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HEC Forum

, Volume 31, Issue 4, pp 283–294 | Cite as

Implementation of Japan’s First Clinical Research Regulatory Law: Background, Overview, and Challenges

  • Akira AkabayashiEmail author
  • Eisuke Nakazawa
  • Aru Akabayashi
Article
  • 28 Downloads

Abstract

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.

Keywords

Research regulation Law Ethics committee Japan 

Notes

Author Contributions

AkA: conceptualization, writing—original draft, writing—review and editing. EN: conceptualization, formal analysis, writing—review & editing. ArA: conceptualization, formal analysis, writing—review and editing

Funding

Funding was provided by Pfizer Health Research Foundation.

Compliance with Ethical Standards

Conflict of interest

Akira Akabayashi is President of the Japan Association for Bioethics; this paper reflects the author’s personal academic analyses and opinions and does not represent JAB’s official position. Both Akira Akabayashi and Eisuke Nakazawa get a grant from Medical Technology Practical Application and a General Promotion Support Grant from the Japan Agency for Medical Research and Development (AMED), however, no money is used from the grant for this study.

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Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  1. 1.Department of Biomedical Ethics, School of Public HealthThe University of Tokyo Graduate School of MedicineTokyoJapan
  2. 2.Division of Medical Ethics, Department of Population HealthNew York University School of MedicineNew YorkUSA

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