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American Journal of Medical Quality
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Commentary: Quality Improvement Projects: How Do We Protect Patients' Rights?

Louis H. Diamond, MB, ChB, FACP

Medstat, louis.diamond{at}medstat.com

Alan S. Kliger, MD

Yale University School of Medicine, New Haven, Conn, Chairman, Department of Medicine, Hospital of St. Raphael, New Haven, Conn

Richard S. Goldman, MD

University of New Mexico Health Sciences Center, Albuquerque, NM, and Emeritus, Renal Medicine Associates

Paul M. Palevsky, MD

Renal Section, VA Pittsburgh Healthcare System, University of Pittsburgh School of Medicine, Pittsburgh, Pa

A recent ruling by the Office of Human Research Protection (OHRP) has renewed an ongoing debate over whether Institutional Review Boards (IRBs) should have oversight not only over clinical research but also over quality improvement projects (QIPs). The authors discussed the similarities and differences among clinical practice, QIPs, and clinical research, pointing out issues to consider when identifying the most appropriate method for QIP oversight and accountability. They note that potential solutions must address ethical issues (eg, patient safety, privacy, and self-determination) and weigh the effect of the underlying QIP goal (administrative versus clinical improvement) on an individual patient and patient populations. They conclude that because QIPs are an extension of clinical practice and have elements of clinical research, it too should have an oversight system. Institutional or regional quality improvement boards, operating parallel to current IRBs, are suggested as 1 means of ensuring that QIP participants are offered the same protections as those who take part in clinical research.

Key Words: Accountability • clinical practice • clinical research • informed consent • quality improvement

American Journal of Medical Quality, Vol. 19, No. 1, 25-27 (2004)
DOI: 10.1177/106286060401900105
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