PLAN FOR OBTAINING INFORMED CONSENT TO USE STORED HUMAN BIOLOGICAL MATERIALS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这一多中心方案旨在获得适当的知情同意，以存档在所有AACTG试验期间收集的剩余人体生物材料、血液、尿液、组织或其他体液。可能会采集额外的血液样本作为人类DNA的来源，以进行可能的基因分析。这些样本是解决目前无法预测的未来研究问题的重要资源。此外，这些标本代表了独特的队列，这在未来可能无法复制。所有爱滋病临床试验单位的登记人数将不超过50,000人。

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. This multi-center protocol was designed to obtain the appropriate informed consent to archive left-over human biological materials, blood, urine, tissue, or other body fluids, that are collected during all AACTG trials. An additional blood sample may be collected as a source of human DNA for possible genetic analyses. These samples are an important resource for addressing research questions in the future that cannot be anticipated presently. In addition, the specimens represent unique cohorts, which may not be reproducible in the future. No more than 50,000 subjects will be enrolled all across the AIDS Clinical Trials Units.