Hubert Department of Global Health, School of Medicine, Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Stud Fam Plann. 2010 Sep;41(3):217-24. doi: 10.1111/j.1728-4465.2010.00245.x.
Little is known about how the information presented in the informed consent process influences study outcomes among participants. This study examines the influence of informed consent content on reported baseline contraceptive knowledge and concerns among two groups of HIV-serodiscordant and seroconcordant HIV-positive couples enrolled in research projects at an HIV research center in Lusaka, Zambia. We found significant differences in the reporting of contraceptive knowledge and concerns between couples viewing consent materials that included detailed information about contraception and those viewing consent materials that lacked the detailed information. We conclude that the design of informed consent materials should strike a balance between ensuring that participants give truly informed consent and educating participants in ways that do not compromise the assessment of the impact of behavioral interventions.
对于在知情同意过程中呈现的信息如何影响参与者的研究结果，人们知之甚少。本研究考察了在赞比亚卢萨卡的一个艾滋病毒研究中心参与研究项目的 HIV 血清不一致和血清一致的 HIV 阳性夫妇的两组中，知情同意内容对报告的基线避孕知识和关注的影响。我们发现，观看包含有关避孕详细信息的同意材料的夫妇与观看缺乏详细信息的同意材料的夫妇在报告避孕知识和关注方面存在显著差异。我们的结论是，知情同意材料的设计应该在确保参与者真正知情同意和以不影响行为干预影响评估的方式教育参与者之间取得平衡。
