• Boyuan Wen, Guochao Zhang, Chang Zhan, Chen Chen, and Hang Yi.
• 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. 2024 Dec 13.

AbstractThe 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.© The Author(s) 2024. Published by Oxford University Press on behalf of Fellowship of Postgraduate Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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