J Korean Med Sci.  2025 Mar;40(9):e99. 10.3346/jkms.2025.40.e99.

The 2024 Revision of the Declaration of Helsinki and the Future Directions of Korea’s Bioethics and Safety Act

• Kim OJ

• KMID: 2565801
• DOI: http://doi.org/10.3346/jkms.2025.40.e99

Abstract

In October 2024, the World Medical Association’s Declaration of Helsinki (DoH) underwent comprehensive updates that incorporated feedback from global experts and stakeholders. The revised DoH continues to serve as a cornerstone for international and national regulations on medical research ethics. This paper aims to delve into the 2024 amendments to DoH and assesses their impact on South Korea’s Bioethics and Safety Act (Bioethics Act). This paper analyses the congruences and gaps between the revised DoH and the current Bioethics Act, examining the alignment and gaps between the current Bioethics Act and the revised DoH. This study identified necessary revisions to enhance the ethical conduct of medical research in Korea in accordance with international standards. A comparison between the principles of the revised DoH and the provisions of the Bioethics Act revealed essential adjustments required to align the Bioethics Act with updated ethical guidelines. These findings underscore the broader implications for Korea's regulatory framework on human research ethics, emphasizing the need for a strategic integration of global ethical standards into the country’s legal structure. The revised DoH emphasizes the active role of research participants and the fair inclusion of vulnerable groups. In Korea, the Bioethics Act, last revised in 2013, aligns closely with the DoH but requires further updates to reflect the 2024 amendments.

Keyword

Research Ethics; Declaration of Helsinki; Bioethics; Law; Korea

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