Should children decide whether they are enrolled in nonbeneficial research?
Should children decide whether they are enrolled in nonbeneficial research?
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DOI：
10.1162/152651603322614382
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发表时间：
2003-09-01
影响因子：
13.4
通讯作者：
Shah, S
中科院分区：
文献类型：
--
作者：
Wendler, D;Shah, S
美国联邦法规要求调查人员进行非营利性研究，以获得有能力提供研究的儿童的同意。不幸的是，还没有关于哪些孩子能够同意的分析，甚至没有什么能力来证明同意的能力。为什么要求调查人员在让一些儿童参与不能提供直接利益的补偿潜力的研究之前，获得一些儿童的积极同意，而不是其他儿童的积极同意？我们认为，儿童研究决策的范围应该建立在尊重自主和不伤害的原则基础上。这些原则意味着，同意的门槛应定为14岁，在非有益研究的背景下，应对所有儿童采取异议要求。
The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research.