Clinical research

Clinical research is crucial in enhancing patient care and developing new treatments in all healthcare settings (Santos-Lozano et al 2015). In healthcare it is generally considered to be the sole evidence-based means of testing and determining whether a new approach to treatment or care is better than current practice, and is crucial for identifying, treating, inhibiting and curing diseases (Sacristán et al 2016). The COVID-19 pandemic has demonstrated the importance of clinical research in terms of discovering new treatments as a way of overcoming an international healthcare crisis (Luo and Qin 2020). In cancer care, clinical research is central to improving methods of early diagnosis and developing anticancer treatments, which have increased patient survival rates and quality of life (Vickers 2018).

Research nurse roles

Research nurse roles vary depending on the type and phase of research, as well as the research setting, which can range from purpose-built clinical research facilities to standard outpatient departments (Faulkner-Gurstein et al 2019). The area or disease under investigation also influences the role of research nurses (Faulkner-Gurstein et al 2019), for example in cancer research it is essentially clinical. Furthermore, nurses working in cancer research often require competence in chemotherapy and systemic anticancer therapies as well as knowledge of their effects on patients’ physical and emotional well-being (Ness 2020), while respiratory research nurses are likely to be skilled in areas such as spirometry (Huband et al 2018).

In cancer clinical research, nurses have a crucial role in delivering experimental treatment, care management and patient advocacy during clinical trial care pathways that are often complex and emotionally challenging for patients (McCabe et al 2019). Cancer is a unique area of clinical research in that it does not involve ‘healthy’ volunteers (Vickers 2018). Therefore, in this specialty, it is fundamental for research nurses to have high levels of competency in terms of their clinical skills, cancer nursing care and communication skills, to ensure optimal patient care (Ness 2020).

The wide range of research nurse roles means that nurses can be involved in various tasks, such as: preparing clinical trial documentation; submitting study proposals for regulatory approval; coordinating clinical trials; taking and processing samples, for example blood spinning; and following procedures for international transport of research samples. However, the core principles of the role are to act as patients’ advocates, monitor their health, record vital signs, administer treatments, and provide education, advice and holistic support to patients and their families – essentially using the same skills as in any area of nursing practice (McCabe et al 2019).

Misconceptions about research nursing

While nurses have always been involved in clinical research, research nursing was only established as a standalone specialism in 2006, at around the same time as the formation of the National Institute for Health Research (Jones 2015). There are variations in research nurses’ working arrangements, line management and career pathway compared with more established nursing specialties such as ward-based staff nurses or cancer nurse specialists, and further work is required to develop this unique area of nursing (Faulkner-Gurstein et al 2019).

As a relatively new specialty, it is perhaps unsurprising that the role of research nurses is often not fully understood by other nurses and nursing students, and this lack of understanding across the profession compounds the challenges associated with recruiting to these essential posts (Kunhunny and Salmon 2017). This is supported by Boulton and Beer’s (2018) research, which suggested that misconceptions and a lack of clarity about what the research nurse role entails are among the leading factors that contribute towards recruitment and retention issues. Other authors support this claim, suggesting that research nurses ‘fell into’ their career and had minimal awareness of what the role was before their employment, and that the lack of a defined career framework was a major concern (Jones 2015, Cleary et al 2016, Abou Hashish 2017).

A recurring theme in the literature is the confusion between the roles of research nurse and nurse researcher. Although these roles are different – research nurse is a clinical role while nurse researcher is an academic role – they are frequently confused (Jones 2015, Faulkner-Gurstein et al 2019). Further work is necessary to ensure that the research nurse role is covered in undergraduate nurse education programmes and to introduce additional practice placements in clinical research settings to enhance understanding of this area of practice (Hill 2018).

Clinical research in undergraduate nurse education

The Code: Professional Standards of Practice and Behaviour for Nurses, Midwives and Nursing Associates (Nursing and Midwifery Council 2018) states that nurses must ‘always practise in line with the best available evidence’. Although clinical research is crucial to generating this evidence and research nurses are central to the delivery of such research, there is little in the literature to suggest that this topic is routinely included in undergraduate nurse education curricula (Whitehouse 2017).

The Council of Deans of Health (2019) suggested that most, if not all, learning on research in undergraduate nurse education curricula focuses on developing nurse researchers, rather than raising awareness of clinical research nursing. The report also acknowledged the importance of ensuring that nurses and other allied health professionals are research literate when they qualify. In addition, it suggested that evidence-based practice, research methods and dissertation modules should be included in undergraduate nurse education, but again the focus is on academic research rather than clinical research (Council of Deans of Health 2019).

It appears that most courses and modules in clinical research nurse education are delivered at postgraduate level (Universities and Colleges Admissions Service (UCAS) 2021a), with entry requirements for those applying stating that they must be healthcare professionals working in an area of clinical research or already hold a degree-level qualification (UCAS 2021b).

