인체유래물은행 관련 법제도의 한계점과 개선방안: 동의 능력이 없거나 불완전한 성인 인체자원 기증자에 대한 보호를 중심으로

Abstract

Due to the development of genome analysis technology and big data utilization technology, human resources stored in a human material bank can be used in a much more diverse and broader range of biomedical research fields. These human resources can only be used if the consent of the human resource donor has been lawfully obtained in accordance with the method prescribed by the Bioethics and Safety Act (hereinafter referred to as the “Bioethics Act”). In this regard, this study aimed to examine the limita- tions of the legal system in relation to the human material bank from the perspective of protecting vulnerable adult human resource donors who lack or have incomplete capacity to consent, with a focus on dementia patients, and to seek ways to improve them. Limitations include the lack of provisions in the Bioethics Act that can serve as a basis for obtaining consent from a representative, the lack of professional training for members of the Institutional Review Board to investigate and oversee the operation of human material banks, the lack of sufficient standards to ensure proper evaluation of the Institu- tional Review Board under the Institutional Review Board Evaluation and Certification System, and the lack of a system to monitor the adequacy of consent forms for donations of commonly acquired human materials, etc., including the need to obtain consent from the representative. We proposed practical remedies to improve this.