57 - Closing Time: Reconciling Lapsed Studies in an External IRB Portfolio

Background:  In late 2023, the Reliance Team found that 10% of our external IRB of Record (xIRB) submissions had lapsed continuing review expiration dates, raising compliance and portfolio accuracy concerns. In early 2024, we launched a successful clean-up program and can now offer insights for other institutions undertaking similar efforts.

Program

Description:  We first leveraged our electronic submission system to send new automated reminders to study teams containing instructions for submitting key updates (i.e., continuing review or closure) for their xIRB study. Next, we developed a report within eIRB+ to identify studies remaining lapsed over 30 days. This report informed our successive and escalating communication plan. Two successive rounds of communications followed for those identified studies. Specifically, we manually posted additional reminder comments, with submission requirements and instructions, and then sent emails directly to study teams. Subsequently, we re-ran the report and began manual administrative closures. Studies lapsed before 2020 were administratively closed and newer lapsed studies were reviewed to determine if further follow-up was needed. If follow-up was necessary, the matter was escalated to the xIRB, department administrators, and leadership.

Program

Assessment:  We claim significant success and impact via the implemented clean-up program, as evidenced by outcome metrics and the creation of tools for future implementations. These tools include IRB system reports to detect lapsed studies, metric capture of cleanup progress, and SOP formulation. Studies requiring case-by-case troubleshooting required a disproportionate amount of time to address; a common IRB and HRPP challenge. Implementations of similar programs must be prepared to account for such edge-cases. Based on our experience, we find that an iterative approach to process development was crucial to refining the process while managing the most demanding aspects of implementation. Our initial findings, supported by data, chart the successful resolution of our original targeted studies and show a trend of decrease in the amount of newly lapsed studies. In planning to implement the clean-up process as a routine procedure in the future, we anticipate better compliance outcomes and easier resolution of future lapse studies.

Limitations: The manual processes involved in this project, including running reports, logging comments, and following up with study teams at multiple time points, are inherently time consuming. Smaller HRPPs may need to consider strategies for cross-training or restructuring FTEs and explore alternative methods for organizing and monitoring communications with study teams before implementing similar processes manually. Technical limitations of systems and reporting capabilities, which will vary by institution, were identified as well.

Discussion:  This clean-up program successfully enforced local requirements for xIRB studies, and ensured key study updates were submitted in our online system to enhance the accuracy of the portfolio. It also underscored the importance of engaging with study teams throughout the lifespan of the study; providing a touchpoint and education opportunity post-execution of reliance greatly improved study teams’ understanding of expectations and requirements. It’s our suggestion that other institutions clearly document xIRB requirements in their SOPs, validate their educational support materials, and garner leadership support for escalation processes prior to implementing this clean-up program.