The role of clinical research nurse (CRN) is pivotal to the success of research, and modern-day conduct of research and clinical trials requires dedicated staff. Those in the role not only have clinical nursing responsibilities, but are also required to have knowledge and understanding of research protocols and governance in conducting and managing all aspects of clinical research and trials.
The popularity of the CRN role as a career option has grown significantly over the past decade. However, there is limited information concerning the perception of the CRN role, the responsibilities of postholders and their contribution to the NHS. Consequently, the role remains widely misunderstood by many healthcare colleagues. The familiarity and overlapping nature of nursing duties and responsibilities contributes to this misunderstanding, making it easy to overlook the significant differences between one nursing role and another.
The clinical nurse, who is a registered nurse in clinical practice, and the CRN are equally important nursing specialties, and an understanding of both roles is essential to ensure that their work is complementary. Over the years, many healthcare institutions have taken on more clinical research studies and trials, requiring collaboration between registered nurses in clinical practice and CRNs. This partnership is crucial to patient recruitment, engagement and retention in clinical trials (ie to promoting a positive patient experience) and to the research delivery and output as a whole.
When there is insufficient understanding of roles between colleagues, there is a risk that collaboration could create barriers, with each nurse having overexpectations of the other's role. For example, where a patient is participating in a clinical trial, the nurse caring for the patient may think the CRN will take over some care responsibilities. Conversely, the CRN may have expectations that the registered nurse will perform some of the clinical study procedures for participating patients in their care. To avoid such misunderstanding about the roles it is important to create opportunities to consider the clinical nurses' perception of the role of the CRN in the renal department
The study reported in this article involved a survey conducted as part of an initiative for improvement in research delivery within the renal research unit of King's College Hospital NHS Foundation Trust, London. It came at a time of increasing research activities, which require the collaboration and engagement of healthcare colleagues (specifically clinical nurses), which are central to meeting research metrics, output and delivery. The main objective was to investigate the understanding by clinical nurses of the CRN role. In addition, the survey aimed to contribute to the development of strategies to increase research awareness and to explore opportunities to improve working relationships.
In this article, the term ‘clinical nurse' has been used to refer to a registered nurse licensed to perform nursing duties and responsibilities.
Methods
A questionnaire was designed to answer the improvement initiative question. Purposive sampling was used to distribute the survey, with 15 nurses from three clinical settings in the renal unit selected to take part: 7 (46%) from renal wards, 4 (27%) from the main dialysis unit and 4 (27%) from the renal outpatient department (ROPD).
In the questionnaire, respondent were asked to provide demographical information (eg years working in the trust, nursing band, clinical setting), understanding of the role of the CRN, including awareness of any research or trials being conducted within the renal department, the visibility of the CRNs in the clinical area, the benefits, issues and concerns of patients' participation in a research, and how their view on how clinical-research working relationship could be improved.
The responses were collated and analysed using descriptive analysis. This allows data to be summarised in the simplest form, revealing trends and relationships, as described in the Results section.
Nursing and research: why are they important?
Nursing is a complex, wide-ranging profession and, regardless of specialty and setting, nursing and nurses are an integral part of the NHS. The Nursing and Midwifery Council (NMC) (2018a)Code outlines the professional standards of practice and behaviour nurses must uphold:
- Prioritise people
- Practice effectively
- Preserve safety
- Promote professionalism and trust.
The International Council of Nurses (2002) has highlighted the importance of nurses being authorised and prepared to be involved in research. Nursing encompasses the autonomous and collaborative care of individuals of all ages, families, groups and communities, sick or well, in all settings, and includes the promotion of health, prevention of illness, and the care of ill, disabled and dying people (World Health Organization, 2021),.
The Health and Social Care Act 2012 introduced a statutory duty to promote research on the health secretary and all levels of the NHS, along with the powers to support it. The NHS Constitution (Department of Health and Social Care (DHSC), 2021) supports research as one of its key agendas:
‘… through its commitment to innovation and to the promotion, conduct and use of research to improve the current and future health and care of the population.’
Clinical research helps to find new and better ways to detect, diagnose, treat and prevent disease; it involves studying people, data or samples of tissue from people to understand health and disease. This makes clinical research an essential part of the health service. Moreover, the need for inclusion of research in healthcare practice is more than simply advancement in knowledge and technology.
‘Evidence from research influences and shapes the nursing profession, and informs and underpins policy, professional decision-making and nursing actions.’
This does not only guarantee that nurses deliver the best possible care for patients, to ensure a positive patient experience, but also encourages nurses to be active in making changes that are reactive and pragmatic in the ever-changing healthcare landscape.
