You need sponsorship - legal, not financial
Find out how to gain study sponsorship form UHS, mandatory under the Research Governance Framework for Health and Social Care.
It is a legal requirement for all Clinical Trials of Investigational Medicinal Products (CTIMPs) to have a sponsorI, under the Medicines for Human Use Clinical Trials Regulations 2004 and the Amendments Regulations 2006, .
UHS's agreement to act as sponsor is not full R&D approval for the study and is conditional on full UHS R&D approval being gained through the normal R&D approval process (see conditional agreement, below)
When UHS will act as sponsor
Where there is no third party sponsor, University Hospital Southampton NHS Foundation Trust (UHS) will usually act as sponsor for research where:
- The research involves any UHS resources, staff or patients
- The chief investigator (CI) is a substantive employee of UHS
- The chief investigator (CI) holds an honorary contract with UHS and a substantive employment contract with the University of Southampton (UoS)
- The research study is a 4th year medical student project that involves UHS premises, staff, patient and/or resources
- The UoS Clinical Trials Unit (UoS CTU) is managing the study
Please note: all University of Southampton staff must also submit their project to the University Research Governance Office| via the IRGA form and relevant documents. | via the IRGA form and relevant documents.
How to apply for UHS to act as your sponsor
If you wish UHS to act as sponsor for your research study you should complete a sponsor request form and email the following documents to ResearchManagement@uhs.nhs.uk and email the following documents to :
Where the Trust agrees to act as sponsor we will provide a provisional sponsorship letter outlining responsibilities; UHS may then be named as the sponsor on subsequent applications to the Medicines and Healthcare products Regulatory Agency (MHRA), National Research Ethics Service (NRES) etc.
UHS's agreement to act as sponsor is not full R&D approval for the study and is conditional on full UHS R&D approval being gained through the normal R&D approval process.