Family Practice Vol. 21, No. 1, 92-98
© Oxford University Press 2004, all rights reserved.
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Developing research management and governance capacity in primary care organizations: transferable learning from a qualitative evaluation of UK pilot sites
a Department of General Practice and Primary Care and d Institute of Community Health Sciences, Barts and The London, Queen Mary's School of Medicine and Dentistry, Medical Sciences Building, Mile End Road, London E1 4NS, b School of Management, University of Surrey, Guldford, Surrey and c Mid Devon Primary Care Research Group, Devon, UK; e Present address: Department of Primary Care and Population Sciences, University College London, Holborn Union Building, Highgate Hill, London N19 5LW
E-mail: sara.shaw{at}pcps.ucl.ac.uk
Received 6 May 2003; Accepted 8 September 2003.
Shaw S, Macfarlane F, Greaves C and Carter YH. Developing research management and governance capacity in primary care organizations: transferable learning from a qualitative evaluation of UK pilot sites. Family Practice 2004; 21: 92–98.
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Abstract |
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Background. The capacity and capabilities for undertaking primary care research have increased both within and outside of the UK in recent years. The UK Department of Health aims to facilitate this further by establishing a national network of primary care organizations (PCOs) ready to act as hosts for shared research governance systems. However, it is unclear which models offer the most effective option. In addition, there is confusion over new processes and concern that researchers may be deterred from addressing important questions.
Objectives. The research ascertains how PCOs selected as pilot sites have organized research management and governance (RM&G).
Methods. We adopted a case study approach involving interviews with key informants in a purposive sample of eight pilot PCO (RM&G) sites.
Results. Motivating factors for PCOs to host RM&G included the possibility of additional resources and more effective use of research to improve service delivery. A range of organizational models were adopted, often reflecting existing strategic alliances. It is envisaged that it will not be effective or cost-effective for many PCOs to make individual arrangements for RM&G, and so models are already developing among groups of PCOs and partner organizations. The extent of partnerships between PCOs varied with concern over critical mass and dilution of expertise in larger groupings. The development and implementation of systems in pilot sites was facilitated by the support of the wider PCO in recognizing research as a valued and integral part of the organization; the effective management of relationships and the establishment of equal partnership arrangements for RM&G, and the effective use of existing R&D infrastructure and expertise.
Conclusions. RM&G partnerships vary according to local circumstances. It is likely that groupings will develop in the future with increasing co-terminosity and across wider health organization boundaries, such as Strategic Heath Authorities (in the UK) or primary care research networks. Critical mass of RM&G arrangements is likely to be linked to levels of research activity. There are real concerns over the levels of bureaucracy associated with the implementation of research governance; however, those PCOs that develop as RM&G sites have the opportunity to enrich their organizations and expand clinically relevant R&D. Partnership working within PCOs and with primary care research networks, academic departments or acute trusts, may be the key to success. Those undertaking research within primary care settings outside of the UK can learn important lessons from the UK experience and ensure development of high quality research that informs improvements in patient care.
Keywords. Health policy, organization and administration, primary health care, research.
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Introduction |
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The last two decades have witnessed active promotion of evidence-based decision making across the world. However, the knowledge base that currently exists to support primary care is not adequate for the challenges faced by health professionals in this setting.1 Research is required to allow for the development of new knowledge, and high quality and relevant research requires a well-developed infrastructure. This is well accepted in most Western countries,2 with a wider recognition of the need to assist developing countries to build their own research capabilities.3
In the UK, the Department of Health has explicitly promoted a research and development (R&D) strategy for the National Health Service since the early 1990s.4 This included the development of a framework for research governance in 2001, which aimed to improve research quality and safeguard the public through setting and monitoring standards which must be met by all research in health and social care systems.5 This has wide implications for the way research is both managed and conducted, and can provide valuable lessons to other countries interested in pursuing a similar route.
