| Budget Amount *help |
¥5,460,000 (Direct Cost: ¥4,200,000、Indirect Cost: ¥1,260,000)
Fiscal Year 2014: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2013: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2012: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
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| Outline of Final Research Achievements |
This research studied the ethical and legal ramifications of medical research involving human subjects, which include requirement of informed consent, review of study plan by the ethics review board, protection of personal information, and incidental findings. Enquiry into the recent proposal to revise the so-called Common Rule by the US DHHS was also conducted. On the practical side, I participated in the joint meeting of the expert committees to revise Ethical Guidelines for Epidemiological Research and Clinical Research, and create a new set of Ethical Guidelines for Medical and Health Research involving Human Subjects by the MHLW and MEXT from Dec. 2012 through Dec. 2014. I made specific proposals regarding such issues as general consent, research use of existing samples and data, required entries of research protocols and informed consent disclosure documents, consent requirement for the research involving minors, and most of them were embodied in the final guidelines.
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