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确定家长对手术日的态度同意进行研究

Monica Caldeira-Kulbakas¹, Carolyne Pehora¹, R J Williams¹

¹Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.

Paediatric anaesthesia

|February 26, 2026

概括

大多数家长都同意进行手术当天的研究,但研究类型很重要. 随机对照试验 (RCT) 和年幼儿童需要替代性同意时间才能获得道德自愿知情同意.

科学领域:

医学伦理学医学伦理学
儿科研究的研究.
临床试验招聘工作人员

背景情况:

手术前一天的同意对麻醉研究来说具有挑战性.
作为代理决策者的父母负担可能会影响对当天研究方法的意愿.
了解父母的态度对于伦理研究实践至关重要.

研究的目的:

评估家长对手术当天研究的态度.同意.
确定研究类型是否影响父母在手术当天同意的意愿.
确定偏爱另类同意时间的子组.

主要方法:

使用利益相关者采访开发反复性的问卷.
根据孩子的年龄,手术史和家庭研究经验对参与者的分层.
基于情景的评估父母对研究风险和同意时间的看法.

主要成果:

大多数家长认为,对大多数研究类型来说,手术当天的同意是道德上合适的.
随机对照试验 (RCT) 是一个例外,由于时间限制,只有一半认为当天同意是适当的.
与青少年的父母相比,较小孩子的父母更可能喜欢另类的接触时间.

结论:

儿科研究人员可以通过普遍接受手术当天的同意来放心.
特定的子组,特别是幼儿的父母和RCT,需要量身定制的同意策略.
对于已确定的子组,建议采用替代的同意时间方法,以确保道德自愿知情同意.

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