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Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults.

作者信息

Liddell Kathleen, Kompanje Erwin J O, Lemaire François, Vrhovac Bozidar, Menon David K, Bion Julian, Chamberlain Douglas, Wiedermann Christian J, Druml Christiane

机构信息

Faculty of Law, University of Cambridge and Cambridge Genetics Knowledge Park, UK.

出版信息

Wien Klin Wochenschr. 2006 Apr;118(5-6):183-91. doi: 10.1007/s00508-006-0577-2.

DOI:10.1007/s00508-006-0577-2
PMID:16773486
Abstract
摘要

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Acta Neurochir (Wien). 2005 Jun;147(6):633-9; discussion 639-40. doi: 10.1007/s00701-005-0525-3. Epub 2005 Apr 7.
2
Recombinant activated factor VII for acute intracerebral hemorrhage.重组活化凝血因子 VII 用于急性脑出血
N Engl J Med. 2005 Feb 24;352(8):777-85. doi: 10.1056/NEJMoa042991.
3
The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient.
欧盟成员国的紧急研究中的医学研究：理论与实践之间的紧张关系。
Intensive Care Med. 2014 Apr;40(4):496-503. doi: 10.1007/s00134-014-3243-6. Epub 2014 Feb 26.
4
Clinical research into the ICU: clouds at the horizon, once again.重症监护病房的临床研究：地平线再次出现阴霾。
Intensive Care Med. 2013 Aug;39(8):1479-80. doi: 10.1007/s00134-013-2974-0. Epub 2013 Jun 13.
5
Medical teachers' attitudes towards science and motivational orientation for medical research.医学教师对科学的态度及医学研究的动机取向
Wien Klin Wochenschr. 2009;121(7-8):256-61. doi: 10.1007/s00508-009-1148-0.
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Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE.意大利针对无法表示同意的成年患者开展的临床研究：在欧盟2001/20/CE号指令实施之后。
Intensive Care Med. 2007 Feb;33(2):316-8. doi: 10.1007/s00134-006-0458-1. Epub 2006 Nov 30.
欧盟临床研究指令：关于无行为能力患者在欧盟成员国立法中的实施现状。
Intensive Care Med. 2005 Mar;31(3):476-9. doi: 10.1007/s00134-005-2574-8. Epub 2005 Feb 15.
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.
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What are local issues? The problem of the local review of research.什么是地方性问题？研究的本地审查问题。
J Med Ethics. 2004 Jun;30(3):313-7. doi: 10.1136/jme.2003.004051.
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When are research risks reasonable in relation to anticipated benefits?与预期收益相比，研究风险何时是合理的？
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Impracticability of informed consent in the Registry of the Canadian Stroke Network.加拿大卒中网络登记处中知情同意的不可行性。
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