Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Researchers


Description of the Research
In an institution that requires an IRB application and submission of study materials to the IRB in order to make exempt determinations, long turnaround times and arduous back and forth via email bogged down researchers’ abilities to perform exempt research. In response to these issues, our institution's IRB initiated the express review process. These 30 minute in-person appointments were created as a means of aiding researchers in the revision of their study documents. The goal of the express review concept was to accelerate the exemption process while building an environment of collaboration between the IRB office and the research community.

Description of Program
The IRB office set aside weekly blocks of time for express review appointments (initially three hours, one day a week). The principal investigator (PI), upon scheduling the express review appointment, submits all of their study documents approximately 24 hours in advance and IRB staff review the documents within this time frame. The PI comes to the IRB office for a 30 minute appointment during which IRB staff walk them through any necessary revisions to their documents. Provided all revisions can be made in the 30 minute appointment, researchers can leave the appointment with their exempt notice in hand. 

Since initiating this process in April 2013, the IRB office has completed 470 express review appointments, which have not only dramatically improved turnaround time for exempt determinations, but have led to an increase in positive feedback received from the research community. Average turnaround time for exemptions decreased from 20 days to 11 days. Increases in staff size allowed the office to expand the weekly express review time blocks to nine hours per week to allow for more flexibility in scheduling. The in-person interactions have allowed IRB staff to provide personalized education to researchers about study specific issues while building an environment of collaboration and teamwork. One notable challenge of the express review process is that researchers self-classify their study in order to make the appointment. In instances where the research study does not fit into the criteria for exemption, researchers may not have allowed for enough time for review under the expedited or full board procedure since they were anticipating the much shorter turnaround time. 

However overall, the implementation of the express review process has led to a decrease in turnaround time while improving the relationship between the IRB office and the research community.