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.