Improving informed consent: Stakeholder views.
Improving informed consent: Stakeholder views.
复制标题
DOI：
10.1080/23294515.2017.1362488
复制
发表时间：
2017-07-01
影响因子：
--
通讯作者：
Matthews, Alicia K
中科院分区：
文献类型：
--
作者：
Anderson, Emily E;Newman, Susan B;Matthews, Alicia K
目的：需要创新来改善研究中的知情同意过程。我们的目标是从关键的知情同意者（研究参与者和负责获得知情同意的人）那里获得信息，以告知多媒体知情同意应用程序的潜在开发。方法：本描述性研究采用混合方法。对前研究参与者和负责获得知情同意的研究人员/研究人员的志愿者样本进行了5次90分钟的焦点小组讨论。与会者还完成了一项简短的调查，以衡量背景资料以及对研究和使用技术的知识和态度。建立定性方法进行焦点小组和数据analysis.RESULTS：我们进行了五个焦点小组，共41名参与者：三组与前研究参与者（总n = 22），两组与研究人员和研究协调员（总n = 19）。总体而言，以前参加过研究的人对他们的经历有积极的看法。然而，进一步的讨论表明，知情同意程序往往达不到其预期目标。两组的调查结果是根据三个主要主题：同意书的内容，知情同意过程的经验，以及技术的潜力，以改善知情同意过程。第四个主题，需要奠定知情同意的投入，出现了从researchersgroups.CONCLUSIONS：我们的研究结果添加到以前的研究表明，使用互动技术有可能提高知情同意的过程。然而，我们的焦点小组调查结果提供了额外的见解，即技术不能取代对知情同意过程至关重要的人际关系。需要进行更多的研究，纳入主要利益攸关方的意见，以确保多媒体同意程序不会重复纸质同意书的错误。
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.