A qualitative study exploring the role of clinical trials nurses in Australia

Abstract

This study investigated the role that registered nurses play in the conduct of clinical trials in Australia. Current literature describing the roles and responsibilities of nurses working in clinical trials is mainly anecdotal in nature with very little published original research. The aim of this study was to explore the role of registered nurses in clinical trials from the perspective of clinical trial nurses and medical research principal investigators. Interviews were conducted within both groups of health professionals with data analysed using Gadamer’s hermeneutic methodology to identify and create themes that describe the reality of the role that registered nurses play in the conduct of clinical trials in Australia. The findings revealed that registered nurses working in clinical trials research enacted their role from within their professional nursing framework applying their nursing experience and clinical knowledge in clinical trials research conduct and management. As well as this, key challenges in regards to their role in the informed consent process, collegial support and establishing their identity within the broader nursing community were identified. In conclusion, this study has identified that there is need to explore more around the role of clinical trial nurses and to define the scope of practice for nurses in this role.