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European Society of Intensive Care Medicine statement. Clinical research in intensive care unit.

作者信息

Lemaire F

机构信息

Service de Réanimation Médicale, Hôpital Henri Mondor, 51, avenue du Mal. de Lattre de Tassigny, 94010 Creteil, France.

出版信息

Intensive Care Med. 2002 Sep;28(9):1218-9. doi: 10.1007/s00134-002-1417-0.

DOI:10.1007/s00134-002-1417-0
PMID:12400565
Abstract
摘要

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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。
Med Etika Bioet. 2002 Spring-Summer;9(1-2):12-9.
2
Sponsorship, authorship, and accountability.赞助、作者身份及责任。
N Engl J Med. 2001 Sep 13;345(11):825-6; discussion 826-7. doi: 10.1056/NEJMed010093.
3
Intensive Care Med. 2006 Nov;32(11):1697-705. doi: 10.1007/s00134-006-0305-4. Epub 2006 Aug 8.
4
The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis.欧盟指令与研究中无行为能力受试者的保护：伦理分析
Intensive Care Med. 2004 Sep;30(9):1723-9. doi: 10.1007/s00134-004-2367-5. Epub 2004 Jun 30.
5
'Treat first, ask later?' Emergency research in acute neurology and neurotraumatology in the European Union.“先治疗，后询问？”欧盟急性神经病学和神经创伤学领域的紧急研究
Intensive Care Med. 2004 Jan;30(1):168-9. doi: 10.1007/s00134-003-2044-0. Epub 2003 Nov 21.
6
A European directive for clinical research.
Intensive Care Med. 2003 Oct;29(10):1818-20. doi: 10.1007/s00134-003-1963-0. Epub 2003 Sep 18.
Safeguarding patients in clinical trials with high mortality rates.
Am J Respir Crit Care Med. 2001 Jul 15;164(2):190-2. doi: 10.1164/ajrccm.164.2.2011028.
4
Non-therapeutic research in the EU in adults incapable of giving consent?欧盟针对无法给出同意的成年人开展的非治疗性研究？
Lancet. 2001 Mar 17;357(9259):818-9. doi: 10.1016/S0140-6736(00)04189-1.
5
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言：涉及人类受试者的医学研究伦理原则》
JAMA. 2000 Dec 20;284(23):3043-5.
6
Informed consent for research purposes in intensive care patients in Europe--part I. An official statement of the European Society of Intensive Care Medicine. Working Group on Ethics.欧洲重症监护患者研究目的的知情同意——第一部分。欧洲重症监护医学学会官方声明。伦理工作组
Intensive Care Med. 1997 Mar;23(3):338-41. doi: 10.1007/s001340050337.
7
Equipoise and the ethics of clinical research.equipoise与临床研究伦理
N Engl J Med. 1987 Jul 16;317(3):141-5. doi: 10.1056/NEJM198707163170304.
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False hopes and best data: consent to research and the therapeutic misconception.虚假的希望与最佳数据：研究同意与治疗性误解
Hastings Cent Rep. 1987 Apr;17(2):20-4.