医学人体试验中受试者权益保护问题探微——对《赫尔辛基宣言》修订的几点思考  

Protection of Human Participants' Rights in Medical Research:Reflections on the Amendments to Declaration of Helsinki

作　　者：尚爻[1] 刘芳[1] 李义庭[1] 

机构地区：[1]首都医科大学卫生管理与教育学院,北京100069

出　　处：《医学与哲学（A）》2014年第3期87-89,共3页Medicine & Philosophy:Humanistic & Social Medicine Edition

摘　　要：《赫尔辛基宣言》自颁行以来已六次修订,为适应医学研究领域的新情势,世界医学会征询中华医学会对2008年版《赫尔辛基宣言》的修改意见,中华医学会委托医学伦理学分会组织专家进行意见征集与调研活动。在整理和总结上述修订意见的基础上,进一步研究探讨了关于受试者知情同意、受试者风险评估、受试者权益保障、医学伦理委员会伦理监督职能、程序伦理等问题,并提出了基于中国国情的考虑与建议,以期借鉴国际医学伦理典籍,共谋我国医学伦理的发展,为保护受试者方面贡献力量。Declaration of Helsinki has been amended for six times since its enactment in 1964. To adapt the new trends in medical research, the World Medical Association has consulted Chinese Medical Association for opinions on the amendments to Declaration of Helsinki （2008）. Chinese Medical Association has entrusted experts from Medical Ethics Branch with the collection and research of the opinions. Based on the organization and summary of these opinions, this article has further discussed the informed consent, the risk evaluation, and the right insurance of the participants, the supervisory function of the Medical Ethics Committee, procedural ethics, as well as some considerations and advices conforming to the situation in China, so as to develop the medical ethics in China and contribute to the protection of the participants.

关 键 词：《赫尔辛基宣言》 医学人体试验 受试者权益 

分 类 号：R-052[医药卫生]