인간대상연구 심의시 개인정보 보호관련 법적 쟁점 및 유의사항 : 생명윤리법 개정에 대한 제언

The Bioethics and Safety Act (the “Bioethics Act”) was originally enacted on January 29, 2004, and came into effect on January 1, 2005. This statute underwent a comprehensive revision on February 1, 2012, with the revised provisions taking effect on February 2, 2013. The primary objective of the amended Bioethics Act is to safeguard bioethics and safety, thereby enhancing public health and improving the quality of life by preventing violations of human dignity and harm to individuals during research involving human subjects, human materials, and processes involving embryos and genetic material. The revisions to the Bioethics Act have introduced certain provisions concerning personal information, which conflict in several respects with the concept of personal information under the generally applicable Personal Information Protection Act (PIPA). These discrepancies primarily concern the definition of personal information, the concept of pseudonymization and anonymization, and the conditions under which personal information may be provided to third parties. The protection of personal information is a matter that warrants careful legal and ethical consideration, as it directly intersects with the fundamental constitutional principles of human dignity and respect for life, which are enshrined in the Constitution of the Republic of Korea. Given the significant number of institutions in Korea engaged in human subjects research and human materials research, the importance of ensuring that personal information is handled in accordance with both bioethical standards and privacy regulations cannot be overstated. Researchers in these institutions are required to obtain approval from an Institutional Bioethics Committee (IBC) before proceeding with their studies. While these committees are tasked with evaluating a broad range of bioethical issues, they face significant challenges when reviewing personal information-related concerns. These difficulties arise from the lack of alignment between the standards set forth in the Bioethics Act and those of the PIPA. In light of the practical difficulty associated with reviewing the diverse internal regulations governing research reviews across domestic institutions, this article provides a comprehensive analysis of the legal challenges and considerations related to the protection of personal information that arise during the IBC’s review of human subjects research conducted at Chungnam National University. It also proposes specific amendments to the Bioethics Act in order to address these issues more effectively.