The nursing profession has been around since the first humans and has gone through various transitions, shaping how it is practised and perceived. Consequently, nursing practice has undergone fascinating changes, influenced by events such as wars and major disease outbreaks, as well as shortages of other healthcare workers, all of which have facilitated advances in practice (Mackey and Bassendowski, 2017; World Health Organization (WHO), 2017). Through these changes, the profession has seen the extension of the scope of practice and the birth of new specialties. These developments provide a well of inspiration, from which lessons can be drawn in shaping the future of the nursing profession and patient care.
This article explores the role of the advanced clinical practitioner (ACP) in clinical research and highlights the significant developmental milestones and challenges ACPs face in clinical research. Interventions that could be implemented within the UK context to enhance the utilisation of the broader ACP workforce in clinical research are proposed.
ACPs are experienced registered nurses, midwives and allied health professionals (NMAHPs), practising within Health Education England's (HEE) multiprofessional framework for advanced clinical practice (HEE, 2017). The framework establishes standards and qualification, and highlights four pillars of advanced clinical practice:
- Clinical practice
- Leadership and management
- Education
- Research.
While acknowledging that ACPs are composed of professionals from a variety of disciplines, this article places particular emphasis on nurses.
Historical perspectives
Historically, the pioneers of the nursing profession were clear about their vision of advancing practice and empowering nurses to practise with autonomy, as they progress through their careers (Matthews et al, 2020). Florence Nightingale, considered the mother of modern-day nursing, played a vital role in ensuring that nurses were able to develop in their role and be recognised as autonomous practitioners, incorporating advanced level practice (Matthews et al, 2020; McEnroe, 2020). Since Nightingale's time, this vision has been facilitated through tailored educational programmes, ensuring that nurses can appreciate and employ a comprehensive approach to delivering patient care at advanced level without medicalising care (WHO, 2017). Today, the idea of nurses practising within an expanded scope is supported by WHO (2017).
There is an expectation that nurses will continue to develop post-registration and augment their skills to practise in advanced capacities as they progress through their careers; however, how this is to be realised is not clearly and uniformly defined. Different countries have different systems, so advanced practice is defined to some extent by where a nurse is practising geographically (Scanlon et al, 2020).
Globally, advanced practice has existed in some form since the 1960s and, like the mother profession, it has also gone through different developmental phases (Maier et al, 2016). In the UK, nurse and academic Barbara Stilwell is credited for pioneering advanced practice by setting up the first training programme in 1990, based at the Royal College of Nursing (RCN) Institute (King et al, 2017; Leary and MacLaine, 2019). The development of advanced practice in the UK has included the involvement of stakeholders, such as the RCN, the Nursing and Midwifery Council (NMC) and government agencies.
Each of these stakeholders has input into the development and implementation of advanced practice, however, it is important to ensure that the recipients of the care provided by advanced practitioners – namely patients – are involved in the advanced practice discussion (Peate, 2019), through patient and public consultations.
Evolution of ACPs
The number of nurses practising at advanced level has in recent years increased globally, which has been attributed to attempts to fill the workforce shortfall (Maier and Aiken, 2016a; 2016b). Shortages in the medical workforce, in part arising from the regulation of the working hours of junior doctors through the European Working Time Directive since 2004, arguably exacerbated the issues motivating government agencies to help fill the gap with nurses (Maybury, 2014; Mukherjee et al, 2021). However, government policies aimed at reducing costs, while bridging this workforce gap, have been criticised as putting the quality of care at risk, the argument being that this is an attempt to replace doctors with a cheaper nurse alternative. It has become evident, however, that ACPs are neither intended to replace doctors, nor that they are an inexpensive alternative (King et al, 2017; Spence, 2019; Thompson and McNamara, 2022) – ACPs are experienced professionals who bring a wealth of knowledge and experience to the healthcare team.
The urgent need to develop the skills of nurses through education has been championed by professional nursing bodies and other key players, with improved patient outcomes cited as a key incentive to supporting continuous professional development and the extended scope of practice (King et al, 2017; Mackey and Bassendowski, 2017; WHO, 2017; Peate, 2019). This has led to nurses taking on more responsibilities and extending their scope of practice.
Interprofessional collaborations have also been identified as a positive instrument for improving patient outcomes and increasing access to specialist care (Goldsberry, 2018; Evans et al, 2020a; Hardy et al, 2021). There is, therefore, an attempt to standardise advanced practice across the healthcare professions, leading to the introduction of the multiprofessional ACP role (HEE, 2017). Due to the distinctive scope of practice within each non-medical healthcare profession, this poses a challenge in attempting to define advanced clinical practice and its professional identity.