There have been initiatives at King's College Hospital NHS Foundation Trust to promote research and to increase awareness of research nursing, with research activities included in practice and job plans. The aim has been to encourage nurses to become involved, whether as a supporter or active participant, and even to lead and deliver their own research. Examples include:
- Holding annual celebrations of International Clinical Trials Day on May 20 from 2014 onwards
- Offering a 1–2-day placement with a research team for those attending a university credit renal course
- Providing protected time to spend with a research team for those on preceptorship or who are supernumerary or new starters in a department.
Clinical nurse and clinical research nurse
There is no such thing as a conventional nurse, as nursing roles will vary depending on specialty. Although being a nurse involves multiple overlapping roles and responsibilities, there is a core of universally accepted basic roles and duties. Bringing these together under seven platforms, the NMC (2018b) places the focus on outcome-based requirements, and requires nurses to:
- Be an accountable professional
- Promote health and preventing ill health
- Assess needs and plan care
- Provide and evaluate care
- Lead and manage nursing care and working in teams
- Improve safety and quality of care
- Co-ordinate care.
It is important to note that nurses encourage a more unified holistic treatment plan and act as the link between the patient and the multidisciplinary team. Thus, nurses have a pivotal role in the team.
The nurse's role is continuously evolving, responding and adapting to changes in circumstances, as was the case for the author when the CRN role became a new career option. Clinical research nursing is a specialty whereby the conduct of research and the care of participants is the focus of practice. Aside from the more recognisable nursing responsibilities, the CRN's role is guided by the Good Clinical Practice (GCP) principles (National Institute for Health Research (NIHR), 2019). These are international ethical, scientific and practical standards to which all clinical research must adhere.
The role of the CRN is also driven by the study protocol, whereby a schedule of events, procedures involved and conduct of research will vary as per study requirements. Box 1 summarises the CRN roles according to the National Institute for Health Clinical Centre (2010). CRNs play a vital role in delivering clinical research, according to the Royal College of Nursing (RCN) (2022) and, ultimately, improving patient care and treatment pathways.
Box 1.The role of clinical research nurse
- Assuring participant safety
- Ongoing maintenance of informed consent
- Integrity of protocol implementation
- Accuracy of data collection
- Data recording
- Follow-up
- Study procedures – may include administration of investigational drugs, performance of procedure, clinical assessment, or psychosocial intervention
- Additional nursing care may be necessitated by the response to the study intervention
Source: National Institute for Health Clinical Centre, 2010
Results: understanding of the CRN role
Although the literature confirms the importance of research and the crucial role that the CRN plays in the success of clinical research and in improving patient care and outcomes, the results of the study described in this article showed that 40% of respondents either misunderstood or had no idea of the role of the CRN, with 60% having limited or basic understanding. These findings confirm those of Jones (2015): that healthcare colleagues often, mistakenly, use the terms nurse researcher and CRN interchangeably, due to lack of understanding of the difference between the two nursing titles. Survey respondents commonly described a CRN as someone who collects data, designs and conducts their own research and is not involved in direct patient care, which are within the role of the nurse researcher.
The current survey highlighted that less than half (47%) of the nurses were aware of clinical research and trials being conducted in the renal department of King's College Hospital NHS Foundation Trust. Only 26.7% confirmed having information about clinical research and trials disseminated to them. This was influenced by the fact that most research is designed to include patients considered to be ‘well’; these are individuals who normally attend their outpatient appointments who do not have an acute condition requiring hospitalisation or who are not inpatients, unless it is stated or allowed in the research protocol. This is reflected in the results of the survey questionnaire, because the majority of patients recruited to research and trials are enrolled via the outpatients department, which means that ROPD staff are more research aware than their counterparts on the wards.
The reason patients are recruited from outpatient clinics is because in this setting they are more likely to meet the criteria of a research study protocol and potentially be eligible and safe to participate; this is in contrast to patients on the ward, who will have concurrent medical issues requiring medical intervention and care. Strict adherence to research eligibility criteria ensures that the safety, welfare and wellbeing of patients are protected and that the conduct of research accords with the GCP principles, in particular, principles 2, 3, 5 and 9 (see Box 2) (NIHR, 2019).
Box 2.Relevant good clinical practice principles for patient selection
- Principle 2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks
- Principle 3. The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over the interests of science and society
- Principle 5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol
- Principle 9. Freely given, informed consent should be obtained from every subject prior to participation in a clinical trial
Source: National Institute for Health Research, 2019
In addition, the CRN is responsible for patient recruitment into a study,. The inclusion and exclusion criteria set by the study protocol must be followed rigorously, with patients' safety paramount throughout the course of the research, as per the GCP principles.
In the view of about 70% of the clinical nurse respondents to the survey, there was a lack of communications between themselves and CRNs. A contributing factor was that the CRNs were less visible to ward staff than to staff in the ROPD and dialysis unit, as per the survey's findings. Although information has been disseminated and was presented at the weekly academic meeting of the renal department, it was reported by respondents to the survey that nursing colleagues' workloads, staffing issues and hands-on patient care priorities prevented them from accessing research information and attending academic meetings.
