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

BACKGROUND: Obtaining 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. METHODS: We 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. RESULTS: Our 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. CONCLUSIONS: If 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.

The meaning of patient involvement and participation in health care consultations: a taxonomy.

A number of trends, pressures and policy shifts can be identified that are promoting greater patient involvement in health care delivery through consultations, treatments and continuing care. However, while the literature is growing fast on different methods of involvement, little attention has been given so far to the role which patients themselves wish to play, nor even of the conceptual meanings behind involvement or participation. This article reviews the current models of involvement in health care delivery as derived from studies of professional views of current and potential practice, prior to examining the empirical evidence from a large-scale qualitative study of the views and preferences of citizens, as patients, members of voluntary groups, or neither. Individual domiciliary interviews were carried out with 44 people recruited from GP practices in northern England. These respondents were then included in a second phase of 34 focus groups in 6 different localities in northern and southern England, of which 22 were with individuals unaffiliated to any voluntary/community groups, 6 related to local voluntary/community groups with specific interests in health or health care, and 6 related to groups without such specific interests. A final set of 12 workshops with the same samples helped to confirm emergent themes. The qualitative data enabled a taxonomy of patient-desired involvement to be derived, which is contrasted with professional-determined levels of involvement identified from the literature. Participation is seen as being co-determined by patients and professionals, and occurring only through the reciprocal relationships of dialogue and shared decision-making. Not everyone wanted to be involved and the extent to which involvement was desired depended on the contexts of type and seriousness of illness, various personal characteristics and patients' relationships with professionals. These levels are seen to provide basic building blocks for a more sophisticated understanding of involvement within and between these contexts for use by professionals, managers, policy-makers and researchers.

Predicting and comparing patient satisfaction in four different modes of health care across a nation.

This study aims to inform strategic policy makers and managers about the value of general population surveys by determining and comparing dimensions of satisfaction in four different health services in Scotland: general practice, domiciliary care, outpatients and inpatients (including day cases). The research design involved secondary data analysis of a national telephone survey conducted to inform the development of a national health plan. The database was created using a stratified quota sample of 3052 people of 16 years and above resident in Scotland in 2000. The main outcome measures investigated were overall measures of patient satisfaction with each type of service. Principal components analysis was used to determine the dimensions. Interest was in the extent to which patients, many of whom were the same (having used more than one service), evaluated different services in similar ways, as well as those factors specific to each service. Using logistic regression, the results demonstrate that interpersonal care and information, and desired improvements in service were universal and key explanatory dimensions in all services, followed by a combination of access, physical facilities, time and quality of food, depending on relevance to the service. These factors, particularly interpersonal care and information, distinguished well the highly satisfied from the others, with age providing further discrimination between non-hospital patients, while gender added to discrimination between inpatients. In conclusion, despite the limitations of telephone interviews, it is feasible to ask about several services at the same time and for the answers to reflect common underlying dimensions of evaluation found in more exhaustive research within each service. These factors offer a set of summary measures by which services can be easily evaluated at a strategic level and point to where efforts to increase patient satisfaction can be maximised.