The ethics of using quality improvement methods in health care

Joanne Lynn, Mary Ann Baily, Melissa Bottrell, Bruce Jennings, Robert J. Levine, Frank Davidoff, David Casarett, Janet Corrigan, Ellen Fox, Matthew K. Wynia, George J. Agich, Margaret O'Kane, Theodore Speroff, Paul Schyve, Paul Batalden, Sean Tunis, Nancy Berlinger, Linda Cronenwett, J. Michael Fitzmaurice, Nancy Neveloff DublerBrent James

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)666-673
Number of pages8
JournalAnnals of Internal Medicine
Issue number9
StatePublished - May 1 2007
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


Dive into the research topics of 'The ethics of using quality improvement methods in health care'. Together they form a unique fingerprint.

Cite this