How to determine if a project is human subjects research, a quality improvement project, or both

Abstract

Background: Before undertaking a research project, investigators must determine if the planned activity is human subjects research or a quality improvement project because specific regulations govern the conduct of human subjects research. Making this determination, however, can be confusing because human subjects research and quality improvement projects share similar characteristics. Methods: The definitions, questions, and examples provided in this article will help investigators decide between quality improvement projects and human subjects research or determine when to seek regulatory guidance. Results: While quality improvement and human subjects research are both rigorous processes and at times involve similar meth-ods, the two types of studies have distinctly different overall aims. Quality improvement projects use data-driven methods to improve health delivery and quality. Such projects examine changes in human behavior and are largely experiential learning pro-cesses. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Conclusion: In most instances, the goals of human subjects research and quality improvement projects do not intersect, and quality improvement projects are generally not subject to US Department of Health and Human Services (HHS) regulatory pro-tections. However, some projects are both quality improvement and human subjects research, and sometimes, a quality improvement project develops into a human subjects research project. Investigators must be aware of the criteria defining human subjects research to ensure that HHS regulations for the protection of human subjects are applied when necessary.