Protecting Against Unintended Risk From Student Quality Improvement Projects in Health Care.

Quality improvement (QI) project design is an essential characteristic of degree programs for future health care leaders. The use of evidence-based practices strengthens patient safety and organizational efficiency. The curriculum for advanced degree programs emphasizes and requires a QI project for each student, often allowing the activity to occur at the student's place of employment, thus creating a dual responsibility (student-employee). In the past two decades, institutional review boards (IRBs) and practitioners have struggled with incorporating uniformity in the review of research versus QI design. Despite the efforts of experts in ethics and calls to develop formal processes, consistency issues are still a challenge in traditional IRB review models. The process to mandate the IRB as the sole decision-maker for QI projects may lead to overregulation and bottlenecks in the institutional workflow. In this report, the author attempts to reconcile the causes of overregulation and also draw attention to potentially unrealized risks to patient privacy and protections. The proposed effort aims to (1) proactively establish when governance models are necessary for the population of student-employees conducting QI projects, and (2) promote interaction and cooperation when addressing ethical and regulatory standards outside of the IRB to reduce overregulation for student-employee QI projects. The author also describes a novel heatmap for risk identification and introduces the 5Circle Student Employee Venn for Quality Improvement model as a proposed mechanism to help institutions design more appropriate governance structures for student-employee QI projects. Finally, the author suggests ways by which institutions can increase efficiency and reduce overregulation of QI.