Human Subjects Research Enhancements Program

本人类受试者研究增强提案解决了对人类受试者保护和数据安全以及监测的急剧增加的要求，这是由于（a）美国健康基金会越来越关注临床研究和（B）对患者权利和保护以及研究人员教育的监管和伦理要求不断增加。我们的计划包括三个部分，每个部分都旨在提高我们在未来多中心AHF研究中保证数据安全性和患者保密性的能力，其中一些研究正在规划阶段。它们是： ?便利IRB活动的设备，如电话会议和IRB程序培训， 通过在瓦尔哈拉的AHF Naylor Dana研究所安装视频会议团队站， - 促进用于监测和协调不良事件报告的跟踪系统，通过 购买和安装“Oracle Clinical”，这是一个支持设计的软件包， 临床试验的管理和分析。 ?提供一种改进的方式来协调协作的IRB的活动， 交换信息和批准多个机构使用的同意书， 提供（a）对艾滋病毒/艾滋病联合会计算机网络的远程访问和（B）艾滋病毒/艾滋病联合会内联网的设计和实施。

iThis proposal for human subjects research enhancements addresses the dramatically increased requirements for human subject protection and data safety and monitoring resulting from both (a) American Health Foundation's increasing focus on clinical research and (b) increasing regulatory and ethical requirements for patients' rights and protections as well as education for researchers. Our plan consists of three components, each designed to improve our ability to guarantee data security and safety and patient confidentiality in future multi-site AHF studies, a number of which are in the planning stages. They are: ? Equipment to facilitate IRB activities such as teleconferencing and training in IRB procedures, through installation of a videoconferencing Team Station at AHF's Naylor Dana Institute in Valhalla - Facilitating a tracking system for monitoring and coordinating adverse event reporting, through purchase and installation of "Oracle Clinical," a software package that supports design, management and analysis of clinical trials. ? Providing an improved means to coordinate the activities of collaborating IRBs that allow for the interchange of information and approval of consent forms used in multiple institutions, through provision of (a) remote access to the AHF computer network and (b) design and implementation of the AHF Intranet.