Cresswell Pip, Gilmour Jean
Nurs Prax N Z. 2014 Mar;30(1):17-28.
Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.
临床试验是在人类参与者身上进行的，以回答有关疾病诊断、治疗和预防的最佳方法的问题。参与者必须在了解临床试验的工作方式及其目的的情况下，给予知情同意才能参与临床试验。随机对照试验提供了有力的证据，但其复杂的设计对于临床医生和参与者来说都难以理解。越来越多地，确保随机对照试验中的知情同意已成为临床研究护士职责的一部分。本研究的目的是使用定性描述方法深入探讨临床研究护士在知情同意过程中的作用。对三名临床研究护士进行了访谈，并使用主题分析方法对数据进行了分析。确定了三个主题来描述确保知情同意的过程。第一个主题“准备阶段的合作关系”，探讨了在启动知情同意过程之前所需的各种关系。第二个主题“与参与者合作”，强调了确保自愿性和理解以及患者权益倡导的必要性。第三个主题“与项目的合作关系”，突出了临床研究护士通过对参与者进行适当的招募和随访，对试验回答研究问题的能力所做出的贡献。在随机对照试验中获得知情同意是复杂的，需要多种合作关系。运用了各种各样的技能来保护试验参与者的安全并促进高质量的研究。本研究所得信息有助于更深入地理解临床研究护士的作用，并表明试验中的知情同意过程可以由护士主导。为了获得同行、雇主和行业的认可，承认护理角色的这一方面很重要。