The responses to the survey also showed that senior nurses (20% of respondents) have a better understanding of the CRN role and that they are more aware of clinical research studies and trials being conducted in the renal department than junior colleagues. The level of research awareness among senior nurses, who are Band 7 and Band 8a, and accounted for one fifth of the respondents of this survey, was due to their years' of experience (>5 years) and level of responsibilities in their current role. In addition to clinical and management duties, they have the responsibility to be proactive in promoting, supporting and helping drive initiatives in the renal department (including research projects). It is also within their remit to attend meetings such as the academic meeting (ie discussion of research projects), compared with junior colleagues, who are in the main clinically based.
Despite the lack of communication between registered nurses and CRNs, and the lack of understanding of each other's roles, 86.7% of the nurse participants strongly considered that clinical research and trials are beneficial to patients; 80% of those who took part in the survey said they would refer patients to the CRN and 93% said they would encourage patients to participate in clinical research and trials.
Some common themes emerged from the responses to the survey, which revealed aspects that nurses considered would improve the way forward to augment clinical research:
- Good communication
- Timely co-ordination of the schedule of events
- Combining clinical–research activities
- Integration of research roles with registered nurses in clinical practice.
These findings highlighted that good communication is not only important in any patient-centred activities, but that it is also crucial when collaborating with other nurses and health professionals. This ensures that both nurses and CRNs can have the opportunity to understand each other's roles, that they will be in a good position to give support and that they will be better prepared to address any issues as they arise. According to Arnold and Boggs (2019), having good communication establishes trust and a collaborative working relationship that can facilitate good decision-making, maintain motivation levels and help achieve the anticipated outcomes.
It is also important to recognise that the nursing role has expanded to more than simply caring for an individual patient. In the context of this study, it is the area of clinical research; and this recognition and understanding of the role is the key to the success of collaborative working. Collaboration between clinical nurses and CRNs can influence reforms to the NHS: nurses can advocate for new policy, care pathways and frameworks and encourage the delivery of evidence-based care based on research outcomes.
Common themes that emerged from the survey responses presented above can be used to explore opportunities to develop strategies to increase research awareness and improve working relationship between healthcare colleagues. Arising from the findings of this survey, strategies and approaches have been implemented to help bridge the gap between clinical nurses and the CRN, with CRNs involved in the following:
- Working with the practice development nurse (PDN) to incorporate research in the development plan for nurses, eg to include a research-focused study day
- Taking part in ward manager forum and senior nurses' meetings, where a research team will be given a slot to present and inform of the current research activities
- Encouraging better collaborative working with healthcare colleagues, with research and standard care procedures being performed at the same time, to minimise patients' hospital visits, waiting times and the need to repeat procedures (eg blood tests, urinalysis, ECG and vital signs)
- Promoting research information through posters and recruitment materials, as approved by the Research Ethics Committee and Research and Development department, in communal areas at King's College Hospital, specifically within the renal department
- Providing information to healthcare colleagues on the research studies being carried out, to equip them with the knowledge to briefly discuss the research with patients, and also enable them to make direct referrals to the research team of patients who may be eligible and would benefit from participation in the research.
This co-development of strategies is crucial for raising the Trust's research profile within the NHS and the local comprehensive research network, in order to not only increase patient recruitment, engagement and retention, but also to meet research metrics, delivery and output.
Limitation
This was a small survey focusing on one specialist area. However, the findings have benefits that are potentially transferable to wider research delivery units or specialties to further improve research nursing practice.
Conclusion
In the past decades, clinical research nursing has become a popular career path for nurse. However, the CRN's role remains unclear to most nursing colleagues and other health professionals. Developing an approach to resolve this and to help bridge the gap between these two important nursing specialties – namely, nurses delivering direct patient care and CRNs, is pivotal.
Therefore, a better understanding of each other's roles, improved communication and clinical-research integration will not only enhance good working relationships between these equally important nursing specialties, but will also bolster the success of clinical research.
KEY POINTS
- Research awareness is an important part of nursing practice and it is vital to improve understanding of one another's role between nurses working on the wards and clinical research nurses (CRNs)
- The findings show that communication and collaborative working between clinical nurses and CRNs are pivotal
- The survey highlighted why it is important to understand the role of clinical research nurses in terms of research delivery and improving patient outcomes
CPD reflective questions
- After reading this article, which additional learning have you identified regarding clinical research and the role of clinical research nurses?
- How will you use this learning to improve research output in your department?
- How has your understanding of clinical research changed after reading this article, and how do you think it will impact on your practice?