Re-engineering adverse event processing at the University of Utah Institutional Review Board

Institutional Review Boards are charged to protect the rights and safety of subjects in human research. This charge includes the processing of reportable adverse events. Rapid changes in the regulatory and social environment have led to variable quality in the processing of adverse events. This study describes efforts to understand and rectify this variability at the local Institutional Review Board at the University of Utah. Process re-engineering methods are used to achieve this goal, including 1) the creation of a team, mission, and evaluation plan, 2) a qualitative and quantitative baseline assessment, 3) process redesign (including an automation plan), and 4) implementation of the redesigned process into the automated system. The results of the study revealed several new findings. A qualitative assessment indicated the need for added accountability and redundancy in the adverse event process. A quantitative assessment of paper forms in a sample of 520 submitted adverse events demonstrated a lack of accessibility (16.5% of selected forms), completeness (17,8% of forms missing reporting essentials), and quality (9.1% of forms). Process redesign elements informed by these results include extensive automated validation and mandated documentation for submission. Rapid Prototyping coupled with usability testing had direct positive results on the implementation of a new, automated IRB adverse event processing system. In summary, poor quality and reliability of adverse event processing in human subjects research was found and remedied by process re-engineering and automation efforts.