Determining if a proposed project is a non-research quality improvement (QI) activity or research involving human subjects is challenging. Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.
By design, many QI projects are systematic in nature. Most QI projects do not meet the definition of research though because they are not designed to be generalizable. Research studies are intended to create new knowledge that can be generalizable to other populations and settings, while QI in health care uses existing knowledge to improve health care outcomes within a local health care institution or setting.
It is important to note that some QI projects may also be research (systematic and generalizable) and therefore require IRB approval. The table below illustrates some of the key differences between research and (non-research) QI.