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欧洲医疗伦理委员会的监管

Regulation of healthcare ethics committees in Europe.

作者信息

Steinkamp Norbert, Gordijn Bert, Borovecki Ana, Gefenas Eugenijus, Glasa Jozef, Guerrier Marc, Meulenbergs Tom, Rózyńska Joanna, Slowther Anne

机构信息

Department of Ethics, Philosophy and History of Philosophy, Radboud University Medical Centre Nijmegen, Internal Post 137, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.

出版信息

Med Health Care Philos. 2007 Dec;10(4):461-75. doi: 10.1007/s11019-007-9054-6. Epub 2007 May 23.

DOI:10.1007/s11019-007-9054-6
PMID:17520343
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2778685/
Abstract

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt to improve HECs' accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries.

摘要

在本文中,探讨了医疗保健伦理委员会(HECs)是否以及应如何受到监管这一问题。本文由两部分组成。首先,来自八个欧盟成员国的作者描述了各自国家的现状,并阐述了他们认为最合适的监管形式的理由。在第二部分中,对各国的报告进行了分析。建议对医疗保健伦理委员会的监管应集中且宽松。集中监管被认为有助于提高医疗保健伦理委员会的问责性、相关性和可比性。为了促进生物医学公民意识和伦理反思,监管同时应宽松而非严格。应支持医疗保健伦理委员会独立审议伦理问题并提供主动和被动的建议,且仅在例外情况下进行干预。一种例外情况是当医疗机构中的情况暂时不利于伦理审议时。鉴于欧洲一体化,应采取措施为东欧和西欧国家制定一致的政策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5a0/2778685/4c6931eca92e/11019_2007_Article_9054_Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5a0/2778685/4c6931eca92e/11019_2007_Article_9054_Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5a0/2778685/4c6931eca92e/11019_2007_Article_9054_Fig1.jpg

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本文引用的文献

1
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.欧洲议会和理事会2001年4月4日关于协调各成员国有关在人用药品临床试验实施中适用良好临床实践的法律、法规及行政规定的第2001/20/EC号指令。
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Making the (Business) Case for Clinical Ethics Support in the UK.为英国的临床伦理支持提出(商业)案例。
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PLoS One. 2020 Jul 14;15(7):e0235509. doi: 10.1371/journal.pone.0235509. eCollection 2020.
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Clinical Ethics Consultation in the Transition Countries of Central and Eastern Europe.中东欧转型国家的临床伦理咨询。
Sci Eng Ethics. 2020 Apr;26(2):833-850. doi: 10.1007/s11948-019-00141-z. Epub 2019 Oct 5.
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Ethical case interventions for adult patients.针对成年患者的伦理案例干预措施。
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Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS).我们是否理解干预措施?复杂干预研究可以为我们评估临床伦理支持服务(CESS)提供哪些启示?
BMC Med Ethics. 2019 Jul 15;20(1):48. doi: 10.1186/s12910-019-0381-y.
The current state of clinical ethics and healthcare ethics committees in Belgium.
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J Med Ethics. 2005 Jun;31(6):318-21. doi: 10.1136/jme.2003.006924.
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HEC Forum. 2001 Dec;13(4):381-92. doi: 10.1023/a:1014700703484.
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