Bioethics Governance in the Era of Regenerative Medicine Act ; From Basic Research to Medical Care through Clinical Study

2017 Fiscal Year Final Research Report

• Project/Area Number: 26293117
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Partial Multi-year Fund
• Section: 一般
• Research Field: Medical sociology
• Research Institution: Shiga University (2016-2017); Doshisha University (2014-2015)
• Principal Investigator: IDA Ryuichi 滋賀大学, 役員, 学長 (40127543)
• Co-Investigator(Kenkyū-buntansha): 鶴山 竜昭 京都大学, 医学研究科, 特定教授 (00303842) ; 青井 貴之 神戸大学, 科学技術イノベーション研究科, 教授 (00546997) ; 川村 孝 京都大学, 環境安全保健機構, 教授 (10252230) ; 森崎 隆幸 東京工科大学, 医療保健学部, 教授 (30174410) ; 一家 綱邦 国立研究開発法人国立がん研究センター, 研究支援センター, 室長 (50453981) ; 鈴木 美香 京都大学, iPS細胞研究所, 特定研究員 (60555259) ; 児玉 聡 京都大学, 文学研究科, 准教授 (80372366)
• Project Period (FY): 2014-04-01 – 2018-03-31
• Keywords: 生命倫理 / 再生医療 / ガバナンス / 倫理審査 / iPS細胞 / 細胞治療 / バイオバンク・データベース

Outline of Final Research Achievements

Regenerative Medical Care Act of 2013 regulates three categories of cell therapy, using namely, multipotent stem cells used first in human such as ES cell and iPS cells, adult stem cells and other cells, with a specified review by three kind of procedure of these three categories accordingly, in order to ensure the safety and the ethical consideration as well as to control the treatments not covered by health insurance.
Our research was conducted through five tracks, i.e., (1)Theoretical foundation of biomedical ethics of regenerative medicine, (2)Search for applicable ethical principles, (3)Building up a set of practical ethical standards, (4)Ethical and medical review system (5)Case studies of regenerative medical care, in order to cet up a bioethics governance　framework.

Free Research Field

国際生命倫理、国際法