○SHINJI FUSHIKI2 (1.Center for Quality Assurance in Research and Development, Kyoto Prefectural University of Medicine, Kyoto, Japan, 2.Kyoto Chubu Medical Center, Nantan City, Japan)
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Schedule
Session information
Committee's Seminar
medical ethics/bioethics
[RCS1] Committee's Seminar
Amended ethical guidelines for medical research, reflecting personal information protection act
Thu. Jun 15, 2017 6:30 PM - 8:30 PM Room No.2 (6F Sub Hall)
Chair:Kyoko Itoh(Department of Pathology and Applied Neurobiology, Kyoto Prefectural University of Medicine, Graduate School of Medical Science)
[Aim]
Evidence-based medicine can be provided on the basis of “clinical research”, including randomized controlled studies. “Clinical research” in Japan is regulated currently by the national guideline, called “Ethical guideline on the medical research for human”, implemented from 1st April, 2015. In addition, a new act will be implemented in the near future, which specifies two types of clinical research, one is for drugs or medical instruments as yet unapproved by the government or the health insurance system, and another being the clinical research funded by pharmaceutical companies or manufacturers. Furthermore, the currently available ethical guidelines on medical research should be conformed to a recently revised act on treating the personal information. Therefore, it is our urgent need to be aware of the dramatically changing trend of governing “Clinical research”.