Integrated Human Research Subjects Protection Project

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Human Research Subjects Protection is a vital interest for a large and widely distributed, research intense academic health care operation like the Duke University Health System. The challenges to optimizing research subject protection include making certain that all faculty are aware of critical issues in research subject protection, such as the definition of research, and insuring that their training is up-to-date. Duke has a unique opportunity to create an integrated system of human research subject protection based on the simultaneous implementation of three new software systems: 1) an electronic IRB system utilizing Webridge Extranet Portal software; 2) a common research data repository that stores information on all Duke faculty, including compliance information; 3) a university-wide intention to implement Zope as the standard content management program. As these common platforms are implemented, it provides an opportunity to integrally include human subjects protection components. Whenever an investigator electronically submits a new protocol or grant application, the recipient office's software can query the Research Data Repository (RDR) to determine whether the investigator has up-to-date training and conflict of interest information. Software indicators can be set if there are outstanding issues within any Duke office regarding a compliance issue, although the most important issues will be those related to human research subjects protection. Another example would be if a faculty member submitted a protocol involving a novel drug or device. The eIRB software could query the Regulatory Support Office database to be certain the issue of an IND or IDE had been internally addressed. This integrated approach should be a model for other institutions planning a similar move to system-wide electronic document management. In addition, the fact that Intranet-based electronic submission can occur over a wide geographic range means that other regional programs, like the National Institute for Environmental Health Sciences (ten miles from Duke), can consider collaborating, and in the long term, other institutions could direct their investigators to web-based teaching modules at Duke (or elsewhere) when appropriate.