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.

该项目的目的是通过教育计划在南佛罗里达大学（USF）上加强和加强人类主题保护计划，并与中部佛罗里达大学（UCF），奥兰多，佛罗里达州，佛罗里达大学和大学社区医院（UHC），佛罗里达州坦帕市（不维持与USF的私人医院）分享这些举措。通过在人类主题研究的道德方面开发教育和培训机会，利用最先进的电子和印刷媒体来实现这一目标。有针对性的受众包括（1）首席研究人员（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，开发和传播电子发表的教育计划，包括印刷和电子媒体的材料，可帮助研究人员和研究人员计划和进行道德上合理的研究； *针对研究人员，研究人员，IRB成员，IRB支持人员以及目前招募的研究参与者的设计和开发，该研究人员，研究人员，IRB成员，IRB支持人员以及与人类学科研究相关的网站的链接，目前招募的研究参与者。 该图书馆还将包括内部开发或通过其他媒体提供的教育材料； *电子出版的小册子和小册子的设计，开发和传播，这些小册子和小册子侧重于潜在的研究主题的信息，概述注册受试者的权利和责任的材料以及进行人类受试者研究时的PI职责；和 *设计，开发和实施电子需求评估工具，以评估研究参与者的知情同意过程，以确保对参与研究的研究的适当理解。 USF IRB教育/培训计划是一项综合计划，它将通过关注与每个感兴趣方面的人类学科研究的道德原则来确保更大的人类主题保护：机构，IRB，PI和研究人员以及研究参与者。使用最先进的技术，USF将与UCF，UCH和基于社区的机构共享其教育计划，该机构在坦帕湾地区进行人类主题研究。