Background
Cross-sector research partnerships are an important component of the contemporary research landscape. The National Institute for Health Research (NIHR), for example, invests over £1 billion per year supporting partnerships between National Health Service (NHS) organisations and universities in England. Most notably, these include NIHR Biomedical Research Centres (BRCs) and NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) [
1‐
4]. The United Kingdom Department of Health also invests efforts and resources in wider multi-stakeholder partnerships, including Academic Health Science Centres (AHSCs) and Academic Health Science Networks [
5‐
7], described as the NHS’s “
gateway to the life sciences industry” [
8]. All these structures encourage strong links with industry and high levels of patient and public involvement and engagement.
The goal of NIHR BRCs is to accelerate both ‘T1’ translational research (from the laboratory bench to clinical trials) and ‘T2’ translational research (from clinical trials to implementation in clinical practice and policy) [
2,
9]. The first wave of these BRCs was established in 2007; as of April 2017, there are 20 such centres nationally. As stated by the NIHR, their aims are to [
4] drive innovation in the prevention, diagnosis and treatment of ill-health, translate advances in biomedical research into benefits for patients, and help the NHS contribute to the nation’s international competitiveness.
Whilst NIHR BRCs are specific to the United Kingdom, the idea for cross-sector research partnerships aimed at rapidly promoting and translating life sciences and technology research into benefits for patients originated in the United States of America [
10]. These networked structures are now a global phenomenon [
11,
12], intended to generate synergies that drive innovation and accelerate the translational research pathway [
3].
There is evidence to suggest that NIHR BRCs, including one in Oxford, have had some positive impacts on resource targeting, management and governance in translational research for patient benefit at the interface between NHS organisations, universities and industry, but there is also some evidence of negative impacts and a number of as yet unexploited opportunities to maximise the value of biomedical research [
13‐
15]. Research on similar cross-sector translational research partnerships in other countries suggests that they sometimes, but not always, achieve their goals [
16‐
18]. Some authors have argued that cross-sector partnerships in rapidly-developing, high-technology fields may generate substantial research waste as patients’ needs and priorities are overlooked in favour of the relentless pursuit of innovation and commercial influences that conflict with the pursuit of the public good [
19‐
21]. Others have taken the opposite view and argued that there is evidence of significant societal impact and economies of scale from such partnerships [
22]. A recent review that asked whether concentrating research funding into a small number of very large research centres (as in BRCs) was likely to produce economies or diseconomies of scale concluded that there were examples of both in the literature [
23].
Underpinning the policy of ‘innovation, health and wealth’ is the implicit assumption that pursuit of the first of these goals (innovation) through what has been termed the ‘managed network’ approach [
24] will – if strategic drivers are appropriately aligned – generate the second two [
25‐
27]. The rationale for this policy is that, in order to keep pace with rising expectations and growing demand, especially when innovation generates interventions that are both effective and costly, the health sector needs to become more efficient, embrace innovations that are both effective and cost-effective, and generate additional income. Potentially, this can be achieved through a thriving regional innovation system that accelerates economic growth and wealth creation while at the same time generating worthwhile innovations for use in the NHS.
From its inception, the NIHR has strongly supported patient and public involvement and engagement (PPI/E), the former being defined as involvement of patients in the design, delivery and dissemination of research, and the latter as outreach from research scientists to communities and citizens [
28]. The many and varied PPI/E activities by NIHR BRCs appear to align respectably with calls for the ‘democratisation’ of science [
29,
30] and have produced some (albeit relatively weak) evidence of societal impact [
31]. However, there is also evidence that the underpinning values driving high-technology biomedical research may sometimes be at odds with those of patients and citizens [
32‐
34], and that, whilst BRC-funded researchers have been content for patients and the public to ‘tinker at the edges’ with science through consultation and outreach, some remain opposed to genuinely democratic partnerships in which citizens and scientists collaboratively set a research agenda and jointly oversee its delivery [
35].
