Abstract Monitoring of quality of care has always been an important part of health care. Self-regulation and external standards require care providers to furnish safe environments for the patient. Similarities in methods used by quality improvement (QI) projects and clinical research have created some confusion in differentiating the two practices. This article reviews the current literature and differences between QI and research. In addition, the article identifies and discusses four criteria: intervention, risk, audience, and data source, which allow investigators to differentiate between the two practices and follow the appropriate procedures for project review. Copyright 2003, Elsevier Science (USA). All rights reserved.