An overview of the various contracts used in clinical research collaborations
This guidance is designed to assist academic staff, primarily those working in Faculty of Health and Medicine and related science disciplines, who are involved in clinical research projects, particularly in non-commercial settings. It aims to provide a comprehensive overview of the various types of contracts and agreements that researchers may encounter when receiving funding, either as lead applicants or collaborators. The guidance will cover the key types of contracts, their purposes, and how they interrelate. By understanding these various agreements and their implications, academic researchers can more effectively navigate the complex landscape of clinical research collaborations, ensure compliance with regulations, and facilitate smooth execution of their studies.
Defined terms are explained in the glossary section at the end of the guidance.
What is classed as a Non-Commercial Study?
A Non-Commercial Study is one whereby there is no pharmaceutical company or industry as the trial Sponsor. The Sponsor is usually the University or an NHS Trust. An example of this might be an investigator led study whereby funds are coming into the University from a research council or charity to conduct clinical research into a research question posed and driven by that researcher / research team.
What type of contracts might I require for my study?
- a) Funding Agreement:
- Purpose: Defines the terms under which a funder will make an award to support your research.
- Key elements: payment terms, reporting obligations, intellectual property ownership, liabilities.
The lead researcher known as the Principal Investigator (PI) is primarily responsible for Lancaster’s compliance with these terms. It will be important to reflect the funding terms throughout the contracting process with any collaborators.
- b) Collaboration Agreement (CA):
- Purpose: Defines the terms of collaboration between multiple institutions or parties.
- Key elements: Roles and responsibilities, intellectual property rights, publication rights, and funding distribution.
- Data sharing considerations: Include clauses on data ownership, access rights, and sharing protocols.
- c) Material Transfer Agreement (MTA):
- Purpose: Governs the transfer of research materials between institutions.
- Key elements: Terms of use, restrictions, and intellectual property rights.
- Data sharing considerations: May include provisions for sharing associated data.
- d) Data Sharing Agreement (DSA):
- Purpose: Specifically addresses the terms of data sharing between parties.
- Key elements: sets out the method and means of processing data, data types, access rights, security measures, and use limitations.
- Importance: Critical for ensuring compliance with data protection regulations where the data to be processed is personal identifiable data.
- e) Model Non-Commercial Agreement (mNCA):
The United Kingdom Clinical Research Collaboration has published a suite of model agreements that sponsors and host institutions can use 'off the shelf' for commercial research on medical devices, research with contract research organisations, and commercial research in primary care. The 2018 mNCA was developed principally for use with clinical trials and medical device studies but can be used for other types of clinical studies (such as observational).
- Purpose: Standardised agreement for non-commercial research involving the NHS.
- Key elements: Adapted for academic-led studies, covering sponsorship, funding, and governance.
- Data sharing considerations: Includes provisions for data management and sharing.
- f) Organisation Information Document (OID):
- Purpose: Provides essential information about the participating organisations.
- Key elements: Capacity, capability, and compliance information.
- Data sharing considerations: Covered in Appendix 4: Data Processing Agreement and Appendix 5: Data Sharing Agreement of the mNCA. These Appendixes are usually sufficient for data sharing between the University and an NHS site.
Use:
- Always used for all types of studies
- Provides a high-level overview of the study and site expectations
What contract terms to use? OID v mNCA
Default position - It is expected that the OID will form the agreement between the University (as the Sponsor or the Collaborator) and the participating NHS / Health Social Care organisation, except where the study falls into the top 4 categories on the Integrated Research Approval System (IRAS) (see below). Where this is the case, all appendices should be completed. The OID is then used to put in place arrangements between practices and the study (for non-commercial studies). It acts as a formal written agreement, including finances, transfer of biological samples (Material Transfer Agreement), data sharing, data processing and intellectual property. If the OID does not form the agreement between the parties Appendix 1 of the OID only should be completed.
For non-commercial studies that are not clinical trials or clinical investigations, the agreed final OID (taken together with the documents in the Local Information Pack and the exchange of correspondence) forms the agreement between the participating NHS / HSC organisation and the University, once confirmed by the participating NHS / HSC organisation. For all other non-commercial studies, it is expected that the model Non-Commercial Agreement (mNCA) is used as the agreement (although the localised OID is still needed in the Local Information Pack, for the information it contains).
The mNCA, on the other hand, is used when:
- You need a formal agreement between the Sponsor (i.e. when Lancaster is acting as a Sponsor) and the participating NHS organisation(s).
