摘要
由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求。文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查。
The significant difference between children and adult have been identified in physiology, pharmacology, psychology, recogni- tion and autonomy. There was different characteristics among different children age group. Besides complying with the basic principle of general clinical and trial study, informed consent in clinical and trial study involving children has special requirements in informed information, informed consent procedure, and consent decision. This paper focused on the ethic issues and specificity of informed consent in pediatric clinical and trial study involving children. The paper might provide guidance on the ethic review of informed consent in pediatric clinical and trial study.
出处
《临床和实验医学杂志》
2013年第8期612-614,共3页
Journal of Clinical and Experimental Medicine
关键词
儿童
临床试验
知情同意
伦理委员会
Children
Clinical and Trim Study
Informed Consent
Ethics Committee
作者简介
李艺影，女，北京市神经外科研究所科研办主任，首都医科大学附属北京天坛医院，副研究员
通讯作者：任佩娟，女，首都医科大学附属北京天坛医院伦理委员会秘书，主管护师，E—mail：roj66@126．com
