The legal regulatory structure of human biobanks in Korea: Present and future

• 발행기관: 대한의학유전학회
• 저자명: Na-Kyoung Kim
• 간행물 정보: 『대한의학유전학회지』제22권 제1호, 1~6쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.06.30

국문 초록

This article critically examines the regulatory framework governing human biobanks in Korea, with particular attention to the 2024 revision of the Standard Operating Guidelines for Human Biobanks. It analyzes how the revised guidelines reflect the evolving legal and institutional landscape of human biological material governance. Special emphasis is placed on the four legally recognized pathways for collecting human biological materials under the Bioethics and Safety Act (BioAct), which have been further clarified in the revised guidelines to ensure greater clarity and consistency. The article argues that it is essential, on the one hand, for practitioners to clearly understand each collection pathway and its procedural requirements, and on the other hand, for normative safeguards to be in place to protect donors—without undermining the efficiency of biobank operations. In this context, the guidelines also offer illustrative guidance on how the current Donation Consent Form under the BioAct may be supplemented. The article further discusses concerns related to the independence and ethical competence of Institutional Review Board (IRB), as well as the potential need for a dedicated “provision review board” to enhance procedural rationality—issues that appear to have been reflected in the revised guidelines. In particular, as non-medical organizations increasingly engage in establishing biobanks, it becomes critical to establish robust operational governance to ensure accountability in the processes of collection, storage, and provision. It is within this context that the revised guidelines underscore the need to strengthen IRB independence and mandate the creation of a provision review committee.

목차

Introduction

The Beginning of Regulations on Human Biobanks

Changes in Regulations and Environment Related to Human Biobanks

Premises for the Rational Operation of a Human Biobank

Conclusion

Acknowledgements

Funding

References

키워드

Human biobanks Human material Donation agreement Suprlus material Donor rights Institutional Review Board