我国医学人体试验伦理审查问题研究  

Research about Medical Experiments Investigation Ethics on Human beings in China

作　　者：张建莹[1] 何强[1] 

机构地区：[1]天津中医药大学,天津300073

出　　处：《中国卫生产业》2016年第7期66-68,共3页China Health Industry

摘　　要：随着我国近年来医学事业的迅猛发展,人体试验的科研项目越来越多。人体试验是我国医学科研发展中不可替代的必要手段之一,它带给人类的双重影响也引起了全社会的高度重视。对我国医学人体试验进行伦理审查至关重要,它不仅保护受试者的合法权益,对我国医学科研的健康发展也起到了积极作用。尽管我国对医学人体试验伦理审查已有了初步的概念,但是对伦理审查的职能、性质不够规范;伦理委员会组建和监管方面存在问题;医学人体试验伦理审查的相关法律并不完善等。如何改善我国医学人体试验伦理审查,保护受试者合法权益不受侵犯,保障医学科研健康发展都是本文将要探讨研究的主要问题。With the rapid development of Chinese medicine these years,a growing number of research projects involving human subjects.Human trial is an irreplaceable means and the double impacts it brings also attracted attention of the whole society.Ethical review of human subjects in medical research for the development of the whole has a vital role.At present,China has been on a preliminary human trials of medical ethics review of the concept,but understanding of the nature and functions of the ethics review is not enough,and regulatory aspects of the formation of the ethics committee is also problematic.Our country does not have a special law to regulate human trials of medical ethics review,and the relevant laws and regulations are not perfect.Here＇s some main problems we still need to work on,how to improve our medical experiments investigation on human beings,human subjects under protected,guaranteeing medical experiments way to right.

关 键 词：医学人体试验 人体试验伦理审查 伦理委员会 研究者告知义务 受试者知情同意 

分 类 号：R-052[医药卫生]