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Question: ArrayHow to define whether a child meets the conditions for signing informed consent? Do you need to define competency standards in the plan? (GCP No. 57 of 2020, Chapter 4, Article 23) @ @ How to define the ability of a child to sign an informed consent form can be referred to in Article 19 of the Civil Code. Minors over the age of eight can sign a written consent form by themselves. In addition, guidelines for children's informed consent can be established at the program or project level to guide standard operations within the same program and obtain ethical approval. Further considerations can be found in the following documents: ICH E11 (R1): Appendix: Clinical Investigation of Medical Products in the Pediatric Population link: http://www.cde.org.cn/guide.do?method=downloadAtt&codeStr=5b36d6fd50f251fc&type2=1NMPA Guidelines for Clinical Trials of Pediatric Population Drugs (2016 No. 48) Link: https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20160307164401912.html

Answer：

如何界定儿童签署知情同意书的能力，可参考民法典第十九条，八周岁以上的未成年人可以由本人签署书面赞同书（Written Assent Form）。

另外，可以在方案或项目层面设立相关儿童知情同意的指南来指引同一方案内部的标准操作并获得伦理批准更多考虑原则可参考以下文件：

ICH E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

链接：http://www.cde.org.cn/guide.do?method=downloadAtt&codeStr=5b36d6fd50f251fc&type2=1

NMPA《儿科人群药物临床试验技术指导原则》（2016年第48号）

链接：https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20160307164401912.html