Empirical Study to Inform Regulatory Discussions on Human Cell-Based Interventions and Basic Research

2024 Fiscal Year Final Research Report

• Project/Area Number: 21K10326
• 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: Kyoto University
• Principal Investigator: Fujita Misao 京都大学, iPS細胞研究所, 特定教授 (50396701)
• Project Period (FY): 2021-04-01 – 2025-03-31
• Keywords: iPS細胞 / 再生医療 / ヒト胚 / 生命倫理学 / 質問紙調査

Outline of Final Research Achievements

This study analyzed 3,467 publicly available documents to examine the current state of cell-based interventions offered through private medical services, revealing systemic issues related to safety and financial burden. Some therapies labeled as regenerative medicine lacked scientific evidence, and the reporting of adverse events was found to be insufficient. In addition, surveys of the general public and researchers regarding the creation of germ cells and genome editing of human embryos highlighted notable differences in the social acceptance of emerging biotechnologies, along with a wide range of concerns and values.

Free Research Field

生命倫理学

Academic Significance and Societal Importance of the Research Achievements

本研究は、再生医療やヒト胚等に関わる基礎研究に関連する制度設計や規制の見直しに向けた知見を提供するものである。自由診療で行われる再生医療の実態調査からは、科学的根拠が乏しい治療への対応や、安全性報告体制の脆弱さ、規制の曖昧さなど、法制度の構造的課題を明らかにした。また、配偶子作製やヒト胚にゲノム編集を加える研究に関する質問紙調査では、一般市民と研究者の認識ギャップ等を踏まえ、当事者を含む多様な声を反映した対話の必要性を提示した。