Quality Improvement and Clinical Audits: What Is the Ethical Oversight?

INTRODUCTION Quality improvement (QI) is described by the Agency for Healthcare Research and Quality as the process to test, understand, and revise processes constantly to improve the way care is delivered to patients. A high-reliability healthcare organization (HRO) is one that participates in QI and clinical audits as part of standard work. To achieve this, real and potential threats to reliability are solved quickly through both cognitive and behavioral standards used every time. Patient outcomes including reduction in patient harm, empowering patient decision-making, and improving health equity and delivery of services are enhanced through ongoing QI initiatives. Quality improvement has often been described as existing in a zone between clinical practice and health research. There is confusion of what constitutes the foundations of QI and what is required in terms of ethical oversight and by whom. There is limited international collaboration to achieve consensus on what ethical oversight or frameworks should apply to QI initiatives. A systematic qualitative review exploring the ethical issues in a learning healthcare system revealed the following: