How researchers define vulnerable populations in HIV/AIDS clinical trials.
How researchers define vulnerable populations in HIV/AIDS clinical trials.
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研究人员如何在艾滋病毒/艾滋病临床试验中定义弱势群体。
DOI：
10.1007/s10461-010-9785-x
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发表时间：
2010
影响因子：
4.4
通讯作者：
Gifford,AllenL
中科院分区：
文献类型：
--
作者：
Sengupta,Sohini;Lo,Bernard;Strauss,RonaldP;Eron,Joseph;Gifford,AllenL
在这项研究中，我们采访了研究人员，要求他们在HIV/AIDS临床试验中定义弱势群体，并对三种弱势群体的联邦法规提供反馈。访谈数据提供了一个概念框架，并对内容进行了分析，以确定可接受性或与法规的不一致。从研究人员确定的易受伤害的入组者的几个特征开始，概念框架说明了在临床研究中如何将入组者视为易受伤害的可能情况。内容分析确定了影响艾滋病毒/艾滋病研究人员对孕妇、囚犯和儿童进行临床试验的能力的障碍，条例为此规定了额外的保护。这项研究挑战了目前关于联邦法规以群体为基础的方法来定义弱势群体的想法。
In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers’ ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations’ group-based approach to defining vulnerable populations.