在儿科使用通用知情同意服务 (gICS) 进行现场电子同意:创建专门的设置并收集同意数据
Katharina Danhauser1,2, Larissa Dorothea Lina Mantoan1,2, Jule Marie Dittmer1,2
1Department of Pediatrics, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich, Munich, Germany.
PLOS digital health
|November 25, 2024
概括
电子同意系统显著减少了儿科研究中的错误. 通用知情同意服务 (gICS) 在获取临床试验和生物库样本存储的多重同意方面证明有效.
科学领域:
- 临床研究信息学
- 儿科生物银行 儿童生物银行
- 信息化同意技术 信息化同意技术
背景情况:
- 在临床试验和生物银行中,知情同意是必不可少的,特别是在需要未成年人的同意和监护人的同意的儿科研究中.
- 电子同意系统提供了潜在的好处,如减少错误和简化多个同意的文件.
- 将电子同意纳入现有研究基础设施提出了挑战.
研究的目的:
- 评估通用知情同意服务 (gICS) 在儿科研究中的电子同意的可用性.
- 评估gICS在多用户,多研究研究环境中的集成能力.
- 为了比较电子与纸质同意流程的错误率.
主要方法:
- 一项为期54周的研究,涉及1061名儿童和青少年 (3-17岁) 在儿科研究环境.
- 使用gICS进行电子同意和同意,并对生物银行进行单独的纸质同意.
- 分析了2066份同意书 (945份纸质同意书,121份电子同意书).
主要成果:
- 与纸质方法相比,电子同意显著降低了94.7%的错误易感性.
- 该gICS系统已成功实施并集成到现有研究基础设施中.
- 收集了1121份电子同意和945份纸质同意,其中包括348名生物银行参与者.
结论:
- 该gICS是一个可行的和有效的工具,用于电子同意在儿科研究,包括复杂的场景,如生物银行.
- 电子同意系统显然提高了数据完整性,并减少了儿科临床试验中的错误.
- 成功实施凸显了gICS在各种研究研究中更广泛应用的潜力.
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