agreement — chosen by the nature of the relationship between the parties, not by habit. Sending samples calls for a material transfer agreement; an NHS-regulated commercial trial calls for a model Clinical Trial Agreement; charity- or government-funded research uses the MNCA; and multi-party R&D with shared IP uses a Lambert or Brunswick collaboration agreement. Picking the wrong one causes avoidable delay, as UK funders and the NHS expect the correct template used unmodified.

    A research contract template UK researchers reach for is not one generic document but one of four distinct families, each governed by a different body with different rules on amendment. This article maps each template to the relationship it was built for.

    What counts as a UK research contract template?

    A UK research contract template is a standardised legal agreement, published and maintained by a national body (the Health Research Authority, UKRI, or the Association of Research Managers and Administrators), for a specific category of research relationship. The HRA states plainly: “there are several different model agreements, and you should use the one that is most appropriate for your study type and sponsorship arrangements.” Under the National Directive on Commercial Contract Research, HRA and Health and Care Research Wales (HCRW) Approval is typically issued conditionally on using the unmodified template — a waiver is possible only in exceptional circumstances.

    • Material Transfer Agreement (MTA) — for transferring biological or physical materials only
    • Model Clinical Trial Agreement (mCTA) family — for NHS-regulated commercial and non-interventional studies
    • Model Non-Commercial Agreement (MNCA) — for publicly or charity-funded research with no commercial sponsor
    • Collaboration agreement (Lambert Toolkit or Brunswick Templates) — for multi-party R&D where intellectual property is shared

    Material Transfer Agreements (MTA): moving materials, not money

    An MTA governs the transfer of physical or biological materials — tissue, cell lines, reagents, data-carrying media — between organisations, without itself constituting a clinical trial or a funded collaboration. Where an NHS or Health and Social Care (HSC) organisation is involved, the model Material Transfer Agreement published by the HRA is the required unmodified template. Where the transfer is purely between two universities or not-for-profit bodies, the Brunswick Material Transfer Agreement, hosted free by the Association of Research Managers and Administrators (ARMA), is the standard route.

    Use an MTA — not a collaboration agreement — whenever the relationship is a one-directional or reciprocal transfer of materials with no joint research programme, no shared funding, and no clinical intervention attached.

    Clinical Trial Agreements (mCTA): the NHS-regulated route

    An mCTA is the mandatory unmodified contract for a commercial sponsor running a regulated clinical trial at an NHS or HSC site. The family also includes the mCIA (medical devices), ATMP-mCTA (advanced therapy medicinal products), PC-mCTA (primary care) and mNISA (non-interventional commercial studies) — each scoped to a specific trial type.

    An updated suite of UK model agreements came into use on 28 April 2026, reflecting changes to the Clinical Trials Regulations that took effect the same day, per HRA and the Clinical Trials Toolkit. New IRAS submissions are expected to use the current versions.

    Template Used when Host / steward Modifiable?
    MTA (HRA) Transferring materials to/from an NHS/HSC organisation Health Research Authority No — unmodified use expected
    Brunswick MTA Transferring materials between universities/not-for-profits ARMA No — off-the-shelf template
    mCTA / mCIA / ATMP-mCTA / PC-mCTA / mNISA Commercial or non-interventional trials at NHS/HSC sites HRA + NIHR No — mandated under the National Directive on Commercial Contract Research
    MNCA Non-commercial, publicly/charity-funded research at NHS/HSC sites HRA No — policy expectation of unmodified use
    Lambert Toolkit collaboration agreements University-business R&D with shared IP GOV.UK / UKRI-endorsed Yes — a decision guide selects from several IP models
    Brunswick collaboration agreements University-university or not-for-profit R&D ARMA Limited — designed for use largely as published

    MNCA: the template for non-commercial research

    The Model Non-Commercial Agreement (MNCA) is the UK-wide template for research at NHS or HSC organisations that is funded by government, charity or academic sources rather than a commercial sponsor. Unlike commercial contract research, there is no equivalent National Directive mandating its use, but the HRA maintains a clear “policy expectation that the appropriate UK template will be used without modification,” and warns that departing from this “may result in prolonged central and participating NHS organisation review.” Administrators searching for an “mnca template” should treat it as the non-commercial counterpart to the mCTA family, not a lighter-touch version of a collaboration agreement.

    Collaboration agreements: Lambert Toolkit vs Brunswick Templates

    Collaboration agreements apply where two or more organisations jointly conduct research and need to allocate intellectual property, publication rights and liability — a fundamentally different problem from moving materials or running a regulated trial. The Lambert Toolkit, published on GOV.UK and endorsed by UK Research and Innovation (UKRI), is built for university-business collaborations: it offers a decision guide plus seven model agreements for one-to-one projects and four consortium agreements for multi-party collaborations, each reflecting a different approach to IP ownership and exploitation.

