使用技术来增加覆盖范围和优化对大规模研究计划的同意体验
Emma Coen1, Daniel P Judge2, Samantha Norman3
1Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Journal of clinical and translational science
|February 6, 2025
概括
使用增强同意 (EC) 方法改进研究同意过程在参与者决策,知识或满意度方面与标准同意 (SC) 没有显著差异. 这两种方法都确保了参与者对基因组查计划的强有力的理解和满意度.
科学领域:
- 基因组医学是基因组医学.
- 生物伦理学生物伦理学
- 在知情同意的情况下同意.
背景情况:
- 研究研究的知情同意过程可能对参与者来说是复杂和繁重的.
- 提高参与者对同意的理解和满意度对于伦理研究行为至关重要.
- 基于人口的基因组查计划需要高效和有效的同意程序.
研究的目的:
- 为了提高参与者同意的经验在我们的DNA中SC计划,一个基于人口的基因组查倡议.
- 评估与标准同意 (SC) 相比,增强同意 (EC) 程序对参与者决策,研究知识和满意度的影响.
- 评估参与者的偏好,并确定未来同意改进的领域.
主要方法:
- 一项实用性研究比较了两种同意程序:使用PDF文档的标准同意 (SC) 和使用图形图和真假问题进行增强同意 (EC).
- 从SC组的109名参与者和EC组的96名参与者收集的数据.
- 评估决策控制,学习知识,满意度和同意时间.
主要成果:
- 标准同意和增强同意程序都导致了强有力的决策控制和高水平的参与者知识和满意度.
- 在关键结果中,在SC和EC组之间没有观察到统计学上显著的差异.
- 增强的同意体验要求参与者需要更长的完成时间.
结论:
- 虽然增强同意方法没有比标准同意取得统计学上显著的改善,但这两种方法都有效地支持参与者的理解和满意度.
- 需要进一步的研究来探索参与者接受同意信息的偏好,包括视频等多媒体格式.
- 未来的同意程序代应该考虑结合不同的模式和语言选项,例如西班牙语版本.
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