Lewis Cindi A, Dewhurst Stephen, McMahon James M, Bunce Catherine A, Keefer Michael C, Alio Amina P
a Department of Public Health Sciences , University of Rochester Medical Center , Rochester , NY , USA.
AIDS Care. 2014;26(11):1452-60. doi: 10.1080/09540121.2014.920074. Epub 2014 May 28.
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.
HIV疫苗试验的知情同意程序（ICP）面临着独特的挑战，若对其基于历史的结构和形式加以改进，将有所助益。在此，我们提出一个理论框架，为系统评估和应对这些挑战提供依据。所提出的框架遵循一条线性路径，始于自愿性这一前提条件，接着是有效决策的三个主要变量（能力、信息提供和理解），然后是拒绝或同意参与的相应结果。现有文献表明，以文化适宜的方式提供信息以及疫苗试验参与者由此产生的理解，是影响有效决策真实性的最重要因素之一，尽管它们可能会被其他因素所凌驾，例如个人利他主义、不信任以及与HIV相关的污名。因此，通过社区合作促进信息的双向传播以及制作更符合文化特点的同意书材料，是增强知情同意程序的一个关键契机。通过以分类和关联的方式直观概述对知情同意有效性最为关键的问题，本文提供的框架为HIV疫苗研究人员提供了一种工具，借助该工具可以更系统地评估并进而改进知情同意程序。
