改善知情同意：利益相关者的观点。
Improving informed consent: Stakeholder views.
作者信息
Anderson Emily E, Newman Susan B, Matthews Alicia K
机构信息
a Neiswanger Institute for Bioethics, Stritch School of Medicine, Loyola University Chicago.
b Center for Clinical and Translational Science , University of Illinois at Chicago.
出版信息
AJOB Empir Bioeth. 2017 Jul-Sep;8(3):178-188. doi: 10.1080/23294515.2017.1362488. Epub 2017 Aug 2.
PURPOSE
Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app."
METHODS
This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis.
RESULTS
We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups.
CONCLUSIONS
Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.
目的
需要创新来改进研究中的知情同意程序。我们旨在从关键利益相关者（研究参与者以及负责获取知情同意的人员）那里获取意见，以为多媒体知情同意“应用程序”的潜在开发提供信息。
方法
这项描述性研究采用了混合方法。对前研究参与者以及负责获取知情同意的研究人员/研究工作人员的志愿者样本进行了5次90分钟的焦点小组讨论。参与者还完成了一项简短的调查，该调查测量了背景信息以及关于研究和技术使用的知识与态度。使用既定的定性方法进行焦点小组讨论和数据分析。
结果
我们进行了5次焦点小组讨论，共有41名参与者：3组是前研究参与者（共22人），2组是研究人员和研究协调员（共19人）。总体而言，曾参与过研究的个人对其经历持积极看法。然而，进一步讨论发现知情同意程序往往未达到其预期目标。两组的调查结果根据三个主要主题呈现：同意书的内容、知情同意程序的体验以及技术改善知情同意程序的潜力。研究人员小组提出了第四个主题，即需要外行对知情同意提供意见。
结论
我们的研究结果补充了先前的研究，表明使用交互式技术有可能改善知情同意程序。然而，我们焦点小组的研究结果提供了额外的见解，即技术无法取代知情同意程序核心的人际联系。需要开展更多纳入关键利益相关者观点的研究，以确保多媒体同意程序不会重蹈纸质同意书的覆辙。
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