The NHS Research Governance Framework for Health and Social Care (RGF) requires all research to have a designated Sponsor, who takes overall responsibility for the design and conduct of research.
Any employee of the Trust who wishes to undertake research within their employment capacity is entitled to request the Trust to act as a Sponsor for that research.
The Trust reserves the right to refuse sponsorship of a research project if deemed that the project cannot be adequately supported e.g. funding, resources, monitoring or the peer/scientific review deems the project of low value or it does not meet the requirements outlined in the applicable regulatory guidelines, this includes (but not limited to):
- The RGF (as amended)
- The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended)
- ICH GCP E6 (R1)
- EU Clinical Trials Directive 2001/20/EC
- EU GCP Directive 2005/28/EC.
The R&D Office should be approached as early as possible in the process. Before a decision is made an internal assessment (peer review and risk assessment) will be undertaken to ensure safety and scientific quality of the proposal.
The R&D Office should be approached prior to any submission to the REC and MHRA (if CTIMP) as all investigators will be asked to provide prove of Sponsor. No submissions can be made to the relevant bodies or authorities until Sponsorship has been confirmed by the NWLH NHS Trust R&D Office.
The following documents should be submitted:
- Protocol (this will be peer reviewed within approx. three weeks of submission to R&D, this timeline may be delayed if a suitable reviewer cannot be identified)
- List of Investigators and possible co-investigators
- Costing of the research and funding source (The R&D Office can provide guidance if required)
After peer review, the project will be tabled for assessment by the R&D Team where safety issues, intellectual property potentials and the cost-implication of the project to the Trust will also be reviewed. Should the R&D Office find that there is possible Intellectual Property or Innovation arising as a result of the project, help will be offered to the Investigators to realise its full potential.