50. Informed consent in clinical trials: Is there a role for clinical research facility nurses? (382)
Sara Jones, Ward Manager, Addenbrookes Clinical Research Centre, Addenbrooke's Hospital Cambridge Cambridge, United Kingdom
sara.p.jones@gmail.com
Abstract:
Background:
This poster presentation addresses the issue of informed consent specifically in the context of clinical trials. Informed, voluntary and ongoing consent of patients is fundamental to the conduct of any ethical research. However, the impact of stress and illness on a patient’s decision-making capacity may be at its greatest in the exact circumstances in which trial participation is suggested. Indeed clinical experience of working in a dedicated research facility has highlighted the highly variable level of understanding amongst patients who have signed a consent form and entered a clinical trial.
Research:
Questions In this poster, the following questions are highlighted:
• Why do people enter clinical trials?
• How do we judge levels of understanding of research terms and design?
• What can we learn from those who choose not to consent?
Key findings of a literature review are presented, together with a discussion of the specific role of nurses working within dedicated clinical research facilities (a rapidly growing area within the UK supporting government policy and research infrastructure development). Finally, a number of recommendations for further research, impact on practice and education of nurses working in the research field are proposed.
Recommended reading list:
• Barrett,R(2005) Quality of Informed Consent:Measuring understanding among participants in oncology clinical trials.Oncology Nursing Forum.32(4):751-756
• Donovan, J., Brindle, L., Mills, N., (2002). Capturing users’ experiences of participating in cancer trials, European Journal of Cancer Care, 11: 210-216
• Joffe, S. (2001). Quality of informed consent in cancer clinical trials, The Lancet November 24 :358
Source of Funding: N/A
Amount in Funding: N/A
Biography:
Having worked in acute hospital nursing for the majority of my career, I have always been fascinated by research developments changing healthcare practice. I currently work in a dedicated clinical research facilty, supporting research within the clinical setting.