More broadly, BRCs lack an explicit link to the wider policy context for their work. NIHR BRCs are depicted as facilitating a pathway from basic bench science through to clinical practice, but – surprisingly – the surrounding policy context does not figure in core documents describing their scope and purpose [
3,
9,
25]. Yet, this policy context heavily conditions that process of translation at every stage. It determines, for example, what other funds are available, what rules govern different stages of research such as clinical trials, what intellectual property rules apply to products versus service changes, and how different innovations relate to the financing and organisation of the NHS [
4].
In sum, multi-stakeholder research partnerships, particularly in high-technology biomedical research with significant commercialisation potential, appear to be characterised by inherent complexity, multiple drivers, conflicting values and contested metrics of success. The potential synergies associated with these new organisational forms are considerable, but they are not guaranteed. Whilst the goals of ‘innovation’, ‘health’ and ‘wealth’ have been rhetorically aligned in policy documents and support a plausible narrative, they do not always march in step. Work must be done to maximise synergies, minimise waste and ensure responsible research and innovation.
Accordingly, as the NIHR Oxford BRC enters its third 5-year funding period (2017–2022), we present this study protocol for a programme of research seeking to (1) apply the existing evidence base on how best to support the various partnerships in this large, knowledge-based, multi-stakeholder research system; and (2) research how these partnerships play out in a new and ambitious programme of translational research.
Rationale for this study protocol
Developing, pre-registering and publishing a study protocol for this novel programme of research spanning the entire NIHR Oxford BRC and other cross-sector research partnerships in the Oxford region is an important step towards maximising the value of the NIHR’s investment in research. It has the potential to strengthen the scientific rigour of the proposed research, optimise the efficiency of the research process, and improve the reproducibility of results, for the reasons stated below.
First, carefully developing and scrutinising research questions – both by the ‘Partnerships’ core research team and through independent oversight and external peer review – at the research design stage can simplify data collection, make data analysis more rigorous, and strengthen the quality of reporting [
36]. We have developed this study protocol in collaboration with all researchers involved in the ‘Partnerships’ cross-cutting theme and have incorporated critical input from the leaders of other BRC themes and an external advisory group. To strengthen the quality of reporting and the potential for theorising, we will use published methodology for ‘n of 1’ case study research [
37‐
39], adapting as appropriate to the unique nature of the case(s) under scrutiny.
Second, transparency can improve the quality of research and avoid duplication of effort by different researchers conducting similar research [
40]. While registering experimental clinical studies on websites such as clinicaltrials.gov is now standard practice, this is not the case for qualitative case studies. To increase transparency and discoverability of our research, we have created a dedicated project page on a social networking site for scientists (see Dissemination section below). Moreover, to ensure unrestricted access to our research, we commit to publishing in open access journals.
Finally, publishing a study protocol helps mitigate publication bias, which (when it occurs) limits the available evidence base and wastes time and resources on repeating studies that have been conducted elsewhere. Large-scale organisational case studies of knowledge translation are rarely published unless they describe positive findings, which suggests that this study design may currently be particularly open to publication bias [
41]. By publishing our study protocol, we make a public commitment to publishing all of our research, including both positive, negative and ambiguous findings.
Discussion
This study protocol has described the rationale and methodology for a novel approach to building and strengthening the various partnerships in the NIHR Oxford BRC and beyond as it embarks on its third 5-year period of NIHR funding from 2017 to 2022. We have presented our BRC as a crucial case study – a setting in which many of the preconditions for success are already in place, hence a good place to test a new approach for enhancing that success. We have introduced three linked theoretical perspectives (Triple Helix, Mode 2 Knowledge Production and Value Co-creation) relevant to the operation of large, multi-stakeholder health research partnerships. We have described the structure and governance of a new ‘Partnerships for Health, Wealth and Innovation’ cross-cutting theme, and, within that theme, we have outlined our plans to support and evaluate a maximum variety sample of cases in different aspects of partnership working. Finally, we have emphasised the importance of creating an ongoing narrative of progress to aid collective sense-making and maintain an over-arching (and evolving) vision.
