摘 要 儿童用药临床试验的开展是儿童用药安全的重要保障，知情同意则是保障受试者权益的关键环节。与成年人相比，处于生长发育期的儿童在生理、心理等方面均有其特殊性。因此，对儿童参与临床试验的知情同意获得有特殊要求。

    关键词 临床试验 儿童 知情同意

    中图分类号：R951 文献标识码：C 文章编号：1006-1533(2015)19-0009-03

    Informed consent on clinical trail of drug for children*

    TANG Yan， XI Yiqun**

    (Outpatient and Emergency Management Office， Shanghai Children’s Hospital， Shanghai 200062， China)

    ABSTRACT Clinical trail of drug for children is an important guarantee for the safety of children medication. Informed consent is the key link in the protection of the rights and interests of the subjects. Compared with adults ......