The invisible vulnerable: the economically and educationally disadvantaged subjects of clinical research.

The invisible vulnerable: the economically and educationally disadvantaged subjects of clinical research.
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隐形弱势群体:临床研究中经济和教育上处于不利地位的受试者。

DOI:
10.1111/j.1748-720x.2003.tb00065.x
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发表时间:
2003
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:
Stone,THoward
Stone,THoward
中科院分区:
--
文献类型:
--
作者:
Stone,THoward

文献摘要

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U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.