Informed consent to participation in research is an important protector of potential subjects' rights and autonomy. Ethical research involving critically ill people is challenging because their medical condition often makes obtaining informed consent impossible. This is especially true in the prehospital setting, where additional barriers to obtaining informed consent exist. A recently published Canadian policy (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) specifies circumstances under which an exception to the requirement for informed consent may be granted so that vulnerable individuals are not denied the potential benefits of participating in research. This article reviews the rationale for the Tri-Council Policy Statement and illustrates some problems with its application in the context of a Canadian prehospital study on continuous positive airway pressure. A new risk analysis model and a national research ethics board are discussed as possible ways to facilitate interpretation and application of the current exception of informed consent policy.

译文

知情同意参与研究是潜在受试者权利和自主权的重要保护者。涉及重症患者的伦理研究具有挑战性,因为他们的医疗状况通常使获得知情同意成为不可能。在院前环境中尤其如此,因为在获得知情同意方面存在其他障碍。加拿大最近发布的一项政策 (三理事会政策声明: 涉及人类的研究的道德行为) 规定了在何种情况下可以给予知情同意要求的例外,以便弱势群体不会被剥夺参与研究的潜在好处。本文回顾了Tri-Council政策声明的基本原理,并说明了在加拿大对持续气道正压的院前研究中应用该声明的一些问题。讨论了一种新的风险分析模型和国家研究伦理委员会,作为促进当前知情同意政策例外的解释和应用的可能方法。

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