The UK policy framework for health and social care research is the government policy that outlines standards and expectations for the ethical conduct and proportionate, assurance-based management of research in health and social care, so as to support and facilitate high-quality research in the UK that commands the confidence of care users. and the public. The policy mandates that all research falling under the remit of the Secretary of State for Health must have a formal sponsor. This includes all research in health and social care that involves NHS patients, their tissue or information or is funded with public funds. There are similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit.

It is good practice that any research outside the NHS, should also have a sponsor to take on the specific responsibilities of the role.

The sponsor is responsible for ensuring that the following arrangements are in place before a study begins:

• the research team to have access resources and support to deliver the research as proposed;
• ensure that the study is legally compliant and all risk has been effectively assessed;
• to allocate responsibilities for the management, monitoring and reporting of the research to a suitably qualified party.

The sponsor has to be satisfied there is agreement on appropriate arrangements to:

• record, report and review significant developments as the research proceeds, particularly those which put the safety of individuals at risk;
• approve any modifications to the design, obtain any regulatory authority required, implement them, and make them known.

For non-commercial research, sponsor is usually the substantive employer of the researcher leading the project, or in cases of student researchers, the institution where the student is registered. The university will usually sponsor research when a university employee has designed the study and is acting as the chief investigator or where the project is being conducted by a Lancaster University student in order to obtain an educational qualification.

There are certain circumstances when the university will not be able to sponsor research. For Example, the university is not currently able to sponsor CTIMPs. However, in these cases, the university will help researchers seek an appropriate alternative sponsor. We would encourage health and social care researchers who need a research sponsor to contact the Clinical Research Governance Team as early as possible in the grant development phase, as well as when the funding is awarded, in order to discuss arrangements and suitable sponsorship. Should the university be unable to sponsor your project, we will support you in finding an alternative.

The university must review your project in full and provide explicit consent to act as a sponsor. You must notify the Clinical Research Governance team of your intention to name Lancaster University as your sponsor before you submit your funding application.

• For clinical trials, the team will discuss the study with the Health and Social Care Research Sponsorship Committee and issue a ‘Sponsorship in Principle’ letter at the time of funding application where necessary. This will be provisional and subject to a full review once the funding is awarded, to confirm sponsorship.
• For all other clinical research, you will need to provide notification to the sponsorship team, who will give a provisional indication of sponsorship. This is subject to a full review of your final project when funding has been awarded and your documents are ready for ethical and regulatory review.

Please see the flow diagrams that describe the process pre and post-funding.

The researcher is responsible for getting all proposal documentation reviewed by the Clinical Research Governance Team. The team will provide feedback on the study and advise if the university will provide 'Sponsorship in Principle' before a funding application is submitted. For clinical trials or high-risk studies, this may involve liaising with the Health and Social Care Research Sponsorship Committee.

Once funding is awarded the researcher must prepare all regulatory documentation, and other trial documentation and submit it to the Clinical Research Governance team for review and approval.

On receipt of a full sponsorship letter, you may submit the trial documentation to the relevant parties.

For more information contact:

Clinical Research Governance Officers: sponsorship@lancaster.ac.uk