摘要
2024年10月,第75届世界医学会全体大会通过了《赫尔辛基宣言》第十次修订版本。采用文本分析方法,系统比较2024年版与2013年版《赫尔辛基宣言》的变化。研究发现:新版本在保持原有框架的基础上,吸纳了近年来人类社会的价值观和文明发展共同成果,主要呈现出三个方面的变化:一是更新核心术语,通过引入脆弱性、结构性不平等、环境可持续性等新理念,在价值观方面进一步强调人的尊严、权益和自主性;二是细化条款内容,尤其关注研究对象的脆弱性、自由和充分的知情同意、突发公共卫生事件伦理原则以及伦理委员会职责等;三是增强强制性表述,在研究责任方面深入强化价值追求的正义性。修订内容体现了医学研究伦理“人本导向”的基本原则,为未来医学研究的伦理发展指明了方向。未来,中国应加强伦理委员会建设、积极构建研究参与者保护体系并不断推进医学伦理国际合作,为全球医学研究贡献中国智慧。
In October 2024,the 75th World Medical Association General Assembly adopted the tenth revised version of the Declaration of Helsinki.Using textual analysis,this paper systematically compared the changes between the 2024 version and the 2013 version of the Declaration of Helsinki.This study found that,while maintaining the original framework,the new version incorporated the common achievements of the values and civilizational development of human society in recent years,mainly presenting changes in three aspects.First,the core terms were updated,and new concepts such as vulnerability,structural inequality,and environmental sustainability were introduced to further emphasize human dignity,rights and interests,and autonomy in terms of values.Second,the contents of the provisions were refined,especially focusing on the vulnerability of research subjects,free and full informed consent,ethical principles in public health emergencies,and the responsibilities of the ethics committee,as well as the standardization of implementation continued to be improved in the research process.Third,mandatory expressions were strengthened,and the justice of value pursuit was further reinforced in terms of research responsibilities.The revised contents reflected the“human-oriented”fundamental principle in medical research ethics,indicating the direction for future ethical development in medical research.In the future,China should strengthen the construction of ethics committees,actively build a protection system for research participants,and continuously promote international cooperation in medical ethics,to contribute Chinese wisdom to global medical research.
作者
刘时雨
马靖茹
王明旭
LIU Shiyu;MA Jingru;WANG Mingxu(School of Public Health,Xi’an Jiaotong University,Xi’an 710061,China)
出处
《中国医学伦理学》
北大核心
2025年第4期412-419,共8页
Chinese Medical Ethics
基金
2022年国家社科基金一般项目“生物安全信息共享法律制度构建研究”(22BFX205)
2023年国家社会科学基金后期资助重点项目“社交机器人‘拟人化’伦理风险研究”(3FZXA011)。
关键词
赫尔辛基宣言
医学伦理
医学研究
人本导向
Declaration of Helsinki
medical ethics
medical research
human-oriented
作者简介
刘时雨,女,研究方向:健康传播、卫生政策与伦理、医学人工智能应用及伦理研究;通信作者:王明旭,男,研究方向:医学伦理学、卫生政策与管理、健康教育。
