Abstract
PURPOSE OF REVIEW: Quality improvement (QI) work is a cornerstone of health care, and a growing area within nephrology. With such growth comes the need to ensure that QI activities are implemented in an ethically responsible manner. The existing institutional research board (IRB) framework has largely focused on reviewing the ethical suitability of traditional research projects, and it can be challenging to know if QI initiatives require formal ethics oversight. Several tools have been developed to assist in distinguishing between the two, such as the "A pRoject Ethics Community Consensus Initiative" tool. Our objective was to demonstrate how QI is distinct from research, to outline how QI-focused IRB process is used across Canada, and to develop a practical aid for clinicians embarking on QI-related projects. SOURCES OF INFORMATION: Publicly available institutional Web sites from academic and select nonacademic sites across Canada. METHODS: Institutional Web sites across all academic centers within Canada were examined to determine local QI-specific ethics review processes. We have provided examples of QI processes from select community sites. We have developed a tool to assist clinicians navigate the ethical challenges of QI projects and to determine whether their project may require ethics approval. KEY FINDINGS: This overview of the considerations of the research ethics approval process helps clinicians to determine whether IRB approval is required for QI studies. Examples of the current ethical processes employed in both academic and community institutions across Canada demonstrate the variability between centers. We have included examples of fictional nephrology-oriented QI initiatives to illustrate when ethics approval may be considered, along with a flowchart. This summary highlights the opportunity for QI-specific IRB review processes to be standardized across Canada, along with the need for creation of a separate stream with dedicated expertise for QI project review. LIMITATIONS: We did not do a formal environmental scan of the QI IRB review process in all hospital institutions across Canada.