Abstract
BackgroundObtaining the necessary approvals and permission for clinical research requires successful negotiation of the ethical and R&D layers of the NHS. Differences in structure and governance frameworks feature between the constituent nations of the UK (England, Scotland, Wales and Northern Ireland), which adds complexity to cross-national studies. Difficulties in carrying out research in the NHS in the UK due to bureaucratic and time-consuming governance processes have led to the development of a new system of application and co-ordination from 2009. This paper illustrates how this new system fails to be consistent and streamlined and is unlikely to become so unless changes are made to the implementation and management of the governance processes.MethodsWe present a case study of the research governance process at the survey stage of an investigation into the use, preferences and need for information by people making choices or decisions about health care. The method involved home-based, face-to-face interviewing in a questionnaire survey in relation to decisions about lymphoma treatment, Down's syndrome screening in pregnancy, and caring for people with dementia.ResultsOur experience of the ethics stage was very positive, noting an efficient process of application and a speedy decision, both in relation to the initial application and to subsequent substantial amendments. By contrast, the R&D stages were very slow, most with unexplained delays, but some offering contradictory advice and exhibiting a lack of clear guidance and training for NHS staff. The R&D arrangements in Scotland were far quicker and more likely to be successful than in England. Overall, the delays were so severe that substantial parts of the research could not be delivered as planned within the funding timescale.ConclusionsIf high-quality research in the NHS, particularly in England, is to be delivered in a timely and cost-effective way, R&D processes for gaining research governance approval need improvement. Attention is needed in process implementation and management, particularly in relation to staff training, as well as clarity in guidance and communication within and between organisations.
Highlights
Obtaining the necessary approvals and permission for clinical research requires successful negotiation of the ethical and Research and Development (R&D) layers of the National Health Service (NHS)
The case study we describe below concerns the final stage of this design, which involves a questionnaire survey in Scotland and England, using face-to-face, homebased interviews, of people who faced decisions in one of three situations: whether to have treatment for a diagnosis of lymphoma; whether to have an antenatal test for Down's syndrome; and, where a person with dementia should live by people caring for them in an unpaid capacity
Ethical approval Due to the multi-centre nature of this research stage, ethical approval was sought via one of the Research Ethics Committees (RECs) in Scotland, which acted on behalf of all RECs
Summary
Obtaining the necessary approvals and permission for clinical research requires successful negotiation of the ethical and R&D layers of the NHS. Difficulties in carrying out research in the NHS in the UK due to bureaucratic and time-consuming governance processes have led to the development of a new system of application and co-ordination from 2009. This paper illustrates how this new system fails to be consistent and streamlined and is unlikely to become so unless changes are made to the implementation and management of the governance processes. A new system providing a consistent and streamlined process for gaining NHS permission for clinical research in England Against a backdrop of severe and sustained criticism of the NHS research governance arrangements in the UK over the last 10 years, the above strapline [1] heralded a more efficient and integrated system for conducting research in the NHS from 2009 onwards.
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