Ongoing modernization has meant that the UK health service has included radical organizational change in the shape of new primary care organizations (PCOs). In England, these are referred to as Primary Care Trusts (PCTs) and are set to become increasingly important, controlling 75% of the health service budget by 2004. This brings substantial opportunities for enhancing research to support good clinical practice and local service development.
With widespread involvement in commercial and university-led research and an increasing volume of research led by primary health care professionals, it is unlikely that there are many PCOs in which research is not already taking place. With increasing recognition of R&D as a major contributor to strategies for quality improvement, PCOs cannot afford not to take responsibility for research in their locality. All PCOs therefore need to address issues around the management and governance of research.
To facilitate this, the Department of Health is establishing a national network of Primary Care Trusts to act as hosts for shared research governance systems from April 2003. It is envisaged that it will not be effective or cost-effective for many of these organizations to make individual arrangements, and so models are already developing among groups of PCTs and partner organizations. However, little is known about the most effective size and organization of partnerships and the structures and systems needed to govern research most effectively. We have been working with the UK Department of Health over the last year to establish and evaluate eight research management & governance (RM&G) pilot sites. We sought to ascertain how PCOs selected as pilot sites have organized, or plan to organize, RM&G. We have used our findings to develop guidelines for the future development of PCOs hosting RM&G and to discuss implications for policy makers, PCOs and researchers both within and outside of the UK.
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Methods |
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Because of the need to explore organizational context and to identify how particular RM&G issues were addressed, we adopted a case study approach as part of the evaluation of selected pilot RM&G sites. We interviewed key informants in each site6 and collected contextual information pertaining to research activity and planning via a structured pro forma, designed by the research team. The research process is summarized in Figure 1.
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Pilot RM&G sites were selected by an expert reference group (Department of Health Primary Care RM&G Development Group) including representation from the research team. The selection process was informed by the collection of data by the research team on PCO plans for RM&G across England.7 This allowed for identification of those organizations taking a lead on RM&G development. A total of eight pilot sites were selected. Criteria for inclusion ensured sites with existing arrangements in place, a range of geographical locations across England and maximum variation of the organizational models identified. Pilot sites and their partner PCOs at the time of the evaluation are shown in Figure 2. This demonstrates variation in the size of groupings selected. Each site received up to £30 000 from the Department of Health to support the arrangements needed for pilot status.
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Case studies aimed to evaluate current and planned RM&G arrangements within each organization, the effectiveness of these arrangements and barriers to implementation. Common themes across sites were also extracted. A draft interview guide was piloted with an R&D Lead in one research-active PCO. A summary of topics covered in the semi-structured interviews with pilot sites is provided in Box 1. Key informants included the organization's R&D Lead (and R&D Manager where appropriate); a Board or Professional Executive Committee representative (e.g. Chief Executive, Director of Clinical Governance or Director of Public Health); and one or more representatives from partner organizations (e.g. research network, acute trust or Strategic Health Authority).
| BOX 1 Topics covered in interviews with key informants How the PCO developed its research agenda and the scope of research. The model of research management and governance in the PCO and how this was decided. The logistics of research management and governance, such as investment in infrastructure or development of systems for monitoring research activity. The successes of the system developed and problems encountered in implementing RM&G plans. The perceived benefits of hosting research management and governance and advice for a PCO trying to set up a similar model. Assistance the PCO may need to deliver on its RM&G agenda. Functions PCO (RM&G) sites might provide, other than research management and governance. How the PCO might widen its involvement in research.
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All interviews were audio-taped with consent, transcribed and analysed using Framework, an approach designed for policy analysis.8 The framework used for charting and analysis of data was developed by the researchers (SS, FM and CG) from the needs of the evaluation and the nature of the data generated. Although the results are not generalizable across all PCOs, they aim to describe key processes in establishing research governance and highlight areas of good practice which should be transferable between organizations.
