世界医学会《赫尔辛基宣言》2024版修订述评  

A Review of the 2024 Revision of the World Medical Association Declaration of Helsinki

作　　者：张海洪 丛亚丽[2] ZHANG Haihong;CONG Yali(The Research Department,Peking University Health Science Center,Beijing 100191,China;School of Health Humanities,Peking University,Beijing 100191,China)

机构地区：[1]北京大学医学部科学研究处,北京100191 [2]北京大学医学人文学院,北京100191

出　　处：《医学与哲学》2024年第21期18-23,共6页Medicine and Philosophy

摘　　要：2024年10月19日,世界医学会第75届全体大会通过了最新修订版《赫尔辛基宣言——涉及人类参与者的医学研究伦理原则》(以下简称《宣言》)。此次修订工作组由19个国家和地区的医学会代表组成,历时30个月。从参与修订工作亲历者的视角,对《宣言》的修订过程、主要修订内容及其相关伦理考虑进行介绍,包括从“受试者”修改为“参与者”,从“脆弱人群”到“脆弱性”,责任主体扩展,从“知情同意”到“自由和充分的知情同意”等,讨论《宣言》修订的亮点和有待继续推进的工作,以期为国内同行更好地理解《宣言》最新伦理要求、强化研究参与者保护提供一定的参考。October 19,2024,the 75th General Assembly of the World Medical Association adopted the latest revision of the Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Participants.This revision was undertaken by a working group comprised of representatives from medical associations across 19 countries and regions and spanned a period of 30 months.This review provides an insider perspective on the revision process,key updates,and related ethical considerations,including terminology changes such as from"subject"to"participant"and from"vulnerable populations"to"vulnerability".It also discusses the expansion of accountability,the shift from"informed consent"to"free and informed consent",and highlights areas for further work.This review aims to offer insight for domestic colleagues to better understand the Declaration's latest ethical requirements and strengthen the protection of human participants.

关 键 词：《赫尔辛基宣言》 研究参与者 脆弱性 自由和充分的知情同意 

分 类 号：R-05[医药卫生]