Naylor et al (2014) suggested that clinical research placements have benefits for both nursing students and research teams, and that they are essential to enhancing students’ understanding of the unique experience of patients involved in clinical trials and the role of nurses in this. Similarly, Mason (2018) recognised that pre-registration experiences of clinical research can inspire the research nurses of the future. However, Whitehouse (2017) suggested that nursing students’ clinical research placements can vary in quality and that the topic of research nursing should be introduced earlier in undergraduate nurse education programmes to address misconceptions about it.

Ethical considerations

Permission to deliver the educational sessions and to ask nursing students to complete the questionnaires was granted by all the universities involved. As this was a service implementation project, ethical approval was not required. No identifiable participant information was used. Questionnaires were given to and collected from students by staff from the organisations involved then passed on to the project team to review and analyse the data.

Pre-intervention questionnaire data

Data from the pre-intervention questionnaire show that most of the 733 respondents had minimal understanding of the role of research nurses, with only 19% (n=139) responding that they knew what the role of a research nurse in cancer research was (Table 1). Further analysis suggests there were also misconceptions about the role (Table 3), for example some respondents believed it is an academic role or that research nurses are involved in service improvement, while others believed it involves genealogy or epidemiology. Clinical research was mentioned, but comments such as ‘look at cells and biological patterns in cells’ and ‘do clinical trials’ indicated that respondents did not have an accurate conception of the nurse’s role in this area of practice. This suggests that none of the respondents knew what a research nurse’s role entails.

Table 1.

Do you know what the role of a research nurse in cancer research is?

The effect of a lack of understanding of the role was evident in the pre-intervention responses to the question ‘based on your current understanding of the role, would you consider a research nurse post on graduating?’, which indicated that 84% (n=616) of the respondents would not and 6% (n=42) were undecided (Table 2). Some of the comments in Table 5 provide an insight into why there were so many negative responses to this question, explaining what ‘least attracted’ respondents to this role. Themes such as ‘lack of patient contact’, ‘not clinical’ and ‘no awareness of role’ indicate misconceptions about the research nurse role and the potential adverse effects of these on recruitment.

Table 2.

Based on your current understanding of the role, would you consider a research nurse post on graduating?

Reviewing the data provided by the 10% (n=75) of students who indicated that they would consider this post on graduating shows they also had misconceptions about the role (Table 4). Responses to the question on what most attracted students to the post suggest that they believed it was academic, had better working arrangements and in some cases included a service improvement element. This could result in a concerning situation in which nursing students might apply for research nurse posts without an accurate understanding of what they involve, which could subsequently exacerbate retention issues in cancer research nursing.

Post-intervention questionnaire data

The post-intervention questionnaire data indicate a positive shift towards understanding the research nurse role. Most respondents (99%, n=725) said they understood the role, and this was confirmed by the students’ comments (Table 6), which accurately described various practical elements of the role and identified it as a specialist clinical nursing post with patient contact. The effect of this new and more accurate understanding is seen in Table 2, which reveals an increase of 55 percentage points in students who would consider research nursing as a career. The responses in Table 7 offer some reasons for this and demonstrate that respondents regarded the role as clinical, involving patient contact and the use of a range of fundamental nursing skills.

Table 8 provides an overview of reasons why several of the respondents would not consider a research nurse post, even with an accurate understanding of what it entails. Some respondents wanted to work in a different discipline, while others believed it was a post better suited to more experienced nurses and would consider it in the future.

One significant finding identified from the data was that respondents had experienced a lack of, or indifferent, practice placements in clinical research settings. Respondents suggested there was limited access to placements in clinical research, and the students who had accessed these often described negative experiences (Table 8). Chapman (2017) stated that it is only by understanding practice in relation to theory that nurses’ knowledge and skills can remain relevant and up to date. In this context, the data collected before and after the educational sessions suggest that further work is necessary to support this in relation to the research nurse role.

Limitations

The findings detailed in this article are based on an analysis of feedback from questionnaires given to students as part of a pilot educational engagement project. This approach to data analysis has limitations in that the information was not collected to address a specific research question and details were not requested about what year individual students were in or their access to clinical research practice placements, which raises issues in relation to testing a hypothesis and research bias (Cole and Trinh 2017). In addition, the geographical area of data collection was limited, so it might not provide a true representation of the entire UK undergraduate education system.

Future developments

Findings from the project were presented to the charity Cancer Research UK to inform the development of a national programme to enhance understanding of the role of cancer research nurses. In addition, the learning experiences of the students and facilitators, and the resources developed for the project, will be used to establish a national programme for undergraduate nurse education. This will initially be driven by Cancer Research UK’s senior research nurse network and aims to provide further learning opportunities for nursing students across the UK. Ultimately, the resources will be made more widely available for use by any research programme through the Excellence in Research Programme for Clinical Research Nurses (Cancer Research UK 2021).

Work is under way at Newcastle upon Tyne Hospitals NHS Foundation Trust to adopt the educational sessions to develop sustainable educational opportunities with regards to research nursing for local universities that provide undergraduate nurse education.