Recognising a watershed moment: opportunities for clinical research nursing and midwifery

It does not seem that long ago that we were sitting in the canteen of the old Royal Infirmary of Edinburgh, chatting about writing what would turn out to be our first joint publication: ‘Professional issues associated with the role of the research nurse’ (Hill and MacArthur 2006). Since then, this article has been cited almost 70 times and it is exciting to still see it cropping up in publications over the last few years. Having said that, it is so old that ‘clinical’ had not even been added to the job title yet!

The International Association of Clinical Research Nursing (IACRN) defines clinical research nursing as ‘the specialised practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol’. They delineate five domains within the role that focus on: human subject protection, care coordination and continuity, contribution to clinical science, clinical practice and study management (IACRN, 2012).

Looking back to our publication, in terms of clinical research nursing and midwifery (CRN/M), 2006 seems like a bygone time when, in Scotland at least, development opportunities were scarce, promotion was rare, appraisal of performance barely existed and understanding of the role was patchy, at best. If we compare that to the contemporary position in most Western countries, the differences are stark. There are now national and international bodies that offer support to nurses and midwives in these roles, an ever clearer career structure, a growing repertoire of training possibilities and increasing numbers of students undertaking practice learning in clinical research environments. Perhaps most significantly in the last two years since the first COVID-19 trials began, there has been a palpable growth in the appreciation and recognition of the value of CRNs and CRMs. Indeed, the very fact that the Journal of Research in Nursing has commissioned a focussed edition on these roles is testament of how far things have come. For that, we think every CRN and CRM should be proud of everything they have achieved

However, also key to this progression is how these individuals have come together to coalesce and collaborate. From our own first experiences of the local CRN community in Edinburgh, through to the truly global reach today, we strongly believe that the willingness to share and a commitment to make sure that others do not have to ‘re-invent the wheel’ are fundamental principles in the community. We can see examples of this in the #whywedoresearch Twitter phenomenon, standardised job descriptions in many countries, ever more groups forming in Australia, China, Japan, South Africa and Sweden and, more recently, the initiatives led by the National Institute for Health Research (NIHR) in the United Kingdom. The latter under the inspiring leadership of Professor Ruth Endacott, who was appointed as the Director of Nursing and Midwifery in 2021. These, along with other developments, including the NIHR 70@70 Senior Nurse and Midwife Research Leaders programme and encouraging plans in Ireland, led by the Irish Research Nurse and Midwife (IRNM) group, mean that the future looks exciting and full of possibilities. Additionally, a census facilitated by research nurse and midwife leaders from England, Northern Ireland, Scotland, Wales and the IRNM attempted, for the first time, to establish the number of CRN/Ms in the United Kingdom and Ireland. This project, led by Claire Whitehouse, has identified ∼7500 CRN/Ms working in the United Kingdom and Ireland. Whilst acknowledging that this will not reflect the full workforce, it represents a hugely important step in establishing key demographics about the CRN/M profession in this part of Western Europe. We look forward to seeing more analysis of this data and future studies exploring changes from this baseline.

Another exciting development is the number of CRN/Ms who are undertaking doctoral level studies, often focussed on the experiences and impact of the CRN/M role. This helps to ensure that there is a growing evidence base for the work that this professional group undertakes and also assists in developing the leadership potential within the workforce. In a post-pandemic world, the attributes of this workforce will undoubtedly be highly valued by the healthcare community, as well as the public, with the latter being clearly evidenced in Derek Stewart’s inspirational Perspectives piece in this edition.

Whilst there have been great strides in many areas, specific educational preparation for clinical research professionals remains a gap in most countries. This does not only relate to CRN/Ms, as others including clinical trial pharmacists, data managers and trial monitors are also in need of this; however, it is something that should be addressed to strengthen developments in leadership, practice and education.

