Introduction to the Revised Standard Operating Procedures of the Institutional Review Board at the Korea Disease...

To introduce the revised standard operating procedures (SOPs) of the Korea Disease Control and Prevention Agency (KDCA) Institutional Review Board (IRB) and provide practical guidance to support researchers in complying with bioethics regulations and efficiently submitting review applications.

Based on the Bioethics and Safety Act and its enforcement regulations, we systematically organized the key contents of the revised SOPs, including IRB composition, review types and procedures, required documents, and important considerations for researchers.

The KDCA IRB played a crucial role in reviewing the research protocols before study implementation to ensure the protection of research participants' rights and welfare as the highest priority. The 2025 revised guidelines systematically specify the IRB composition and authority, clarify review types and procedures, and establish a Data Subcommittee to address ethical issues in big data and artificial intelligence research. Three types of reviews were conducted based on the risk level and characteristics of the research: regular, expedited, and exempt reviews. All the review processes were integrated using the e-IRB system.

The revised SOPs incorporated additional provisions for the systematic operation of the KDCA IRB and included detailed practical information to assist researchers in submitting and proceeding with IRB applications. This establishes a foundation for supporting researchers' compliance with bioethics regulations and effectively responding to the evolving research environment.