Sponsorship and Co-Sponsorship Policy for Clinical and Related Research
Purpose
The purpose of this policy is not only to describe the sponsorship and co-sponsorship models available to the University, but also to ensure that sponsor responsibilities are allocated appropriately and that the University is able to discharge those responsibilities effectively throughout the lifecycle of a research study. This policy applies to all clinical and health-related research conducted by the University of Glasgow. This includes research falling within the scope of the UK Policy Framework for Health and Social Care Research, Clinical Trials of Investigational Medicinal Products (CTIMPs), Clinical Investigations of Medical Devices (CIMDs), in vitro diagnostic (IVD) studies, software as a medical device (SaMD) studies, and other regulated or non-regulated studies involving human participants, human tissue, or human data. All studies requiring formal sponsorship must undergo review to ensure that appropriate governance arrangements, risk assessments, insurance and indemnity provisions are in place before sponsorship is confirmed. All research involving human participants, their data, or biological materials must obtain approval from the appropriate ethics review body before commencing. The applicable ethics and regulatory approval pathway will depend on the nature of the study and the relevant legal and regulatory requirements.
The Research Regulation and Compliance Team (rrc@glasgow.ac.uk) provides advice and guidance on sponsorship, ethics review pathways, regulatory approvals, governance requirements, and sponsor responsibilities. Investigators are encouraged to engage with the team at the earliest possible stage of study development to ensure that appropriate oversight arrangements are identified and that all necessary approvals are secured in a timely manner.
Background
The University of Glasgow is committed to supporting high-quality clinical and health-related research that is ethically conducted, scientifically robust, proportionately governed and compliant with applicable legal and regulatory requirements. In discharging its responsibilities as a research sponsor, the University seeks to ensure:
- The safety, rights, dignity and wellbeing of research participants.
- Compliance with applicable legal, ethical and regulatory requirements.
- Proportionate and risk-based governance arrangements.
- Clear accountability for the conduct and oversight of research.
- Effective stewardship of institutional resources and expertise.
- The delivery of high-quality research that generates reliable and meaningful outcomes.
|
Policy Name |
Sponsorship and Co-Sponsorship Policy for Clinical and Related Research |
|
Approved by |
Research Planning and Strategy Committee |
|
Implementation date |
31 May 2008 |
|
Last reviewed |
06 Mar 2024 |
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Last edited |
13 Oct 2026 |
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Owner |
MVLS Research Regulation and Compliance Office |
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Date of next review |
13 Oct 2029 |
|
Version |
2.0 |
Scope
Any regulated or non-regulated research involving human participants, human tissue, or human data that is undertaken to advance knowledge of health, disease, healthcare, medical technologies or human biology.
1. Definitions
1.1 Sponsor
The individual, organisation or group of organisations responsible for initiating, managing and establishing appropriate arrangements for the conduct of a clinical research study. For studies falling within the UK Policy Framework for Health and Social Care Research, the Sponsor is responsible for ensuring that appropriate arrangements are in place to initiate, manage, finance (where applicable), monitor and oversee the conduct of the research. For Clinical Trials of Investigational Medicinal Products (CTIMPs), sponsor responsibilities are defined by the applicable UK Clinical Trials Regulations and associated Medicines and Healthcare products Regulatory Agency (MHRA) guidance. For Clinical Investigations of Medical Devices (CIMDs), in vitro diagnostic (IVD) studies, software as a medical device (SaMD) studies and other regulated medical device research, the sponsor is responsible for ensuring appropriate arrangements are in place to fulfil obligations applicable to the study under relevant legislation and regulatory guidance.
1.2 Co-Sponsorship
An arrangement whereby two or more organisations jointly undertake sponsor responsibilities for a research study. The allocation of sponsor responsibilities is determined on a study-specific basis and documented within a formal written agreement which clearly defines the responsibilities undertaken by each organisation. Co-sponsorship does not imply that all sponsor responsibilities are shared equally. Responsibilities may be allocated to the organisation best placed to discharge a particular function whilst maintaining appropriate oversight and accountability arrangements.
