The University's sponsorship process for clinical research
A sponsor is required for all clinical research.
The sponsor's role is to:
- take legal responsibility for initiating and managing the study
- provide insurance for the study
The sponsor is not necessarily the funder and many funding bodies are unable to provide sponsorship.
University sponsorship process
The University usually assumes sponsorship when a University employee has designed the study and is acting as the chief investigator.
The University must actively consent in writing if it is to act as sponsor.
If you would like the University to sponsor your study, please contact the Research Governance, Ethics and Assurance team (RGEA) as early as possible:
- For clinical trials, please contact at the time of funding application.
- For other clinical research studies please send your documents for sponsorship review when they are prepared. Timelines for the review process will be agreed at the time the application is assigned to a member of the RGEA team for review (which, depending on workload, may be several days after you send us your full document set). It is important that you adhere to these timelines to allow RGEA to process your application efficiently.
Before submission to a research ethics committee all relevant study documentation for research proposals must be reviewed by RGEA staff.
Note that RGEA will need to review your documentation prior to submission to the MS IDREC subcommittee if the study involves healthy volunteers and recruitment of NHS staff as participants, or usage of NHS facilities, premises or identifiable data.
Please see the CUREC pages for more information.
The purpose of the RGEA sponsorship review is to:
- check that the proposed research and written protocol are appropriate
- assess the quality of the application to anticipate REC queries
- ensure appropriate information is provided to potential participants in outward facing documents
- confirm that information sheets and consent forms follow HRA REC guidelines
- ascertain that requisite legislation and guidance is being applied
- ensure University insurance will cover the participants for harm as a consequence of negligence
- confirm whether no-fault cover will also apply
- all substantial amendments are approved by RGEA before submission to CUREC, NHS REC and HRA (NHS sites in England), the MHRA or NHS trusts (with NHS sites outside England)
- non-substantial amendments including changes in end date, additional sites for non-CTIMP, and minor administrative changes, will need to be reviewed/approved by the sponsor before submission to HRA or relevant NHS trusts
- all annual progress reports, development safety update reports (CTIMPs only) and end of trial/study notifications must be copied to RGEA
RGEA maintain a database of all University-sponsored and hosted clinical research to facilitate compliance with applicable governance, regulations and reporting timelines. It is vital you send us regular study updates as the database is used for preparing annual insurance returns to the University’s insurance provider, including data on the number of participants, number of sites and start/end dates.
For most studies, the Research Governance, Ethics & Assurance Team can confirm indemnity within the letter of sponsorship.
However, certain categories of research must be referred by the Research Governance, Ethics & Assurance Team to the University insurance officer for individual consideration before doing so.
Research involving any the following will need to be referred:
- children under 5 years old
- investigation of processes of conception/contraception
- participants who are pregnant
- participants from outside the UK
- administration of drug/device/vaccine which has been designed, developed or manufactured by the University
- any genetically engineered product
The Research Governance, Ethics & Assurance Team will liaise with the insurance officer to determine whether cover can be arranged and, if so, any potential cost.
Unless your study is on the Research Governance, Ethics & Assurance Team's database, indemnity is not assured.
It is important that both the IRAS form and the participant information sheet include the correct indemnity statements. This is assessed individually on review of the study or trial. The Research Governance, Ethics & Assurance Team will advise on appropriate wording.