Ethical issues arise in QI because attempts to improve quality may inadvertently cause harm, waste scarce resources, or affect some patients unfairly. For example, efforts at earlier administration of antibiotics for pneumonia may lead to overuse, or efforts to encourage cancer screening may prompt useless, risky, and expensive tests in people who are too near death to benefit. In addition, some activities using QI methods have been categorized as research that uses patients as subjects, which brings the activities under the ethical and regulatory requirements governing human subjects research, including review by institutional review boards (IRBs) (7). Putting improvement activities under research regulations can precipitate substantial delays, costs, and conflicts (8–11). Key federal agencies have disagreed about the boundaries between research and QI, and QI practitioners, health care organizations, agencies that fund research, policymakers, and IRB members are uncertain about ethical and legal requirements. The situation has already generated disincentives to engage in QI.