F02 - Developing a System of IRB Precedent: Value, Approaches, and Challenges

IRBs often rely on institutional memory in making decisions about challenging protocols, but a more systematic approach to developing and accessing IRB "precedents" can offer important benefits in terms of consistency, predictability, transparency, efficiency, and overall HRPP/IRB quality. However, creating a system of precedent requires an approach to summarizing IRB decisions and indexing them in a way that they can meaningfully inform future work; this can be challenging within an individual IRB and even more so across IRBs. In this session, speakers will make the case for using IRB precedent, describe an IRB chair's individual efforts to rely on prior decisions, explain a recent pilot study testing different approaches to retrospectively crafting IRB decision summaries, outline a current pilot study aiming to develop IRB decision summaries at the point decisions are made, and explore the future work needed to overcome barriers to incorporating IRB precedent into practice as a way to facilitate quality improvement.