Improvement of informed consent and the quality of consent documents
Improvement of informed consent and the quality of consent documents
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DOI：
10.1016/s1470-2045(08)70128-1
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发表时间：
2008-05-01
期刊：
影响因子：
51.1
通讯作者：
Moore, Rosemary
中科院分区：
文献类型：
--
作者：
Jefford, Michael;Moore, Rosemary
关于知情同意的指导方针旨在保护患者并促进合乎道德的研究行为。为了给予知情同意，个人应该了解研究的目的、过程、风险、益处和替代研究（或拟议的临床干预），并就是否参与做出自由、自愿的决定。许多参与者对临床试验的各种特征了解不完全。与书面知情同意文件的长度、格式和语言相关的问题是常见的。在这里，我们分析了书面同意书，特别是在临床研究的背景下，以及临床医生或研究者与患者之间的讨论。我们审查改进同意书的策略，特别是使用简单的语言。研究者和患者之间的讨论提出了建议，以提高参与者对知情同意过程的理解和满意度。
Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.