Enhancing Subject Protections through Education

通过教育加强主体保护

• 批准号: 6780033
• 负责人: MICHAEL. IAN PHILLIPS
• 金额: $ 10万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6780033
• 关键词: Internet; clinical research; computer system design /evaluation; educational resource design /development; ethics; health related legal; health science research support; information dissemination; informed consent; telecommunications; training

The goal of this project is to enhance and strengthen the human subject protections program at the University of South Florida (USF) through educational initiatives and to share those initiatives with the University of Central Florida (UCF), Orlando, Florida and the University Community Hospital (UHC), Tampa, Florida (a private hospital that maintains no affiliation with USF). This goal will be achieved by developing educational and training opportunities on the ethical aspects of human subject research utilizing state-of-the-art electronic and print media. Targeted audiences include (1) Principal Investigators (PI) and research staff; (2) Institutional Review Board (IRB) members and support staff; and (3) human research participants. Desirable outcomes include: * Design, development, and dissemination of electronically published educational programs, including materials in print and electronic media, that assist investigators and research staff in planning and conducting ethically sound research studies; * Design and development of a web-based IRB Resource Library for investigators, research staff, IRB members, IRB support staff, and potential and currently enrolled research participants that will contain information, documents, and links to web sites relevant to the ethical conduct of human subject research. This library will also include educational materials developed in-house or available through other medias; * Design, development, and dissemination of electronically published pamphlets and brochures that focus on information for potential research subjects, materials outlining enrolled subjects' rights and responsibilities, and PI responsibilities when conducting human subject research; and * Design, development, and implementation of an electronic needs-assessment tool for evaluating the informed consent process of research participants to ensure appropriate level of understanding of the research in which they participate. The USF IRB Education/Training Initiative is a comprehensive program that will ensure greater human subject protections by focusing on the ethical principles of human subject research as it pertains to each party of interest: the Institution, the IRB, the PI and research staff, and the research participant. Using state-of-the-art technology, USF will share its educational programs with UCF, UCH, and community-based institutions conducting human subject research within the Tampa Bay area.

该项目的目标是通过教育举措加强南佛罗里达大学 (USF) 的人类受试者保护计划，并与佛罗里达州奥兰多市中佛罗里达大学 (UCF) 和大学社区医院分享这些举措(UHC)，佛罗里达州坦帕（一家与南佛罗里达大学没有任何隶属关系的私立医院）。这一目标将通过利用最先进的电子和印刷媒体开发人类受试者研究伦理方面的教育和培训机会来实现。目标受众包括 (1) 首席研究员 (PI) 和研究人员； (2) 机构审查委员会 (IRB) 成员和支持人员； (3)人类研究参与者。理想的结果包括： * 设计、开发和传播电子出版的教育计划，包括印刷和电子媒体材料，协助调查人员和研究人员规划和开展符合道德规范的研究； * 为研究者、研究人员、IRB 成员、IRB 支持人员以及潜在和当前注册的研究参与者设计和开发基于网络的 IRB 资源库，其中包含与道德行为相关的信息、文件和网站链接人类课题研究。 该图书馆还将包括内部开发的或通过其他媒体提供的教育材料； * 设计、开发和传播以电子方式出版的小册子和小册子，重点关注潜在研究对象的信息、概述登记对象权利和责任的材料以及进行人类对象研究时 PI 的责任；和 * 设计、开发和实施电子需求评估工具，用于评估研究参与者的知情同意过程，以确保他们对所参与的研究有适当的理解。 USF IRB 教育/培训计划是一项综合性计划，将重点关注人类受试者研究的道德原则，因为它关系到各利益方：机构、IRB、PI 和研究人员，以及研究参与者。 USF 将利用最先进的技术，与 UCF、UCH 以及在坦帕湾地区进行人类课题研究的社区机构共享其教育计划。