Contents
1 Background
Under the UK Framework for Health and Social Care Research all health and social care research projects require a sponsor. The sponsor is the individual, organisation or partnership that takes overall responsibility for proportionate, effective arrangements being in place to fund, set up, run and report on a research project. The sponsor has overall responsibility for the research and is normally expected to be the employer of the chief investigator in the case of non-commercial research.
Deciding to accept sponsorship of a study or trial is an important decision as the organisation accepts responsibility for the study and the risks associated with it.
The majority of research studies conducted at Rotherham Doncaster and South Humber (RDaSH) are sponsored and led by other external organisations. Research that is initiated and led by RDaSH researchers should be sponsored by RDaSH if it can be demonstrated that the risks involved in that research are acceptable.
The sponsor is responsible for ensuring that the proposed research respects the dignity, rights, safety, and wellbeing of research participants. The UK Framework for Health and Social Care Research requires that all research projects must have a sponsor identified and declared prior to the commencement of the project.
In addition, under the Medicines for Human Use (Clinical Trials (CT)) Regulations (2004) all research projects involving the use of investigational medicinal products (IMPs) must have the sponsor declared to the competent authority. In the UK the competent authority is the Medicines and Healthcare Products Regulatory Agency (MHRA).
1.1 Definition
A sponsor is an individual, group or organisation which takes responsibility for the quality, conduct and financial management of a research project. All research conducted within the NHS is required to have a research sponsor. The trust does not allow an individual to take on the responsibility of sponsor.
The key responsibilities of a sponsor, as outlined by the Department of Health and Social Care (DHSC), are:
- authorisation arrangements prior to study start
- good clinical practice (GCP) for conduct, monitoring and reporting of the study
- pharmacovigilance, where relevant
The sponsor takes primary responsibility for ensuring that the design and conduct of the study meets appropriate standards and that arrangements are in place for the management and reporting of the project. This will include, for appropriate studies, ensuing a favourable opinion from an NHS Research Ethics Committee (REC) has been obtained and approval from the Health Research Authority (HRA) prior to opening the study. In addition, the requirement to ensure compliance with the terms of any approvals, and regulation, means that a sponsor may monitor, audit or inspect a project at any point in the project’s duration.
A sponsor can delegate responsibilities to other parties for which they remain ultimately responsible. Where there is delegation of responsibility, clear agreements describing allocation of responsibilities and rights must be reached, documented and enacted.
A summary of the sponsor’s responsibilities can be obtained from the Health Research Authority (opens in new window).
Appendix A, as derived from Department of Health and Social Care guidelines, outlines the sponsor’s responsibilities in relation to trust research studies.
2 Aim
This procedure has been produced in accordance with Medicines for Human Use (Clinical Trials) Regulations (2004) and subsequent amendments, and the UK Framework for Health and Social Care Research (2005). This procedure will outline the procedure for submitting a research project for a sponsorship decision. This procedure applies to all research studies undertaken at the trust that are requesting the trust to act as the sponsor organisation.
3 Scope
This policy sets out how arrangements for authorisation of research sponsorship are approved for all healthcare research activity in the trust and management of study agreements.
Applicable to any internal and external staff requesting sponsorship of research studies by the trust and study teams working on projects sponsored by the trust.
4 Link to overarching policy and, or procedure
- Research governance policy
- Research contracting LWI
5 Procedure or implementation
5.1 Determining the sponsor organisation
For studies where the trust is not the lead NHS institution, the assignment of sponsorship will be determined by the lead site.
The research governance manager determines the study sponsor using information from the Research Ethics Committee form or the model non-commercial agreement (mNCA) and enters the sponsorship status on the master operational tracker.
