Sponsorship

It is national policy that all health and social care research has a sponsor. A sponsor is legally required for all clinical trials as stipulated in Clinical Trials Regulations and the UK Policy Framework for Health and Social Care.

What is Research?

Research is designed and conducted to generate new knowledge. To determine whether a piece of work is research versus audit or service evaluation, useful resources are:

https://www.hra-decisiontools.org.uk/research/

https://www.hra-decisiontools.org.uk/research/docs/definingresearchtable_oct2017-1.pdf

What is the Sponsor’s role?

• To take overall responsibility for the research to ensure proportionate, effective arrangements are in place to set up, run and report a research project
• Ensuring appropriate indemnity or insurance for the study
• Ensuring patient / participant safety and rights

A sponsor can delegate specific responsibilities to any other individual, company, institution or organisation that is willing and able to accept them. Any delegation of responsibilities will be formally agreed and documented by the sponsor.

For further information the sponsor’s responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.

When can the Royal Devon Devon University Healthcare NHS Foundation Trust (Royal Devon) act as sponsor?

Where there is no third-party sponsor, the Royal Devon will usually act as sponsor for research where:

• The chief investigator (CI) is a substantive employee of Royal Devon
• The chief investigator (CI) is a clinical academic practising in the Royal Devon with an honorary Royal Devon contract.

Sponsorship is an ongoing process and is conditional on a scientifically sound protocol, feasible within the setting and fully financed.

When will the Royal Devon not act as sponsor?

The Royal Devon are unable to act as sponsor for student studies. Please approach the university where the qualification is being obtained for sponsorship services. The HRA provide useful guidance on their website

https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/

As per Research and Development (R&D) policy, the Royal Devon is unable to sponsor international studies.

A sponsor is not required for projects that are not clinical research, for example no sponsor is required for service evaluations or an audit. At Eastern Services, we advise contacting your speciality governance to register an evaluation or the Clinical Audit Department for advice on an audit. At Northern Services contact the Audit or the QI team. Contact information for these departments can be found on the staff intranet.

How do I apply for the Royal Devon to be the sponsor?

Research projects must apply for sponsorship with the Royal Devon whether they are a clinical trial of an IMP or device, interventional trial, human tissue project, or an observational study.

If you would like the Royal Devon to sponsor your study, please contact the R&D Department as early as possible at rduh.research-eastern@nhs.net.

The investigator must submit an application for Trust sponsorship to the R&D team, supported by the following documentation in the first instance:

• Trial proposal/ draft protocol/ grant application
• Outline funding plan

After a grant has been awarded, the R&D team will require further documentation to enable continuous sponsorship assessment including the following:

• Research Protocol
• IRAS form
• Any patient facing documentation as applicable e.g. participant information sheet and consent
• All study other related documentation i.e. questionnaires
• An Organisational Information Document and Schedule of Events (or SoECAT if done at grant stages) for sites outside of Royal Devon

Before agreeing to act as sponsor, the Royal Devon will need to assure itself that the study is within the sponsorship scope, of a high scientific quality, feasible, fully funded and that the protocol contains all required information. 

For further details regarding sponsorship application please refer to R&D SOP S09.

Conditional agreement

By confirming the Trust Sponsorship in Principle, the Royal Devon is not giving permission for the study to commence. Sponsorship in Principle is conditional on all relevant approvals being in place and provision of adequate funding. Sponsorship will only be granted once any issues raised by the risk assessment have been addressed.  The R&D team will issue the CI with written confirmation of Sponsorship in Principle which will also outline CI responsibilities and a link to the electronic library of R&D SOP’s.

What are my on-going obligations?

The Chief Investigator is the overall lead researcher for a study whether at one site, or a number of sites. Ongoing responsibilities include:

• Conducting the project to the agreed protocol in accordance with laws and good practice.
• Ensuring delegation of duties by experienced staff are signed off on the trial delegation log and that staff members are competent in the duties/responsibilities expected by them
• Preparing and providing information to participants and safeguarding the safety, rights, dignity and well-being of participants.
• All amendments are provided to the sponsor for review before submission to NHS REC and HRA, and the MHRA and NHS trusts as applicable.
• Keeping R&D up-to-date on progress and any issues of concern.
• All safety events involving RD&E patients must be reported to R&D as Sponsor as specified in the protocol and as per R&D SOPs
• All annual progress reports, development safety update reports (CTIMPs only) and end of trial/study notifications must be sent to/reviewed by the sponsor.
• Arranging to make findings and data accessible.
• Feeding back results to participants
• Any publications arising from the research conducted at this site must be sent to the R&D Office as part of the on-going Research Governance Process

For any further advice regarding sponsorship, queries can be directed to either the Royal Devon R&D team at rduh.research-eastern@nhs.net or contact Ali Kerridge, Sponsored Study Manager at alison.kerridge@nhs.net.