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Identifying a Sponsor
Who is the Research Governance Sponsor?
The Research Governance Sponsor is the organisation which accepts and takes on the legal responsibility for the research project. This includes overseeing the management of the project in participating sites.
Projects with Commercial Involvement - Will the funder of the work be the Research Sponsor? Many CTIMPs are Sponsored by Pharmaceutical companies. If it is not clear who the Sponsor is and there is commercial involvement, you should check with the funding body if they intend to be the Research Governance Sponsor.
In general, the Research Governance Sponsor is normally the organisation which substantively employs the Chief Investigator. The Chief Investigator has the responsibility for managing the trial (writing the protocol, managing and running the study, enrolment of patients, reporting to regulatory authority as required and writing the study report) this is regardless of where the project will take place. Some of these main responsibilities can be formally delegated to other persons or institutions. For any research that takes place in the context of the NHS in England there must be a sponsor. If the sponsor is outside the United Kingdom, it must have a legal representative in the United Kingdom
Where the study is funded by a research council, medical charity or other non-commercial body, the funder may be willing to act as a Sponsor, especially if it employs members of the research team or retains an interest in any intellectual property that is generated.
For any research study covered by this research governance framework, it is for the sponsor to be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing.
Student Projects or Projects undertaken as part of a academic course
Where a project is being undertaken as part of academic study, then the University where the course is being undertaken will be the Research Goverance Sponsor. This is regardless of where the project will be taking place and where the patients are being accessed. The University and the project supervisor is responsibile for the design, management and running of the study. The LTHT will extend normal indemnity arrangements to projects which are being undertaken by normal R&D Approval arrangments.
The student and supervisor will be responsible for ensuring that they have checked that all regulatory approvals are obtained prior to the project commencing.
CTIMP (Clinical Trials of an Investigational Medicinal Product)
If no formal sponsor is formally identified the clinical trial may not proceed within the Leeds Teaching Hospitals NHS Trust or University of Leeds.
Both the Leeds Teaching Hospitals NHS Trust (LTHT) and University of Leeds (UoL) will act as Sponsor. In order to accept this responsibility, the organisations need to be assured that there are adequate arrangements in place for the management of the study. The Researcher must contact the Quality Assurance Department at the draft protocol stage, if their clinical trial requires sponsoring by one of these organisations.
The Quality
Assurance Department will provide guidance throughout the trial set up. Standard
work instructions and templates have been developed to assist Researchers in
the correct process to follow for acceptance
of Sponsorship by the LTHT or UoL.
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