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最佳利益是否是将无行为能力受试者纳入临床研究的相关决策标准?

Is best interests a relevant decision making standard for enrolling non-capacitated subjects into clinical research?

机构信息

Stony Brook University School of Medicine, Winthrop University Hospital, 222 Station Plaza North, Suite 518, Mineola NY 11501, USA.

出版信息

J Med Ethics. 2011 Jan;37(1):45-9. doi: 10.1136/jme.2010.037515. Epub 2010 Oct 15.

DOI:10.1136/jme.2010.037515
PMID:20952491
Abstract

The 'best interests' decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the context of modern norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision.

摘要

“最佳利益”决策标准用于临床护理,为那些没有明确或推断意愿的无行为能力个体做出必要的健康决策。它也被广泛认为是将一些无行为能力的成年人纳入临床研究(如急诊、重症监护和痴呆症研究)的基础。然而,最佳利益标准要求选择提供可用选项的最高净效益,而临床研究很少符合这一标准。在现代生物伦理学规范的背景下,最佳利益标准很少支持研究的替代同意,也不应作为常规规定接受。

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