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Quality improvement (QI)/quality assurance (QA) has evolved from an informal retrospective review of individual cases involving critical incidents, to large retrospective analyses and evaluation of physicians, departments, hospitals, and healthcare systems. Some forms of QI activity actually represent human subjects research, with potential for patient harm. As such, similar ethical imperatives should apply in protecting patients from unconsented research when QI initiatives involve significant changes in patient care. As rationing and cost-containment efforts increase, institutional review boards (IRBs) may come under increasing pressure, and therefore experience conflicts of interest, with regard to evaluation of cost-containment QI activities. The Electronic Medical Record (EMR) carries powerful potential as a tool in QI and cost-containment efforts. Use of patient records carries risk for future privacy conflicts necessitating revision of the Code of Federal Regulations (CFR) and OHRP's regulatory authority in federal policy creation.