New specialty
Within the nursing profession, advanced clinical practice continues to evolve and is fast spreading across various nursing specialties (Evans et al, 2020a; 2020b) and recent years have seen significant growth with the introduction of new specialties. One of these has been clinical research nursing – although, it must be noted that nurses have always been directly or indirectly involved in research – but this was previously regarded as an addition to the nursing role, rather than as a full specialty (National Institute for Health and Care Research (NIHR), 2011).
The desire to improve patient outcomes and the advancement of science have necessitated greater investment in clinical research. As a result, nurses have been given a key role in clinical research, to ensure that patients taking part in clinical trials receive dedicated and safe care (Hastings et al, 2012; Herena et al, 2018) – and this has led to the birth of clinical research nursing.
The definition of a clinical research nurse is that of a registered nurse employed specifically to undertake research in a clinical setting (NIHR, 2011; 2019). In the UK, the NIHR has been instrumental in the development of this new specialty, publishing the first competency framework for the role in 2008, with regular updates following (NIHR, 2011). The framework sets out the scope of practice for clinical research nurses and the skills required in the role, as well as providing a development plan for research nurses, and further outlining levels of expected competencies to be achieved by research nurses based on seniority (NIHR, 2011). Individual organisations have adopted and implemented the NIHR's framework to suit local demand.
Research nurses are expected to advance their practice. At the highest level (Band 8) indicated in the framework, nurses are expected to be competent and autonomous leaders. They are also expected to provide support, training and supervision for junior members of the team (NIHR, 2011). These expectations resonate with three of the four pillars of advanced clinical practice – leadership and management, education and research – the clinical practice pillar, however, is not included.
Advanced clinical practice in clinical research
The NIHR framework does not specifically mention advanced clinical practice, although there is an expectation for nurses to advance their practice. It is worth reiterating that the NIHR framework is for clinical research nursing in general and not necessarily for advanced clinical practice, hence this may explain the omission. As nurses advance in their careers, the framework expects them to practise more in an administrative capacity and less in a clinical role, thereby making senior clinical research roles managerial (NIHR, 2011). This presents a challenge for ACPs working in clinical research, because they may experience restrictions in their practice.
This may offer insight into why, although the framework sets out the expectation that nurses will be autonomous at the highest level of their development in clinical research, they are still not permitted to perform certain clinical duties in clinical trials, for example, in those involving Investigational Medicinal Products (IMPs), as noted by Subin (2021). At present, these responsibilities are assigned to medically qualified professionals under the Medicines for Human Use (Clinical Trials) Regulations 2004 and the European Medicines Agency's Guidelines for Good Clinical Practice (2016), which stipulate that decisions such as assessing adverse events (determining causality), physical examination, medical review and the confirmation of eligibility of research participants to participate in a trial are within the remit of medically qualified persons.
Such restrictions on practice are most evident in clinical trials involving IMPs. Even though ACPs are independent prescribers and have requisite knowledge on indications for treatment and medication-related reactions and side-effects (Weeks et al, 2016; Graham-Clarke et al, 2018), they are still not widely allowed to perform these duties in clinical research. In some instances, ACPs are allowed to prescribe the IMP per study protocol – this decision is made by the pharmaceutical company or study sponsor (Subin, 2021). The challenges described above will affect nurses transitioning into the ACP role in clinical research. It is worth restating that ACPs are autonomous practitioners and should be allowed to apply their clinical skills in clinical research..
Ashton (2020) noted that advanced clinical practice in clinical research existed only in four NHS trusts. In view of the fact that clinical research nursing is a developing specialty, it is not remarkable that advanced clinical practice in this new specialty is only slowly gaining acceptance in the healthcare industry (Ashton, 2020; Subin, 2021). There have been calls to extend clinical research investigator education and training to nurses (which is usually physician focused) (Calvin-Naylor et al, 2017), a move that would prepare nurses to practise in advanced capacities in clinical research.
Currently, ACPs working in clinical research are delegated the duties of a sub-investigator, performing clinical tasks such as physical examinations, prescribing, assessment of adverse events, medical reviews and confirmation of eligibility of patients for clinical trials (Subin, 2021). However, as described above there are restrictions on what an ACP can do within each study, which will depend on the study sponsor (Subin, 2021). It is worth reiterating that, although ACPs are deemed competent and autonomous to perform these clinical procedures and to make decisions in clinical practice, their autonomy is restricted within the scope of clinical research (Oxtoby, 2020; Lockwood et al, 2022).
The vital contribution made by ACPs to clinical research has been highlighted both in the UK and internationally, with calls to make more effective use of nurses in this role. This would expand the capacity of clinical research facilities and increase patient access to clinical trials (Welch et al, 2017; Ashton, 2020; Braun-Inglis et al, 2022). It is important that ACPs are enabled and trusted to apply their skills and experience in clinical research, in the same way they do in clinical practice.
