42 - Creating an IRB Memory Bank for IRB Effectiveness

Background: : Institutional Review Board (IRB) decisions that are not based strictly on the regulatory framework often rely on precedent, yet institutions rarely maintain a formal record of unique cases or key deliberations. This limits consistency, institutional memory, and opportunities for improving IRB processes and guidance.

Program

Description: : The Human Research Protection Program (HRPP) of a large institution with two R1 campuses and significant research volume launched an “IRB Memory Bank” to capture unique IRB cases and deliberations. Phase 1 began with the HRPP Director informally documenting precedent-setting discussions while acclimating to their new role. It evolved into a shared Microsoft OneNote folder accessible to the HRPP leadership team. Later, in Phase 2, the entire leadership team began contributing noteworthy cases, even if they were uncertain about their uniqueness. Entries are added after IRB meetings to avoid extending the meeting length. The goal is to recognize patterns, inform internal guidance, and enhance consistency across IRBs. This effort was shared with the IRB members through the post-meeting IRB education. The initiative continues into 2025 as Phase 3, where HRPP staff and IRB Chairs were invited as contributors, with the goal of sharing insights with research-supporting units in the end.

Program

Assessment: : The HRPP supports 10–12 IRB meetings each month across six different IRB Chairs. The IRB Memory Bank fostered cross-team reflection, encouraged consistent decision-making, and highlighted patterns that led to policy and guidance updates. Its open-ended and collaborative nature encouraged staff contributions without fear of error, surfacing important cases that might otherwise have gone undocumented. The Memory Bank quickly became a valuable discussion tool in leadership meetings, facilitating proactive problem-solving and identifying inconsistencies. Early feedback was gathered through informal discussions and observations during these meetings. Within six months, 10 unique cases were documented and categorized into themes such as regulatory compliance (e.g., INDs for multi-site combinational drug studies), recruitment challenges (e.g., payments to secondary subjects), and language barriers (e.g., enrolling non-English speaking participants). Though the current number of entries is modest, early feedback suggests the effort is promoting more consistent and transparent IRB decision-making. Sharing the resource with IRB Chairs bridged knowledge gaps and increased engagement. Additionally, the HRPP Director has recently joined national efforts, such as AEREO, to explore benchmarking and shared learnings.

Limitations:: Currently, the Memory Bank's intake solely relies on staff voluntarily contributing cases after meetings, which may result in underreporting or subjective selection. Additionally, this initiative is still in its early stages of development, and outcomes are largely observational rather than systematically measured at this time. Future steps may include targeted training on identifying noteworthy cases and implementing automated reminders to staff post-meetings.

Discussion: : The IRB Memory Bank is a scalable, low-cost approach that other institutions can easily adopt to strengthen IRB effectiveness. By institutionalizing precedent tracking, IRBs can enhance consistency, support staff development, and inform policy improvements. As the initiative grows, sharing insights from this project with other research supporting units like Cancer Centers and CTSAs may foster aligned decision-making across disciplines, further strengthening IRB effectiveness across the enterprise. Institutions seeking to improve transparency and institutional knowledge may benefit from implementing similar tools.