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Results |
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A total of 28 interviews were undertaken across the eight sites, with three or four interviews in each. Only one person declined due to workload and time pressures. All interviewees engaged readily with the topic, particularly R&D Leads, who played a pivotal role in driving forward the RM&G agenda at an organizational level.
A number of themes emerged from the data: the motivational aspects for leading on RM&G; the impact of historical relationships and boundaries on the development of organizational models and strategic alliances; the structures and systems needed to implement RM&G plans; and the factors facilitating this.
Motivations to become lead RM&G sites
All sites selected by the expert reference group agreed to participate in the pilot and evaluation. Seven sites identified common motivating factors for taking on RM&G, including a desire to develop partnership arrangements and share both workload and resources to best effect; to raise the profile of the PCO; and to address recruitment and retention issues through developing research opportunities.
All sites wished to encourage greater involvement in research: "It's about profiling research with a new organization, profiling the organization with the research." (Chief Executive, Trust A). The potential for gaining additional resources, increasing the quality and management of research and improving service delivery were important motivating factors.
Key individuals and leadership in research
Five sites specified the enthusiasm and commitment of individuals as the prime driver for developing RM&G. This was particularly in relation to R&D Leads, but included PCO Chief Executives and research enthusiasts in the PCO. Leadership and influencing skills, the ability to co-ordinate activities and teams across departmental and organizational boundaries and strategic management skills were seen as essential attributes for R&D Leads. However, there was concern regarding over-reliance on such individuals and their "... ability to inspire the people around them." (Director of Clinical Governance, Trust B).
Organizational models adopted
The pilot RM&G sites adopted a range of organizational models and structures for developing and implementing research governance. These were built around existing and planned alliances with PCOs and other organizations at the time of evaluation. Key alliances are detailed in Table 1 which highlights RM&G partners and the number of other PCOs involved in arrangements.
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There did not appear to be any link between organizational models adopted for RM&G and the motivational aspects outlined above.
Critical mass
Sites attempted to identify the critical mass of research activity and relevant expertise required for development. In the first instance, small partnerships tended to form which were dependent on historical relationships and geographical boundaries. Longer term plans included expansion, with suggestions including coverage across a Strategic Health Authority (organizations with a performance management role, covering between five and 15 PCOs).
Between May and September 2002, information on RM&G plans was provided for 247 (79%) PCTs in England.7 Of these, 11 indicated that they did not intend to develop in partnership with any other PCOs, with a further 41 not in any partnership arrangements at the time and unsure of future plans. It was felt that organizational plans to develop RM&G in isolation from other PCOs may pose particular challenges. Pilot sites felt that it is important to be "... big enough to have a bit of muscle when it came to developing a centre for research." (Director, R&D Consortium A). Concern focused on the dangers of localized and lower quality research being undertaken in such models.
Conversely, some pilot sites also expressed concern about larger RM&G groupings being spread too thinly, with potential for expertise and capacity to be diluted and long-term sustainability affected.
Strategic partnerships
Involvement with other partners allowed relatively scarce research skills and resources to be shared. Partnerships included those with a very specific focus on research governance and others with a broader remit (e.g. developing research strategies and collaborative programmes of research). This varied according to local circumstances. Organizational summaries detailing key partnerships within pilot sites are available in Department of Health guidance on RM&G for primary and community care organizations.7
Table 1 demonstrates that acute trusts played a major role in developing RM&G for three of the pilot sites, with offices physically located with an acute trust. This reflected previous working relationships and existing expertise in managing research. In some cases, research expertise concentrated in the local Research and Development Support Unit (RDSU) provided a focus for the development of research governance systems.
In most cases, effective links with academic units were already established in relation to research activity, education and professional development. These, in conjunction with RDSUs and primary care research networks (PCRNs), provided a means for developing scientific review of research proposals, providing expert input to R&D Committees, developing strategy, identifying partners to lead and collaborate with in conducting research, and facilitating research capacity building through access to skills and training.
