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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Lack of international consensus on ethical aspects of acute stroke trials
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Lack of international consensus on ethical aspects of acute stroke trials

机译：在急性中风试验的伦理方面缺乏国际共识

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Acute stroke trials are becoming increasingly multinational. Working toward a shared ethical standard for acute stroke research necessitates evaluating the degree of consensus among international researchers. We surveyed all 275 coinvestigators and coordinators who participated in the AbESTT II study (evaluating abciximab vs placebo) about their experience with their local institutional review board (IRB) or equivalent, as well as, about their personal beliefs regarding the ethical aspects of acute stroke trials. A total of 90 coinvestigators from 15 different countries responded to our survey. Among the IRBs represented by the responding coinvestigators, only 18% allowed surrogate consent to be obtained over the phone. Although 52% allowed the participation of subjects with aphasia, only 5% allowed the participation of subjects with neglect/hemi-inattention. The National Institutes of Health Stroke Scale score was deemed adequate to establish decisional capacity based on language by 62% of the coinvestigators and 36% of the IRBs. A belief that IRB regulations cause unnecessary delays and fear in relatives/patients was reported by 67% of coinvestigators, and the belief that granting an exemption from informed consent under specific circumstances is appropriate was reported by 41%. There appears to be considerable international diversity in the ethical priorities and informed consent standards among different IRBs and investigators in stroke research. The stroke community should make an attempt to standardize the consent process used in research. Given the critical nature of the time to treatment in stroke care, these standards should be integrated into current frameworks of clinical care and research. The absence of an ethical consensus can become a barrier to advancing stroke treatment internationally.
机译：急性中风试验正变得越来越跨国。为达到急性卒中研究的共同伦理标准而努力，有必要评估国际研究人员之间的共识程度。我们调查了参加AbESTT II研究（评估abciximab与安慰剂）的所有275名共同研究者和协调者，了解他们在当地机构审查委员会（IRB）或同等机构中的经验，以及他们对急性中风的伦理观念的个人看法审判。来自15个不同国家的90位共同调查人员对我们的调查做出了回应。在由共同调查者代表的IRB中，只有18％允许通过电话获得代理同意。尽管52％的人允许失语症患者参与，但只有5％的人允许失语/半注意力不集中的受试者参与。 62％的共同研究者和36％的IRB认为，美国国立卫生研究院卒中量表评分足以建立基于语言的决策能力。 67％的共同调查者认为，IRB法规会导致亲属/患者不必要的延误和恐惧，另有41％的人认为，在特定情况下给予知情同意豁免是适当的。在卒中研究中，不同的IRB和研究人员之间，在伦理优先事项和知情同意标准上似乎存在着很大的国际差异。中风社区应该尝试标准化研究中使用的同意程序。鉴于中风治疗时间的紧迫性，这些标准应纳入当前的临床治疗和研究框架。缺乏道德共识会成为国际上推进中风治疗的障碍。

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