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Assent in paediatric research: theoretical and practical considerations

机译:同意儿科研究:理论和实践考虑

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摘要

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children's sustained dissent should be respected in all cases.
机译:世界各地的准则都要求儿童表示同意他们参与大多数研究。然而,关于审查委员会应如何执行此要求的内容,几乎没有提供进一步的指导,包括哪些儿童能够提供同意,以及何时可以基于研究为参与研究的儿童提供潜在的重要临床益处而放弃同意的要求。本文认为,允许儿童有能力自己做出决定的重要性支持了这一同意的要求。这表明,当孩子们能够理解所研究的内容时,他们就可以表示同意。尽管各个孩子的成长情况有所不同,但现有数据显示大多数孩子在大约14岁时就具备了这种能力。在开发出评估单个孩子的同意能力的手段之前,应将此年龄作为同意的门槛。此外,保护儿童免受伤害的重要性表明,应尊重所有儿童,包括那些无法表示同意的儿童的持不同政见者。当研究参与提供了潜在的重要医疗利益(在研究范围之外无法获得)的可能性时,可以免除同意的要求,但分析表明,在所有情况下都应尊重儿童的持续异议。

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