学術雑誌論文 体系的な倫理審査を目指して : 「倫理審査フローシート」の開発とその特長(依頼論文)

田代, 志門  ,  松井, 健志

4pp.1 - 17 , 2016-03-31 , 北海道生命倫理研究会
ISSN:2187-834X
内容記述
A research ethics committee (REC) has its paramount function in protecting human subjects in medical research. In this article, we propose and explain how to use the Ethics Review Worksheet that we have developed in order to make ethics review process more effective and efficient. Characteristically, the Worksheet is composed of a comprehensive checklist of important viewpoints based on research ethics theories, and also carefully designed to follow the actual process of ethics review. With this worksheet, therefore, we believe REC members can go through a research protocol without any omission of the needed points for review as well as can prevent such an inefficient discussion, for example, that a REC points out a flaw in the informed consent document before judging scientific validity and making an appropriate risk-benefit assessment of the proposed protocol.
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http://ir.cc.sapmed.ac.jp/dspace/bitstream/123456789/6817/1/%e5%8c%97%e6%b5%b7%e9%81%93%e7%94%9f%e5%91%bd%e5%80%ab%e7%90%86%e7%a0%94%e7%a9%b6_4_1.pdf

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