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在描述潜在试验参与者的危害和益处时,参与者信息传单是不充分的
Laura Cuddihy1,2, Jeremy Howick3, Ellen Murphy2,3
1Oncology Day Ward, St. James's Hospital, James Street, Dublin 8, Ireland.
Trials
|May 1, 2024
概括
参与者信息传单 (PILs) 在如何传达潜在的试验益处和危害方面显示出显著的差异. 坚持最佳实践原则可以提高临床试验同意的一致性和透明度.
科学领域:
- 临床试验 临床试验
- 在知情同意的情况下同意.
- 患者的自主权 患者的自主权
背景情况:
- 在临床试验中,知情同意至关重要,尊重患者自主权,详细说明潜在的风险和益处.
- 参与者信息传单 (PIL) 是传递这些信息的关键文件.
- 这项研究调查了在PIL中介绍好处和危害的方式的变化.
研究的目的:
- 检查参与者信息传单 (PILs) 中对潜在试验益处和危害的陈述的变化.
- 评估最近制定的信息共享良好做法原则的遵守情况.
主要方法:
- 分析了来自爱尔兰和英国临床试验单位和设施的214份参与者信息传单 (PIL) 和知情同意表格.
- 由两位作者对七个既定原则进行独立评估,其中的差异由第三方解决.
主要成果:
- 七项原则在不同 PIL 的应用中存在很大差异,不论受试者或试验类型.
- 没有一个PIL使用了所有七个原则;一些 (4%) 没有使用. 27%详细说明了所有已知的危害,45%详细说明了所有已知的益处,8%没有详细说明两者.
- 根据接受者的年龄 (成年人与儿童) 和疾病区域,信息有所不同.
结论:
- 在描述PIL中的潜在试验益处和危害方面存在重大不一致.
- 实施七项良好实践原则可以提高一致性,道德决策,信任和透明度.
- 建议使用标准化的 PIL 模板进行长期改进.
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