A comparison between Japan and overseas and its future perspective regarding structure and operation of "Human Research Protection" in clinical research

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K10278
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 58010:Medical management and medical sociology-related
• Research Institution: Osaka University
• Principal Investigator: Yamamoto Yoichi 大阪大学, 医学部附属病院, 教授 (20335342)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 被験者保護 / 研究倫理 / 倫理委員会 / CAPA / 弱者 / CRB / IRB / 構造

Outline of Final Research Achievements

My research results are summarized in “Questions on Human Research Protection in Japan”. Its content is as follows: -How to protect human subjects? -The comparison of IRBs between in Japan and overseas -Criteria for IRB approval and exemption review in the US -Review on research involving vulnerable people -The importance of CAPA -Required consultation systems as an organization -Differences in the ways of introducing a single IRB review. Lastly, I suggested our future directions: -Moving from vertically structured regulations to common rules -Clarifying the national department responsible for the future of clinical research and trials in Japan -Quality assurance in Japanese clinical research -Activation of independent activities -Employment system that allows for accumulation of know-how. All these are deeply related to regulatory, social, administrational structures or frames, and hard to tackle. However, without improving them, we will be left behind from international standards.

Free Research Field

研究倫理

Academic Significance and Societal Importance of the Research Achievements

日本の被験者保護体制が国際的視点から取り残されつつあること、その原因として、多くは構造（しくみ）に係る問題であり根が深いこと、しかし、これらが改善されなければ、日本は益々国際基準から取り残されることを指摘した。そして、多難ではあるが、5年から10年かけてでもこれらに取り組む必要があるとした。当該研究成果を、関係者とWebinarを通じて共有できたこと、そして、成果物としての冊子を配布することで、多くの賛同を得ることができれば、関係者の様々な改善に向けての取り組みが始まるものと期待する。