    Where both parties are universities or similar not-for-profit organisations, the Brunswick Suite of Templates, hosted by ARMA, provides an equivalent academic research collaboration agreement designed to avoid renegotiating IP terms from scratch on every project.

    • Choose the Lambert Toolkit when a business is a party and IP exploitation terms need active negotiation
    • Choose Brunswick Templates when all parties are universities or not-for-profit research organisations

    Choosing the right template by relationship type

    The decision is governed by relationship type, not by project size or funding value. Ask three questions in sequence: is anything commercial being run as a clinical trial at an NHS/HSC site (mCTA family); if not, is material simply moving between organisations with no joint programme (MTA); if not, is the research funded non-commercially at an NHS/HSC site (MNCA); and only if none of those apply — a multi-party research collaboration with shared IP — does a Lambert or Brunswick collaboration agreement apply.

    Frequently asked questions

    What is a model Clinical Trial Agreement (mCTA)?

    An mCTA is the HRA-published, NIHR-supported unmodified contract required for commercial, industry-sponsored clinical trials run at NHS or HSC organisations, mandated by the National Directive on Commercial Contract Research alongside sibling templates for devices, ATMPs and primary care.

    What is the difference between an MTA and a collaboration agreement?

    An MTA covers only the transfer of physical or biological materials between two parties with no joint research programme. A collaboration agreement — Lambert Toolkit or Brunswick — governs a shared research programme with joint intellectual property, publication rights and liability, making it a materially broader and more negotiated document.

    What is an MNCA and when is it used?

    The MNCA (Model Non-Commercial Agreement) is the UK template used when non-commercially funded research — government, charity or academic — takes place at an NHS or HSC organisation. It mirrors the mCTA’s unmodified-use expectation but applies where no commercial sponsor is involved.

    Can I modify a UK model agreement instead of using it unmodified?

    Only with a granted waiver, which the HRA warns “is liable to add many months of central negotiation” and “is unlikely to be agreed.” Any proposed modification must be disclosed in the IRAS cover letter with a tracked-change version and a change-by-change rationale.

    Implications and what to check next

    The practical takeaway is procedural discipline: identify the relationship first, select the corresponding UK template second, and reserve bespoke drafting for the rare case where no UK template exists — a justification that must itself be stated clearly in the IRAS application, since HRA guidance notes this “may expedite the review.” Following the 28 April 2026 regulatory changes, administrators should check the HRA’s model agreements page and the Clinical Trials Toolkit before assuming a previously downloaded template is still current. Institutions building internal contracting guidance should map each incoming request against these four relationship types before a bespoke agreement is drafted — this discipline is what keeps study set-up close to the pre-cleared norm rather than the multi-month waiver-negotiation outlier.

  • MNCA Template: 2026 UK Non-Commercial Agreement

    The MNCA template is the UK-wide Model Non-Commercial Agreement published on the Integrated Research Application System (IRAS), used by non-commercial sponsors — universities, NHS trusts, and charities — to confirm a participating NHS or HSC organisation’s capacity and capability to deliver a non-commercial interventional study, and it must be used unmodified except for its yellow-highlighted schedule fields.

    The Model Non-Commercial Agreement (MNCA) is a standardised contract between a non-commercial research sponsor and each NHS or HSC organisation participating in a study, distinct from the model Clinical Trial Agreement (mCTA) used for commercially sponsored trials. Research offices searching for the current version need to know not only where to find it, but when it applies, how it differs from its commercial counterpart, and what changed in the April 2026 update to the UK’s suite of model agreements.

    What Is the MNCA (Model Non-Commercial Agreement)?

    The mNCA was first published in 2008 by the UK Clinical Research Collaboration to remove the need for bespoke legal negotiation on every non-commercial study site. It sets out the responsibilities of the sponsor and the NHS or HSC organisation, including indemnity, data protection, intellectual property, and governance oversight, in a single UK-wide template.

    “Non-commercial” in this context describes the sponsorship arrangement, not the funding source: a study funded in part by a commercial entity but sponsored by a university, NHS trust, government department, or Research Council still uses the mNCA rather than the mCTA. The agreement covers interventional research, including clinical trials of investigational medicinal products (CTIMPs), medical device studies, and other interventional designs such as trials of surgical technique.

    MNCA vs mCTA: How Do the Two Agreements Differ?

    The core distinction is sponsorship type. The mNCA applies to non-commercial sponsors; the mCTA (model Clinical Trial Agreement) applies to commercially sponsored trials, typically run by pharmaceutical or biopharmaceutical companies, and was originally developed through a Department of Health and Association of the British Pharmaceutical Industry (ABPI) collaboration. Both sit within a wider suite of UK model agreements maintained for use across all four nations.

