All clinical trials of investigational medicinal products in the EU and or research carried out in the NHS or social care must have an identified legal sponsor (as stipulated in Clinical Trials Regulations and the UK policy framework for health and social care).
If your research is of this type you must identify a sponsor and seek formal confirmation they are willing to take on sponsor responsibilities. Non-NHS healthcare research or non-healthcare research may also require oversight and insurance, as per legal sponsor responsibilites. These studies should apply through the Imperial Ethics Process: https://www.imperial.ac.uk/research-ethics-committee/
It is no longer possible to obtain ethics approval or submit a UK grant application for healthcare research without first identifying who will act as legal sponsor. Many UK funders and NHS RECs now require evidence of sponsorship via a signed letter.
Non commercial sponsor
Imperial College London or NHS Healthcare Trust can act as sponsor if:
- The project is Investigator led and Imperial is the employer or
- The Investigator has an honorary appointment with Imperial and has funds being administered through Imperial.
Imperial cannot sponsor anyone else as we cannot legally uphold the requirements of sponsorship without an active employment contract.
Your project will have commercial funding but the protocol has been designed by you as an employee of Imperial. Your project will have a P-number associated to the funding or your project wil be "own account" and you will have developed the protocol. Your project may be charity-funded and may involve tissue samples or only observations.
Non UK sponsor
If the sponsor is outside of the UK but wishes to run the study within the UK then a legal representative is required. They will be the main contact point for the study going through ethics. If you are asked to be a legal representative for a study in the UK please contact the RGIT for advice. The role is administrative rather than legally responsible. The role is only legally required for CTIMP studies.
Investigator as a sponsor
We advise that a College or Trust employee never take on sponosr responsibilities for a research study as this would require full insurance (in excess of £25 million). A research team would also be needed to carry out monitoring and auditing etc.
Sponsor not needed
RGM contact details
Research Governance Manager responsiblr for : Hammersmith Hospital, Charing Cross Hospital and Imperial College London campus at Chelsea and Westminster Hospital.
Cheuk Fung Wong
Research Governance and Quality Assurance Manager for : Royal Brompton Hospital, London North West Hospitals, St Marys Hospital and South Kensington Campus.
Clinical Trials Manager responsible for Investigational Medicinal Products (CTIMPS) across all sites.