From COVID-19 to Global Standards: Redefining Korean Bioethics and Research Ethics
摘要
This chapter examines the impact of the COVID-19 pandemic on South Korea’s research ethics framework and its subsequent realignment with evolving global standards, particularly the 2024 revision of the Declaration of Helsinki (DoH). South Korea’s robust biomedical research output and significant participation in international clinical trials underscore the critical need for a strong ethical foundation. The chapter analyzes South Korea’s rapid response to the pandemic’s immediate challenges, focusing on streamlined ethical review, adapted informed consent procedures, and modifications to clinical trial conduct. A thematic analysis explores key ethical challenges such as prioritizing participant safety, ensuring effective national research governance, and fostering meaningful community engagement. The chapter then investigates the long-term initiatives implemented to strengthen national research governance, enhance institutional capacity for research ethics, and establish a comprehensive framework for research integrity. Finally, it assesses the alignment of the Korean Bioethics and Safety Act with the 2024 DoH, identifying areas needing revision, such as terminology, the treatment of vulnerable populations, and data governance, to ensure continued harmonization with evolving international ethical standards and promote a truly participant-centric research culture. The Korean experience during the pandemic informs recommendations for future improvements in research ethics and governance.