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.
If the College is to act as sponsor for a clinical trial, please arrange this through the Research Governance and Integrity Team (RGIT), which also acts as the NHS R&D, by sending the following:
- A completed insurance registration form
- A copy of the research protocol
- A copy of the ethics application form and ALSO the participant information sheet and consent.
After carrying out a risk assessment, legal compliance review and ensuring that appropriate insurance is in place, the JRCO will issue a sponsorship letter, required to apply for ethical approval and MHRA authorisation. You must not assume that the College will sponsor your project until you have received this confirmation.
Documented assurance that the College has accepted the role of sponsor will also be made available to other parties as necessary, such as to the trial funders.
You must not register your project with an ethics committee until sponsorship has been confirmed by the JRCO.
|Type||Where to find|
|Key contacts||Clinical Divisions; RGIT
|Useful links||JRCO - Imperial as sponsor
JRCO - is a sponsor needed?
JRCO - Insurance
NIHR Clinical Trials Toolkit - Sponsorship
NIHR Clinical Trials Toolkit - confirm sponsor
|NIHR benchmark||Prior to NIHR 70-day benchmark|
|Process map links||This activity occurs in the feasibility stage:
> Imperial College London as sponsor
> Imperial College Hospital NHS Trust as sponsor