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Eran Bellin, MD and Nancy Neveloff Dubler, Llb

Eran Bellin is with the Department of Outcomes Analysis and Decision Support, Montefiore Medical Center, and the Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, NY. Nancy Neveloff Dubler is with the Division of Bioethics, Montefiore Medical Center, and the Department of Bioethics, Albert Einstein College of Medicine, Bronx, NY.

Correspondence: Requests for reprints should be sent to Eran Bellin, MD, Montefiore Medical Center, Department of Outcomes Analysis and Decision Support, 55 E Gun Hill Rd, Bronx, NY 10467 (e-mail: ebellin{at}montefiore.org).

Historically, quality assurance studies have received scant ethical attention. The advent of information systems capable of supporting research-grade continuous quality improvement projects demands that we clearly define how these projects differ from research and when they require external review. The ethical obligation for the performance of quality assurance projects, with its emphasis on identifiable immediate action for a served population, is a critical distinction. The obligation to perform continuous quality improvement is a deliverable of the social contract entered into implicitly by patients and health care providers and systems.

In this article, the authors review the ethical framework that requires these studies, evaluate the differences between quality assurance studies and classic research, and propose criteria for requiring external review.

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