Necessary interventions
Advanced practice in clinical research and the wider healthcare system has resulted in significant improvements to patient outcomes, both in the UK and internationally (McDonnell et al, 2015; Lavery and Whitaker, 2018; Serena et al, 2018; Gerber et al, 2019; Schober, 2019; Ashton, 2020; Subin, 2021). In view of this, there is a need to develop initiatives to ensure that patients receive the specialist and advanced care they need. The effective utilisation of ACPs in clinical research is needed to ensure that patient access to clinical research is enhanced, while ensuring that all practice is patient focused.
The regulation of advanced practice has been identified as a potential tool to address the current confusion surrounding the role (Leary and MacLaine, 2019; Hooks and Walker, 2020). However, the need for regulation has been questioned, among others, by Hardy et al (2021) and the type of regulation required is yet to be addressed. ACPs are registered practitioners, which means that advanced level regulation may take a different form from their initial registration. The RCN's credentialling model is an example of a potential approach to the regulation of ACPs (RCN, 2018a; 2018b; 2018c): this takes the form of post-qualification certification, which ensures practitioners meet the required standards and are accountable for their practice decisions. Regulation will ensure the standardisation of education and practice. There is a need for collaboration between the nursing regulator, the NMC, and the nurses' professional body, the RCN, to develop and implement a reliable structure for ensuring the effective regulation of ACPs. Regulation would provide the evidence that study sponsors require to allow ACPs to lead in clinical trials without unnecessary restrictions.
The research pillar of advanced clinical practice is often subjugated to the other pillars (Fielding et al, 2022), leaving a significant gap in the practice of advanced practitioners. There is the need to embed research within the job description of ACPs, and ensure this is clearly outlined in their job plans, which provide specific detailed goals for each role and outline a road map to achieve them. Since research is part of the ACP role, all nurses in these positions should be assigned to lead at least one clinical trial or study relevant to their specialty as part of their job plan. This would keep them actively involved in clinical research and set the pace for the creation of hybrid roles that would enable ACPs to practise in their specialties at the same time as working within clinical research, leading clinical trials. The approach has the potential for increasing recruitment into clinical trials, enhancing the patient experience and ensuring the smooth delivery of clinical research (Welch et al, 2017; Braun-Inglis et al, 2022). Such an initiative would help balance the practice of ACPs who do not have full-time or part-time research roles.
There is an urgent need for engagement and collaboration between NHS organisations, clinical research regulatory agencies and pharmaceutical companies to facilitate the development of the ACP role in clinical research, to ensure that the knowledge, skills and experience of ACPs is valued and utilised appropriately.
Clinical research practitioners (CRPs), who are currently unregistered non-clinical research staff, are another untapped resource (Faulkner-Gurstein et al, 2019) that could be used to support research delivery and, specifically, support ACPs in clinical research. For instance, CRPs could be used to support the non-clinical aspects of a study, leaving the ACP to focus on clinical components. This would ensure that the ACP was not overwhelmed and could deliver more clinical research. Such a move would have the potential to create a research-supportive environment, allowing ACPs to balance their clinical practice with their role in clinical research.
Conclusion
Advanced clinical practice is continuing to develop (Evans et al, 2020b) and, as such, it presents an opportunity to shape the future of practice and define the professional identity of ACPs. The key contribution that ACPs make to clinical research should provide an incentive to stakeholders to make a conscious effort to ensure that funding is put in place for ACP education and to create more opportunities for ACPs. There is also a need for research into the nature of regulation required for ACPs. It is also important to determine how practice can be standardised to resolve the existing confusion around advanced clinical practice, which is exacerbated by the fact that the role spans different healthcare professions. Empowering ACPs to practise with autonomy in clinical research, as they would in clinical practice, would benefit both patients, the research community and nurses themselves.
KEY POINTS
- Advanced clinical practitioners (ACPs) should be empowered to practise with autonomy in clinical research
- There is a need for engagement between the NHS, research sponsors, government agencies and other relevant stakeholders to help shape the ACP's role in clinical research
- The utilisation of ACPs in clinical research benefits patients and enhances access to clinical trials
- Regulation is required to resolve the existing confusion that surrounds the ACP role
CPD reflective questions
- Do clinical practitioners (ACPs) in your clinical area contribute to clinical research?
- How have ACPs in your clinical area impacted patient care?
- Consider the experience and skills of colleagues who are ACPs. Do you think they should be given the responsibility to practise autonomously in clinical research?
- How do you think regulating ACPs would help affirm their competence and autonomy?