青少年疫苗试验中简化同意书的理解。
Comprehension of a simplified assent form in a vaccine trial for adolescents.
机构信息
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal Pediatric Infectious Disease Branch, Bethesda, Maryland, USA.
出版信息
J Med Ethics. 2013 Jun;39(6):410-2. doi: 10.1136/medethics-2012-101286. Epub 2013 Jan 24.
INTRODUCTION
Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general.
METHODS
Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative.
RESULTS
123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.
CONCLUSIONS
Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.
简介
未来针对青少年的 HIV 疫苗功效试验需要确保参与者理解研究概念，从而真正获得知情同意。一项针对青少年的乙型肝炎疫苗试验为检验青少年对疫苗试验要求的总体理解提供了宝贵机会。
方法
青少年与研究调查员一起审查简化的同意书，然后完成一份理解问卷。一旦入组，所有青少年都接受了 HIV 检测，结果均为 HIV 阴性。
结果
123 名青少年完成了问卷（平均年龄为 15 岁；63%为男性；70%为西班牙裔）。总体而言，只有 69 名（56%）青少年正确回答了所有六个问题。
结论
参加乙型肝炎疫苗试验的青少年对研究设计和各种方法学概念（如治疗组设盲）的理解程度存在差异。
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