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知情同意
Informed Consent


Christine Grady ... 其他 • 2017.03.02

临床研究的变化——知情同意

 

王黛芳,郑强*

北京大学工学院工业工程与管理系;北京大学药物信息与工程研究中心

* 通讯作者

 

临床研究的知情同意(informed consent)是为了保证受试者理解研究中的获益和风险,并做出自主理性的选择。知情同意有“知情”和“同意”两层含义,“知情”包括研究信息的揭示和受试者对信息的理解,“同意”包括受试者自愿同意和授权的过程。信息技术的发展正在改变知情同意的过程,引发了对传统干预性临床研究和基于生物样本或大数据的非干预性研究的新思考。本期《新英格兰医学杂志》发表的一组综述文章介绍和探讨了信息技术在知情同意中的应用和挑战1

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本篇多章节综述文章概述了改进和扩大研究者与参与者知情同意过程的创新性方法,以及涉及具体创新领域的短篇文章。

 

知情同意的变化

Christine Grady, R.N., Ph.D.

 

在为进行研究而获取知情同意的传统互动中,研究者向潜在参与者提供关于新的治疗、诊断或预防性干预的信息,然后要求参与者阅读并签署详细的书面同意文件。这种传统形式逐渐变得过时。在大多数临床研究中,知情同意在伦理学方面具有必要性,其尊重人们判断参与研究是否符合其利益,包括避免受到剥削和伤害这一权利1,2。在知情同意过程中,参与者有机会了解参与研究的相关信息并做出自愿选择3。道德准则和法规要求知情同意,除非得到机构审查委员会的明确豁免4-7,因此知情同意是在参与者为知识进步做出贡献的同时保护他们权利和安全、健康的一种方式。

在过去的50年中,知情同意过程越来越受到监管并被标准化,但是挑战依然持续存在并且难以克服8。同意书越来越长、越来越复杂,模糊了重要的细节,并且经常被设计为服务于机构和申办方的利益。数据显示,参与者对研究信息通常仅有非常有限的理解,即使他们已经签署了同意书8。技术进步推动了研究方法和信息传播的变化,这些进步已经影响了我们如何看待针对研究的知情同意,而这增加了知情同意的新方式以及获取知情同意的新选择出现的可能性。





作者信息

Christine Grady, R.N., Ph.D., Steven R. Cummings, M.D., Michael C. Rowbotham, M.D., Michael V. McConnell, M.D., M.S.E.E., Euan A. Ashley, F.R.C.P., D.Phil., and Gagandeep Kang, M.D., Ph.D.

 

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