Akabayashi Akira, Nakazawa Eisuke, Akabayashi Aru
Department of Biomedical Ethics, School of Public Health, The University of Tokyo Graduate School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Division of Medical Ethics, Department of Population Health, New York University School of Medicine, 227 East, 30th Street, New York, NY, 10016, USA.
HEC Forum. 2019 Dec;31(4):283-294. doi: 10.1007/s10730-019-09379-3.
In April 2018, Japan's first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law's application brings numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field.
2018年4月，日本首部规范临床研究的法律生效。该法律旨在加强对研究诚信和利益冲突的监管，而这在现行行政指南下一直受到限制；该法律还规定了法律处罚措施。然而，新规定的范围完全限于评估未经批准药物或已批准药物的非标签使用的研究，以及接受公司资助的研究。另一方面，该法律的实施带来了诸多复杂问题，包括设立新的审查委员会、当前正在进行的研究过渡的繁琐程序，以及关于尽最大努力范围的模糊性。因此，这一变化给该领域带来了巨大压力和混乱。本文概述了该法律及其背景，并从管理伦理委员会和在该领域提供研究伦理支持的实际角度讨论了其未来前景。
