Ethical and Regulatory Considerations on Biobanking in the Republic of Korea

Korean biobanks are now adapting to integrate the new paradigm of precision medicine into their fundamental role of promoting health technology. Since the enactment of Bioethics and Safety Act in 2004, the Republic of Korea has developed a regulatory framework that reflects ethical principles. However, the existing regulation of biobanks has recently proven to be limited in responding to newer ethical and legal issues that have arisen. First, as there is an emerging trend for human biospecimens to be stored, managed and distributed as digitalized data, the current role of the Distributive Review Committee may become less important compared to the Data Access Committee. Second, even if public health data is anonymized, the risk of identifiability is growing. This makes a third point relevant, informed consent is crucial to respect the autonomy of patients and research subjects, but current consent rules need to change to reflect the interactive and dynamic communication process, in which information and communication technology (ICT) plays an increasingly prominent role. Fourth, even though data sharing for research is expected to be altruistic and the sale of human biospecimens and genome data remains prohibited, data sharing practices have become more complicated and are closer to commercial use and commercialization. Given these challenges, there is a pressing need for continuing and deeper deliberation in order to develop a more comprehensive and responsive governance framework.