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.
BSUH 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 BSUH 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 new eligibility criteria for student-research in September 2021. Students and their supervisors will need to use the HRA online student research toolkit student research toolkit and complete all sections before being able to submit an application through IRAS.
Continuous Professional Development for Principal and Chief Investigators
We encourage both current and aspiring Principal and Chief Investigators seeking sponsorship to complete the ‘Clinical Trials Management CPD Course’ which is delivered twice a year by the University of Sussex.
Taught over five days this course will explore all aspects of clinical trial management including study design, set up and on-going management, as well as the roles and responsibilities of Principal or Chief Investigator. All participants will be healthcare professionals with active roles in clinical trials, and this course will further develop clinical research skills and expertise. The module is offered free of charge to those healthcare professionals working in clinical research within Kent, Surrey and Sussex with support from the Local Clinical Research Network. For further information, dates and application form visit Clinical Trials Management CPD Course – BSMS
Requesting research sponsorship from BSUH
If you would like BSUH to act as sponsor for your research, please get in touch via bsuh.sponsorship.approvals@nhs.net as early as possible in the development of your research idea.
The R&D 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 the 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, Brighton and Sussex Universities Hospitals NHS Trust (BSUH) 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@sussex.ac.uk
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 to bsuh.sponsorship.approvals@nhs.net and will be reviewed 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).
Amendments
Contact
For more information on how to start the sponsorship process and dates of panel meetings, please contact bsuh.sponsorship.approvals@nhs.net
