J Korean Med Assoc.  2024 Nov;67(11):668-673. 10.5124/jkma.2024.67.11.668.

Significance and implications of the 2024 revision of the Declaration of Helsinki

• Kim OJ

• KMID: 2561737
• DOI: http://doi.org/10.5124/jkma.2024.67.11.668

Abstract

Background
The Declaration of Helsinki is the first self-regulatory professional standard developed by physicians for guiding medical research. Revised ten times, most recently in October 2024, it continues to evolve as a living document for medical research ethics. This study examined the key components and significance of the most recent revisions.
Current Concepts
The Declaration of Helsinki was initially developed in response to unethical research conducted by Nazi doctors during World War II. It has since evolved into a globally recognized ethical framework that shapes both international and domestic law. The 2024 revision resulted from extensive international collaboration within the global community. Notable changes include replacing the term “subjects” with “research participants” and broadening the scope of responsibility to encompass the entire research team, not just the physicians. A new understanding of vulnerability was introduced, underscoring the fair and responsible inclusion of people with vulnerability. In addition, provisions for post-trial access to treatment were strengthened.
Discussion and Conclusion
The 2024 revision process was marked by transparency and fairness, ensuring the updated declaration appropriately reflects contemporary challenges in research ethics. This revision incorporates modern developments and addresses evolving issues, including those highlighted by the global pandemic. The updated declaration offers a comprehensive framework for conducting ethical research in the 21st century, promoting a more inclusive, responsible, and transparent approach to research practices.

Keyword

Helsinki Declaration; Bioethics; Research ethics; Research subjects; Research ethics; 헬싱키 선언; 생명 윤리; 연구 윤리; 연구대상자; 취약성