The ethics of using quality improvement methods in health care.
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.
Lynn
Joanne
J
RAND Corporation, Arlington, Virginia, USA.
Baily
Mary Ann
MA
Bottrell
Melissa
M
Jennings
Bruce
B
Levine
Robert J
RJ
Davidoff
Frank
F
Casarett
David
D
Corrigan
Janet
J
Fox
Ellen
E
Wynia
Matthew K
MK
Agich
George J
GJ
O'Kane
Margaret
M
Speroff
Theodore
T
Schyve
Paul
P
Batalden
Paul
P
Tunis
Sean
S
Berlinger
Nancy
N
Cronenwett
Linda
L
Fitzmaurice
J Michael
JM
Dubler
Nancy Neveloff
NN
James
Brent
B
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