STUDY 3: EFFECTIVENESS OF CONSENT MONITORING IN AIDS CLINICAL TRIALS

研究 3：艾滋病临床试验中同意监测的有效性

• 批准号: 7716883
• 负责人: Sohini Sengupta
• 金额: $ 0.06万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716883
• 关键词: Acquired Immunodeficiency Syndrome; Award; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consent; Consent Forms; Educational Intervention; Effectiveness; Enrollment; Funding; Grant; Informed Consent; Institution; Monitor; Protocols documentation; Randomized Controlled Trials; Research; Research Design; Research Ethics; Research Personnel; Resources; Source; Study Subject; United States National Institutes of Health; improved

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 作为PI KO1研究伦理学奖的一部分，研究3将评估同意监测方案的有效性，以此作为改善AIDS临床试验受试者对他们已经入学的临床试验的理解的手段。具体目的是：（1）评估研究对象对同意书不同方面的基线理解； （2）通过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）比较接受教育干预措施与没有的受试者的受试者之间的知情同意保留差异。