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.
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