London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; Addictions Research Group, Sangath, Porvorim, Goa, India.
Addictions Research Group, Sangath, Porvorim, Goa, India.
Asian J Psychiatr. 2021 Dec;66:102870. doi: 10.1016/j.ajp.2021.102870. Epub 2021 Sep 23.
Only around 50-75% of individuals fully understand the various aspects of informed consent in research. The aim of our study was to examine whether supplementing the conventional paper-based informed consent process with an audiovisual aid improves participants' understanding of the informed consent process and the information conveyed to them. Participants from two mental health/substance use intervention development studies were recruited for this study through consecutive sampling. They were then administered the traditional paper information and consenting process by itself or in combination with a video depicting the procedures of the study. Subsequently a bespoke questionnaire was administered to assess the participants' understanding of the information conveyed to them about the parent study. The various domains of the questionnaire were compared between those who were administered the two different consenting processes using the chi square test. 27 (58.7%) participants were administered the traditional consenting process and 19 were administered the video-supplemented consenting process. The video-supplemented consenting process was not superior to the traditional paper-based informed consent process on any of the domains examined. In settings with participants having a limited education, and in research involving people with mental health or substance use problems, further research is necessary to identify contextually relevant best practices for the informed consent process.
只有大约 50-75%的人完全理解研究中知情同意的各个方面。我们的研究旨在检验在传统的纸质知情同意过程中加入视听辅助手段是否能提高参与者对知情同意过程和向他们传达的信息的理解。这项研究通过连续抽样从两项心理健康/物质使用干预措施发展研究中招募了参与者。然后，他们单独或结合描述研究程序的视频接受传统的纸质信息和同意过程。随后，专门设计了一份问卷来评估参与者对关于母研究的信息的理解。使用卡方检验比较了那些接受两种不同同意过程的参与者在问卷各个领域的表现。27（58.7%）名参与者接受了传统的同意过程，19 名参与者接受了视频补充的同意过程。在任何检查的领域，视频补充的同意过程都不比传统的基于纸张的知情同意过程优越。在参与者教育程度有限的环境中，以及在涉及心理健康或物质使用问题的人群的研究中，有必要确定知情同意过程的与背景相关的最佳实践。
