Assent in paediatric research: theoretical and practical considerations
Assent in paediatric research: theoretical and practical considerations
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DOI：
10.1136/jme.2004.011114
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发表时间：
2006-04-01
影响因子：
4.1
通讯作者：
Wendler, DS
中科院分区：
文献类型：
--
作者：
Wendler, DS
世界各地的指导方针要求儿童同意他们参与大多数研究。然而，关于审查委员会应如何实施这一要求，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儿童提供重要临床益处的可能性而放弃同意要求，几乎没有提供进一步的指导。本文件认为，同意的要求是支持的重要性，让儿童谁是有能力作出自己的决定。这表明，当孩子们能够理解所讨论的研究时，他们能够表示同意。虽然每个孩子的发展情况各不相同，但现有数据表明，大多数孩子在14岁左右就发展出了这种能力。在制定出评估儿童个人同意能力的工具之前，应将这一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，所有儿童，包括那些无法表示同意的儿童的持续异议应得到尊重。虽然同意的要求可以免除时，研究参与提供了重要的医疗利益，是不可用的研究范围外的潜力，分析表明，儿童的持续异议应在所有情况下得到尊重。
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.