Web-Based Human Subjects Protocol and Training Program

基于网络的人类受试者协议和培训计划

• 批准号: 6591460
• 负责人: MARY BETH BURNSIDE
• 金额: $ 14.88万
• 依托单位: UNIVERSITY OF CALIFORNIA BERKELEY
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591460
• 关键词: Internet; educational resource design /development; health science research support; information systems; online computer; university

We propose to develop two new programs for the Berkeley campus: a web-based system for human subjects research protocol review and data management; and a new program to provide researchers with training in the ethical conduct of human subjects research. A team composed of campus computing services professionals, a training professional with web design experience and an organizational development professional will work under the direction of the Faculty Chair of the Committee for the Protection of Human Subjects. The Research Protocol System (RePS) provides a web portal for secure access to all research protocols: human, animal, radiation and biohazard. Researchers, reviewers and administrators are able to write, edit, review, track and store protocols. The portal design and animal protocol module are complete and in final testing; rollout is scheduled for Summer 2002. We request funds to develop the human subjects module. Team members will work with faculty and research staff to design the interface, forms and content. The protocol will be a live document that can be amended to reflect changes, and a record of each prototcol's history will be stored on-line. The protocol system will provide the capability for questionnaires and other research documents to be scanned and linked to a specific protocol. Included in the proposal is construction of an interface with the Sponsored Projects Office database (which will support Just-in-Time review of NIH proposals) and an interface to the Financial Conflict of Interest Committee database. We will hire an organizational development professional to analyze and streamline business processes related to human subjects research administration. Funds are also requested to develop a new training program in tandem with the human subjects protocol module. This will give us the opportunity to incorporate effective training into the protocol submission and review process. A trainer with experience in web design will design the training program and materials to include current regulations and best practices. The training program will emphasize issues of particular concern to Berkeley researchers, for example risk assessment in human subjects research that does not involve invasive procedures.

我们建议为伯克利校园开发两个新项目：一个基于网络的人类受试者研究协议审查和数据管理系统；以及一项为研究人员提供人类受试者研究道德行为培训的新计划。由校园计算服务专业人员、具有网页设计经验的培训专业人员和组织发展专业人员组成的团队将在人类受试者保护委员会教席主席的指导下工作。 研究协议系统 (RePS) 提供了一个门户网站，用于安全访问所有研究协议：人类、动物、辐射和生物危害。研究人员、审阅者和管理员能够编写、编辑、审阅、跟踪和存储协议。门户设计和动物协议模块已完成并正在进行最终测试；计划于 2002 年夏季推出。我们请求资金来开发人类受试者模块。团队成员将与教师和研究人员合作设计界面、形式和内容。该协议将是一个实时文档，可以进行修改以反映变化，并且每个协议的历史记录将在线存储。该协议系统将提供扫描问卷和其他研究文档并链接到特定协议的功能。提案中包括建设 与赞助项目办公室数据库的接口（这将支持对 NIH 提案的及时审查）以及与财务利益冲突委员会数据库的接口。我们将聘请一名组织发展专业人员来分析和简化与人类受试者研究管理相关的业务流程。 还需要资金来开发与人类受试者协议模块相结合的新培训计划。这将使我们有机会将有效的培训纳入方案提交和审查过程中。具有网页设计经验的培训师将设计培训计划和材料，以包括现行法规和最佳实践。该培训计划将强调伯克利研究人员特别关注的问题，例如不涉及侵入性程序的人体研究中的风险评估。