- The study involves more complex arrangements that require a detailed legal agreement (interventional research or clinical trials).
- There are specific terms related to funding, responsibilities, or resource allocation that need to be formally agreed upon.
- You need to clearly define roles, responsibilities, and liabilities between your institution and the NHS partners.
Clinical Trial Agreement
‘Clinical trials’ are defined as all studies which fall into the first four study categories of question two on the Integrated Research Approval System (IRAS) filter page namely:
- clinical trial of an investigational medicinal product
- clinical investigation or other study of a medical device
- combined trial of an investigational medicinal product and an investigational medical device
- other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
In cases whereby the research study is classed as a Clinical Trial then the appropriate model agreement should be used. If there is no commercial funding party, sponsoring the Clinical Trial the mNCA template should be used. The mNCA is structured to meet the requirements of non-commercial Sponsors. The mNCA was developed principally for use with interventional research scenarios, including clinical trials, medical device studies, research using patient data and research using human tissue.
Participant Identification Centres (PICs)
PICs are organisations from which clinicians or clinical units will refer potential participants to a research team based at the University, for assessment and possible recruitment to a study.
PICs are not set up using the OID. If PICs are sub-contracted by, and refer participants to the University, a model non-commercial PIC agreement should be used. This ensures that the correct data processing terms are used between the Sponsor, (Site, as applicable) and the PIC.
Data Sharing Considerations
Data sharing considerations are particularly crucial in clinical research studies due to the complex ethical, legal, and scientific implications involved. In these studies, researchers often handle sensitive patient information, collaborate across multiple institutions, and generate valuable datasets that could benefit the wider scientific community. Proper data sharing practices ensure patient privacy protection, compliance with regulations like General Data Protection Regulation (GDPR), and adherence to ethical standards. They also facilitate transparency, reproducibility, and the maximisation of research impact. For academic researchers, navigating these considerations is essential to maintain public trust, fulfil funder requirements, and contribute to the advancement of medical knowledge. Moreover, well-structured data sharing agreements can foster collaboration, prevent misunderstandings, and protect the interests of all parties involved. As such, understanding and implementing robust data sharing practices is not just a regulatory requirement, but a fundamental aspect of responsible and impactful clinical research in the academic setting. Some key areas that a Data Sharing Agreement or Data Processing Agreement will cover are:
- a) General Data Protection Regulation (GDPR) compliance:
- Ensure all agreements comply with GDPR requirements.
- Address data minimisation, purpose limitation, and storage limitation principles.
- b) Anonymisation and pseudonymisation:
- Clearly define processes for de-identifying data in all relevant agreements.
- Specify responsibilities for maintaining anonymity/pseudonymity.
- c) Data access and transfer:
- Detail secure methods for data transfer between collaborators.
- Specify access controls and authorisation processes.
- d) Data retention and destruction:
- Include clauses on how long data will be retained and methods of secure destruction.
Who should complete the relevant documents /contracts?
Agreements that are provided on the IRAS/HRA webpages known often as the “Model Agreements” (including the: OID, nMCA for trials and nMC-PICA) have been pre-approved for use by the Contracts Office and are to be drafted by the Clinical Research Governance Team. Should changes be requested to the core terms of said agreements by the collaborating partner then the Contracts Office should be consulted.
If the Model Agreements are updated and re-issued the Contracts Office will need to review and approve them as templates going forward.
Where there are costings attached to a clinical study or trial for example in the case of commercially sponsored trials then the Contracts Office should be instructed to draft the appropriate Model Agreement in the usual way i.e. via the Costings Teams issuing an ACP alert to instruct the Contracts Office to commence drafting / review.
To note
Guidance for researchers on completion of an OID
Final Point
This guidance provides a starting point for academic staff to navigate the complex landscape of research agreements and data sharing in clinical research. It's important to note that specific requirements may vary depending on the nature of the research, funding sources, and institutional policies. Always consult with the Contracts Office and Research Support teams for tailored advice.
Glossary of terms
HRA – Health Research Authority – oversee the approval process for research in the NHS in England.
HRA Approval - is the process for research in the NHS in England. It comprises a review by an NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance, and study-wide research governance checks undertaken by dedicated HRA staff.
IRAS – Integrated Research Application System (IRAS)
mNCA - model Non-Commercial Agreement
OID - Organisation Information Document
PIC - Participant Identification Centres
Sponsor - refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The Sponsor does not actually conduct the investigation unless the Sponsor is a Sponsor-investigator.