Keywords: Nurse/Research/Clinical Nursing Practice trial/Education/Career Discussion ●This article has been double-blind Nursing research peer reviewed Clinical research nurse and nurse research roles are distinct but often confused with each other. Understanding both will help nurses pursue the right research career path Clinical research nurse or nurse researcher?

In this article... 5 key Outline of the clinical research nurse role points Research is a Details of the nurse researcher roles 1growing area for Growth and future expectations for both roles nursing careers The roles of 2clinical Author Helen Claire Jones, modern matron intrinsic part of many multidisciplinary research nurse and for research, Guy’s and St Thomas’ teams. Roles and responsibilities have nurse researcher Foundation Trust developed and nurses can now progress have both Abstract Jones H (2015) Clinical research up the salary scale as their skills increase. developed over nurse or nurse researcher? Nursing Times; Much of the growth is the result of the recent years 111: 19, 12-14. development of the research network Although the This article gives an overview of two infrastructure across the country, which 3roles have research-related roles that can form part began with the establishment of the similarities they of a nurse’s career path: clinical research National Cancer Research Network in 2001. both require nurse and nurse researcher. It highlights The publication of Best Research for Best unique skills and the influences on both roles, and the skills Health (Department of Health, 2006) led to can each be a and differences within them, as well as the setting-up of the National Institute of career path offering advice on how nurses can access Health Research (NIHR) and further The National either role. growth of the research networks system 4Institute of to cover all therapeutic areas. Health Research esearch is at the heart of evi- Many organisations have a growing has had a major dence-based healthcare, and its CRN workforce across numerous clinical impact on the importance in the NHS has areas. This growth has occurred in line development of Rrecently increased. The Health with an increase in research activity across both of these roles and Social Care Act (2012) acknowledged many organisations. In 2013-14 the NIHR Fully funded the importance of research and pledged to Clinical Research Networks recruited more 5training embed it as a core function of the NHS. than 600,000 patients to studies. More schemes are Nurses’ involvement in research has than 3 million patients have been recruited available to help grown, and two distinct roles have since 2008 (The Guardian, 2014). support nurses emerged to enable them to forge a career in to develop as this area: clinical research nurse and nurse Role responsibilities and skills researchers researcher. These roles are now recognised As the CRN workforce has grown, the role within the profession (Box 1). has become multifaceted: CRNs take The terms “clinical research nurse” and increasing responsibility across the whole “nurse researcher” are often confused and research pathway, from setting up studies used interchangeably (MacArthur et al, to closing them down and archiving all 2014; Johnson and Stevenson, 2010) but study-related documents. The role focuses each role – and its requirements – varies around the coordination and management considerably. Each role’s skills and respon- of clinical trials to ensure adherence to: sibilities are unique, and each can be a » Study protocols and procedures; career path in its own right. Table 1 (p14) » Research governance requirements; highlights the key differences. » Patient safety. Clinical trial studies often involve Clinical research nurse testing new drug treatments or devices Growth in the role (interventional studies), but can also The clinical research nurse (CRN) role has include non-treatment studies (observa- Nurses must ensure the safety of patients

Alamy become an established and increasingly tional studies), such as those that may in research studies by observing symptoms

