Sponsorship & Regulatory Approvals

Sponsorship

Does my research need university sponsorship? 

A sponsor is required for all clinical research.

  • Why does clinical research need a sponsor?

    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 involve NHS patients, their tissue or information. 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.

    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;
    • to allocate responsibilities for the management, monitoring and reporting of the research.

    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.
  • When can the university act as sponsor?

    The university will usually sponsor research when a university employee has designed the study and is acting as the chief investigator.

    There are certain circumstances when the university will not be able to sponsor research. However, the university will help researchers seek an appropriate alternative sponsor. If you want to know more about this contact the Sponsorship team.

  • How do I apply for the university to be a sponsor?

    The university must provide consent to act as sponsor.

    • For clinical trials, you must receive a ‘Sponsorship in Principle’ letter at the time of funding application. This will need to be actively confirmed once funding is awarded and your documents for sponsorship review are prepared.
    • For all other clinical research, you will need to get written confirmation of sponsorship when your documents are ready for ethical review. 

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

  • Sponsorship review

    For clinical trials, the researcher is responsibile for getting all funding documentation reviewed by the sponsor. The sponsor will provide feedback on the study and advice if the university will provide 'Sponsorship in Principle'.

    Once funding is awarded the researcher must prepare all regulatory documentation, and other trial documentation and submit it to the Clinical Trial Sponsorship Committee for review and approval. 

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

    For all other clinical research, the researcher is responsible for sending all documents to the Faculty Ethics committee for review and approval. On receipt of a full sponsorship letter you may submit the trial documentation to the relevant parties. 

    For more information:

    For clinical trials contact clinical.research@lancaster.ac.uk

    For all other clinical research contact your Faculty Ethics Officer.

Regulatory Approvals

Does my research need NHS ethics approval?

Do find out if your research will need to be presented to an NHS REC for review and approval use the HRA ethics toolkit to help you understand.

If you need further help and advice contact your Faculty Ethics Officer.

 

What other regulatory approvals will I need?

All studies falling into the category of CTIMPs require authorisation by the Medicines and Healthcare Products Regulatory Agency. Application is via the Integrated Research Application System (IRAS).

You will need to pay a standard application fee and a fee for any amendments until trial completion.

All other clinical trials will need to obtain ethics approval from either Lancaster University or NHS Ethics. If you need further help and advice contact your Faculty Ethics Officer.