Another important component is the work of the IACRN, which formed in 2009 and has members in Africa, Asia, Australia/New Zealand, Europe and North America. Since its inception, the IACRN has led or been involved in a number of important developments, including the Domains of Practice for Clinical Research Nursing (CRN 2010 Domains of Practice Committee, 2009), working with the American Nursing Association to recognise clinical research nursing as a specialised area of practice, co-authoring a scope and standards document (American Nurses Association, 2016), developing an international leadership programme, devising a certification by portfolio programme to underscore the specialised skills and knowledge that CRN/Ms possess and more recently publishing a book offering a Clinical Research Nursing Core Curriculum (McCabe and Ness, 2021). These advances put the IACRN at the leading edge of many CRN/M improvements.

All of these developments indicate that clinical research nursing and midwifery is at a crucial crossroads. Indeed, even before the pandemic Faulkner-Gurstein et al. (2019) proclaimed that the United Kingdom ‘is in the midst of a golden age for clinical research’. The opportunity to grasp the future and lead an historical change of course is there, and it is incumbent on all in the community to ensure that the potential is maximised and CRN/Ms are at the vanguard of clinical research.

We were very pleased with the response to the call for this focussed edition and are delighted to publish what we believe is the first international collection of papers on clinical research nursing and midwifery, with contributions from the United Kingdom, Ireland, United States, Australia and China. Whilst this reflects the international nature of clinical research nursing and midwifery, there are no accurate descriptions of the number and distribution of CRN/Ms across the world. However, using the ClinicalTrials.gov database (the US National Library of Medicine database of privately and publicly funded clinical studies conducted around the work; https://clinicaltrials.gov/ct2/home) as a crude proxy measure, it is evident that beyond these countries there must be sizeable CRN/M populations in the rest of Europe with smaller, perhaps more isolated, CRN/Ms working in the Middle East, Africa, South America and North Asia (including Russia and Ukraine). As will be seen in some of the international papers in this collection, there remain challenges reaching out to colleagues in these parts of the world.

The edition benefits from two powerful Perspectives pieces; the first from practitioners and the second from a patient. Milne, Peddie and Hickey have written a very rich reflective piece on the experience of the CRN team in the Glasgow Clinical Research Facility during the COVID pandemic, something that will resonate with thousands of CRN/Ms across the world. This is wonderfully supplemented by Natalie Elliot who was a student nurse undertaking a placement in the same facility. She highlights that the impact of this experience has made her more curious, adaptive and innovative as well as developing her critical thinking. The second by Derek Stewart reminds us all of the importance of making research findings and evidence readable and understandable, and to ensure that they benefit all.

The papers in this edition address four themes: (i) conceptual exploration of the CRN role; (ii) working practice of CRNs; (iii) the CRN role in promoting inclusion and (iv) leadership to support research capacity building. There is a clear sense in the existing literature and these papers that CRNs continue to search for effective depictions of their unique contribution. There are potentially two perspectives to consider in this endeavour: the first is for the CRN profession itself as it seeks to set out the distinctive nursing/midwifery skills and knowledge that effectively enhance research delivery; and secondly to inform the wider health community how they combine expert research and clinical skills. Three papers in this collection offer new perspectives that address both standpoints and have the potential to further enhance the recognition and value of this specialist role.

Tinkler, Robertson and Tod’s critical realist synthesis on perceptions of the CRN role by other healthcare professionals illuminates potential physical, social and emotional factors present in clinical settings that either enable or limit CRNs’ ability to offer patients the opportunity to participate in research. Their analysis emphasises the role of the CRN as a communicator, connector, boundary spanner, advocate and influencer; attributes which go beyond existing competency-based definitions of the role. The authors highlight the importance of human agency and resilience within the CRN role, viewing both as being crucial in mediating interactions at the interface between research and clinical care. In her commentary, Helen Jones endorses this work as a means of enabling CRNs to recognise and enhance their effectiveness, as well as identify barriers that may impede the integration of research into routine care.

As an international collaboration of CRN leaders, Hansen et al. offer an innovative methodological approach to proposing a conceptual model that aims to capture the value and core concepts of the CRN. Once again, the underpinning rationale for this work stems from a sense of misconceptions about clinical research nursing. The authors identify four domains of the CRN role that, like the previous paper, includes an emphasis on the integration of clinical care and research. The discussion stresses that a CRN is first and foremost a nurse and that their role in developing trust with research participants is at the heart of what they do. In her commentary, Judy Newton echoes the desire to more positively integrate clinical and research activity and for CRNs to be valued for their nursing skills, which she emphasises as being driven by a focus on care, compassion and safety.