Previous sociological studies of multi-stakeholder research partnerships have shown that they are inevitably characterised by structural complexity, competing interests, ambiguous loyalties and colliding institutional logics [
64,
65,
72,
73]. Synergy may increase as co-governing partners work together, leading to convergence of perspectives by progressive alignment of purpose, values and goals, and growth of mutual understanding and respect. However, this is by no means inevitable; others have used the term ‘collaborative entanglement’ to depict an ongoing instability of the system that will never attain an easy synergy [
74]. In some cases, organisations traditionally thought of as odd bedfellows join forces at an early stage to generate a grant application that is “
draped in the formal collaborative language and procedures prescribed by funding agency protocols”, but in reality they continue to “
view each other pragmatically as consultants, clients or even competitors, rather than partners” [
75].
Multi-stakeholder health research partnerships have been widely studied using ethnographic case study methods [
64,
65,
72‐
78]. However, to the best of our knowledge, this is the first study that uses linked interdisciplinary theoretical perspectives from innovation studies, sociology of science, and business and management to study multi-stakeholder partnerships in a BRC over 5 years. Another strength of this study is in using the principles of action research to inform real-time action and system change while also making a generalisable contribution to the knowledge base.
However, this study also has potential limitations. The ‘Partnerships’ theme has finite human and financial resources and it will not be logistically possible to explore all aspects of the questions listed in Table
1. Key data may not exist or may not be fully accessible to the research team. Ongoing access to undertake research on a multi-stakeholder research partnership, and real-time feedback of emerging findings in a way that shapes the work of that partnership, have both been shown to depend on the development of democratic relationships and mutual trust, which in turn stem from a smooth set-up phase and acknowledged early wins [
79]. Much depends on these relational preconditions, which are highly contingent and cannot be achieved purely by establishing the “right” governance structures [
78].
It is also important to note that the study design is intentionally a single (‘n of 1’) large case study containing multiple (‘small n’) focused case studies, selected for their contrasting features. This model, favoured by leading organisational scholars as the most appropriate one for studying complex systems [
38,
71], is designed to generate illuminative insights and naturalistic generalisability through the use of thick description and reflexive theorising. The study design will not generate statistically representative data, nor is it primarily intended to produce cross-case theoretical insights (as would occur, for example, in a small-n realist evaluation). In other words, we seek to answer the important and context-bound question ‘what is going on here and what can we learn from it?’, not ‘what is the effect size?’ or ‘what works for whom under different circumstances?’
The single case study design has been chosen because the NIHR Oxford BRC is a unique, dynamic and continuously evolving research system that will be influenced by future research policy developments and organisational changes. As we write this, the United Kingdom faces a changing context for scientific research, drug regulation and health services delivery as a result of its decision to leave the European Union. The unfolding of research partnerships will need to be carefully analysed with relation to what may turn out to be dramatic changes in their external context. We believe the use of the single case study for such a study is amply justified on theoretical grounds and have provided detailed philosophical explanation elsewhere [
37,
80]. However, the n of 1 organisational case study is not well understood by many in the biomedical research field. There is, therefore, a risk that our findings will lack credibility in the eyes of those who value a more experimental approach and expect a ‘control group’.
In sum, this paper has described the rationale, aims, objectives and methodology for an ambitious programme of work to both support and systematically study the work of one of the largest and – currently – most successful of the NIHR’s BRCs as it enters its third 5-year funding period. The case study appears to contain many of the key ingredients for success, but there are also many unknowns, finite resources and an unstable external context. We anticipate that our methodology will, at the very least, produce a meaningful narrative in 5 years’ time of how the NIHR Oxford BRC’s fortunes unfolded and why.