    Agreement Full name Typical sponsor
    mNCA Model Non-Commercial Agreement University, NHS trust, charity, Research Council
    mCTA / CRO-mCTA Model Clinical Trial Agreement Pharmaceutical or biopharmaceutical company
    mCCIA / CRO-mCCIA Model Commercial Chief Investigator Agreement Commercial sponsor, with an NHS-employed chief investigator
    mCIA / CRO-mCIA Model Clinical Investigation Agreement Commercial sponsor of a medical device investigation
    mNISA / CRO-mNISA Model Non-Interventional Study Agreement Commercial sponsor of a non-interventional study

    When Must Institutions Use the Unmodified MNCA?

    For commercial contract research, the Health Research Authority’s National Directive on Commercial Contract Research makes use of the unmodified UK template agreements a formal policy mandate, and HRA and HCRW Approval are usually issued conditionally on that use. Non-commercial research carries a materially lighter obligation: there is no equivalent directive, only a policy expectation that the appropriate unmodified template is used, and departing from it risks prolonged central and site-level review rather than automatic non-approval.

    Waivers to use a modified or bespoke agreement are possible in either case but are granted only in exceptional circumstances, generally where no UK template exists for the project type. A waiver request can add many months to study set-up and, according to the HRA, is unlikely to be agreed.

    What Changed in the April 2026 Model Agreement Update?

    Updated versions of the mNCA, alongside the mCTA, mCCIA, mCIA, mNISA and the hub-and-spoke agreements, came into use on 28 April 2026, the date the reformed UK clinical trials regulations for CTIMPs took effect, alongside separate policy changes affecting non-CTIMP studies. According to the Health Research Authority, new studies submitted through IRAS on or after that date must use the April 2026 versions; earlier versions are no longer accepted for new submissions.

    Existing contracts already in place do not need to be reissued. Any new contract entered into with a participating NHS or HSC organisation from 28 April 2026 onward, however, must use the current version. The Four Nations Contracting Leads group, which oversees the model agreement suite across England, Scotland, Wales and Northern Ireland, reviews feedback and considers further amendments roughly every six months, so research offices should treat “the current mNCA” as a version that moves rather than a fixed document.

    Where the MNCA Fits Among Other IRAS Model Agreements

    Several related, non-commercial documents sit alongside the full mNCA and are easily confused with it:

    • Organisation Information Document (OID) — a lighter-weight document used for non-commercially sponsored projects at sites where a full contract is not proportionate, recording site-specific arrangements rather than standalone legal terms.
    • IRAS PIC agreement — used where a site acts only as a Participant Identification Centre, referring or identifying potential participants without delivering study procedures itself, so it carries narrower obligations than the mNCA.
    • Model non-commercial hub and spoke agreement — used where one NHS organisation coordinates delivery across several satellite sites for a single non-commercial study.

    Choosing the wrong document among these is one of the most common causes of delay at site set-up, since each is reviewed against different assessment criteria under HRA and HCRW Approval.

    Frequently Asked Questions

    What is an mNCA?

    The mNCA is the UK-wide template contract used between a non-commercial research sponsor and a participating NHS or HSC organisation. It confirms the site’s capacity and capability to deliver the study and is expected to be used without modification beyond its highlighted schedule sections.

    What is the model commercial chief investigator agreement?

    The mCCIA is used where a commercial sponsor engages a chief investigator who is employed by an NHS or HSC organisation, rather than contracting the organisation itself as the delivery site. A CRO-mCCIA variant adds a contract research organisation as a third party.

    What is the Organisation Information Document?

    The Organisation Information Document (OID) is shared with participating NHS and HSC organisations as part of the local information pack for non-commercial studies. It records agreed site arrangements and, in some cases, doubles as the contract for the study rather than sitting alongside a separate mNCA.

    What This Means for Research Offices

    The practical implication of the April 2026 update is version control, not new legal risk: institutions that continue using pre-2026 mNCA templates for new IRAS submissions will have them rejected at validation, adding avoidable delay to study set-up. Research offices should build a routine check of the IRAS templates page into contract-issuing workflows, since the Four Nations Contracting Leads group’s six-monthly review cycle means further updates are a standing possibility rather than a one-off event.

    More broadly, the mNCA’s “unmodified template plus policy expectation” model reflects a wider shift in research administration toward standardised, negotiation-light contracting — the same logic that underpins standardised data-sharing agreements and role-attribution frameworks elsewhere in the research lifecycle. Institutions that treat the mNCA as a living document, tied to the regulatory calendar rather than a static PDF, will spend less time in central review and more time delivering studies. Research offices building out an internal glossary of contracting and governance terms alongside the mNCA may also find it useful to cross-reference the CASRAI Dictionary for related research-administration terminology.