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Ensuring Ethical Conduct of Quality Improvement Activities in Health Care

Principal Investigator: Mary Ann Baily
Funder: The Commonwealth Fund

This project researched policy options for ethical oversight of quality improvement activities in health care.  Quality improvement (QI) refers to a broad range of systematic, data-guided activities designed to improve the process of delivering clinical care. QI activities have elements in common with clinical research, including the potential to harm people affected by them. As a result, for some time there has been uncertainty about the relationship between QI and the system for protecting human subjects of research. The project produced a background paper for a meeting sponsored by the Institute of Medicine and the American Board of Internal Medicine Foundation, and policy recommendations.