Electronic Enhancement of IRB Safety Monitoring

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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.