The role and potential contribution of clinical research nurses to clinical trials

Karen Spilsbury*, Emily Petherick, Nicky Cullum, Andrea Nelson, Jane Nixon, Su Mason

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

88 Citations (Scopus)

Abstract

Aims and objectives. This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. 

Background. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. 

Design. Qualitative focus group study. 

Methods. A focus group interview was carried out with CRNs (n = 9)employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside fieldnotes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. 

Findings. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. 

Conclusions. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal ‘participant observers.’ Such observations enhance understanding of the contexts being studied. 

Relevance to clinical practice. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Original languageEnglish
Pages (from-to)549-557
Number of pages9
JournalJournal of Clinical Nursing
Volume17
Issue number4
Early online date5 Apr 2007
DOIs
Publication statusPublished - Feb 2008

Keywords

  • clinical research nurse
  • clinical trials
  • management
  • nursing
  • qualitative study

ASJC Scopus subject areas

  • Nursing(all)

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