Human Subjects Research Protections at UT Austin

这项申请的目的是申请额外的，也是最后一年的资金，以扩大德克萨斯大学奥斯汀分校目前的努力，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，我们实施了一个电子IRB应用程序，改进了用于跟踪每个方案的行动的人类受试者数据库，增强了培训模块和验证系统，并传播了关于德克萨斯大学奥斯汀分校的新电子工具的信息。目前这项建议的具体目标是： 1.扩展IRB申请的电子提交，增加电子系统，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)不符合规定和不良事件报告和跟踪；d)修订表格；以及e)学生研究表格。 2.开发和实施由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.开发和实施一个电子系统，该系统将在IRB会议纪要中提供更详细的实时文件，记录方案修订和管理要求。 4.在2004年5月举办了一次关于人类研究的全国首脑会议，重点是社会和行为科学，由德克萨斯大学奥斯汀分校、国立卫生研究院和人力厅联合主办。 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德克萨斯大学奥斯汀分校的系统纳入其人类研究保护计划。 我们的目的是为大学进行人类研究保护计划认证协会(AAHRPP)的认证做准备。在过去的财政年度中，从NIH获得的资金使我们能够加强对人类研究的监督，并加强研究合规机制。这份提案中概述的活动将进一步为我们的认证做好准备，并为德克萨斯大学奥斯汀分校未来几年预期的健康研究的显著增长做好准备。

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.