TY - JOUR
T1 - The ethics of using quality improvement methods in health care
AU - Lynn, Joanne
AU - Baily, Mary Ann
AU - Bottrell, Melissa
AU - Jennings, Bruce
AU - Levine, Robert J.
AU - Davidoff, Frank
AU - Casarett, David
AU - Corrigan, Janet
AU - Fox, Ellen
AU - Wynia, Matthew K.
AU - Agich, George J.
AU - O'Kane, Margaret
AU - Speroff, Theodore
AU - Schyve, Paul
AU - Batalden, Paul
AU - Tunis, Sean
AU - Berlinger, Nancy
AU - Cronenwett, Linda
AU - Fitzmaurice, J. Michael
AU - Dubler, Nancy Neveloff
AU - James, Brent
PY - 2007/5/1
Y1 - 2007/5/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=34248392698&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34248392698&partnerID=8YFLogxK
M3 - Article
C2 - 17438310
AN - SCOPUS:34248392698
SN - 0003-4819
VL - 146
SP - 666
EP - 673
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 9
ER -