South Florida Human Subjects Benchmarking Coalition

迈阿密大学通过人类受试者研究增强计划寻求资金，以通过南佛罗里达人类受试者研究基准联盟的发展来支持和扩大其活动。该联盟将评估其机构审查委员会和人类受试者办公室的职能和有效性，以确定和开发加强人类受试者研究和保护实验方案中登记的人类受试者的新机会。迈阿密大学已经设计并将很快实施综合临床研究和保护系统。该系统为人类受试者研究协议、通信跟踪和审计机制、不良事件报告和教育计划提供了网络结构。部署这一 该系统将促进对人类受试者研究活动的监测和报告。将与联盟伙伴分享实施这一系统的关键信息，这些信息构成这一应用的基础。具体目标是制定和应用IRB结构的基准;进行访谈和调查以评估个人实践;比较机构样本中人类受试者的安全和福利;为合作机构提供实时通信机制;提供教育知识研讨会;提供合作IRB培训倡议（CITI）认证， 合作机构;并提供一个采用在线双语版本的教育系统。合作机构将通过一个基于网络的门户网站获得个人和集体基准结果，使机构能够就机构和程序改革作出知情的决定。

The University of Miami seeks funding through the Human Subjects Research Enhancement Program to support and expand its activities through the development of the South Florida Human Subjects Research Benchmarking Coalition. The coalition will assess the function and effectiveness of their institutional review boards and human subject offices in order to identify and develop new opportunities for enhanced human subject research and the protection of human subjects enrolled in experimental protocols. The University of Miami has designed and will soon implement the Integrated Clinical Research and Protection System. This system provides a network structure for human subject research protocols, tracking and auditing mechanisms for communications, adverse event reporting, and educational initiatives. The deployment of this system will advance the monitoring and reporting of human subject research activities. Critical information from the implementation of this system will be shared with coalition partners and forms the basis of this application. The specific aims are to develop and apply benchmarks for IRB structure; conduct interviews and surveys to assess individual practices; compare the safety and welfare of human subjects across a sample of institutions; provide a real-time communication mechanism for collaborating institutions; provide educational knowledge workshops; provide Collaborative IRB Training Initiative (CITI) certification to collaborating institutions; and provide an educational system that employs a on-line bilingual version. Collaborating institutions will receive access to individual and collective benchmark results via a web-based )ortal allowing institutions to make informed decisions regarding institutional and procedural change.