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題 名 | 由生命倫理學原則之價值導向檢視臺灣人體試驗委員會制度及其倫理與法律規範=Survey of Taiwan's Institutional Review Board's System and Its Ethics and Law Regulations from the Value Orientation of Bioethics Principles |
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作 者 | 曾建元; | 書刊名 | 淡江人文社會學刊 |
卷 期 | 20 2004.09[民93.09] |
頁 次 | 頁129-141 |
分類號 | 410.1619 |
關鍵詞 | 知情同意; 人體試驗; 基因治療; 醫療法; 人體試驗委員會; Informed consent; Clinical trial; Genetic therapy; Medical law; Institutional review board; |
語 文 | 中文(Chinese) |
中文摘要 | 〈醫療法〉第五十七條規定實施人體試驗應先取得接受試驗者之書面同意;受試驗者為無行為能力或限制行為能力人,應得其法定代理人之同意,此為臺灣醫療法規當中,最早有關病患知情同意權(告知後同意Informed Consent)之規定,而呈現出對於受試驗者個人自主決定權的高度尊重,惟此一規定與〈醫療法〉第四十六條之手術實施和〈安寧緩和醫療條例〉之安寧緩和醫療知情同意權納入家屬參與決定的含糊規定出現價值立場的不一致性,實又與臺灣傳統中國社會之家庭決定導向之生命倫理學原則價值立場有所扞格,在實踐上是否出現與法規範之落差,乃殊值得注意,更者,基因治療之人體試驗尚牽涉及更為複雜的家庭與社群基因資訊揭露而可能引發之倫理課題,其影響已不僅及於受試驗者個人,如何在尊重個人自主決定權之餘,經權家庭與社群之利益,在既有的法規範下,恐怕人體試驗委員會的決定,已成為最重要的倫理與法律抉擇基準。 本文即擬以基因治療時代的臺灣人體試驗委員會制度及其倫理與法律規範為考察對象,探討以個人、家庭與社群為中心的生命倫理學原則價值導向的競合問題與解決方法。 |
英文摘要 | The Article 57 of "Medical Laws" regulates the implementation of clinical treatment and requires the patient's written agreement; in case the patient is incapacitated or of limited capacity, the consent of the patient's legal agent is required. This is the first regulation with respect to patient agreement (Informed Consent) in Taiwan's medical laws and regulations; and it also shows the high degree of respect for the patient's decision-making rights. However, this regulation is not consistent with the value of Article 46, Medical Laws' operation and execution, and the Hospice Palliative Medical Regulation's family's participation in the patient agreement for hospice palliative medical treatment. Furthermore, it also conflicts with the values of traditional Chinese society's ethical principles with it family-decision making orientation. Therefore, it is worth noticing whether there is any difference between practice and law regulation. Moreover, clinical treatment in genetic therapy also involves more complicated ethics issues resulting from the disclosure of family and community genetic information, which not only affects the patient. But in addition to respect for personal decision-making rights, it is required to measure family and community benefits; the decisions of the Institutional Review Board under present laws and regulation probably become the most important base for the selection of ethics and laws. This article surveys Taiwan's Institutional Review Board's system and its ethics and law regulations in an era of genetic therapy, and explores the competition and cooperation problems and solutions of the value orientation in Bioethics principles centered on the person, family and community. |
本系統中英文摘要資訊取自各篇刊載內容。