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


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.


Research regulation Law Ethics committee Japan 


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 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.


  1. Akabayashi, A., Slingsby, B. T., Nagao, N., Kai, I., & Sato, H. (2007). An eight-year follow-up national study of medical school and general hospital ethics committees in Japan. BMC Medical Ethics,8, 8.CrossRefGoogle Scholar
  2. Akabayashi, A., Slingsby, B. T., Nagao, N., Kai, I., & Sato, H. (2008). A five year follow-up national study of ethics committees in medical organizations in Japan. HEC Forum,20(1), 49–60.CrossRefGoogle Scholar
  3. Akabayashi, A., Slingsby, B. T., & Takimoto, Y. (2005). Conflict of interests: A Japanese perspective. Cambridge Quarterly of Healthcare Ethics,14(4), 277–280.CrossRefGoogle Scholar
  4. McCurry, J. (2014). Former Novartis employee arrested over valsartan data. Lancet,383(9935), 2111.CrossRefGoogle Scholar
  5. Normile, D. (2013). Japan. Tampered data cast shadow on drug trial. Science,341(6143), 223. Scholar
  6. Normile, D. (2014). Biomedicine. Faulty drug trials tarnish Japan’s clinical research. Science,345(6192), 17. Scholar
  7. Slingsby, B. T., Nagao, N., & Akabayashi, A. (2004). Administrative legislation in Japan: Guidelines on scientific and ethical standards. Cambridge Quarterly of Healthcare Ethics,13(3), 245–253.CrossRefGoogle Scholar
  8. Tanimoto, T., Kami, M., & Shibuya, K. (2013). Research misconduct and scientific integrity: A call for a global forum. Lancet,382(9896), 940. Scholar
  9. Tashiro, S. (2018). The reform of Japanese Research Ethics Committees 2008–2017. Iryo to Shakai,28(1), 79–91 (in Japanese).CrossRefGoogle Scholar

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

Personalised recommendations