Comparative Legal Study for Developing New Legal and Ethical Rules of Medical Research

2014 Fiscal Year Final Research Report

• Project/Area Number: 24610004
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Bioethics
• Research Institution: Kobe University
• Principal Investigator: MARUYAMA Eiji 神戸大学, 法学(政治学)研究科(研究院), 教授 (10030636)
• Project Period (FY): 2012-04-01 – 2015-03-31
• 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 / 偶発的所見 / 人を対象とする医学系研究に関する倫理指針 / 一般的同意

Outline of Final Research Achievements

This research studied the ethical and legal ramifications of medical research involving human subjects, which include requirement of informed consent, review of study plan by the ethics review board, protection of personal information, and incidental findings. Enquiry into the recent proposal to revise the so-called Common Rule by the US DHHS was also conducted. On the practical side, I participated in the joint meeting of the expert committees to revise Ethical Guidelines for Epidemiological Research and Clinical Research, and create a new set of Ethical Guidelines for Medical and Health Research involving Human Subjects by the MHLW and MEXT from Dec. 2012 through Dec. 2014. I made specific proposals regarding such issues as general consent, research use of existing samples and data, required entries of research protocols and informed consent disclosure documents, consent requirement for the research involving minors, and most of them were embodied in the final guidelines.

Free Research Field

生命倫理学