Research Centre for Public Policy and Regulatory Governance, Faculty of Law and Administration, University of Silesia in Katowice, Katowice, Poland.
Department of Neurology; Centre of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.
Trials. 2021 Jan 14;22(1):57. doi: 10.1186/s13063-020-04969-w.
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited.
Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components.
In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.
We found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.
知情同意是当代基于自主的医疗实践的基本概念，它促进了医患关系的共同决策模式。因此，患者能够理解他们所给予的同意的程度对于当今所追求的医学的伦理可行性至关重要。然而，对患者理解知情同意基本组成部分的研究表明，他们的理解水平有限。
系统地在 PubMed 和 Web of Science 数据库中进行了检索，以确定关于知情同意的文献，特别是患者对特定知情同意组成部分的理解。
共检索到 14 篇相关文章。在大多数研究中，很少有临床试验参与者正确回答了检查他们对同意内容的了解程度的项目。参与者对自愿参与、盲法（不包括关于研究人员盲法的知识）和随时退出的自由表现出最高水平的理解（超过 50%）。只有极少数患者理解安慰剂概念、随机化、安全问题、风险和副作用。
我们发现，参与者对基本知情同意组成部分的理解程度较低，这令人担忧，因为这种理解的缺乏破坏了当代临床试验实践的伦理支柱，并质疑了患者在共同医疗决策过程中充分和真正参与的可行性。
