Human Subjects Research Protections at UT Austin

本申请的目的是要求额外的，最后一年的资金，以扩大在德州奥斯汀目前的努力，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，完善了用于跟踪每个协议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 Austin新电子工具的信息。本提案的具体目标是： 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; c）不合规和不良事件报告和跟踪; d）修订表;和e）学生研究表。 2.开发并实施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、实时的方案修订和监管要求文件。 4.在2004年5月举行一次关于人类受试者研究的全国首脑会议，重点是社会和行为科学，由UT Austin，NIH和OHRP联合主办。 5.举办技术研讨会，分享电子工具的目的，从而使其他机构将UT奥斯汀的系统纳入其人类研究保护计划。 我们的目的是准备由人类研究保护计划认证协会（AAHRPP）认证的大学。在过去的一个财政年度里，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。本提案中概述的活动将使我们进一步为认证做好准备，并为UT Austin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.