Electronic Enhancement of IRB Safety Monitoring

当前，在国家一级前所未有地重视提高社会保障水平 保护人类受试者。内布拉斯加大学医学中心(UNMC)长期以来一直 因拥有模型IRB而被公认。尽管如此，UNMC的保护人类方案 科目(PPHS)可以而且应该得到加强。该项目旨在将UNMC的PPHS带到 通过开发和实施基于电子的不良事件(AE)跟踪来实现下一个级别 该系统将协助调查人员提交环境影响评估报告(AER)，并促进IRB 对研究的风险-收益关系和同意的充分性进行持续评估 文件。将在以下时间提供按协议列出的累积AE安全报告摘要 持续审查，以提高IRB对积极研究的重新审查的效率。UNMC的最终目标是使用声发射跟踪系统作为开发 IRB审查的自动提交流程。IRB职能的自动化将减少调查人员和IRB的工作量，从而使资源能够更有效地用于保护人类受试者的权利和福利。

Currently, there is an unprecedented emphasis at the national level on improvement of the protection of human subjects. The University of Nebraska Medical Center (UNMC) has long been recognized for having a model IRB. Nevertheless, UNMC's Program for Protection of Human Subjects (PPHS) can and should be enhanced. This project is designed to take UNMC's PPHS to the next level by developing and implementing an electronic-based adverse event (AE) tracking system which will assist investigators in submitting AE reports (AERs) and facilitate the IRB's on-going assessment of the risk-benefit relationship of research and the adequacy of consent documents. A cumulative AE safety report summary by protocol will be available at the time of icontinuing review in order to increase the efficiency of the IRB's re-review of active studies. It is the ultimate goal of the UNMC to use the AE tracking system as a lead-in to development of an automated submission process for IRB reviews in general. Automation of IRB functions will reduce the workload of investigators and the IRB, thus allowing resources to be used more effectively to protect the rights and welfare of human subjects.