Wen Boyuan, Zhang Guochao, Zhan Chang, Chen Chen, Yi Hang
Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang District, Panjiayuan, Nanli 17, Beijing 100021, China.
Postgrad Med J. 2025 Mar 16;101(1194):371-382. doi: 10.1093/postmj/qgae181.
The Declaration of Helsinki, established in 1964, remains a foundational document in medical research ethics. This review examines the 2024 revision, endorsed by the 75th World Medical Association (WMA) Assembly, highlighting its impact on modern clinical research. Major updates include the shift from "subjects" to "participants," promoting autonomy and active involvement, and the introduction of dual ethical review requirements for cross-border studies to strengthen accountability. New guidelines for data privacy address AI-related ethical concerns, while enhanced community engagement fosters transparency and shared decision-making. Additionally, standards for environmental sustainability encourage research practices that minimize ecological impacts. In response to global health crises such as COVID-19, the revised Declaration sets forth ethical protections to balance participant safety with research urgency during emergencies. Despite these advances, areas for improvement remain, especially in AI ethics, emergency research protocols, and the extension the Declaration's scope to include forensic and specimen research. The 2024 revision thus strengthens the Declaration's role as an adaptive, relevant framework for safeguarding participant rights and research integrity in a changing landscape.
1964年制定的《赫尔辛基宣言》仍然是医学研究伦理领域的一份基础性文件。本综述审视了经第75届世界医学协会（WMA）大会批准的2024年修订版，重点介绍了其对现代临床研究的影响。主要更新内容包括从“受试者”到“参与者”的转变，以促进自主性和积极参与，以及针对跨境研究引入双重伦理审查要求以加强问责制。数据隐私新指南解决了与人工智能相关的伦理问题，而加强社区参与则促进了透明度和共同决策。此外，环境可持续性标准鼓励采用尽量减少生态影响的研究做法。为应对新冠疫情等全球卫生危机，修订后的《宣言》规定了伦理保护措施，以便在紧急情况下平衡参与者安全与研究紧迫性。尽管有这些进展，但仍有改进空间，特别是在人工智能伦理、紧急研究方案以及将《宣言》范围扩大至包括法医和样本研究方面。因此，2024年修订版强化了《宣言》作为一个适应性强、与时俱进的框架的作用，以在不断变化的形势下保障参与者权利和研究诚信。