If sponsorship is allocated to an institution other than the trust, for example, an NHS trust or university:
- the research governance manager informs the chief investigator or principal investigator and study delivery lead of the institution likely to be the sponsor
- the chief investigator or principal investigator contacts the institution identified as likely to be the sponsor of the study for confirmation
- the chief investigator or principal investigator sends the research governance manager documentary evidence (in most cases the sponsor signed Research Ethics Committee form and a copy of the organisation’s indemnity certificate) of the external sponsor and files a paper copy in the investigator site file (ISF)
- where the chief investigator has named their employing university as sponsor the research governance manager makes enquiries to ascertain whether there is a reason why the trust should not act as sponsor
- where no reason is determined the research governance manager confirms that sponsorship should be reassigned to the trust
- if the study involves an investigational medicinal product, the trust cannot currently act as the sponsor, the research governance manager contacts the chief investigator or principal investigator to confirm and assists in assigning an alternative sponsor, in conjunction with the deputy director of research and innovation
5.2 Trust sponsor organisation principles
In principle, the trust will accept sponsorship for research projects that meet the following conditions:
- the trust is the substantive employer of the chief investigator, or the chief investigator has an honorary research contract with the trust
- the chief investigator makes a formal request for the trust to sponsor the study, in accordance with this policy
- the chief investigator and all research staff familiarise themselves with relevant trust research procedures and trust policies
- the chief investigator and all research staff working on the study are suitably qualified by education and experience to carry out their delegated responsibilities. The chief investigator is responsible for ensuring training is documented prior to the start of the study, and regularly monitoring compliance throughout
- that the study is adequately funded or the trust care group has
agreed to cover costs for the duration of the study - a sponsorship risk assessment will be carried out and will be reviewed by the research and innovation panel for any project applying for trust sponsorship. The risk assessment must demonstrate that the risk to the trust of undertaking sponsorship is reasonable and significant risks are appropriately mitigated
- for grant applications requiring sponsorship, if after assessment sponsorship is approved it will be a sponsorship in principle. If the study proceeds to set up, the research and innovation panel will review sponsorship considering whether any conditions have been met and changes to the proposal
- if a sponsorship request is declined appeals can be made to the research and innovation panel, the decision of the research and innovation panel is final
- the chief investigator is responsible for securing all relevant regulatory approvals and maintaining compliance with the UK Policy Framework for Health and Social Care Research and the principles of Good Clinical Practice
- sponsorship will be reviewed, and the process undertaken again if circumstances or risk change significantly
5.3 Applying for trust sponsorship
For studies where the trust is the lead NHS institution and involves trust patients, the trust will normally be the sponsor.
To request the trust to be the study sponsor, the application for research sponsorship form (appendix C) is sent to the chief investigator or principal investigator for completion with support from the research governance manager.
The application for research sponsorship form is validated by the research governance manager.
A risk assessment is conducted by the research governance manager and Grounded Research nominated study delivery lead and any other appropriate team members.
The application for research sponsorship and risk assessment are submitted for review by the research and innovation panel, who decide whether to proceed with sponsorship or not.
The research and innovation panel’s decision is confirmed to the chief investigator or principal investigator by email.
If the application is declined justification of the decision will be provided and the decision can be appealed, as per the research governance policy.
Acceptance of sponsorship is confirmed by sponsor signature on the integrated research application system (IRAS) Research Ethics Committee (REC) application form.
The research governance manager enters sponsorship status on the master operational tracker and files an electronic copy of the evidence in the study folder on L-Drive.
The research governance manager files an electronic copy of the signed Research Ethics Committee form or other evidence of sponsorship in the study folder on L-Drive.
The research governance manager then follows the process described below depending on whether the trust or another institution is the sponsor
5.4 Trust sponsored study
For multicentre studies a model non-commercial agreement (mNCA) with participating sites is required. If funding is to be transferred to the participating sites this must be detailed in the agreement.
The research governance manager completes the model non-commercial agreement, indicating where an area of responsibility is delegated to another participating site. The research governance manager reviews the proposal with the deputy director of research and innovation (or designated nominee), as appropriate.
The research governance manager sends the chief investigator or principal investigator the model non-commercial agreement (for review only).
The research governance manager contacts the research and development office of each participating site to negotiate agreement and signature of the model non-commercial agreement; where a study coordinator (SC) is identified, they may facilitate this process.
The model non-commercial agreement is reviewed by the research contracts manager (as per the research contracting LWI) who provides an assurance sheet and gains internal approvals and signature of the director of finance.
