It is widely acknowledged that the quality of research is greatly improved when nurses are involved at the investigators' site [1,2]. Many discussion papers highlight the knowledge, skills and expertize required by nurses for the conduction of trials [1,3-5].
Nearly 700 000 nurses are registered to work in the United Kingdom (UK) but it is unclear as to how many of these work as clinical research nurses (CRNs) . There is no easy mechanism in the UK to determine what job each registered nurse is employed to undertake. The UK Clinical Research Collaboration (UKCRC) recognize that currently there is no clear role definition or career pathway for CRNs for a whole host of reasons [6,7]. Attempts have been made particularly in America to define the role of neuroscience nurses by conducting surveys to identify and define current practice [8,9]. However, this has not been extended to surveying the role of the CRN in the neuroscience setting. The role of the CRN has proved difficult to clearly define as it has so many facets. This is evident from research conducted to investigate the roles and responsibilities of CRNs, which clearly demonstrate that the position of the CRN is often complex and difficult to characterize [10-13]. This is certainly the situation within neuroscience, with CRNs working at all levels, beginning with the basic requirements of research (which are discussed later) to those who are practicing as independent researchers. There are certain basic requirements needed in order to be effective as a CRN in the neuroscience setting and this paper will attempt to address those skills that are necessary to ensure high-quality research outputs, which have a positive impact on clinical practice and provide better outcomes for the neuroscience patient.
Within the UK and across Europe, recently adopted legislation and changes in the law have resulted in streamlining the research process and harmonizing the standard for design, conduct and analyses, which ensures high-quality research while protecting the rights of trial subjects [14-17]. There are many other pieces of legislation that also influence the conduct of trials not least the implementation of the Mental Capacity Act in England which impacts on the recruitment and care of incapacitated adults in the ICU setting . Familiarity with the legislation regarding research is paramount whichever level a CRN is practicing at. A basic understanding of the requirements is necessary for every CRN but a higher level of knowledge and execution skills are required for a CRN working in a more autonomous setting.
Patient safety is the most important aspect of the CRNs role. In many circumstances the CRN becomes the patient's advocate while ensuring proper conduct of the research trial. No trial can commence in the UK without ethical approval, which is given by a specific Ethics Committee who reviews the trial protocol and ethical application form. In circumstances where a trial takes place in a clinical setting, further approval is required by the Research and Development department. Applications for approval are submitted in parallel to these governing bodies. Following approval, annual reports are required by the Ethics Committee and in many circumstance it is the CRN who compiles this report. Alongside the principal/site investigator, the CRN will be expected to ensure that all members of the research team conduct the trial as it is set out in the protocol and applications sent to the governing bodies. Given that a CRN is expected to conduct a research trial to recognized standards and regulations as laid down by governing bodies of the UK and internationally [14,19], it is therefore vital that the nurse is able to critically read a research protocol, and understand the methodology and its practical application within pragmatic local requirements for the trial.
The CRN works closely with the principal/site investigator in identifying and screening potential trial participants. In this role, the CRN may take part in the process of gaining and continuing informed consent of the trial participant, prior to carrying out procedures and treatments as agreed within the trial protocol. Often in the neuroscience setting, the process of gaining informed consent involves speaking with relatives as the patient in many circumstances may be deemed to be incapacitated, e.g. the severe traumatic head injury patient on the ICU. This requires a greater degree of discernment to assess the situation and ascertain the level of comprehension of relatives who are regularly approached by the research team while they are in a vulnerable state. It is good practice to involve the nurse caring for the patient at this stage given that they have usually built up rapport with the relatives and may be in a good position to advice the research team on the current situation.
Once a patient has been recruited, the CRN keeps in regular contact with the patient, the family and multidisciplinary team as appropriate to the circumstances. The CRN will subsequently conduct the study in accordance with the trial protocol and will have to undertake the practical organization and management of the trial. This includes liaising with members of many departments at the research site, who are involved in the conduct of specific trial procedures, such as pharmacy, biochemistry, scanning departments and diagnostic units.
Expectations of the role of CRN
As previously discussed, the expectations of the abilities of a CRN vary depending on experience. A newly appointed CRN would be expected to have understood the requirements of the study protocol, identify and screen potential participants, ensure that informed consent is an ongoing process, organize and manage required procedures, assist with interventional treatments and record the resulting information. For those who are new to clinical research, it is important that they are given appropriate training to cover the regulatory requirements of governing bodies within and outside the institution in which they are employed [14-20].
