Human Subject Protection Program

人类受试者保护计划

• 批准号: 6777747
• 负责人: ARTHUR BIENENSTOCK
• 金额: $ 24.99万
• 依托单位: STANFORD UNIVERSITY
• 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/6777747
• 关键词: biomedical equipment purchase; computer program /software; computer system design /evaluation; computers; educational resource design /development; electronic recording system; ethics; experimental designs; health science research; health science research support; information systems; informed consent; patient safety /medical error

Stanford University seeks to strengthen its oversight of human subjects research and enhance its protection of human subjects by making optimum use of information technology tools. Specifically, the Research Compliance Office will: 1) Develop infrastructure/technology for computer tracking of human subjects protocols, secure records retention, and electronic protocol submission; 2) Develop means to coordinate the activities of IRBs that allow for the approval of consent forms used in multiple institutions; and 3) Purchase equipment to facilitate IRB activities, such as teleconferencing and computer support. In order to achieve these goals, the Research Compliance Office will enhance the electronic protocol submission system funded by the first HSREP application, funded in September 2002. As with the previous proposal, the advisory team will also be called upon to test various components of the project before release and determine corresponding training needs. The Research Compliance equipment to be used for these enhancements will be maintained as part of the overall IT structure of the University. Stanford's Helpdesk resources and reporting tools will be available and will ensure that the newly acquired software is integrated into the regular information technology offerings.

斯坦福大学寻求加强对人类受试者研究的监督，并通过最佳利用信息技术工具加强对人类受试者的保护。具体而言，研究合规办公室将：1）开发计算机跟踪人类受试者方案、安全记录保留和电子方案提交的基础设施/技术; 2）开发协调IRB活动的方法，以批准多个机构使用的知情同意书; 3）购买设备以促进IRB活动，如电话会议和计算机支持。 为了实现这些目标，研究合规办公室将加强由2002年9月资助的第一个HSREP申请资助的电子方案提交系统。与前一项提议一样，还将要求咨询小组在项目发布前测试项目的各个组成部分，并确定相应的培训需求。用于这些增强功能的研究合规设备将作为大学整体IT结构的一部分进行维护。将提供斯坦福大学的服务台资源和报告工具，并确保将新购置的软件纳入常规信息技术产品。