Korea’s Bio Big Data Project: Importance and Challenges of Governance and Data Utilization

Abstract

Objectives: The Korean government has been developing the National Integrated Biological Data Construction Project(NIBDCP) for over a decade, aiming to establish a comprehensive framework for the collection, production, provision, andutilization of biological data. This study examines the project’s structure, features, and governance framework to identify keyrecommendations for successful implementation. Methods: A systematic analysis of the NIBDCP was conducted, focusingon governance structures, data management protocols, and operational systems. The evaluation emphasized institutionalroles, consent requirements, sustainable data production, and researcher accessibility, identifying areas for improvement. Results: The analysis identified four critical areas requiring enhancement. First, the governance framework should empowerthe Secretariat to clearly define institutional responsibilities and facilitate inter-agency collaboration. Second, data collectionprotocols must address broad consent requirements, including provision of adequate information, explicit consent forsecondary use, itemized withdrawal options, protection of minors’ rights, and improved participant convenience. Third, establishinga systemic and sustainable data production framework is essential, with an emphasis on data quality, standardization,and scalability. Finally, the system for data provision and utilization should enhance researcher accessibility by ensuringdata openness, maintaining a unified Institutional Review Board system, and streamlining application and usage processes. Conclusions: Strengthening governance, upholding ethical standards in data collection, ensuring sustainable data production,and optimizing researcher accessibility are essential for the success of the NIBDCP. These measures will help achieve theproject’s goals and establish a robust model for biological data governance and utilization in Korea.