It is also important that the CRN is capable of adhering to a predetermined protocol, is numerate and has good IT skills, as increasingly data are being captured and transferred electronically. They should be able to communicate with research colleagues at all levels and have excellent time- and project-management skills. The CRN in the neurosciences setting should have post registration experience of the field that is being researched. When research is being conducted in the intensive care environment and where patients may be taken from the unit for investigation, at least two years experience of caring for a critically ill patient would be required.
As a CRN gains more experience she/he will be expected to work with a greater degree of autonomy, which may involve conducting concurrent multi-centre studies. However, this increased experience and expertize does not preclude them from undertaking all tasks required within the research trial. The CRN should have a sound knowledge of research design, methodology and understanding of the analytical process. They would have an active role in the ethical requirements including research ethics submission, the informed consent process and participant support. Their skills should include project management, protocol development including study documentation and experience of presenting information to colleagues. At this level, the CRN would have a research, educational and developmental role within the research projects. They should consider post-graduate education in clinical research at a Master's level in Clinical Research progressing to Doctoral Research.
Attributes of the CRN in neuroscience
The CRN is recognized as a professionally qualified person by patients, volunteers and colleagues within all care settings and works within the guidelines specified in the Code of Professional Conduct . Nurses are also required by law to be registered with the Nursing Midwifery Council (NMC) in order to practice and need to demonstrate that they are maintaining their professional development on a tri-annual basis. Nurses through their prior training and experience develop management and organizational skills, which enable them to be efficient and effective in the co-ordination of concurrent complex research studies. The additional knowledge and skills necessary to work within neurosciences are evident [21,22], and therefore puts an additional burden on attributes required to become a CRN in this setting .
The ability to communicate at all levels is vital in order to build relationships and communicate effectively with the participants, members of the research team and governing bodies. This skill cannot be underestimated. Without superior communication skills, many research trials would not be completed to their optimum potential. The CRN is often central to the research trial and it is therefore essential that she/he is able to be an effective communicator, negotiator and mediator.
Education as a whole plays a significant role in the effective conduct of a research trial. In many circumstances obtaining high-quality data involves co-operation from a number of individuals working at a research site. In order to achieve this, the investigator and CRN will need to ensure that all members of the multidisciplinary team are aware of the research trial and what role they play in it. This involves providing educational opportunities such as lectures or seminars to inform and educate the multidisciplinary team of the trial protocol and provide opportunity for questions. Similarly, the participants need to be educated to ensure compliance with protocol and this can be challenging in situations where patients suffer from neurological deficits as a result of injury or disease. The process of providing information should be continuous with feedback on trial progression and dissemination of results at the end of the trial.
Having theoretical knowledge of the disease process in neuroscience and recognized management of the disease enables the CRN to understand the required objectives and end-points of research studies while evaluating the validity of the tasks required to provide answers to the research question. The CRN will therefore also be able to disseminate the research findings to colleagues and other healthcare professionals within the field of expertize, enabling the development of evidence-based practice. Many experienced CRN will be expected to participate in the analysis and publication of results. This may be in the form of local lectures to the multidisciplinary team or on a greater scale of writing a paper for a journal and or presentation of the data at a national or international conference.
The post of a CRN has many benefits but also has many down sides, not least the lack of career progression. Attempts have been made to address the issues of career progression in the UK [24,25] and are currently being reinvestigated as there is wide recognition that the career pathway is not as structured as it is for the medical profession . Funding for further education is also problematic, which makes the pursuit of a higher degree more difficult. CRNs often work in isolation and is therefore not a post recommended for someone who likes to work in close contact with others most of the time. Many research posts are short term, with contracts being for 2-3 yr or the duration of the study. This makes for a potentially unstable financial situation for the individuals who take up the post as CRN. The position of the CRN is therefore often complex, with issues surrounding contractual obligations and accountability arrangements being unclear . However, the role is very rewarding and the opportunities for developing further skills and knowledge that enhance the neuroscience nurse's professional development are tremendous.
This paper has demonstrated that experienced neuroscience CRNs are often very highly skilled and poses specialist clinical knowledge alongside a comprehensive understanding of all aspects of the research process. This leads to the facilitation and promotion of evidence-based excellence in the care of neuroscience patients.
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