Dramatic increases in amount of biomedical research, coupled with equally dramatic increases in the level of complexity in regulation and research design, are pushing the human subjects review system to the brink of failure. Although more staff, IRBs, training, and monitoring programs are all important, the overall system will not improve significantly without a transformation in how we coordinate activity within this increasingly complex environment. We therefore propose to develop a model information system for the management of research involving human subjects.
The specific aims of this Electronic Protection System for Subjects (EPSS) are to: ? Create a system in which human subjects applications are filled out electronically and relevant documentation is available electronically. ? Link all those responsible for review and monitoring together in a single integrated web-based system (e.g., IRBs, DMSBs, pharmacy & therapeutics, radiation safety, research administrators). ? Create a prototype platform for just-right, just-in-time training tools for the responsible conduct of research. ? Establish an electronic tracking system for adverse event reports. ? Increase the ease and efficiency of application and review so the human subjects protection system becomes rapid and transparent. Currently available software does not meet the needs of many institutions either because it is built on limited platforms than cannot meet the robust needs of large research institutions or because it is so mired in hosts' legacy systems that it cannot be replicated at other institutions. Furthermore, it often does not incorporate the range of user interfaces needed for the increasingly complex institutional and regulatory environment. The EPSS will be comprehensive, scalable, and replicable. It will complement and extend a larger set of electronic research administration initiatives already underway at the University.The EPSS will be sustained by additional institutionalized support commitments and quality improvement mechanisms, including a users advisory group and listerver, user satisfaction surveys, and system performance metrics.