Acknowledgements
The authors would like to thank the NIHR for funding, Jackie Love for her expert assistance with graphic design, and the following individuals for their contribution to the Partnerships for Health, Wealth and Innovation cross-cutting theme of the NIHR Biomedical Research Centre, Oxford. The people listed below were involved in shaping the ‘Partnerships’ theme, providing feedback on earlier drafts of this manuscript, or both:
Maxine Allen1, maxine.allen@medsci.ox.ac.uk
Jeroen Bergmann2, jeroen.bergmann@eng.ox.ac.uk
Denise Best3, denise.best@medsci.ox.ac.uk
Jacqueline Birks4, jacqueline.birks@csm.ox.ac.uk
Chas Bountra5, chas.bountra@sgc.ox.ac.uk
Alastair Buchan2, alastair.buchan@medsci.ox.ac.uk
Gary Collins6, gary.collins@csm.ox.ac.uk
Stuart Faulkner7, stuart.faulkner@casmi.org.uk
Gary Ford8,9, gary.ford@ouh.nhs.uk
John Geddes10, john.geddes@psy.ox.ac.uk
Alastair Gray11, alastair.gray@dph.ox.ac.uk
Louise Locock12, louise.locock@phc.ox.ac.uk
Alison Noble13, alison.noble@eng.ox.ac.uk
Christopher Pugh14,15, cpugh@well.ox.ac.uk
Mark Sheehan16, mark.sheehan@ethox.ox.ac.uk
Joel Smith17, joel.smith@dph.ox.ac.uk
Adam Stoten18, adam.stoten@innovation.ox.ac.uk
Charles Vincent19, charles.vincent@psy.ox.ac.uk
Glenn Wells20, glenn.wells@ouh.ox.ac.uk
Paul Whyte21, paul.whyte@ouh.nhs.uk
1Business Development, University of Oxford, Joint Research Office, Block 60, Churchill Hospital, Old Road, Oxford OX3 7LE, United Kingdom
2Institute of Biomedical Engineering, Department of Engineering Science, Old Road Campus Research Building, University of Oxford, Oxford OX3 7DQ, United Kingdom
3Medical Sciences Divisional Office, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, United Kingdom
4Centre for Statistics in Medicine, Botnar Research Centre, University of Oxford, Windmill Road, Oxford OX3 7LD, United Kingdom
5Structural Genomics Consortium, Nuffield Department of Medicine, University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Oxford OX3 7DQ, United Kingdom
6Centre for Statistics in Medicine, Botnar Research Centre, University of Oxford, Windmill Road, Oxford OX3 7LD, United Kingdom
7Centre for the Advancement of Sustainable Medical Innovation CASMI), Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, United Kingdom
8Oxford Academic Heath Science Network, Oxford, United Kingdom
9Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom
10Department of Experimental Psychology, University of Oxford, 15 Parks Rd, Oxford OX1 3PH, United Kingdom
11Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford OX3 7LF, United Kingdom
12Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Woodstock Rd, Oxford OX2 6GG, United Kingdom
13Institute of Biomedical Engineering, Department of Engineering Science, Old Road Campus Research Building, University of Oxford, Oxford OX3 7DQ, United Kingdom
14Centre for Cellular and Molecular Physiology, Nuffield Department of Medicine, Oxford OX3 7BN, United Kingdom
15Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom
16Ethox Centre, Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford OX3 7LF, United Kingdom
17Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford OX3 7LF, United Kingdom
18Oxford University Innovation, Buxton Court, West Way, Oxford OX2 0JB
19Risk and Safety Research Group, Department of Experimental Psychology, University of Oxford, 15 Parks Rd, Oxford OX1 3PH, United Kingdom
20Oxford Academic Health Science Centre, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom
21Business Development, University of Oxford, Joint Research Office, Block 60, Churchill Hospital, Old Road, Oxford OX3 7LE, United Kingdom