The UK Policy Framework for Health and Social Care Research (2017) requires all studies to have an identified Sponsor within the UK. The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation, management and conduct of the research study.
Swansea Bay University Health Board operates a Co- Sponsorship model with Swansea University Trials Unit for all clinical intervention studies.
The research protocol provides a detailed description of the objectives, design, methodology, statistical consideration and management of a research study. All protocols must be peer reviewed for scientific quality and relevance as part of research governance requirements.
Usually as part of the funding process, funders would have undertaken a robust peer review of the protocol, equally external Sponsors are responsible for peer review prior to submitting protocols to R&D for approval.
For all in-house Sponsored studies, the Health Board operates a Joint Study Review Committee with Swansea University.
The Committee meets monthly and in particular can offer in-depth statistical and randomisation advice to researchers’ through the support and collaboration of the UKCRC registered Clinical Trials Unit STU, based within the University.
Under the co-sponsorship model, usually all in-house Swansea Bay University Health Board clinical interventional studies will be developed in collaboration with Swansea Trials Unit.
Insurance and indemnity is a pre-requisite for all clinical research and is the responsibility of the Sponsor. A clear statement of who is providing cover and under what circumstances should appear in the study protocol, the participant information sheet and ethics application form.
Commercial or other non-commercial Sponsors of research will be responsible for providing indemnity and extending this indemnity to the Health Board.
Research Governance and Good Clinical Practice (GCP) places a responsibility on Sponsors and NHS sites to implement Standard Operating Procedures (SOPs) for every aspect of clinical trial management. Swansea Bay UHB currently utilise Standard Operating Procedures issued by Swansea Trials Unit available here alongside local SOPs available here.