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

Spilsbury, Karen, Petherick, Emily, Cullum, Nicky, Nelson, Andrea, Nixon, Jane and Mason, Su (2008) The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17 4: 549-557. doi:10.1111/j.1365-2702.2006.01872.x

Author Spilsbury, Karen
Petherick, Emily
Cullum, Nicky
Nelson, Andrea
Nixon, Jane
Mason, Su
Title The role and potential contribution of clinical research nurses to clinical trials
Journal name Journal of Clinical Nursing   Check publisher's open access policy
ISSN 1365-2702
Publication date 2008-02
Sub-type Article (original research)
DOI 10.1111/j.1365-2702.2006.01872.x
Open Access Status
Volume 17
Issue 4
Start page 549
End page 557
Total pages 9
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell
Language eng
Formatted 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.

  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 field notes 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.
Keyword Clinical research nurse
Clinical trials
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Nursing, Midwifery and Social Work Publications
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Citation counts: TR Web of Science Citation Count  Cited 26 times in Thomson Reuters Web of Science Article | Citations
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Created: Tue, 20 May 2014, 14:21:35 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work