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, and utilization of biological data. This study examines the project's structure, features, and governance framework to identify key recommendations for successful implementation.

Methods: A systematic analysis of the NIBDCP was conducted, focusing on governance structures, data management protocols, and operational systems. The evaluation emphasized institutional roles, 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 empower the Secretariat to clearly define institutional responsibilities and facilitate inter-agency collaboration. Second, data collection protocols must address broad consent requirements, including provision of adequate information, explicit consent for secondary use, itemized withdrawal options, protection of minors' rights, and improved participant convenience. Third, establishing a 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 ensuring data 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 the project's goals and establish a robust model for biological data governance and utilization in Korea.