Sponsorship

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.
• For studies that will only be recruiting NHS staff by virtue of them being a current or former employee of the NHS (e.g. advertising within the NHS or using NHS emails) and are thus eligible for Sponsorship and University ethics committee review, refer to the MS IDREC information about this.

Timelines for the review process will be agreed at the time the application is assigned to a member of the RGEA team for review. It is important that you adhere to these timelines to allow RGEA to process your application efficiently.
 

Following the decision by FRGPC in November 2022, a sponsorship fee must be included in the costings of certain clinical research studies sponsored by the University. A charge will be levied on commercially-funded clinical studies and trials, where the University is to be the sponsor. These funds must be received before a study receives sponsorship. 

The relevant costing estimate will be provided by RGEA on request and will be based on the characteristics of the proposed study or trial. Email RGEA.Sponsor@admin.ox.ac.uk to request an estimate of costs or for further information. 

Before submission to a research ethics committee all relevant study documentation for research proposals must be reviewed by RGEA staff.

Note that Sponsorship review will be required in addition to MS IDREC review where the study involves healthy volunteers and recruitment of NHS staff as participants, or use of NHS facilities/premises.

Please see the MS IDREC application page 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. For further details please see insurance for research. 

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.