Ethical review elements in drug clinical trials involving children
10.13699/j.cnki.1001-6821.2016.02.029
- VernacularTitle:涉及儿童的药物临床试验伦理审查要素
- Author:
Chun-Yan GUO
1
;
Xiao-Ling WANG
;
Tian-You WANG
;
Zhong-Dong DU
Author Information
1. 首都医科大学 附属北京儿童医院 药学部
- Keywords:
children;
clinical trial;
ethical;
informed consent
- From:
The Chinese Journal of Clinical Pharmacology
2016;(2):186-189
- CountryChina
- Language:Chinese
-
Abstract:
Children participating in clinical trials is an important mean of promoting the healthy development of children medication and drug safe-ty.But children as a vulnerable group , stringent ethical review is an im-portant means to protect their interests.This article analyzed the drug clinical trial program for children and the special nature of informed con-sent and ethical review , in order to better carry out the ethical review of clinical trials of medicines for children.
