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Theoretical model of critical issues in informed consent in HIV vaccine trials

机译：HIV疫苗试验中知情同意的关键问题的理论模型

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The informed consent process (ICP) for HIV vaccine trials poses unique challenges and would benefit from improvements to its historically based structure and format. Here, we propose a theoretical framework that provides a basis for systematically evaluating and addressing these challenges. The proposed framework follows a linear pathway, starting with the precondition of voluntariness, three main variables of valid decision-making (competency, provision of information and understanding) and then the consequential outcome of either refusal or consent to participate. The existing literature reveals that culturally appropriate provision of information and resultant understanding by the vaccine trial participant are among the most significant factors influencing the authenticity of valid decision-making, though they may be overridden by other considerations, such as individual altruism, mistrust, and HIV-related stigma. Community collaborations to foster bidirectional transmission of information and more culturally tailored consenting materials, therefore, represent a key opportunity to enhance the ICP. By providing a visual synopsis of the issues most critical to IC effectiveness in a categorical and relational manner, the framework provided here presents HIV vaccine researchers a tool by which the ICP can be more systematically evaluated and consequently improved.
机译：HIV疫苗试验的知情同意程序（ICP）提出了独特的挑战，将从其历史基础的结构和形式中受益。在这里，我们提出一个理论框架，为系统地评估和应对这些挑战提供基础。拟议的框架遵循线性路径，从自愿性的先决条件，有效决策的三个主要变量（能力，信息提供和理解）开始，然后是拒绝或同意参与的结果。现有文献表明，疫苗试验参与者在文化上适当提供信息和由此产生的理解是影响有效决策的真实性的最重要因素，尽管这些因素可能会被其他考虑因素所覆盖，例如个人利他主义，不信任和艾滋病相关的污名。因此，社区合作可促进信息和更具文化适应性的双向材料的双向传输，这是增强ICP的重要机会。通过以分类和相关的方式提供对IC效能最关键的问题的视觉概要，此处提供的框架为HIV疫苗研究人员提供了一种工具，可以通过该工具对ICP进行更系统的评估并因此得到改善。

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