English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  全文笔数/总笔数 : 112721/143689 (78%)
造访人次 : 49518353      在线人数 : 768
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
搜寻范围 查询小技巧：
  • 您可在西文检索词汇前后加上"双引号"，以获取较精准的检索结果
  • 若欲以作者姓名搜寻，建议至进阶搜寻限定作者字段，可获得较完整数据
    •  进阶搜寻


    请使用永久网址来引用或连结此文件: https://nccur.lib.nccu.edu.tw/handle/140.119/114430


    题名: 評人體研究法的倫理審查機制－憲法疑義與修正建議
    The Ethics Review Mechanism under the Human Subjects Research Act: Constitutional Problems and Suggestions to Reform
    作者: 陳仲嶙
    Chen, Chung-Lin
    关键词: 人體研究法;倫理審查委員會;研究倫理委員會;研究自由;學術自由;違憲審查
    Human Subjects Research Act;Institutional Review Board;Research Ethics Committee;Freedom of Research;Academic Freedom;Judicial Review
    日期: 2015-12
    上传时间: 2017-11-07 14:43:47 (UTC+8)
    摘要: 我國二○一一年通過的人體研究法，將倫理審查機制之適用，擴大及於藥品人體試驗以外的其他人體研究，是我國研究管制上的一項重大發展，對人體研究中受試者權益之保障意義匪淺。但是，倫理審查機制要求對研究計畫進行事先審查，產生限制研究自由的疑慮。倘若未妥善設計，可能因為審查者基於自身價值觀或學術意見而干預研究計畫之內容，造成對研究自由之戕害。不幸的是，研究自由的考量在人體研究法的立法中並未受到注意。本文認為，我國人體研究法下的倫理審查機制具有高度之違憲嫌疑。相關規定構成針對言論內容之事前限制，但其規範設計恐無法通過事前限制所觸發的嚴苛審查。同時，本法適用範圍之規定亦有不夠明確的問題。本文建議，在適用範圍、審查權限與救濟機制這三個面向進行改革。而在修法之前，審查會、衛福部與法院，亦應體察憲法價值，將研究自由之精神融入對相關法條之解釋與適用。
    The enactment the Human Subjects Research Act in 2011 is a significant development in Taiwan’s research regulation, The said act covers various kinds of research involving human subjects and extends the requirement of ethics review beyond drug clinical trials. Ethics review mechanism, which requires a prior review of a research project, raises the issue concerning the freedom of research. If the mechanism is not carefully designed, reviewers might intervene in the content of research projects or even reject the projects because of different viewpoints and, consequently, create an undue burden on the freedom of research. Unfortunately, consideration regarding the freedom of research was absent in the enactment of the Human Subjects Research Act. This study argues that the ethics review mechanism under the Human Subjects Research Act is likely to be unconstitutional. The regulation at issue constitutes a content-based prior restraint and its design cannot overcome the heavy presumption of unconstitutionality born by prior restraints. In addition, the provision regarding the scope of application is too vague. To solve these constitutional problems, this article proposes reforms in terms of application scope, review power, and remedy mechanism. Before the law is revised, IRBs, authorities, and courts should also interpret related provisions with the constitutional spirit of free research to limit review discretion and allow administrative appeals and litigations.
    關聯: 政大法學評論, 143, 191-237
    数据类型: article
    DOI 連結: http://dx.doi.org/10.3966/102398202015120143004
    DOI: 10.3966/102398202015120143004
    显示于类别:[政大法學評論 TSSCI] 期刊論文

    文件中的档案:

    档案 描述 大小格式浏览次数
    143-4.pdf1857KbAdobe PDF2326检视/开启


    在政大典藏中所有的数据项都受到原著作权保护.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏，無償提供學術研究與公眾教育等公益性使用，惟仍請適度，合理使用本網站之內容，以尊重著作權人之權益。商業上之利用，則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作，已盡力防止侵害著作權人之權益，如仍發現本網站之數位內容有侵害著作權人權益情事者，請權利人通知本網站維護人員(nccur@nccu.edu.tw)，維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - 回馈