Determining when quality improvement initiatives should be considered research - Proposed criteria and potential implications

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 imp rovement occupies an uncertain territory between clinical care and research , this difference is extremely important, If a quality improvement initiati ve is research, federal regulations require a variety of procedures that mu st be followed to protect the human subjects involved. Conversely, if the s ame 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 re viewed and regulated as research if (1) the majority of patients involved a re not expected to benefit directly from the knowledge to be gained or (2) if additional risks or burdens are imposed to make the results generalizabl e. Implementation of these criteria offers the possibility that the rights and interests of those who participate in quality improvement initiatives w ill be protected.