临床试验中儿童知情同意的自主权利

Children's Autonomy Rights in Informed Consent during Clinical Trial

儿童自主权利的立法理念正在普及化,儿童生命自主权利的确立体现现代社会对人类个体生命尊严与价值无条件维护的人道主义精神立场。然而,践行儿童知情同意的自主原则却是一大难题。一是知情同意的自主原则本身受到质疑和批判;二是儿童只具备潜在的理性判断能力,尚未发展完善;三是儿童和其家庭之间的权属关系在现代语境下需要厘清和限定。因此有必要强调一种“共同体参与”的新型知情模式介入,通过“第三方共同体”,既限制传统的家长主义,又真正贯彻儿童作为个体生命所享有的自主权利,切实保护儿童的权益。

The legislative idea of children's autonomous rights is being popularized,and the establishment of children's autonomous rights of life embodies the humanitarian spirit of the modern society's unconditional maintenance of the dignity and value of human life.On the other hand,the practice of children's principle of informed consent is indeed a big problem:firstly,the principle of informed consent is questioned and criticized;secondly,children only have the potential for rational judgment,which has not yet been developed;thirdly,the ownership relationship between children and their families needs to be clarified and limited in the modern context.Therefore,it is necessary to emphasize the intervention of a new type of informed model of“community participation”.Through the“third party community”,it not only limits traditional patriarchy,but also truly implements the autonomous rights of children as individual lives,and effectively protects the rights and interests of children.