77 - Is this Single IRB in Disguise?

Background:  As IRB reliance has become more common, misconceptions and confusion has led to an increase in external investigators from other academic institutions being adding to local study applications with requests for reliance agreements with their institutions. As the requests increased, the workload increased for the IRB and counsel.

Program

Description:  Three changes were implemented to address the increased in workload and ensure compliance with sIRB review and charging requirements. Rules were implemented about when reliance agreements would not be pursued including for exempt research and when there was no federal funding for the study in question. This was implemented in order to make fair and consistent decisions. Second, a robust triage process was implemented to identify exempt research and studies that were not federally funded. Education was provided by the Associate Director to the requesting study team about why reliance was not going to be pursued. Lastly, questions and prompts were added in to the account request form that is completed by external researchers. These included notifications to requestors of when we will consider reliance before they submit the form. This would allow requestors to determine early in the process if reliance was appropriate and would be considered.

Program

Assessment:  Implementing rules for when reliance would not be pursued led to consistent messaging to research teams. We found that the consistent messaging lead to fewer requests because once teams were aware, they did not pursue future requests for reliance. The robust triage process was found to be a great opportunity for education of research teams. It allowed us to identify a number of researcher misconceptions including that departed faculty could stay on study team/ access medical records and that IRB Reliance was required for data sharing. It also uncovered that many researchers were unaware of when single IRB was and was not required and provided an opportunity for resources and information to be shared. Triaging and identifying these misconceptions early decreased workload of IRB staff/ counsel as it led to fewer agreements being prepared and processed. We evaluated the effect of these interventions and found a decrease in the number of agreements of between 35% and 67% depending on the month. It also ensured that reliance arrangements were all consistently being charged for.

Limitations: The changes were all launched simultaneously so it is difficult to determine which had the most impact. However, as there were still external researchers being added to study teams inappropriately, this is an indicator that the updates to account request form have not been particularly successful. It's also difficult to measure this change as we do not know how many requests were not submitted because they realized it was not appropriate.

Discussion:  The implementation of these changes not only decreased workload which is a priority for many IRB offices. It also allowed us to identify gaps in researcher knowledge, not only about reliance but about data sharing and departing faculty. This has lead to discussions with other departments and universities to share information and practices that benefits researchers in other university areas. These changes allow an extra assurance that every time single IRB services are used, the services are charged for consistently to ensure compliance with charging rules. Lastly, fewer reliance agreement decreases our legal liability at the institution.