The purpose of this study was to gain an understanding of the contribution of Clinical Research Nurses (CRNs) to the clinical research enterprise. Ninety-seven eligible responses were received for the internet-based survey which collected demographic data and free text responses to four open-ended questions regarding the experience of nurses working in the clinical trials, their educational preparation and their role pathways. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy’s Quality Caring Model® of relationship-centred professional encounters. The researchers highlighted key themes related to dual loyalty to both study participants and the research protocol, relationships and nursing care, interdisciplinary team membership and contribution to science.
Gaps in educational preparation and professional pathways also emerged as an important consideration.
The paper correctly highlights that the role of the CRN has become more visible with the onset of the COVID-19 pandemic, although CRNs have been pivotal to the efficient conduct of clinical trials for decades. The paper also comments on the diversity of the CRN roles and the settings in which CRNs work. Earlier studies have focused on CRNs located in hospital settings and/or clinical research facilities (Hill and MacArthur, 2006; Tinkler et al., 2018); however, CRNs also work in other areas such as the pharmaceutical and regulatory industries amongst others. Experiences from these CRNs are also important in understanding the CRN impact on the research landscape. The majority of responses came from CRNs based in American Academic Medical Centres and whilst the general consensus is that the majority of CRNs are based in AMC facilities, the sampling method means that one could question whether this is actually a true reflection of the CRN workforce. Six percent of responses came from the UK and 4% from Ireland. The IACRN has three international chapters (UK/Ireland, Japan and Beijing-China). Dissemination of the survey to these chapters may have obtained additional data unique to these regions adding diversity to the results.
This study usefully suggests that CRNs have a positive perception of their impact on the research enterprise. The study highlights themes that are also common in other countries:
• The knowledge and skills associated with the CRN role differ from the theory covered in undergraduate nursing education. The day-to-day logistics of coordinating a study, whilst also ensuring the rights, safety and well-being of research participants are respected, are skills that are learnt on the job; and
• Clearly defined career pathways specific to the CRN role are lacking. Career opportunities are likely to come with experience, development of skills and postgraduate study.
These themes resonate internationally and should be considered by the wider CRN community.
Biography
Carole Schilling has worked in clinical research for over twenty years in a variety of roles such as Research Nurse, Clinical Research Associate, Quality and Regulatory Affairs Manager and Project Manager. Carole is currently working as a Clinical Nurse Manager coordinating hepatology and gastrointestinal clinical trials.
References
- Hill G, MacArthur J. (2006) Professional issues associated with the role of the research nurse. Nursing Standard 7(20): 41–47. [DOI] [PubMed] [Google Scholar]
- Tinkler L, Smith V, Yiannakou Y, et al. (2018) Professional identity and the clinical research nurse: a qualitative study exploring issues having an impact on participant recruitment in research. Journal of Advanced Nursing 74(2): 318–328. [DOI] [PubMed] [Google Scholar]