Comparative Study of Legal and Ethical Governance of Medical Research

2017 Fiscal Year Final Research Report

• Project/Area Number: 15K03242
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: New fields of law
• Research Institution: Kobe University
• Principal Investigator: Maruyama Eiji 神戸大学, 法学研究科, 名誉教授 (10030636)
• Project Period (FY): 2015-04-01 – 2018-03-31
• Keywords: インフォームド・コンセント / 個人情報保護 / 倫理審査委員会 / 人を対象とする医学系研究に関する倫理指針

Outline of Final Research Achievements

This research studied the ethical and legal ramifications of medical research involving human subjects focusing on informed consent, personal data protection, and ethics committee. The revision of the US Common Rule, the EU Clinical Trials Directive and Regulation, and the UK and French research governance systems were explored. Domestically, critical evaluation was made of the revision of Ethical Guidelines of Medical Research Involving Human Subjects during 2016 to 2017 after the 2015 amendment of Personal Information Protection Act. Logical inconsistencies were pointed out in the revised guidelines by means of public comments, journal articles and lectures. Investigation was also made about the drafting of administrative regulations to implement the Clinical Research Act that was enacted in 2017 and came into effect in April 2018.

Free Research Field

医事法学