Information Technology for Human Subjects Protection

这项提案是为了响应卫生与公众服务部的一项倡议而提出的，该倡议旨在加强对接受NIH大量支持的机构的人类主题研究的监督。这项申请建议创建信息系统基础设施的基础，使锡达斯-西奈医学中心(CSMC)能够不断加强对人类受试者研究的监督。CSMC是最大的非营利性私人组织 密西西比河以西的一家医院。目前有500多名活跃的人类 主题研究方案。2000年，CSMC 53.3%的研究奖项-2030万 美元-由联邦机构提供资金。该项目的目标是开发一个在线提交、报告、跟踪和审查系统，以加强CSMC的人类主体保护计划。电子人体主体保护计划(EHSPP)旨在：(1)加强安全和道德的制度性教育计划 (2)提高IRB对人体研究安全进行的监督和监测的水平；(3)提高IRB审查的质量和效率；以及(4)通过改善多个机构研究审查和监督实体之间的协调，改善全系统对人类研究进行的法规和伦理原则的遵守。EHSPP将包括在线提交、跟踪和审查功能，以及广泛的教育帮助文本和参考链接。EHSPP还将允许强大的信息管理和报告能力。随着eHSPP的每个模块上线，以及在实施完成的eHSPP时，将通过监测质量和效率指标以及通过管理前后的用户调查对其进行评估。在授权期结束后，将根据需要持续进行更广泛的成果评价和系统修改。

This proposal is submitted in response to an initiative of the Department of Health and Human Services to strengthen oversight of human subject research at institutions that receive substantial NIH support. This application proposes to create the foundation of an information systems infrastructure that will enable Cedars-Sinai Medical Center (CSMC) to continuously enhance the oversight of human subject research. CSMC is the largest private non-profit hospital west of the Mississippi River. There currently are more than 500 active human subject research protocols. In 2000, 53.3% of research awards at CSMC - 20.3 million dollars - were funded by federal agencies. The goal of this project is to develop an online submission, reporting, tracking, and review system that will strengthen the human subject protection program at CSMC. The Electronic Human Subject Protection Program (eHSPP) aims to: (1) strengthen the institutional education program for the safe and ethical conduct of clinical research; (2) increase the level of IRB oversight of, and monitoring for, the safe conduct of human subject research; (3) enhance the quality and efficiency of IRB reviews; and (4) improve system-wide compliance with regulations and ethical principles governing the conduct of human subject research through improved coordination between multiple institutional research review and oversight entities. The eHSPP will include online submission, tracking, and review functionality, as well as extensive educational help text and reference links. The eHSPP also will allow for robust information management and reporting capabilities. As each module of the eHSPP is brought online, as well as upon implementation of the completed eHSPP, it will be evaluated by monitoring quality and efficiency indicators as well as through the administration of pre/post user surveys. More extensive outcome evaluations and system modifications will be conducted on a continuous as needed basis subsequent to the grant period.