世界医学会赫尔辛基宣言:涉及人类参与者的医学研究伦理原则(2024修订)  

World Medical Association Declaration of Helsinki:ethical principles for medical research involving human participants(2024 revision)

作　　者：柴叶静[1] 张立生[1] Chai Yejing;Zhang Lisheng(Department of Medical Periodical Press,The Fourth Hospital of Hebei Medical University,Shijiazhuang City,Hebei Province 050011,China)

机构地区：[1]河北医科大学第四医院期刊社,石家庄市050011

出　　处：《中华疼痛学杂志》2024年第6期858-863,共6页Chinese Journal Of Painology

摘　　要：2024年10月19日,在芬兰赫尔辛基召开的第75届世界医学会全体大会正式通过了《赫尔辛基宣言》最新修订版本。这也是自1964年首次颁布至今,第10次修订并达成共识。本次修订中,将"受试者"调整为"参与者";多处"应该"改为"必须",以强化参与者的权益保护;特别关注特殊研究对象的脆弱性;单独强调自主知情同意;强调在突发公共卫生事件中的伦理原则等。本文详细对本次修订版进行了编译,供我国临床研究参照执行。On October 19,2024,the 75th General Assembly of the World Medical Association held in Helsinki,Finland,officially passed the latest revision of the Declaration of Helsinki,which was the 10th revision and consensus since its initial promulgation in 1964.In this revision,the term"subject"was adjusted to"participant";multiple instances of"should"were changed to"must",to strengthen the protection of participants’rights;particular attention is paid to the vulnerability of specific research subjects;the importance of free and informed consent was emphasized separately,and ethical principles in public health emergencies was underlined.This article provided a detailed compilation of this revised version for reference and implementation in clinical research in our country.

关 键 词：赫尔辛基宣言 治疗 临床研究性 修订 

分 类 号：D92[政治法律—法学]