Quality Improvement and Ethical Oversight

Quality improvement (QI) activities and human subjects research have each made significant contributions to the improvement of health care. Many argue that QI differs from human subjects research in its purpose and scope. Quality improvement aims to improve health care quality and outcomes through local innovations and adaptation in the processes and systems of care. Human subjects research, in contrast, is defined as a “…systematic investigation … designed to develop or contribute to generalizable knowledge” (1) about health and illness. Although distinctions in purpose and scope may have once justified a different approach to research oversight, differentiation between research and QI activities has become murkier in recent years. Scrutiny of the oversight of human subjects research has increased, and QI activities have more often used the methods of research, generated information that is useful beyond local needs, and published their findings. The result has been uncertainty and disagreement about whether QI differs enough from clinical research to justify a less intense form of oversight. Some people believe that if a QI activity is a form of human subjects research, it should fall under the existing regulations and oversight framework for the latter activity. Others feel that QI is not research and therefore does not require the kind of oversight required for human subjects research, despite the similarities between the 2 entities (2–6).

The confusion about whether or when QI is human subjects research has reportedly resulted in lengthy delays in QI projects, criticism by regulatory authorities, rejection of manuscripts by journals for lack of informed consent procedures, and feelings of considerable frustration on the part of QI professionals and other interested parties (7–9). These factors can be serious disincentives to engage …