篇名

臺灣研究倫理審查機制簡介   免費試閱

並列篇名

Introduction of Research Ethical Review Mechanism in Taiwan

作者
中文摘要

臺灣研究倫理審查機制最早規定於醫療法,侷限於新藥品、新醫療器材、新醫療技術等高風險的人體試驗,但隨著受試者保護觀念的普及與重視,逐漸擴及於所有臨床試驗及人體研究,陸續制定了許多相關法律與規範。倫理審查委員會是研究倫理審查順利運作的關鍵,臺灣法規對於倫理審查委員會的組織與運作有詳細的規定,藉由良好運作的倫理審查委員會,落實受試者保護的理念。本文將介紹臺灣研究倫理審查之沿革,並介紹倫理審查委員會的相關規範。

英文摘要

In Taiwan, regulation of ethical review was firstly stipulated in Medical Care Act, limiting on high risk human trials involving new drug, new medical device or new medical technology. However, because of the popularization of concept of subject protection, more and more laws and regulations were promulgated, involving all kinds of clinical trials and human research. Ethical Committee (EC) or Institutional Review Board (IRB) is the key to the proper function of ethical review mechanism. There are sophisticated regulations stipulated on the organization and operation of EC / IRB in order to implement the idea of research subject protection. This article will introduce the history of ethical review mechanism and regulations on EC / IRB.

起訖頁

019-028

出版單位
DOI

10.3966/241553062017080010002  複製DOI  DOI查詢

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