Is My Quality Improvement Initiative Also Research? A Primer on Making This Distinction and the Ethical Considerations for Graduate Trainees

The distinction between quality improvement (QI) and research is not immediately clear for graduate students in health services research. The confusion is understandable; there is no uniform definition of QI to compare to research in the medical literature, and the matter is complicated further when QI initiatives are considered research as well. With the increasing growth and focus on QI initiatives in health care, it is important for trainees to know how QI can be incorporated into research programs. Moreover, trainees should be aware of existing criteria to determine whether a QI project also qualifies as research, which has implications for ethical approval.

Definitions of research usually involve the criterion that research contributes to generalizable knowledge. ¹ Most institutional research ethics boards do not consider QI initiatives to require formal ethics review if the project is applying rather than creating knowledge. ¹ The confusion arises when QI initiatives are generalizable, especially if they are testing adherence to a new concept. In response to this criticism of the generalizable criterion for QI research, several suggestions have been made.

Casarett et al proposed that 2 criteria be considered to determine if QI initiatives are also research. ¹ The first is whether knowledge obtained will directly benefit the research participant. This is different from the concept that participants will benefit from contributing to enhanced adoption of tested concepts, as patients often do in QI initiatives. Instead, with this criterion, if knowledge gained will only benefit the study team with publication or presentations outside their organization, the study should be considered research and reviewed by the necessary ethics boards. If participants will benefit from knowledge gained, a second criterion is applied, which posits whether there were additional risks or burdens placed on participants. This would apply to situations when additional laboratory testing was necessary to participate. If this was the case, the study should be considered as QI research versus a QI initiative.

Varkey et al suggested criteria for defining QI as research to include whether the intervention is novel or deviates from usual practice, whether individual participants are the units of observation, if blinding or randomization is applied to participants, and whether additional risks or burdens are experienced by participants. ² Most research ethics boards will have some form of a screening tool that provides investigators with guidance to determine whether a QI initiative is research, based on criteria similar to those discussed above. In Canada, the ARECCI ethics guideline tool has been developed to assist with this determination. ³

QI initiatives have an integral place in graduate training programs. As a trainee, knowing what distinguishes a QI initiative as research is crucial to inform ethical decision making and integrate QI into our health services research armamentarium.