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 that 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 responsibilities. The PI needs to apply for the sponsorship through the Imperial Ethics Process.
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.
Imperial College or ICHT as a sponsor
Imperial College London or Imperial CollegeHealthcare Trust can act as sponsor if:
- The project is Investigator led and Imperial or ICHT is the employer or
- The Investigator has an honorary appointment with Imperial or ICHT and has funds being administered through Imperial.
Imperial College London or ICHT cannot sponsor anyone else as we cannot legally uphold the requirements of sponsorship without an active employment contract.
The project will have commercial funding but the protocol has been designed by the PI at Imperial. The project will have a P-number associated to the funding. If the project has Internal funding or is unfunded it means you need your 'own account' and you will have developed the protocol. Internal funding means 'own account' or unfunded research. Your project may be charity-funded and may involve tissue samples or only observations.
If the sponsor is outside of the UK but wishes to conduct the study within the UK, then a legal representative is required, who will be the main contact point for the study going through ethics application process. 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 Clinical Trials of an Investigational Medicinal Product (CTIMPs).
Investigator as a sponsor
We advise that a College or Trust employee never take on sponsor 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
In rare cases a sponsor may not be needed under regulations/guidelines for your research.
This is usually only the case for research outside the UK and EU e.g. certain Eastern European nations and African states.
However, you must still be aware of other local regulatory requirements including; ethics approval, data protection requirements and obtain the relevant internal approvals (R&D and/or RGIT as appropriate).
Your project will be carried out solely outside the EU.
RGM contact details
Research Governance Manager who has responsibility 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 who has responsibility for: Royal Brompton Hospital, London North West Hospitals, St Marys Hospital, Western Eye Hospital and South Kensington Campus.
Clinical Trials Manager who has responsibility for: Clinical Trials of Investigational Medicinal Products (CTIMPS) across all sites.