One stop or full stop? The continuing challenges for researchers despite the new streamlined NHS research governance process

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.

Navigating the maze: ethics approval pathways for intellectual disability research: Table 1

“…In many cases, requirements have become lengthier and more rigorous, increasing the time and financial costs to researchers,24 25 and creating particular problems for postgraduate candidates or researchers on fixed-term grants with yearly reporting requirements. However, evidence from the UK indicates substantial improvement over the last decade, with clear provision for the inclusion of people without capacity to self-consent in research,22 and more efficient processes for ethical approval 12…”

The effect of the neonatal Continuous Negative Extrathoracic Pressure (CNEP) trial enquiries on research in the UK: Table 1

“…Investigators today, regardless of specialty, face multiple and lengthy approvals processes, progress reports to different agencies at variable intervals and in different formats, aggressive inspections, poorly trained NHS R&D staff, illogical, unnecessary, unreasonable and inconsistent rulings and the need to find ever-increasing financial support to service regulatory requirements 6–11. Responsibility for different aspects of research regulation is held by a number of ‘arms-length’ bodies, adding to the confusion.…”

A methodological study to compare survey-based and observation-based evaluations of organisational and safety cultures and then compare both approaches with markers of the quality of care.

“…This accords with the experience of other researchers. [193][194][195] Requirements varied significantly between sites and were not always clear (in two sites, significant changes were made in what was required during the process). For example, some sites required their own occupational health departments to clear us while others did not; some accepted the Criminal Records Bureau (CRB) check carried out at the request of our own employer, others applied for another or required that we did so.…”