Study sponsorship

About research sponsorship

A sponsor is an individual, organisation or group taking on the responsibility for securing the arrangements to initiate, manage and finance a study. Every research project involving people and their data must have a sponsor. The sponsor is usually one of the organisations taking a lead for particular aspects of the study.

University Hospitals Sussex takes an active role in study sponsorship, and aims to work with investigators to develop their research successfully.

In line with the UK Policy Framework for Health and Social Care Research, in most cases UHSussex expects Universities to accept the role of sponsor for all educational research conducted by their own students.

The Health Research Authority introduced new eligibility criteria for student research in September 2021. Students and their supervisors will need to use the HRA online student research toolkit and complete all sections before being able to submit an application through IRAS.

Requesting research sponsorship from UHSussex

If you would like UHSx to act as sponsor for your research, please get in touch [insert link to open email to: [email protected]] as early as possible in the development of your research idea.

The Research & Innovation Team can advise you on the feasibility of your proposal and the development of an appropriate application in line with Trust policies. We can facilitate access to support through our in-house specialists, NIHR Research Design Service and the Brighton and Sussex Clinical Trials Unit, and help you navigate the funding and regulatory approvals processes. In addition we have a dedicated team of Trial Managers available to support more complex or higher risk research studies.

Pre-Sponsorship Review Panel (PSRP)

All investigators seeking sponsorship by the Trust will initially be required to submit their completed protocol and associated documents to the Pre-Sponsorship Review Panel (PSRP). The PSRP is a joint venture by the University of Sussex, University of Brighton, UHSx and Sussex Partnership NHS Foundation Trust (SPFT). The PSRP is made up of academics, clinical researchers, quantitative and qualitative researchers, research governance representatives, disease area and specialist experts, research nurses, patient and public involvement members, statisticians and trial and data managers.

The Panel uses its wide expertise to review studies and make sponsorship recommendations to each of its four partners. A study that meets the required standards will be recommended for sponsorship by the trust, with or without minor amendments. Where improvements should be made to facilitate ethical, safety and/or regulatory compliance the panel will offer practical feedback, advice, and support to develop the application before it is submitted to the sponsor. If the changes required are significant the proposal would need to go back to the PSRP before it can be submitted to the sponsor. This process improves your chances of sponsorship and successfully securing rapid ethical and regulatory approvals.

Applicants should consult the ‘PSRP Document Submission Checklist’ to ensure all of the appropriate documentation is submitted for review at least 10 days before meetings which are held monthly.

For initial enquiries please contact PSRP [insert link to open new email to: [email protected].

Attending the PSRP meeting

It is recommended that you attend the PSRP meeting (in person or remotely) for about 15 minutes to provide an overview of your proposal, and respond to any panel member questions. Attending will give you access to expertise in:

Qualitative and quantitative research methods
Statistics
Funding
Recruitment
Pharmaceutical and device management
Laboratory and sample management
Imaging
Trial management

Sponsorship Approval

Applications that are recommended for sponsorship by the PSRP should be submitted for review at monthly by the Research Governance and Quality Assurance Group (RGQAG) on behalf of the sponsor. If your application is successful, the group will issue formal sponsorship approval and a Conditions of Sponsorship Agreement. The approval letter will outline any required changes or recommendations from the group that should be addressed before the application is submitted to an independent Research Ethics Committee (REC) and/or the Health Research Authority (HRA).

Making amendments to your research project

If your research is sponsored by UHSussex then any proposed amendment must be reviewed by the Trust as sponsor before the changes are implemented. It is the sponsor’s responsibility to determine whether an amendment is substantial or not, and therefore to determine which bodies need to review and approve the amendment before it can be implemented.

All amendment applications should be submitted to the sponsor using the HRA ‘Amendment Tool’ to categorise the change/s proposed. Guidance and the most recent version of the Amendment Tool can be accessed through the Integrated Research Application System (IRAS). Prior to ‘locking’ the categorised amendment, it must be submitted to the UHSussex sponsorship team along with the updated study documents (please include final and tracked changes if possible). Once the sponsor authorises the amendment the declaration section can be completed, the tool ‘locked for submission’ and a PDF copy generated for online submission to the appropriate bodies.