[This article was originally published in Healthcare Quarterly, Volume 12, Number 2.]

Many people assume that quality improvement (QI) projects pose no ethical issues in relation to participants or their rights. However, members of the Alberta Research Ethics Community Consensus Initiative (ARECCI) submit that all projects that generate knowledge, including QI projects, can create risks to participants that need to be identified, assessed and addressed in the context of the kind of project. The possibility of risk raises the question of ethical conduct in QI projects. Ethical considerations, such as the rights to respect and privacy, protection from harm and voluntary consent, may apply to QI projects, even if the participants are not regarded as research subjects. In this article, we use a case example to illustrate potential ethical issues raised by a QI project, and argue for an ethics review approach that is distinct from that used with research projects. We propose six considerations with guidelines to help assess (and ultimately minimize and mitigate) the risk for participants in QI projects and assist in the appropriate ethical management of these projects.