12 Nursing Times 06.05.15 / Vol 111 No 19 / www.nursingtimes.net For a Nursing Times Learning unit on record keeping, go to www.nursingtimes.net/record-keeping measure patient experience or quality of life Box 1. Nurse researcher related to a longstanding health condition. glossary of Whereas the CRN role involves working on It was recognised more than 30 years terms projects related to treatments and patient ago that the quality of clinical therapeutic ● Principal investigator (PI) The main care, nursing research is based on the studies improved when nurses were researcher, often a doctor, responsible acquisition of new knowledge related to involved (Barnes, 1981). Since then, the role for a research study at a hospital. the progression of nursing. It has been of the CRN has evolved with the influence ● National Institute of Health Research defined as a “systematic inquiry designed from the pharmaceutical industry and the (NIHR) Main Department of Health- to develop knowledge of importance to need for dedicated support in their drug funded body that is responsible for nurses, including nursing practice, development programmes. funding NHS research nursing education and nursing adminis- ● Research governance The process tration” (Polit and Beck, 2006). Governance covering the required guidelines and The role of the nurse researcher is An increase in research governance, legis- legislation around the running of generally part of an academic career path lation and guidelines now means that research studies that allows nurses to undertake further CRNs must ensure all studies within their ● Study site file The main file, which education such as a master’s degree or team are fully compliant with require- contains any document used within the PhD. Like the CRN role, the nurse ments; as a result of this, training in these study and information related to the researcher role has undergone a period of areas is an important initial requirement conduct of the study development over recent years, which has of the role. Although the degree of respon- ● Adverse events Any clinical allowed an increasing number of nurses to sibility may vary, before any patients symptoms experienced by the patient choose this as part of their career. How- consent to a study, CRNs must ensure all during the study, whether related to the ever, unlike the CRN role, where initial necessary approvals have been obtained trial or not entry requires advanced clinical skills and and the relevant correspondence is stored ● Study sponsor Organisation a desire to acquire the relevant research in the study site file. responsible for the management of a skills, the role of a nurse researcher research study requires a baseline knowledge of research Patient safety methodologies. Ensuring the safety of patients in research The UK Clinical Research Collaboration studies is a requirement for the in-depth Study management (2007) examined the role of nurses as collection and reporting of any symptoms Leadership and organisational skills are researchers and identified the barriers that they experience. “Adverse event reporting” also crucial for CRNs. Although the prevented them from pursuing research involves recording all incidents that have responsibility for a clinical trial remains careers. It determined that: occurred to a patient while involved in the with the PI, CRNs often play a key role in » Most nurses involved in research were study, whether related or not. its overall coordination and management. doing so as part of a CRN role, while CRNs are generally patients’ first point This can include groups of studies that working on clinical trials; of contact, so it is important that patients may be at various stages in the research » A major reason for the lack of nurses and other staff involved in their care process. Coordinating and managing doing their own research was that few understand that during the study CRNs trials involves: were sufficiently skilled to lead must be made aware of any new symp- » Helping to identify potential study research programmes. toms. They will be discussed with the prin- participants; The UK CRC therefore recommended cipal investigator (PI) and an assessment of » Helping to recruit patients to the study; the establishment of a clinical academic their severity will be made, along with a » Coordinating all follow-up visits, along training path to support further develop- note of which of the research reporting with any investigations required within ment of nurse researchers. criteria they fit. The CRN will often take these; the lead in reporting these to the study » Collecting and reporting investigation Clinical academic training pathway sponsor. When serious events occur, such results and patient data in a timely Currently, most nurse researchers are as hospital admission or death, the study manner. Within this is a requirement to lecturers who are leading research projects sponsor is informed within 24 hours of the liaise with numerous clinical as part of their academic job, or carrying research team being made aware of them. departments including pathology, out a research study within their current imaging and outpatient areas. clinical role as part of an academic Communication Clinical research nurses will also qualification. The NIHR’s aim is to create Effective communication skills are vital become skilled in many new roles that, more clinical and academic careers in for any CRN, particularly when gaining traditionally, may not have been associated research for nurses. It has played a major patients’ informed consent to participate with a nursing role. Within their study part in helping to develop and fund the in a research study. Although the primary portfolio there may be a requirement to clinical academic training pathway, which responsibility for obtaining consent lies become competent in a particular skill gives nurses the opportunity to apply for with the PI, CRNs have a key role in the related to the clinical area of the study; this fellowship grants to fund their academic initial explanation to patients and relatives can include skills such as skin biopsies studies at various levels. As an initial step, so they fully understand what is involved for dermatology CRNs, or lung function the pathway supports a master’s degree in before deciding whether to take part. tests for respiratory CRNs. All CRNs clinical research places for nurses, mid- If a study involves a new treatment, this will become skilled and competent wives, allied health professionals and explanation may often involve a complex within their clinical area and so their pharmacists who work in the NHS, and discussion of the drug involved and any knowledge level can often be likened to currently allocates funding to 12 higher known or possible side-effects. that of a nurse specialist. education institutions to provide this.

www.nursingtimes.net / Vol 111 No 19 / Nursing Times 06.05.15 13 Nursing Practice “I love my job and in five years’ time I would like to be in the same care home, Discussion continuing to care for older people” Paul Phelue p24

Table 1 clinical research nurse and nurse researcher roles

Function Clinical research nurse Nurse researcher Experience/knowledge Previous experience not initially required when Required to have an initial knowledge and choosing this role understanding of research methodologies Research ideas Carries out research related to other people’s ideas Develops own research ideas Leadership areas May not lead on the getting required approvals but Generally leads on obtaining the required ethics must ensure all in place before study starts and research and development (R&D) approvals Data analysis Not routinely involved in data analysis and reporting Analyses results and reports findings Working methods Often works as part of a team Often works independently Location Usually based within a hospital Often based within a university department Study areas Studies are often treatment related Studies answers an academic questions related to nursing Number of studies Coordinates the running of a group of studies Generally focuses on one project Patient care Often directly involved with patient care pathway No direct involvement with patient care

