在多国实用性随机临床试验SafeBoosC-III中使用的替代同意方法
Maria Linander Vestager1, Mathias Lühr Hansen2,3, Gorm Greisen2
1Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. maria.linander.vestager@regionh.dk.
Trials
|April 4, 2024
概括
在像SafeBoosC-III这样的急性护理试验中,传统的同意是具有挑战性的. 虽然允许推迟同意和选择退出同意的方法,但事先知情同意仍然占主导地位,这表明需要更广泛地接受替代方法.
科学领域:
- 临床试验 临床试验
- 新生儿研究新生儿研究
- 在知情同意的情况下同意.
背景情况:
- 传统的事先知情同意在急症和重症监护机构中带来了挑战,因为治疗窗口很短.
- 探讨了延迟同意和选择退出等替代同意方法,以改善试验招生和有效性.
- 在SafeBoosC-III试验中,研究了极度早产婴儿的大脑氧度监测,允许多个同意策略.
研究的目的:
- 评估SafeBoosC-III试验中不同同意方法 (事先,推迟,选择退出) 的使用情况.
- 在试验的前六个月分析与同意方法相关的担忧和投诉.
主要方法:
- 一项描述性的辅助研究,涉及SafeBoosC-III试验的所有70名主要研究人员.
- 调查问卷分发给主要调查人员,以收集有关同意方法使用和相关问题的数据.
- 数据收集主要集中在试验进行的前六个月.
主要成果:
- 来自61个中心的数据显示,同意方法的采用方式各不相同:43个仅使用事先知情同意,7个仅使用推迟同意.
- 很少有中心使用了选择退出同意,一些中心因使用这种方式而面临道德委员会的拒绝.
- 在试验执行期间,共有23个问题被记录在案.
结论:
- 选择退出同意,虽然在这个跨国试验中协议允许,但接受程度有限,并面临一些伦理委员会的抵制.
- 临床研究界可能需要更广泛地宣传其他同意方法,如选择退出,以实现其全部潜力.
- 这项研究强调了在将同意过程适应重症监护研究现实时面临的持续挑战.
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