The research governance manager files the signed agreement in the trial master file (paper and L-Drive).
The research governance manager determines whether any other agreements with external institutions involved in the study (not in the capacity of a participating site) are necessary, for example, collaboration agreement (CA), NHS sub-contract. The research governance manager consults with the deputy director of research and innovation (or designated nominee) if it is unclear whether any additional agreements should be required.
For non-investigational medicinal product studies, the research governance manager determines whether independent scientific review (ISR) is required.
5.5 Non-commercial, multi-centre study where an external institution is the sponsor
The principal investigator or study coordinator submits evidence of the lead institution’s acceptance of sponsorship (for example, signed Research Ethics Committee application, sponsorship letter).
For studies involving an investigational medicinal product the sponsor or legal representative must be located within the European Economic Area (EEA).
For non-clinical trials of an investigational medicinal products with a non-UK sponsor there must be a legal representative in the UK.
The research governance manager liaises with the study sponsor to determine which agreement the sponsor intends to use (model non-commercial agreement (mNCA) where possible).
If the external sponsor does not propose to use the model non-commercial agreement and offers the organisation information documents (OID), the research governance manager checks the Health Research Authority (HRA) approval letter to determine which agreement has been approved for use.
The research governance manager liaises with the deputy director of research and innovation (or designated nominee) if it is unclear which agreement should be required. The model non-commercial agreement is preferred, but the organisation information document (OID) can be accepted for low-risk studies with Health Research Authority approval.
The research governance manager reviews and negotiates the proposed agreement with the sponsor. If the external sponsor wishes to delegate any of the sponsorship responsibilities to the trust, detail of this must be contained within the agreement, in this case a model non-commercial agreement is always required. The research governance manager reviews the proposal with the deputy director of research and innovation (or designated nominee), as appropriate.
The model non-commercial agreement is signed by the external sponsor and director of finance at the trust (or authorised delegate).
The study sponsor may wish to delegate sponsorship responsibilities to the principal investigator or study coordinator. The study sponsor is responsible for documenting the delegation of any such arrangements and ensuring the relevant parties are aware of their responsibilities.
The research governance manager enters sponsorship status onto the master operational tracker and files an electronic copy of the signed Research Ethics Committee form in the study folder on L-Drive, and paper copy of the Research Ethics Committee form in the investigator site file.
The model non-commercial agreement must be fully executed before confirmation of capacity and capability (CC&C) is provided.
When confirmation of capacity and capability is given the chief investigator, principal investigator or study coordinator receives an NHS confirmation of capacity and capability email.
5.6 Non-commercial, no local investigator study, where an external institution is the sponsor
The chief investigator or study coordinator submits evidence of the lead institution’s acceptance of sponsorship (for example, signed Research Ethics Committee application, sponsorship letter).
The research governance manager liaises with the study sponsor to determine which agreement the sponsor intends to use, OID, or preferably a model non-commercial agreement (mNCA).
The research governance manager reviews the agreement and negotiates any delegated tasks.
The model non-commercial agreement is signed by the external sponsor and director of finance at the trust (or authorised delegate).
The research governance manager files the signed agreement in the investigator site file and the study folder on L-Drive.
A fully executed agreement must be in place before confirmation of capacity and capability (CC&C) is provided.
When confirmation of capacity and capability is given the chief investigator or study coordinator and local contact receives an NHS confirmation of capacity and capability email.
5.7 Commercial studies where the commercial company is the sponsor
The sponsor or chief investigator or study coordinator submits the draft model clinical trial agreement (mCTA) to the research governance manager. The commercial company is identified as sponsor in the model non-commercial agreement and all subsequent documentation.
For studies involving an investigational medicinal product the sponsor or legal representative must be located within the European Economic Area (EEA).
For non-clinical trials of an investigational medicinal products with a non-UK sponsor there must be a legal representative in the UK.
The research governance manager and research contracts manager negotiates agreement on the model non-commercial agreement and organises the appropriate signatures, as per the contracting LWI.
