Sponsorship
The Department of Health Research Governance Framework for Health and Social Care (2005) requires all studies to have an identified Sponsor. The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study, but is not necessarily the funder.
You will need to identify an institution that is willing to take on this role. Many of the main funding bodies are willing to provide grants for research, but are not able to take on the responsibilities of Sponsor.
Oxford University Hospitals (OUH) is willing to accept the role of Sponsor of a research study when it is appropriate to do so; usually when an OUH employee has designed the study and is acting as the Chief Investigator. In any situation, the OUH must actively consent in writing to acting as Sponsor of a study, in signing the REC application and R&D application forms.
If you would like OUH to act as Sponsor for your study, it is important that you approach the R&D Department early in the development of your Study Protocol and associated documents, such as Participant Information Sheets, Consent Forms and Case Report Forms (CRF).
The purpose of the OUH Sponsorship Review is to:
- check that the proposed research and written protocol are appropriate
- assess the quality of the application to anticipate REC/MHRA queries
- ensure appropriate information is provided to potential participants
- confirm that information sheets and consent forms follow NRES guidelines
- ascertain that requisite legislation and guidance is being applied.
Timelines for the review process will be agreed at the time the application is assigned to a member of the OUH R&D team for review. It is important that you adhere to these timelines to allow OUH to process your application efficiently.
OUH R&D Department - Contact us
Guidance documents
University employees
If you are employed by the University of Oxford and would like the University to sponsor your study, please contact CTRG as early as possible.
Clinical Trials and Research Governance (CTRG) - researchsupport.admin.ox.ac.uk
Risk assessment
The Chief Investigator of a clinical trial has responsibility for the design, conduct and reporting of the trial. This includes ensuring the welfare of participants whilst in the trial, the safety of staff and that the trial is conducted according to good clinical practice and legal requirements.
All clinical trials need to undergo a risk assessment before initiation so that foreseeable risks and inconveniences can be weighed against the anticipated benefit for individual trial subjects and the general population as a whole. A trial must only be initiated and continued if the anticipated benefits justify the risks.
Identification of the risks associated with a trial must be performed at an early enough stage in trial development to allow for any necessary modifications to be made to the study design in order to minimise associated risk.