The responsibility of the research should lie with the academic institute or educational provider. Commonly the Academic institution e.g. University or Higher Education Institute will acts as the study ‘Sponsor’ as defined in the RGF 2005.
Students embarking on undertaking clinical research within the Trust should contact the Health Service Research Manager for guidance on the necessary approvals process.
The Study sponsor has the responsibility for arranging scientific and peer review and has the following additional responsibilities:
- Assuring the quality of the research proposed (including assessment of the scientific and ethical quality of the proposal, and of the safety and well-being of participants).
- Assuring the ability of applicant to conduct the proposed research.
- Assuring that sources are available realistically to achieve the proposed research objectives.
- Assuring an active and effective system is in place to monitor and assess the progress of the research.
- Assuring that appropriate arrangements are in place to disseminate the findings of the research.
- Assuring any necessary arrangements for provision of indemnity are in place.
Before making a submission to a REC the research supervisor is required to assess the level of experience of the student, and to provide a level of support that reflects this.
The standard NHS Ethics Application Form will need to be completed. Once a favourable ethical opinion has been provided, R&D approval must be obtained from the Trust before the project can begin.
Any subsequent changes made during the duration of your project need to be reported to the relevant REC by filling in appropriate amendment forms.
On completion of your research project, please notify the relevant R&D Department and REC with this information http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progress-reports/