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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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  • Report on the Establishment of the Consortium for Hospital Ethics Committees in Japan and the First Collaboration Conference of Hospital Ethics Committees.Kei Takeshita, Noriko Nagao, Hiroyuki Kaneda, Yasuhiko Miura, Takanobu Kinjo & Yoshiyuki Takimoto - 2022 - Asian Bioethics Review 14 (4):307-316.
    Hospital ethics committees (HECs) are expected to play extremely broad and pivotal roles such as case consultation, education of staffs on healthcare ethics, and institutional policy formation. Despite the growing importance of HECs, there are no standards for setup and operation of HECs, and composition and activities of HECs at each institution are rarely disclosed in Japan. In addition, there is also a lack of information sharing and collaboration among HECs. Therefore, the authors established the Consortium of Hospital Ethics Committees (...)
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  • Comparison of ethical judgments exhibited by clients and ethics consultants in Japan.Noriko Nagao, Yasuhiro Kadooka & Atsushi Asai - 2014 - BMC Medical Ethics 15 (1):19.
    Healthcare professionals must make decisions for patients based on ethical considerations. However, they rely on clinical ethics consultations (CEC) to review ethical justifications of their decisions. CEC consultants support the cases reviewed and guide medical care. When both healthcare professionals and CEC consultants face ethical problems in medical care, how is their judgment derived? How do medical judgments differ from the ethical considerations of CECs? This study examines CECs in Japan to identify differences in the ethical judgment of clients and (...)
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  • Clinical Ethics Consultation in Japan: What does it Mean to have a Functioning Ethics Consultation?Noriko Nagao & Yoshiyuki Takimoto - 2023 - Asian Bioethics Review 16 (1):15-31.
    This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC’s benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization and service purpose and operation and (...)
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  • Stranger at the consultation: Increasing the diversity in research ethics consultation.Alan Jotkowitz & Ari Z. Zivotofsky - 2008 - American Journal of Bioethics 8 (3):25 – 26.
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