随机对照试验中的知情同意过程:护士主导的过程。

Nursing praxis in New Zealand inc Pub Date : 2014-03-01
Pip Cresswell, Jean Gilmour
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引用次数: 0

摘要

临床试验是由人类参与者进行的,以回答有关诊断、治疗和预防疾病的最佳方法的问题。参与者必须给予知情同意参加临床试验,这需要了解临床试验的工作原理及其目的。随机对照试验提供了强有力的证据,但其复杂的设计对临床医生和参与者来说都很难理解。越来越多地,确保随机对照试验的知情同意已成为临床研究护士角色的一部分。本研究的目的是深入探讨临床研究护士在知情同意过程中的作用,采用定性描述的方法。对三名临床研究护士进行了访谈,并采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“筹备伙伴关系”详细讨论了启动知情同意程序之前所需的关系。第二个主题是参与者的伙伴关系,强调需要确保自愿和理解,以及患者倡导。第三个主题,与项目的伙伴关系,强调临床研究护士通过适当的招募和随访参与者对试验能力的贡献,以回答研究问题。在随机对照试验中获得知情同意是复杂的,需要多方合作。各种各样的技能被用于保护试验参与者的安全并促进高质量的研究。本研究的信息有助于更好地理解临床研究护士的角色,并建议试验中的知情同意过程可以由护士主导。为了获得学院,雇主和行业的认可,重要的是要承认护理角色的这一方面。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The informed consent process in randomised controlled trials: a nurse-led process.

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.

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