Legal Constraints on the Use of Bio Data for Research Purposes and the Introduction of a Dynamic Consent Model as a Solution

This study examined the legal constraints on the utilization of bio data in Korea and argued for the necessity of introducing a dynamic consent model as a solution. The dynamic consent model refers not to the exercise of specific rights or their scope through digital interfaces, but rather to the methods and mechanisms for obtaining consent. Data-based research inherently involves significant uncertainty regarding the scope of future research, the boundaries of similar studies, and the specific data requirements. These elements can change at any point during the research process. This fundamentally conflicts with the basis of personal information norms, which are premised on obtaining prior consent. Therefore, this paper argues that the following improvements are essential to the existing traditional personal information norms. First, the strict requirement for written consent under the current Bioethics Act clearly needs improvement. Specifically, the Bioethics Act details essential elements for implementing written consent at the statutory level, such as prescribing the format of research consent forms and donation consent forms in its enforcement rules. Therefore, implementing a dynamic consent model requires explicit legal grounds stating that consent can be obtained either through written consent or via digital interfaces. Second, implementing a dynamic consent model requires considering either recognizing exceptions to written consent or removing existing written consent obligations. This stems from the intent of the dynamic consent model to fully overcome the limitations of written consent and leverage the advantages of electronic interfaces to effectively utilize data. Third, it is necessary to review whether public management and supervision are required when the content of consent, the scope of the agreed-upon research, or the range of collected data changes during the operation of the dynamic consent model. Under current law, new consent must be obtained when conducting new research, making repeated IRB reviews for re-consent inefficient. As a solution, the implementation burden can be alleviated by permitting comprehensive research designs during initial review and allowing only notification, rather than review, for re-consent when conducting research within the same broad category. In conclusion, the introduction of the dynamic consent model offers tangible benefits: ensuring information transparency for the substantive exercise of data subjects’ rights and enabling continuous consent to accommodate variability during the research process.