A suite of model agreements is now available to assist the proper formation of collaborative projects involving Health and Social Care trusts. This page provides links to these agreements and a headline summary of each. These model agreements are strongly recommended and are accompanied by comprehensive guidance to aid implementation. Versions or options reflect the different governance and legal arrangements of England, Northern Ireland, Scotland and Wales.
In December 2011 updated versions of the clinical trial and clinical investigation agreements (mCTA, CRO mCTA, mCIA and CRO mCIA) were published. Changes include new definitions of staff involved in trials or investigations for related indemnity arrangements, as well as revised anti-bribery and anti-corruption provisions.
The model Clinical Investigation Agreement (mCIA) and model Industry Collaborative Research Agreement (mICRA) were updated again in 2014.
Model Industry Collaborative Research Agreement (mICRA)
The model Industry Collaborative Research Agreement is designed to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK. It is supported by a comprehensive guidance document which sets out its background and aims and details how the agreement should be used in the development of contracts for specific clinical research collaborations.
A decision tree is also available to guide users in identifying when studies are collaborative and whether mICRA is applicable. The agreement has a choice of options for clauses covering intellectual property arrangements and the decision tree guides users through this process.
The model Industry Collaborative Research Agreement was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, universities and the NHS, and the Intellectual Property Office, were brought together with expert legal opinion to develop a model Agreement that can be used to support all collaborative research scenarios. Organisations involved in the working group have agreed a statement of endorsement encouraging widespread use of the model agreement to streamline the contracting process for collaborative research.
Further information: www.nihr.ac.uk/industry/industry-tools.htm.
Model Clinical Trials Agreement for Pharmaceutical Research (mCTA)
The mCTA is a model agreement intended for use by all pharmaceutical and biotech companies sponsoring trials and the NHS hospitals carrying them out, without any modification.
The documents are endorsed for use without modification by Health Departments throughout the UK, the trade bodies (ABPI and BIA), the NHS Confederation, the NHS R&D Forum, the UK Clinical Research Collaboration, the Foundation Trust regulator (Monitor), and the Council of Heads of Medical Schools.
Further information: www.ukcrc.org/regulation-governance/model-agreements/mcta/
Contract Research Organisations Model Clinical Trial Agreement (CRO mCTA)
The CRO mCTA contains fundamentally the same provisions as the mCTA (above). However, in devising the trial-specific agreement the parties have to consider whether it is the sponsor or the CRO (or both) with which the NHS Trust interacts. These options are set out in the model agreement. Therefore, converting the model agreement into a trial-specific agreement is a slightly more complex process than it is with the bipartite mCTA.
Further information: www.ukcrc.org/regulation-governance/model-agreements/cro-mcta/
Model Clinical Investigation Agreement for Medical Technology Industry Sponsored Research in NHS Hospitals (mCIA)
The mCIA is designed to simplify and therefore speed up the process for signing off and initiating trials of medical technology involving NHS patients in NHS hospitals. It removes any need for either sponsors or hospitals to undertake further legal review of contracts in response to another party proposing modifications. It is intended that the mCIA be used routinely without modification by all medical technology industry sponsors of contract clinical research in NHS hospitals in which NHS patients are recruited.
The documents are endorsed for use without modification by the four UK Health Departments and by the Association of British Healthcare Industries, the NHS Confederation, the NHS Forum, the Medical Schools’ Council, the UK Clinical Research Collaboration, the Institute for Clinical Research, and by the Ministerial Medical Technology Strategy Group.
Further information: www.ukcrc.org/regulation-governance/model-agreements/devices-mcia/
Clinical Research Organisation Model Clinical Investigation Agreement (CRO mCIA)
The Contract Research Organisation model Clinical Investigation Agreement (CRO mCIA) is a tripartite agreement between: the company sponsoring commercial research involving medical device(s), the contract research organisation (CRO) managing the research and the NHS organisation where the research takes place. The CRO mCIA is based on the bipartite model Clinical Investigation Agreement (mCIA), which is for use by NHS Trusts and the medical technology industry. This tripartite agreement can be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. It is tailored to be used without modification for CRO-managed clinical investigations of medical devices in patients in hospitals throughout the UK Health Service.
Further information: www.ukcrc.org/regulation-governance/model-agreements/cro-mcia/
Model Agreement for Non-Commercial Research in the Health Service (mNCA)
The model agreement for non-commercial research (mNCA) is a template for documenting the relationship between and the responsibilities of the non-commercial sponsor(s) of a research study and the Health Service organisation where the study takes place. The mNCA is intended for use in non-commercial research studies carried out in Scotland, Wales and Northern Ireland. It can also be used for non-NIHR portfolio studies in England. Usage of the mNCA in this way is supported by the UKCRC Partners.
The mNCA has been developed as a single agreement that ensures compliance with the applicable UK law and institutional arrangements. The clauses in the main body of the agreement are intended to be used without modification or negotiation whilst the Schedules will need tailoring to the specific research situations.
Further information: www.ukcrc.org/regulation-governance/model-agreements/mnca/
Other model agreements that might have some utility for HSC trusts include:
- The Lambert Toolkit – a suite of model research collaboration agreements (for one to one and consortium scenarios) intended for use between universities and companies. The intellectual property clauses have particular merit and have been used in the Model Industry Collaborative Research Agreement (mICRA, see above). More information: www.ipo.gov.uk/lambert.
- Brunswick Material Transfer Agreement – a template that is intended for use between two universities or similar not-for-profit organisations to facilitate routine transfer of materials between academic institutions. Many leading universities have signed up to use this template. More information: www.arma.ac.uk/resources/brunswick-agreements.
The NIHR CRN Industry Costing Template, for costing industry sponsored studies, is available with guidance at www.crn.nihr.ac.uk/can-help/life-sciences-industry/setup-service/.