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未经同意的研究:复苏研究中知情同意的例外与豁免

Research without consent: exception from and waiver of informed consent in resuscitation research.

作者信息

Biros Michelle H

机构信息

Department of Emergency Medicine, MC-825, Hennepin County Medical Center, University of Minnesota, 701 Park Avenue, Minneapolis, MN 55408, USA.

出版信息

Sci Eng Ethics. 2007 Sep;13(3):361-9. doi: 10.1007/s11948-007-9020-y. Epub 2007 Jul 28.

DOI:10.1007/s11948-007-9020-y
PMID:18210229
Abstract

The ethical concept of Informed Consent provides individuals with the right and the opportunity to approve of events that will occur regarding his or her own person. In medicine, informed consent is obtained for treatment and for research participation. However, under some circumstances, prospective informed consent cannot be obtained because of the devastating clinical condition of the patient. In emergency circumstances, treatment is never withheld if obtaining informed consent from a critically ill person is not possible or if a delay while seeking surrogates would further endanger life. In emergency research circumstances, waiving informed consent for study participation is fraught with additional ethical considerations. This article will review a presentation given at the June 2, 2006 conference entitled "The Ethics of Research in Emergency Medicine".

摘要

知情同意这一伦理概念赋予个人权利和机会,使其能够批准关乎自身的即将发生的事件。在医学领域,针对治疗和参与研究均需获得知情同意。然而,在某些情况下,由于患者病情严重,无法事先获得知情同意。在紧急情况下,如果无法从重症患者处获得知情同意,或者在寻找替代决策者时的延误将进一步危及生命,就绝不能延迟治疗。在紧急研究情况下,放弃研究参与的知情同意会引发更多伦理考量。本文将回顾在2006年6月2日会议上发表的题为“急诊医学研究的伦理”的演讲内容。

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1
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Community consultation and public disclosure: preliminary results from a new model.社区咨询和公开披露:新模式的初步结果。

本文引用的文献

1
The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.《贝尔蒙报告》。保护人类研究受试者的伦理原则与准则。
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Implementing the Food and Drug Administration's final rule for waiver of informed consent in certain emergency research circumstances.实施美国食品药品监督管理局关于在某些紧急研究情况下免除知情同意的最终规定。
Acad Emerg Med. 1999 Dec;6(12):1272-82. doi: 10.1111/j.1553-2712.1999.tb00144.x.
5
An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent.在启动一项包含放弃知情同意的紧急研究之前进行社区咨询的方法。
Acad Emerg Med. 1999 Dec;6(12):1210-5. doi: 10.1111/j.1553-2712.1999.tb00135.x.
6
Development of the multiorganizational document regarding emergency research consent.
Acad Emerg Med. 1996 Feb;3(2):101-5. doi: 10.1111/j.1553-2712.1996.tb03395.x.
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Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.急诊研究中的知情同意。急性复苏与重症监护研究人员联盟会议的共识声明。
JAMA. 1995 Apr 26;273(16):1283-7. doi: 10.1001/jama.273.16.1283.
8
Deferred consent. A new approach for resuscitation research on comatose patients.延迟同意:昏迷患者复苏研究的一种新方法。
JAMA. 1986 May 9;255(18):2466-71. doi: 10.1001/jama.255.18.2466.