Fisher Celia B
Center for Ethics Education and Department of Psychology, Fordham University, Dealy Hall, 441 East Fordham Road, Bronx, NY 10458, USA.
J Empir Res Hum Res Ethics. 2010 Jun;5(2):65-80. doi: 10.1525/jer.2010.5.2.65.
This research used open-ended and true-false questions to assess the preparedness of 96 ethnically diverse, economically and socially marginalized adult street drug users to consent to participate in HIV vaccine trials (HVT). Specific areas of consent vulnerability included misconceptions about: (1) the recuperative value and risk of vaccines in general; (2) the presence of the HIV virus within the vaccine and the possibility of contracting or transmitting HIV as a consequence of participation; (3) inclusion criteria and experimental blinds; and (4) distrust in the medical and research establishments. A brief HVT lesson administered to 30 participants was effective in correcting specific HVT knowledge misperceptions and increasing certain, but not all areas of HVT trust. Assessment of post-lesson responses to ethics-relevant questions provides information on respondents' attitudes toward AIDS safe behavior, research risks and benefits, monetary compensation, and willingness to participate. Implications for enhancing informed consent for HVT involving active drug users are discussed.
本研究采用开放式问题和是非题，评估了96名来自不同种族、经济和社会边缘化的成年街头吸毒者参与HIV疫苗试验（HVT）的准备情况。同意方面的具体脆弱领域包括对以下方面的误解：（1）一般疫苗的恢复价值和风险；（2）疫苗中是否存在HIV病毒以及参与试验后感染或传播HIV的可能性；（3）纳入标准和实验盲法；（4）对医疗和研究机构的不信任。对30名参与者进行的简短HVT课程有效地纠正了特定的HVT知识误解，并增加了HVT信任的某些方面，但并非所有方面。对课程后与伦理相关问题的回答进行评估，可提供有关受访者对艾滋病安全行为、研究风险和益处、金钱补偿以及参与意愿的态度信息。本文讨论了在涉及吸毒者的HVT中加强知情同意的意义。
