STUDY 3: EFFECTIVENESS OF CONSENT MONITORING IN AIDS CLINICAL TRIALS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 作为PI的KO1研究伦理奖的一部分，研究3将评估同意监测方案的有效性，以此作为提高艾滋病临床试验受试者对他们已经登记的临床试验的了解的一种手段。具体目标是：(1)评估研究对象对同意书不同方面的基线理解；(2)采用随机对照研究设计，确定教育干预措施的有效性，以增强受试者对知情同意的实际理解；(3)比较接受教育干预的受试者与未接受教育干预的受试者在知情同意保留方面的差异。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. As part of the PI's KO1 Award in Research Ethics, Study 3 will evaluate the effectiveness of a consent monitoring protocol as a means to improve AIDS Clinical Trial subjects' understanding of clinical trials in which they already enrolled. Specific aims are: (1) Assess study subjects' baseline understanding of different aspects of the consent form; (2) determining the effectiveness of an educational intervention to enhance subjects' actual understanding of the informed consent using a randomized controlled study design; and (3) compare differences in informed consent retention between subjects who received the educational intervention versus subjects who had not.