Funding covers applicants’ salary and and consent of study subjects and all data working in a clinical academic role (Asso- course fees, and allows them to be collection. Following this, in-depth ciation of UK University Hospitals, 2012). seconded from their current role to pro- analysis of all data is required to identify To help achieve this, nurses must continu- vide dedicated time to develop these skills. the main study findings. This is a unique ally be made aware of the research options Once they have completed the master’s aspect of the role compared with that of available to them and provided with the degree, nurses can apply for PhD and post- CRNs; their role in studies is generally necessary support to develop into the role doctoral fellowships to further develop completed once all data collection is over, of their choice. This will support the future their research training. Details are avail- especially if their workload is based change in nursing research to equip more able on the NIHR website (Bit.ly/NIHR- around clinical trials. nurses to lead on research projects related TrainingProgs). This programme is to the nursing profession. NT proving successful; four members of the Governance research nurse workforce at Guy’s and St Like CRNs, nurse researchers must ensure References AUKUH Clinical Academic Careers Group for Thomas’ Foundation Trust have been all research governance requirements are Nursing and Midwifery (2012) The Nurse and accepted to study for a 12-month master’s met before the start of their research pro- Midwife Research Clinical Academic: Development, in research, while another has been ject. However, it will be their responsibility Progress and Challenges. Executive Summary. Annual Report of Activity May 2011 to June 2012. accepted for a PhD. to lead on this, including completion and London: Association of UK University Hospitals. submission of all documents. As part of an Bit.ly/AUKUKClinAcademCareers Study management academic pathway, ethics approval will Barnes G (1981) The nurse’s contribution to the Unlike CRNs, whose role is based around need to be sought from their academic Medical Research Councils trial for mild hypertension. Nursing Times; 77: 29, 1240-1245. supporting other people’s research ideas, institution and then the main National Department of Health (2006) Best Research for nurse researchers must be able to develop Research Ethics Service if their project Best Health: A New National Health Research their own ideas into robust research involves patients. Approval from the Strategy. Bit.ly/DHBestResearch The Guardian (2014) NHS Trust Research Activity questions and projects, based around a research and development department League Table 2013/14. structured methodology. If they are within the organisation where they plan to Bit.ly/TrustResearchLeague2013-14 undertaking a research degree they will carry out their research may also need to Johnson S, Stevenson K (2010) Nursing research have support in this from an academic be sought. Nurse researchers must be or research nursing? Two separate terms, two separate careers. Nurse Researcher; 17: 3, 32-40. supervisor. aware of all the requirements within this MacArthur J et al (2014) Professional issues As well as developing a research idea and make the necessary decisions as to associated with the clinical research nurse role. and question, nurse researchers must also what approvals are required. Nursing Standard; 29: 14, 37-43. National Institute for Health Research (2014) NIHR complete any associated documents Annual Report 2013/14. Bit.ly/NIHRReport2013-14 required for the running of the study. This Conclusion Polit DF, Beck CT (2006) Essentials of Nursing may include: Research is a growing area for nurses, who Research: Methods, Appraisals and Utilization. Philadelphia PA: Lipincott Williams and Wilkins. » Participant information sheets and have the opportunity to develop their skills UK Clinical Research Collaboration (2007) consent forms; within two distinct roles. Those working Developing the Best Research Professionals. » Interview schedules; as CRNs may often cross over into the role Qualified Graduate Nurses: Recommendations for » Survey questionnaires; of nurse researcher as part of an academic Preparing and Supporting Clinical Academic Nurses of the Future. London: UKCRC. » Any other data collection tools. programme of study. Awareness of NIHR- Bit.ly/UKCRCResearchProfessionals This is one of the big differences funded schemes is growing and in 2013/14 between the two roles, as CRNs often have the institute awarded 12% of its academic For more on this topic go online... limited or no involvement with this side of training programmes across all of its Ethical approval in studies raising a research project. awards to nurses. An aspirational goal has consent issues Nurse researchers must lead on all been set that by 2030, 1% of the qualified bit.ly/NTEthicalApproval study activities, including identification nursing and midwifery workforce will be

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