All pilot sites saw themselves as providing functions other than governance and planned to co-locate this with research capacity building. Seven of the eight sites specified strong links with a PCRN. Figure 2 shows that these seven sites are entirely encompassed by corresponding PCRNs, which provide research support across the geographical area covered by these RM&G pilot sites.
Factors facilitating the development and implementation of systems
Establishing systems required negotiation both within and between PCOs on the model to be adopted, the best use of resources and the allocation of responsibilities. The four phases identified as being essential to this process are summarized in Figure 3 and focus on stock-taking, engaging key staff within the lead organization and in partner organizations, developing systems and launching and disseminating the system. A number of key factors were identified which facilitated development.
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Mainstreaming R&D and engaging PCOs. Support of senior management was key to ensuring that research was a valued and integral part of the organization. This included the Chief Executive and the rest of the Board and Professional Executive Committee in developing a research culture within the organization and linking at a strategic level with commissioning and service development. Other internal directorates had a role to play in mainstreaming research, including the wider governance teams (e.g. evidence-based decision making in clinical governance), the public health team, and staff involved in teaching and learning. In addition, systems development was facilitated through internal PCO departments such as finance and human resources (e.g. to process honorary contracts for non-NHS researchers).
One of the factors which facilitated involvement of partner PCOs was the level of engagement with the wider R&D agenda. Support for governance arrangements was generated by placing research governance within a wider system of support for and facilitation of R&D (e.g. help in developing protocols) where participation was seen as beneficial, rather than an administrative or bureaucratic chore. In this way "... quite a few researchers do feel that going through that process is actually quite a help." (R&D Lead in Trust C).
Management of relationships. There was a need "... to manage partnerships on a much more effective basis." (R&D Lead in Trust D) ... and ensure that these fit with the wider strategic development for R&D in the locality. Good prior relationships between PCOs and other key partners in terms of joint working and providing shared services provided a sound basis for this.
In terms of geography, resources, research activity and experience, some PCOs had historical relationships which did not provide the most appropriate RM&G groupings. Sites therefore negotiated new relationships crossing traditional geographical and organizational boundaries. This was facilitated by the establishment of equal partnership arrangements and meaningful involvement from the outset, as well as clear definition of roles and responsibilities. It is worth noting that in most cases research governance arrangements seemed to evolve mostly around a nucleus provided by existing relationships before spreading across less familiar boundaries.
Effective use of existing systems and expertise. Existing R&D infrastructure (e.g. PCRNs, research practices and organizations with a strong teaching infrastructure) and a critical mass of research expertise (e.g. collaboration with universities) facilitated development of systems, allowing sites to build on the expertise of other, often more mature, organizations.
Previous assessments of research activity within localities were valuable, as were existing research governance implementation plans. Existing arrangements for research governance in a neighbouring or local Trust (including secondary care and Partnership Trusts) often provided the initial foundations for development.
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Discussion |
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The implementation of the Research Governance Framework is a major policy imperative in the UK. One key driver for this development lies in a European Parliament directive reflecting concerns over pharmaceutical company-sponsored research and the need to ensure high clinical standards with respect to the testing of medical products. Along with a number of incidents in the UK relating to research misconduct, this has fuelled both government and professional commitment to make certain that patients involved in health and social research may be reassured that it is undertaken to the highest standards. European Union member states will need to follow a similar route. Despite differences in models of health care, these and other countries potentially may learn useful lessons from the implementation of research governance procedures in UK primary care.
In the UK, a new-found emphasis on quality in the NHS has witnessed the increased development of specific markers. These have typically focused on hospital services, but more recently have expanded within primary care.9 This has been driven by the policy agenda for continuing professional development and evidence-based decision making to inform improvements in patient care, as well as the greater emphasis on consumerism in public services.10,11 This is reinforced by a recent ministerial statement which underlined the contribution of research to the development of a quality framework for enhanced patient care.12 The statement announced a review of the role of PCTs in relation to both learning and research, due to be reported in December 2003.
