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 sponsor (as stipulated in Clinical Trials Regulations and the Research Governance Framework).

If your research is of this type you must identify a sponsor and seek formal confirmation they are willing to take on sponsor responsibilities.

It is no longer possible to obtain ethics approval or submit a UK grant application without first identifying who will act as sponsor.  Many UK funders and NHS RECs now require evidence of sponsorship via a signed letter.

Sponsorship

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 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 JRCO for advice. The role is administrative rather than legally responsible.

Your project will be carried out solely outside the EU.

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 JRCO as appropriate).
 
Your project will be carried out solely outside the EU.

RGM contact details

brains

Ruth Nicholson

Has responsibility for; Royal Brompton Hospital, London North West Hospitals, St Marys Hospital and South Kensington Campus.

Tel:  +44 020 7594 1862
Room 221
Level 2, Medical School Building
Norfolk Place
London
W2 1PG
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Becky Ward

Has responsibility for; Chelsea and Westminster Hospital, Hammersmith Hospital and Charing Cross Hospital.

Tel:  +44 020 7594 9459
Room 215
Level 2, Medical School Building
Norfolk Place
London
W2 1PG