Abstract
I have a personal and professional interest in this study, with 21 years as a clinical research nurse (CRN) and latterly 7 years as a clinical research nurse manager, overseeing more than 60 clinical research staff across a large health organisation in Scotland.
This study, using the Clinical Research Nursing Domain of Practice (Bevans et al., 2011)-validated framework, aimed to describe global characteristics of the current CRN role, in areas including practice settings, geographic locations, the nature, scope and type of work undertaken and job titles. This research team set out to determine differences in CRNs’ most frequently performed activities, and to determine if these activities are reflective of those previously described in the literature.
The title suggests a global study and the authors acknowledge the comparatively small sample size for this ambition; however, it is in fact limited to being a UK/USA comparative study. Although the ‘snowball’ recruitment strategy initiated by the International Association of Clinical Research Nursing (IACRN) attempted to include CRNs across North America, Europe, Africa, the Middle East, China and Taiwan, this was largely unsuccessful and resulted in this aspect of study aims being unfulfilled. Instead of assessing the global direction of the CRN role, the results present findings for two Western countries with relatively well-developed CRN workforces. From this, the authors have attempted to draw global conclusions from the UK/USA data. Furthermore with only 50 responses from the UK, I have concerns about how representative this is of the current workforce; a recent unpublished scoping exercise has identified a minimum of 7500 research nurses in the UK (Whitehouse, 2021).
One distinction between the UK and USA sample was that UK CRNs appear to be more actively involved in recruiting patients/subjects into studies. This is worthy of more detailed examination. In the UK, we have different levels (bands) of registered nurses who work as CRNs and their activity and role will reflect their relative seniority through their banding. My own experience would suggest that more junior CRNs tend be more actively involved in the recruitment of patients/subjects more frequently than those in senior roles, where the focus may be concentrated on trial and workforce management. What is unclear from the study is the level of seniority of the sample and whether this impacts on dimensions of the role.
Variation in role title across the UK and USA is rightly identified by the authors as a potential issue in addressing CRN workforce matters and role development. Indeed, these variations exist across Scotland although in my own Health Board, we standardised role titles and job descriptions for CRNs in 2007 and this has provided clarity and a definite career structure for our workforce and those that seek to recruit CRNs. There are perhaps opportunities for national and international associations to take forward work in this area, which could in turn make research like this more meaningful.
The authors acknowledge diversification of the CRN role over the last 20 years, without providing substantial detail. Based on my own experience, the most significant evolution in the role of the CRN during my career has been an increase in CRNs’ involvement in the informed consent process, the integration of advanced clinical skills (that has been seen across the entire nursing workforce) into research delivery and increased participation in protocol development, teaching and ethical review. There is a new management role for senior CRNs with large research teams of registered and support staff, compared to the situation 20 years ago when most research nurses in my organisation worked in isolation.
The authors propose that the introduction of non-nursing role in research teams has been undertaken as a cost-saving exercise and caution that omitting registered nurses in the research teams can pose a risk. However, there is a counter argument that there are many roles within a research team that could be safely undertaken by non-registered staff, thus releasing registered nurses to deliver patient care and undertake clinical assessments within the research protocol, thereby increasing safety. In Scotland and other parts of the UK, we have successfully developed specific non-registered clinical and administrative roles to strengthen the research workforce overall.
The authors’ main recommendation is that leadership should be added to the Clinical Research Nurse Domains of Practice, given that 72.5% of the sample in both the UK and USA reported providing leadership in their teams. Recognising the leadership role of the CRN is an important outcome of this work; I believe it should be recognised as a feature of the CRN role at all levels that transitions and increases with career progression. In the UK, the National Institute for Health Research (NIHR) has published an integrated Workforce Framework (NIHR, 2018); this is a multifunctional national resource that contains twelve elements within three domains: clinical research, clinical context and leadership. If the CRN Domains of Practice are extended, then this could serve as a useful framework to inform that work.
This study is a useful starting point for international examination of the CRN role; however, it is limited in terms of global application. There remains a need for research in this area that provides a true international comparison, and the IACRN should remain committed to exploring meaningful ways to target hard-to-reach areas globally and focus on the diversity of registered and non-registered research roles. The paper does add to the growing body of literature, and supports the argument for those of us in the UK to agree core competencies, role titles, expectation and the recognition of research nursing as a specialist role.