1.3 Chief Investigator (CI)
A healthcare professional or researcher responsible for the overall design, conduct and reporting of a research study. The Chief Investigator is responsible for ensuring that the study is conducted in accordance with the approved protocol, applicable ethical and regulatory requirements, and any conditions of sponsorship. Responsibilities include oversight of participant safety, protocol compliance, safety reporting, maintenance of study documentation, communication with the sponsor, and implementation of appropriate corrective actions where required. For Clinical Trials of Investigational Medicinal Products (CTIMPs), the Chief Investigator must be a suitably qualified and appropriately trained healthcare professional as defined by applicable UK clinical trials legislation. The Chief Investigator must possess the education, training, experience and Good Clinical Practice (GCP) knowledge necessary to assume responsibility for the conduct of the trial and fulfil the responsibilities assigned to the role. For Clinical Investigations of Medical Devices, the Chief Investigator should possess qualifications, training and experience appropriate to the nature, complexity and risks of the investigation.
1.4 Healthy Volunteer
An individual recruited for a study without reference to a medical condition and without recruitment through NHS care pathways.
1.5 Student Study
A project where the primary purpose is for obtaining an educational qualification. This includes doctoral research. Studies where the main purpose is to undertake specific research, and the educational qualification is secondary, do not fall into this category.
1.6 Human Tissue
Human Tissue means any biological material obtained from a human body, including tissue, blood, cells, bodily fluids, DNA and other biological samples, that is collected, stored or used for research purposes.
1.7 Human Data
Data means identifiable, pseudonymised or anonymised information relating to an individual, including health, genetic, demographic, behavioural and research-generated data obtained for research purposes.
2. Sponsorship Models
2.1 University Sole Sponsorship
The University will normally act as sole sponsor of a study where it has the expertise, governance arrangements, insurance and operational infrastructure necessary to discharge sponsor responsibilities independently.
2.2 Co-Sponsorship with NHS Greater Glasgow & Clyde
The University and NHS Greater Glasgow & Clyde have established arrangements to support co-sponsorship where sponsor responsibilities are most appropriately shared between both organisations, or the research is regulated and requires authorisation by the MHRA. Examples include Clinical Trials of Investigational Medicinal Products (CTIMPs), Clinical Investigations of Medical Devices (CIMDs), studies requiring NHS clinical oversight or studies making substantial use of NHS facilities, staff, pharmacy services or clinical infrastructure.
Co-sponsorship will normally be considered where:
- The Chief Investigator is substantively employed by the University*; or
- The University Clinical Trials Unit is leading the coordination of a study; or
- The study is strategically important to the University; or
- Significant NHS oversight, infrastructure or clinical services are required.
A formal co-sponsorship agreement must be established before study commencement. *In exceptional circumstances, studies led by Chief Investigators who are not substantively employed by the University may be considered, subject to approval by the Director of the Clinical Research Ecosystem and confirmation that appropriate governance, sponsorship and oversight arrangements are in place.
2.3 Sponsorship of Clinical Research Outside the UK
Sponsorship of clinical research conducted outside the United Kingdom will normally be considered only in exceptional circumstances and where the University is satisfied that appropriate legal, regulatory, governance, insurance and oversight arrangements can be established to enable it to fulfil its sponsor responsibilities effectively.
In addition to UK requirements, consideration will be given to local regulatory approvals, local ethical review requirements, oversight arrangements, contractual agreements with overseas partners and collaborating institutions, monitoring arrangements, data protection requirements, financial governance arrangements, and the availability of appropriate local expertise and infrastructure. Investigators must demonstrate that appropriate mechanisms are in place to enable the University to maintain adequate oversight and discharge its sponsor responsibilities throughout the duration of the study. Additional institutional review and approval may be required before sponsorship outside the UK can be confirmed.
