Human Subjects Research Protections at UT Austin

德克萨斯大学奥斯汀分校的人类受试者研究保护

• 批准号: 6777795
• 负责人: SHARON A BROWN
• 金额: $ 10万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 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/6777795
• 关键词: Internet; clinical research; computer network; computer system design /evaluation; data management; health science research support; informed consent; online computer; training

The purpose of this application is to request an additional, final year of funding to extend current efforts at UT Austin to increase support for research with human subjects. Over the past year with NIH funding, we have implemented an electronic IRB application, refined the human subjects database used to track actions for each protocol, enhanced training modules and verification system, and disseminated information about UT Austin's new electronic tools. The specific aims of the current proposal are to: 1. Extend the electronic submission of the IRB application by adding electronic systems for submission, review, approval, and management of: a) continuing review applications; b) project termination forms; c) non-compliance and adverse event reporting and tracking; d) amendment forms; and e) student research forms. 2. Develop and implement a system of electronic review of protocols by IRB members and ORSC staff using the above electronic submission system. 3. Develop and implement an electronic system that will provide more detailed, real-time documentation in the IRB meeting minutes of protocol revisions and regulatory requirements. 4. Conduct a national summit in May 2004 on human subjects research, focusing on the social and behavioral sciences and jointly sponsored by UT Austin, NIH, and OHRP. 5. Hold a technical seminar for the purpose of sharing electronic tools, thus enabling other institutions to incorporate UT Austin's systems into their human research protection programs. Our intent is to prepare the University for accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Funding received from NIH during this past fiscal year has enabled us to increase our oversight of human research and enhance research compliance mechanisms. Activities outlined in this proposal will prepare us further for accreditation, as well as for the significant growth in health research that is anticipated at UT Austin over the next few years.

本申请的目的是请求额外的最后一年的资金，以扩大德州大学奥斯汀分校当前的努力，以增加对人类受试者研究的支持。在过去的一年里，在 NIH 的资助下，我们实施了电子 IRB 应用程序，完善了用于跟踪每个方案行动的人类受试者数据库，增强了培训模块和验证系统，并传播了有关 UT 奥斯汀分校新电子工具的信息。当前提案的具体目标是： 1. 通过添加电子系统来扩展 IRB 申请的电子提交，用于提交、审查、批准和管理： a) 持续审查申请； b) 项目终止表格； c) 不合规和不良事件的报告和跟踪； d) 修改表； e) 学生研究表格。 2. 开发并实施由 IRB 成员和 ORSC 工作人员使用上述电子提交系统对方案进行电子审查的系统。 3. 开发并实施一个电子系统，该系统将在 IRB 会议记录中提供更详细、实时的协议修订和监管要求记录。 4. 2004 年 5 月举办一次关于人体研究的全国峰会，重点关注社会和行为科学，由 UT Austin、NIH 和 OHRP 联合主办。 5. 举办技术研讨会，以共享电子工具，从而使其他机构能够将 UT Austin 的系统纳入其人类研究保护计划。 我们的目的是为大学获得人类研究保护计划认证协会（AAHRPP）的认证做好准备。上一财年从 NIH 获得的资金使我们能够加强对人类研究的监督并增强研究合规机制。该提案中概述的活动将为我们的认证以及未来几年德州大学奥斯汀分校预计健康研究的显着增长做好进一步准备。