2025 年 56 巻 6 号 p. 271-284
The Single Institutional Review Board (IRB) has been promoted to enhance the efficiency of clinical trials in Japan. However, studies clarifying the extent of use, challenges, and pros and cons of Single IRB systems within Japanese medical institutions are lacking. Therefore, we conducted a questionnaire survey targeting Advanced Treatment Hospital to address these issues. The results revealed that external IRBs were not widely used by the institutions. Some institutions identified the potential advantages of allowing sponsors to request direct review by a Single IRB. However, concerns were also raised, which included difficulties in responding to institution-specific issues, reduced revenue from IRB review fees, and increased administrative burden due to coordination with external IRBs. Addressing the increased burden associated with a Single IRB aligns with the goals of the “2025 Clinical Trial Ecosystem Implementation Promotion Project” led by the Pharmaceuticals and Medical Devices Agency. The 2025 edition of the “Future Direction for the Promotion of Clinical Trials and Studies,” published by the Ministry of Health, Labor, and Welfare, also highlights the need to ensure the quality of IRBs. These findings suggest that future discussions on Single IRB implementation are warranted. All stakeholders should collaborate to establish a Single IRB system that minimizes the burden on medical institutions to promote clinical trials in Japan.
