Vulnerability in clinical research with patients in pain: a risk analysis.

Vulnerability in clinical research with patients in pain: a risk analysis.
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疼痛患者临床研究的脆弱性:风险分析。

DOI:
10.1111/j.1748-720x.2009.00351.x
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发表时间:
2009
期刊:
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
影响因子:
--
通讯作者:
Tait,RaymondC
Tait,RaymondC
中科院分区:
--
文献类型:
--
作者:
Tait,RaymondC

文献摘要

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脆弱性的概念一直是研究生物伦理学中广泛讨论的话题,很大程度上是因为人们对基于研究对象亚群的概念的早期构建不满意。这些亚人群的属性可能会削弱他们提供自主知情同意的能力:相对或绝对没有能力通过协商获得知情同意来保护自己的利益。一些亚人群被认为需要特殊保护,包括儿童、孕妇、囚犯、少数族裔、经济弱势群体、重病患者和被收容的人。近年来,我们还发现了其他亚人群,这些亚人群也具有可能使他们变得脆弱的特征。例如,国际医学会组织理事会将无家可归者、疗养院居民、疑难杂症患者、急诊科患者、雇员、学生以及不熟悉现代医学的社区成员等潜在弱势群体列为潜在弱势群体。
The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial minorities, the economically disadvantaged, the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine.