title: The ethics of using quality improvement methods in health care.
abstract: Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. Most QI activities are not human subjects research and should not undergo review by an institutional review board; rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice.
authors: RAND Corporation, Arlington, Virginia, USA.
authors: Joanne
authors: J
authors: Lynn
authors: Mary Ann
authors: MA
authors: Baily
authors: Melissa
authors: M
authors: Bottrell
authors: Bruce
authors: B
authors: Jennings
authors: Robert J
authors: RJ
authors: Levine
authors: Frank
authors: F
authors: Davidoff
authors: David
authors: D
authors: Casarett
authors: Janet
authors: J
authors: Corrigan
authors: Ellen
authors: E
authors: Fox
authors: Matthew K
authors: MK
authors: Wynia
authors: George J
authors: GJ
authors: Agich
authors: Margaret
authors: M
authors: O'Kane
authors: Theodore
authors: T
authors: Speroff
authors: Paul
authors: P
authors: Schyve
authors: Paul
authors: P
authors: Batalden
authors: Sean
authors: S
authors: Tunis
authors: Nancy
authors: N
authors: Berlinger
authors: Linda
authors: L
authors: Cronenwett
authors: J Michael
authors: JM
authors: Fitzmaurice
authors: Nancy Neveloff
authors: NN
authors: Dubler
authors: Brent
authors: B
authors: James
mesh_terms: D003695:Delivery of Health Care / Q000458:organization & administration / Q000592:standards*; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D011785:Quality Assurance, Health Care / Q000941:ethics*; D014481:United States