我国临床研究伦理审查制度中的问题与对策  

Problems and countermeasures in ethical review system of clinical research in China

作　　者：陈树鹏[1] CHEN Shu-peng(Zhaoqing Medical Junior College,Zhaoqing Guangdong 526040,China)

机构地区：[1]肇庆医学高等专科学校

出　　处：《卫生软科学》2019年第11期66-70,共5页Soft Science of Health

摘　　要：临床研究伦理审查制度是保障医学健康发展的一项重要制度。我国临床研究伦理审查制度发展不够成熟,尚存在伦理审查独立性不强、法律法规的不统一、可诉性不强、上级伦理委员会对下级伦理委员会的伦理审查没有否定权等问题。通过分析这些问题的原因,并借鉴国外相关经验,提出应建立伦理审查复核制度,通过立法明确涉及重大伦理问题的研究范围,建立统一的伦理委员会注册、认证标准,加强伦理审查培训力度,积极探索区域性伦理审查机制和多中心临床研究联合审查机制,加快伦理审查机构的独立性等对策。The ethical review system of clinical research is an important system to ensure the healthy development of medicine.It s development is prematuration,and there are many problems such as the independence of ethical review is not strong,disunity of laws and regulations,justiciability is not strong,there is not deny right of superior ethics committee to the lower level and so on.This paper mainly analyses the causes of these problems,and uses for reference of relevant experience of other countries.It puts forward some countermeasures such as establish to ethical review re-check system,clear-cut range of study which involved significant ethical issue,establish unitive ethics committee s register and approval standards,strengthen the dynamics of ethical review train,actively explore regional ethical review mechanism and multi-centric clinical study joint review mechanism,quicken independence of ethical review institution and so on.

关 键 词：伦理审查制度 知情同意原则 临床研究 

分 类 号：R-052[医药卫生]