Within NHS organisations (and some Higher Education Institutions) there are Research and Development (R&D) Departments or Clinical Research Offices. Organisations that work closely together, for example an NHS Trust and a local university may have joint R&D offices. These offices act on behalf of the organisation(s) to facilitate the local management of all research within that organisation.
An NHS R&D Office must give formal permission (see R&D Submission station) before a research project can take place within their organisation:
- When acting as the sponsor, NHS R&D offices will be involved in the oversight of the trial by guiding the Chief Investigator and managing the risks associated with any trial initiated.
- When acting as a host organisation, NHS R&D offices facilitate the timely risk management and set up of externally sponsored trials and support the Principal Investigators participating in those trials.
Whichever scenario applies, these offices need to be aware of all projects that involve their organisation’s staff or resources, in order to ensure that:
- Appropriate negotiations are initiated with relevant university or NHS departments (and other third parties)
- Appropriate arrangements are put in place to support the research
- Risk management measures are in place, in particular appropriate insurance or indemnity provision.
Researchers are advised to contact their local R&D Office in the early stages of study development so that they can help identify facilities that can provide valuable support.
It will be important when consulting R&D to define how costs are allocated by differentiating between research costs, NHS service support costs and treatment costs in relation to activities specified in the protocol. The Department of Health’s AcoRD guidance should be referred to in this activity.
It is mandatory for all research (CTIMPs and other studies) in the NHS to be conducted in line with the Research Governance Framework(s) and the R&D Office is responsible for ensuring that all research meets these requirements. Country specific versions of the Framework have been published for England, Scotland, Wales (PDF, 675 KB) and Northern Ireland (PDF, 350 KB).