2.4 Typical Sponsorship Model by Study Type
|
Study Type |
Typical Sponsorship Model |
Comments |
|
Non – regulated clinical student research |
University Sole Sponsor |
Where the University has the necessary expertise, governance arrangements and Infrastructure to fulfil sponsor responsibilities. |
|
Healthy volunteer research |
University Sole Sponsor |
Includes physiological, behavioural, nutrition, imaging, digital health and other studies conducted primarily within University facilities. |
|
Human tissue research |
University Sole Sponsor |
Where tissue has been donated to or is held by the University and will not be returned to the NHS for clinical or diagnostic use. |
|
Data-led research |
University Sole Sponsor |
Includes data linkage studies, secondary use of datasets and research using University-managed Truster research Environments (TREs). |
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Other University -led human participant research |
University Sole Sponsor |
Where the University has the necessary expertise, governance arrangements and infrastructure to fulfil sponsor responsibilities. |
|
Clinical Trials of Investigational Medicinal Products (CTIMPs) |
Usually University/NHSGGC Co-Sponsorship |
Subject to formal sponsorship assessment and agreement. |
|
Clinical Investigations of Medical Devices (CIMDs) |
Usually University/NHSGGC Co-Sponsorship |
Subject to formal sponsorship assessment and agreement. Additional regulatory, insurance and manufacturer considerations apply. |
|
Studies requiring NHS clinical oversight |
Usually University/NHSGGC Co-Sponsorship |
Includes studies involving clinical interventions, requiring incidental finding management, or adverse event management. |
|
Studies using NHS infrastructure |
Usually University/NHSGGC Co-Sponsorship |
Includes NHS pharmacy, imaging, clinical facilities or specialist NHS staff. |
|
Non-Regulated Medical Devices, IVDs and SaM D studies |
Case-by-case assessment |
Sponsorship depends on regulatory requirements, insurance arrangements and allocation of manufacturer responsibilities. |
|
Clinical research outside the UK |
Case-by-case assessment |
Sponsorship depends on local regulatory requirements, oversight arrangements and insurance arrangements. |
Please contact MVLS Research Regulation and Compliance Team rrc@glasgow.ac.uk to discuss sponsorship requirements
3. Insurance
3.1 Clinical research sponsors must ensure that adequate insurance arrangements are maintained and are proportionate to the nature and risks of the research being undertaken. The University maintains clinical trials insurance and other relevant insurance arrangements to support the discharge of its sponsor responsibilities, subject to the terms, conditions, exclusions and limits of the applicable policies. Where sponsorship responsibilities are shared, the allocation of liability, indemnity and insurance responsibilities must be clearly documented within the co-sponsorship agreement.
3.2 Special Considerations for Medical Devices and Digital Technologies
The University does not hold manufacturer or product liability insurance for Medical Devices, In Vitro Diagnostic Devices (IVDs), Software as a Medical Device (SaMD), Digital Health Technologies or Health Applications. Appropriate manufacturer responsibilities, insurance arrangements and regulatory obligations must remain with the relevant legal entity.
4. Sponsorship Decisions
The University reserves the right to refuse, decline, suspend, transfer or withdraw sponsorship or co-sponsorship of any research study where it concludes that the University does not have the appropriate expertise, resources, oversight arrangements or institutional capacity to discharge sponsor responsibilities effectively, or where the necessary ethical, legal, regulatory, financial, contractual, insurance or governance arrangements cannot be adequately established or maintained. When determining whether to provide sponsorship or co-sponsorship, the University may consider factors including:
- The risk and complexity of the study;
- The applicable regulatory framework;
- The participant population involved;
- The extent of NHS or external partner involvement;
- Insurance and indemnity requirements;
- Monitoring, oversight and safety reporting arrangements;
- Available institutional expertise and operational capacity;
- Financial sustainability and resource requirements;
- Any international governance considerations.
Authority to approve sponsorship and co-sponsorship arrangements rests with the Dean of Clinical Partnerships and the Director of the Clinical Research Ecosystem, acting under delegated authority from the University and in consultation with relevant institutional stakeholders, in accordance with the requirements of this policy.
5. References
- References
- UK Policy Framework for Health and Social Care Research (Department of Health and Social Care, 2017, as amended): https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/
- Health Research Authority: https://www.hra.nhs.uk/
- Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024. https://www.legislation.gov.uk/uksi/2004/1031/contents
- Medicines and Healthcare products Regulatory Agency (MHRA): https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
- Medical Devices Regulations 2002 (SI 2002/618), as amended. https://www.legislation.gov.uk/uksi/2002/618/contents
- GDPR and Data Protection Act 2018. https://www.gov.uk/data-protection
- Human Tissue (Scotland) Act 2006 and Human Tissue Authority Codes of Practice. https://www.hta.gov.uk/guidance-professionals/codes-practice-standards-and-legislation/codes-practice