The interactive costing template (iCT) should be provided for review alongside the model non-commercial agreement. The interactive costing template is reviewed by the research governance manager and any queries are resolved with the deputy director of research and innovation (or designated nominee).
The agreement is signed by the external sponsor and director of finance at the trust (or authorised delegate).
The research governance manager files the signed agreement accordingly in the investigator site file and in the study folder on L-Drive.
When confirmation of capacity and capability is given the chief investigator, principal investigator or study coordinator receives an NHS confirmation of capacity and capability email.
6 Appendices
6.1 Appendix A Sponsor responsibilities
6.1.1 Sponsor
The organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.
All health and social care research should have a sponsor. This includes all research that involve NHS patients, their tissue or information.
Two or more organisations may agree to act as co-sponsors or joint sponsors. Co-sponsors allocate specific sponsor responsibilities between them whilst joint sponsors each accept liability for all of the sponsor’s responsibilities.
A sponsor can delegate specific tasks to any other individual or organisation that is willing and able to accept them.
Any co-sponsorship, joint sponsorship or delegation of tasks to another party should be formally agreed and documented by the sponsors.
The sponsor’s responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.
6.1.2 Sponsorship of clinical trials of an investigational medicinal product
It is a legal requirement for any clinical trial of an investigational medicinal product (CTIMP) to be sponsored. The sponsor is responsible for ensuring that a clinical trial complies with the legislation and good clinical practice.
If a sponsor of a clinical trial of an investigational medicinal product is a commercial or other non-NHS body, a copy of an insurance or indemnity certificate should normally be included with the Research Ethics Committee application as evidence of the cover in place for the potential liability of the sponsor. This may be a certificate for a trial-specific policy or a block policy covering a number of trials conducted by the sponsor. If the certificate is not yet available, for example because proposed trial-specific cover will not be brought into effect until the trial is ready to start, the Research Ethics Committee will require as a condition of its favourable opinion that a copy of the certificate is provided prior to the start of the trial.
6.1.3 Legal representatives, clinical trial of an investigational medicinal product
If a sponsors of a clinical trial of an investigational medicinal product is not established in the UK or on an approved country list (which initially includes EU or European Economic Area (EEA) countries), it is a statutory requirement to appoint a legal representative based in the UK or a country on the approved country list for the purposes of the trial. Details of the legal representative should be entered in the legal representative section of the integrated research application system.
The legal representative:
- may be an individual person or a representative of a corporate entity
- does not have to be a legally qualified person
- should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted (for example, for service of legal documents)
- should be established and contactable at an address in the UK or a country on the approved country list
- does not assume any of the legal liabilities of the sponsors for the trial by virtue of the role of legal representative and does not therefore require insurance or indemnity to meet such liabilities; but
- may in some cases enter into specific contractual arrangements to undertake some or all of the statutory duties of the sponsor in relation to the trial, in which case the legal representative would also be regarded as a co-sponsor and would then require insurance or indemnity cover
In all cases, evidence should be provided with the application that the legal representative is willing to take on the role of legal representative and is established at an address in the UK or a country on the approved country list. For example, a copy of correspondence between the sponsor and legal representative on appropriate headed paper could be supplied, or a copy of a contract.
Where the legal representative is also a co-sponsor, this should be separately recorded on the application form and details given of the allocation of sponsorship responsibilities. Evidence of insurance or indemnity cover should be provided.
6.1.4 Legal representatives, studies other than clinical trials of an investigational medicinal product
The UK policy framework does not require a UK legal representative of the lead sponsor (or any co-sponsor) for studies other than clinical trials of an investigational medicinal products.
6.2 Appendix B Research registration form
6.2 Appendix C Application for sponsorship
Document control
- Version: 1.
- Unique reference number: 1100.
- Approved by: Research and innovation clinical leadership executive group.
- Date approved: 14 January 2025.
- Name of originator or author: Deputy director of research and innovation.
- Name of responsible individual: Chief medical officer.
- Date issued: 23 January 2025.
- Review date: 31 January 2027.
- Target audience: Everyone involved in the trust.
Page last reviewed: January 23, 2025
Next review due: January 23, 2026
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