臨牀透析 Vol.29 No.4(6)


特集名 透析室での臨床研究 ― 研究デザインと研究のまとめ方
題名 臨床研究倫理
発刊年月 2013年 04月
著者 佐古 まゆみ 独立行政法人国立成育医療研究センター臨床研究センター治験推進室
【 要旨 】 臨床研究倫理について,臨床研究に倫理性が求められる理由と臨床研究の倫理要件について説明した.真に倫理的な臨床研究とは,倫理性,科学的妥当性,社会的価値のすべてを満たすものであることを強調したい.また研究者には,出版倫理に関する知識も必要である.出版倫理については,国際医学雑誌編集者委員会から公表されている「生医学雑誌への投稿のための統一規制:生医学発表に関する執筆と編集」に沿って説明した.
Theme Facilitating clinical and nursing research in nephrology and dialysis
Title Clinical research ethics
Author Mayumi Sako National Center for Child Health and Development Division of Clinical Trials Clinical Research Center
[ Summary ] Ethical issues, involved in clinical research and publication are discussed. Ethical mindsets and actions involved in developing and implementing protocols are described. It must be emphasized that truly ethical clinical research meets the three requirements of morality, scientific validity and social value. When medical personnel are directly involved in clinical research, they must carefully read and understand the guidelines governing clinical and epidemiological research outlined by the Japanese medical community as well as the Helsinki Declaration. Authors of studies must follow the guidelines for writing and editing medical publications (update April 2010). Protection of privacy is essential in relation to the publication ethic issue. Editors and journal writers who publish supplements must take full responsibility for the accuracy of the journal publication and the social liability concerned.
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