Determining When Quality Improvement Initiatives Should Be Considered Research: Proposed Criteria and Potential Implications
Karlawish, Jason H.T.
JAMA. 2000 May 3; 283(17): 2275-2280.
Quality improvement initiatives have become a major force in shaping health care. These initiatives are diverse but share a common goal of generating knowledge that will guide improvements in health care. Although quality improvement occupies an uncertain territory between clinical care and research, this difference is extremely important. If a quality improvement initiative is research, federal regulations require a variety of procedures that must be followed to protect the human subjects involved. Conversely, if the same initiative is not research, the regulations outlining these procedures are not applicable. This article proposes 2 criteria to determine whether a quality improvement initiative should be reviewed as research. Such an initiative should be reviewed and regulated as research if (1) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (2) if additional risks or burdens are imposed to make the results generalizable. Implementation of these criteria offers the possibility that the rights and interests of those who participate in quality improvement initiatives will be protected.
Ethical Review; Ethics; Federal Government; Government; Government Regulation; Guidelines; Health; Health Care; Health Services; Health Services Research; Human Experimentation; Knowledge; Patients; Quality Control; Quality of Health Care; Random Selection; Regulation; Research; Research Ethics; Research Subjects; Review; Rights; Risks and Benefits; Therapeutic Research;
Showing items related by title, author, creator and subject.
Should Patients in Quality-Improvement Activities Have the Same Protections as Participants in Research Studies? Cretin, Shan; Keller, Emmett B.; Lynn, Joanne; Batalden, Paul B.; Berwick, Donald M.; Bisognano, Maureen; Cooper, Jeffrey A.; Chernov, Allan J.; Warburton, Samuel W.; Hayley, Deon Cox; Casarett David; Karlawish, Jason H. T.; Sugarman, Jeremy (2000-10-11)
Taylor, Holly A; Pronovost, Peter J; Faden, Ruth R; Kass, Nancy E; Sugarman, Jeremy (2010-08)Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on ...