Nurses in clinical trials: perceptions of impact on the research enterprise.

Abstract

Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.