Jones et al.’s qualitative survey of 40 CRNs that aims to identify their impact on ‘the research enterprise’ highlights what the authors describe as the ‘dual fidelity’ of the CRN role in terms of balancing the integrity of the protocol and quality of care for participants. They effectively illustrate their findings in a model that integrates the well-established five Domains of Practice (CRN 2010 Domains of Practice Committee) with the Quality Caring Model (Duffy and Hoskins, 2003). There is a real richness in the data within this study; illuminating aspects of the CRN role that point to job satisfaction inherent in contributing to innovation, alongside building relationships and fostering hope for study participants. Carole Schilling welcomes the development of the model in her commentary; however, given around 80% of respondents were from the United States, she highlights concern around the effectiveness of existing dissemination strategies for international studies on the CRN role, an issue similarly experienced in the Fisher et al. study.

Although not proposing any new conceptual exploration of the CRN role, Capili et al.’s study aims to raise awareness of clinical research nursing within undergraduate nursing programmes in four US universities. What is particularly helpful in this paper is the inclusion of links to resource materials that were integrated into the module delivered within the study. Building on the themes within the preceding papers, a striking feature in the videos is the emphasis on the clinical nature of the CRN role, once again highlighting the importance of building relationships with patients and making a difference to their care experience. The two commentaries accompanying this paper offer the perspective of both academic and student: Janyne Afseth reflects that, in her considerable experience, most CRNs come into post only then to discover the scope and activity of the role. Natalie Elliot, who is also the student author in the ‘Putting research nursing on the map’ Perspectives, confirms the absence of clinical research nursing ever being portrayed as a ‘viable career option’ in her undergraduate programme.

Moving on to the working practices of CRNs, the next two papers examine the characteristics of the CRN workforce in very different domains. Hao, Lui and Wu have undertaken what is likely to be the first and most extensive survey of CRNs in China, examining work status and self-reported competency; it could be argued this has the potential to become a landmark paper for benchmarking a non-Western perspective on the development of this professional group. The paper provides significant insight into the organisation of healthcare and society in China along with the emergence of research governance processes in the last 15 years. The findings reveal a contrasting CRN profile to what has been previously reported in Western countries, with a younger, more highly qualified (comparative to the wider nursing population in China) but less experienced CRN workforce. Furthermore, it reveals the influence of work context and management arrangements on competencies and job satisfaction. The survey tool itself offers the potential for replication in the form of an international comparative study of a sample of established and emerging CRN/M populations, something that I (JM) recommend in my own commentary on the study.

A second international collaboration in this collection aimed to extend the description of the CRN workforce, with Fisher et al. developing a survey tool examining the frequency of undertaking 56 activities contained within the CRN Domains of Practice (CRN 2010 Domains of Practice Committee). Although the ambition was to be international, as Jean Bruce highlights in her commentary, the distribution strategy via the IACRN was not hugely successful, with the resulting data analysis being largely limited to the UK and US. Nevertheless, the findings do point to differences in CRN role between the two countries, particularly with regard to participant recruitment and involvement in obtaining informed consent. In terms of frequency of activities, leadership within the interdisciplinary team was clearly evident, leading to the authors recommending that leadership is included as a sixth domain in the widely used framework.

Using Interpretative Phenomenological Analysis, Hill, Ellis and Irvine add depth of understanding on the experience of the CRNs, particularly as they negotiate what he describes as the symbiotic relationship between clinical and research work. Similar to the findings in Hansen et al.’s paper, participants recount questions put to them by clinical colleagues as to whether they are a ‘real nurse’. The duality of practice described in this paper more specifically focuses on possible competing demands of clinical pressures and research delivery requirements (and the CRNs response in terms of ‘helping out’), rather that the clinical and research remit of the CRN role itself. Indeed in her commentary, Naomi Hare points out that the participants in Hill, Ellis and Irvine’s study did not strongly identify their own research role as being clinical. She goes on to suggest the need to work with the CRN profession to ensure their clinical specialism and expertise is realised by themselves.

