The REB has to review human research conducted under their jurisdiction. By definition research is an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. Whereas, quality assurance or program evaluation activities are intended to assess the performance of an organization or its staff, within the mandate of the organization. The primary distinction between research and quality assurance is therefore, in their respective objectives, rather than the methods used. Recognizing that there can be overlap between these two concepts, the REB should be consulted to determine whether or not a specific activity constitutes research. The determination of whether an evaluation study is research and therefore requires REB review should be made on a case-by-case basis, and should be guided by the definition of research in TCPS 2 (see Application to Article 2.1).
The following resource could help distinguish between a research project and a quality improvement evaluation. A pRoject Ethics Community Consensus Initiative (ARECCI) (formerly The Alberta Research Ethics Community Consensus Initiative) has identified a lack of guidelines and other resources to assist project leaders in considering the ethical implications of Quality Improvement and Evaluation projects.
Thus, the group develop two tools grounded in ethical principles to aid project leaders and organizations to ensure respect for the rights of participants in these kinds of projects: