South Florida Human Subjects Benchmarking Coalition

南佛罗里达州人类受试者基准测试联盟

• 批准号: 6778987
• 负责人: Norman Harry Altman
• 金额: $ 25万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6778987
• 关键词: Internet; computer assisted instruction; ethics; health /scientific organization; health science research; health science research analysis /evaluation; health science research support; information dissemination; nonEnglish language; patient safety /medical error; training

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.

迈阿密大学通过人类主题研究增强计划寻求资金，以通过发展南佛罗里达人类受试者研究基准联盟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主题办公室的功能和有效性，以确定并为增强人类受试者研究的新机会以及对实验方案中注册的人类受试者的保护。迈阿密大学设计并将很快实施集成的临床研究和保护系统。该系统为人类主题研究方案，通信，不良事件报告和教育计划提供了网络结构。部署 系统将推动对人类学科研究活动的监视和报告。实施该系统的关键信息将与联盟合作伙伴共享，并构成本申请的基础。具体的目的是为IRB结构开发和应用基准；进行访谈和调查以评估个人实践；比较一个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沟通机制；提供教育知识讲习班；提供协作IRB培训计划（CITI）认证 协作机构；并提供一种采用在线双语版本的教育系统。合作机构将通过基于网络的Ortal获得访问个人和集体基准结果的访问权限，允许机构可以就机构和程序性更改做出明智的决定。