Three papers address the vital issue of role of the CRN/M in promoting inclusion in clinical research and provide significant opportunities for learning and reflection for those in CRN/M roles and wider research teams. The first (and only midwifery paper) reports on an evaluation of a UK-based project undertaken by Whitehouse et al. that was underpinned with a concern about health inequalities as a fundamental feature of the introduction of a programme of research into a specific NHS maternity service. A clear methodology for monitoring indicators of deprivation was implemented and, in fact, demonstrated that for these studies women from more deprived groups were well represented. There is much to learn from this paper about strategies for collaboration between agencies, engagement with prospective participants and adapting recruitment methods based on a detailed understanding of the population. In her commentary, Sonia Whyte applauds the approaches taken and recommends wider monitoring of inclusion data within study design and reporting.

Focussing on the Aboriginal and Torres Strait Islanders, Beer et al. draw important attention to the issue of whether clinical research is accessible to under-represented and under-served groups. Identifying the ethical and moral responsibilities to ensure that the evidence base is representative of and accessible to all populations, the authors offer an effective exploration of potential barriers to participation in research at system, participant and practitioner level. They go on to discuss the role of the CRN in ensuring that issues of inclusion are built into the design, conduct and delivery of research. In her insightful commentary, Linda Wu proposes that CRNs could be the ‘most efficient vessel’ to resolve these essential issues.

Thangthaeng et al. combine critical exploration and practical recommendations on the need to establish gender-affirming environments that will support inclusive and equitable access, recognising that transgender communities frequently face stigmatisation and discrimination in many areas of life. They use the term ‘cultural humility’ in their discussion to highlight the importance of self-reflection for CRNs and the importance of trauma-informed care for all practitioners. They offer detailed recommendations for conducting gender-inclusive studies that are very effectively linked to the CRN Domains of Practice. Given that there is a scarcity of literature on this issue, the two accompanying commentaries provide helpful extensions to the discussion. Gemma Williams recognises that the authors are helping to demystify how to be trans-inclusive but highlights the need to address much wider organisational contexts and cultures that impact on the inclusion of LGBT+ communities. Elena Dimova welcomes this paper as a good starting point and goes on to provide examples of UK-based organisations, strategies and resources that can further support CRNs in this domain.

The final paper takes a different focus and explores strategies to increase awareness of and engagement in research more broadly. Shepherd, Endacott and Quinn evaluate the impact of one NHS Trust’s initiatives associated with the NHS England 70@70 programme that has created leadership development opportunities for many CRNs to influence cultural change. In her commentary, Lynne Stobbart highlights what she describes as a lack of parity between research and clinical practice and supports the types of initiatives evaluated in the paper as going some way towards demystifying research and creating early career opportunities for CRNs and other nurses.

In conclusion, this focussed edition includes a broad range of international papers which, we hope, will both add to the evidence base for clinical research nursing and midwifery and spark the interest of other CRN/Ms to engage with these topics and develop this speciality area of global practice still further. Additionally, as the Journal of Research in Nursing allows for commentaries to be included for each manuscript, there has been an opportunity to contextualise the findings of the papers. This has both re-enforced the importance of the topics and identified future areas of work that could be considered. Last, but certainly not least, the insightful and inspiring Perspectives pieces have helped to remind us all of the central role of the CRN/M in developing new treatments, supporting patients and the public and disseminating evidence in a clear and understandable way.

As a parting note, we would like to say that it has been an immense privilege for us to be the guest editors for this focussed edition of the JRN. We firmly feel that this is a watershed moment for the global clinical research nursing and midwifery community, and it is our sincere hope that this edition has helped to further place a spotlight on the amazing work of these nurses and midwives. We have all come a long way since 2006!

Biography

Gordon Hill is the Assistant Head for International in the School of Health and Life Sciences at Glasgow Caledonian University. His role includes leading on transnational educational developments and student/staff mobility. His background is in clinical research.

Juliet MacArthur is Chief Nurse Research and Development in NHS Lothian, Edinburgh. Her role involves being strategic lead for clinical research nursing and midwifery as well as developing clinical academic careers.