title: The quality improvement-research divide and the need for external oversight.
abstract: 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.
authors.affiliation: Department of Outcomes Analysis and Decision Support, Montefiore Medical Center, Bronx, NY 10467, USA. ebellin@montefiore.org
authors.forename: E
authors.initials: E
authors.lastname: Bellin
authors.forename: N N
authors.initials: NN
authors.lastname: Dubler
mesh_terms: D004992:Ethics, Medical; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000458:organization & administration*; D011446:Prospective Studies; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012107:Research Design / Q000592:standards*; D012189:Retrospective Studies; D017749:Total Quality Management / Q000458:organization & administration*