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  1. Implementation of Japan’s First Clinical Research Regulatory Law: Background, Overview, and Challenges.Akira Akabayashi, Eisuke Nakazawa & Aru Akabayashi - 2019 - HEC Forum 31 (4):283-294.
    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, (...)
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  • A Five Year Follow-Up National Study of Ethics Committees in Medical Organizations in Japan.Akira Akabayashi, Brian Taylor Slingsby, Noriko Nagao, Ichiro Kai & Hajime Sato - 2008 - HEC Forum 20 (1):49-60.
    Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two sections: (...)
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  • An eight-year follow-up national study of medical school and general hospital ethics committees in Japan.Akira Akabayashi, Brian T. Slingsby, Noriko Nagao, Ichiro Kai & Hajime Sato - 2007 - BMC Medical Ethics 8 (1):1-8.
    Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to two separate (...)
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