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)?
- MNCA vs mCTA: How Do the Two Agreements Differ?
- When Must Institutions Use the Unmodified MNCA?
- What Changed in the April 2026 Model Agreement Update?
- Where the MNCA Fits Among Other IRAS Model Agreements
- Frequently Asked Questions
- What This Means for Research Offices
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.
