Challenges in informed consent decision-making in Korean clinical research: A participant perspective
Challenges in informed consent decision-making in Korean clinical research: A participant perspective
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DOI：
10.1371/journal.pone.0216889
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发表时间：
2019-05-23
期刊：
影响因子：
3.7
通讯作者：
Leeid, Iyn-Hyang
中科院分区：
文献类型：
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作者：
Choi, Im-Soon;Choi, Eun Young;Leeid, Iyn-Hyang
本研究调查了知情同意的基本要素是如何在同意过程中实现的，并考察了在韩国获得真正的知情同意所面临的挑战。方法采用目的抽样的方法，从2013年以来参与抗癌药物研究的人员中抽取21名研究对象。我们进行了1:1的深度访谈，并采用框架分析法对数据进行分析。结果在整个访谈中提出的主题分为“披露”、“理解”临床信息和“决定”。以提供者为中心的口头和书面信息被传递给每个参与者。在临床试验期间，研究人员可以评估研究参与者对所提供信息的理解程度的工具很少。虽然参与者对临床试验基本概念的理解不如预期，但他们可能不会通过与试验研究人员的沟通来解决困难。与会者怀疑参与者是否有足够的能力和自由意志提供知情同意。结论在韩国存在知情同意不够真实的担忧。为确保知情同意符合国际标准，应作出更大努力，为获得知情同意制定明确的标准操作规程。
ObjectivesThis study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea.MethodsThrough purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1: 1 in-depth interviews and analysed the data by framework analysis.ResultsThemes raised throughout the interviews were categorised into 'disclosure' and 'understanding' of clinical information and 'decision'. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants' level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent.ConclusionThere is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.