Informed Consent of Clinical Research Involving in Children
10.12026/j.issn.1001-8565.2017.11.16
- VernacularTitle:涉及儿童临床科研的知情同意
- Author:
Jiyin ZHOU
1
;
Jiancheng XU
;
Dan LIU
;
Shengya ZENG
Author Information
1. 陆军军医大学第二附属医院国家药物临床试验机构
- Keywords:
Clinical Research of Children;
Informed Consent;
Selective Informing;
Ethical Review
- From:
Chinese Medical Ethics
2017;30(11):1381-1386
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To summarize the existing problems and countermeasures of informed consent when children,one of the vulnerable groups in China,participate in clinical research,and further to provide reference for ethical review.Methods:We reviewed and comprehensively analyzed the domestic literatures that involved children and required informed consent.Results:Aiming at the unique physiological and psychological cognitive characteristics of children,this paper expounded the rationality of children's participation in clinical research and the timing of choice.It emphasized the existing problems in the process of informed consent such as inadequate informing,verbal acknowledgement,too long or too short time informed by the doctor-in-charge,as well as overspecialization of informed consent,inductive language,not describing potential risks and other incomplete information disclosure.According to these problems,the paper put forward some countermeasures.Conclusions:Informed consent of children's participation in clinical research should follow the general principles,consider children's characteristics,respect their willingness,and avoid unnecessary harm.
