Abstract
Healthcare quality improvement (QI) studies are systematic analyses of processes and outcomes. As such, they meet one of the federal regulatory criteria defining research. They also meet the second criterion in many instances, generalizability of findings, even if it was not the study's original intent. Therefore, to err on the side of patients' rights, any studies involving human subjects or human data must be approved by federally mandated institutional review boards (IRBs) or their designees. This article explores federal regulations to protect research subjects, levels of IRB review, and strategies to simplify the IRB approval process and discusses implications for QI studies.
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