The results of our research demonstrate the range of organizational models being adopted by PCOs to implement research governance. Variations on these models may develop over the coming months as plans progress for a national network of PCOs to implement research governance and as these organizations acknowledge research as being integral to their business.
Findings from the evaluation indicate that RM&G models will initially be informed by historical relationships and tend to develop as smaller groupings. Further clarification is needed as to the optimum critical mass required to sustain RM&G arrangements. Our findings have informed Department of Health guidance7 and the selection of a network of 63 PCTs to act as lead sites for research governance from April 2003. Longer term planning includes the formation of larger groupings. However, critical mass is likely to be more closely linked to levels of research activity than to number of PCOs and partnership arrangements. Future co-terminosity with other organizational structures was not discussed in-depth by pilot sites and remains unclear at the time of writing. This may include ensuring geographical fit with UK Strategic Health Authorities or with PCRNs.
Real concerns remain that the implementation of research governance will result in the increased bureaucratization of primary care research. Our research also indicated confusion with regard to RM&G processes. Guidance has now been produced which should help to clarify areas of uncertainty.7 However, procedures implemented by PCOs may distract and deter some researchers from answering important questions. Other studies have highlighted potential barriers to research activity, including time available.13 The perceived increased administrative burden placed on both novice and experienced researchers has the potential to further reduce protected time for research activity. It would be ironic if the drive to improve quality in primary care R&D resulted in stifling the very activity it intended to nurture. Hence, those countries considering following a similar route would do well to heed these concerns in relation to future research policy and planning and ensure continued capacity and motivation to undertake primary care research.
The Research Governance Framework provides opportunities for development in PCOs.5 Governance and capacity-building elements of research, both within and outside of the UK, tend to be co-located and can provide an important base for the development of primary care knowledge, decision making and organizational development. Concerns over bureaucratization in relation to UK processes may need to be put to one side while PCOs grasp the opportunity provided to build research into the foundations of their organization. This is reinforced by Bryar who acknowledges the perception of research governance as an additional burden for PCOs to grapple with in a time of rapid organizational change but argues that it may provide a means for "... R&D capacity building to become a mainstream NHS activity."14 She argues that this process may provide further impetus to expand clinically relevant R&D undertaken by primary care practitioners.
Possible solutions to encouraging both effective RM&G and increased research capacity in primary care may lie in sharing knowledge and partnership working. This applies to relationships within PCOs (as they develop as learning organizations) and with external organizations and individuals with the necessary knowledge and skills. In terms of research governance, academic departments, RDSUs, PCRNs and other established organizations involved in primary care research provide an obvious source of expertise (e.g. peer review and project monitoring procedures), on which PCOs can draw.15
Other partnerships will be essential to ensure continued capacity building. This will require separate funding. Mappings indicate co-terminosity between PCRNs and most RM&G pilot sites, which may assist in developing this. However, at the time of writing, the future role of PCRNs is unclear. Further clarification may be required as to the core functions of PCRNs in the UK and elsewhere, and their potential role in supporting RM&G in primary care settings.1,16
Primary care research must adhere to policy requirements, ensure effective governance and continue to work in partnership to build capacity. Time will show whether or not the motivations of pilot sites to act as lead RM&G sites were warranted. However, it is envisaged that, despite the challenges PCOs may face in fully discharging responsibilities, those that develop as RM&G sites will enrich their organization as they begin to realize fully the longer term value of research to patient care. Elsewhere in the world, PCOs and their patient populations have the potential to reap valuable rewards by adopting a similar approach.
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Acknowledgments |
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Our thanks go to all pilot sites involved in the evaluation, and particularly to R&D Leads. The team wishes to acknowledge the contribution of Andy Wagner (National Primary Care Research and Development Centre, University of Manchester) in mapping RM&G plans and partnerships across England. This study was funded by the UK Department of Health Research Capacity Development Programme. The views expressed in the paper represent those of the authors and not necessarily those of the funding body.
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