Quality improvement and the need for IRB review.

Improving health care quality is increasingly recognized as a national priority in the United States. As a result, more and more health care organizations can be expected to undertake quality improvement (QI) initiatives. A question being raised with increasing frequency is: "Which QI activities need review by an institutional review board (IRB)?" Structured data collection and analysis is a common characteristic of most QI activities. For some QI projects, the fundamental goal is improved understanding of phenomena presumed to be generalizable to settings other than those directly studied. These activities are research. For other projects, the fundamental goal is improvement in specific processes and systems within specific organizations. These activities are not research. This article proposes that this difference in intent and the fundamental nature of the activity is crucial in deciding which QI initiatives need IRB review. The article presents test questions and markers to distinguish research from other types of QI activities. Those that are not research do not require IRB review. However, because such activities may still put patients at risk, some other review may be necessary. The article proposes five levels of risk and makes recommendations for review by an entity other than the IRB.