Critical care checklists, the Keystone Project, and the Office for Human Research Protections: a case for streamlining the approval process in quality-improvement research.

Checklists have been recently promulgated as a method to enhance patient safety and improve outcomes for critically ill patients. Specifically, recent work performed by researchers from the Johns Hopkins Medical Institutions has demonstrated that the addition of checklists to usual care in the intensive care unit is associated with a decrease in the incidence of catheter-related bloodstream infections. Initially evaluated at the institutional level, this effort has been successfully expanded to the state level as part of the Michigan Keystone Project. Although this work has recently received significant positive attention in the lay press, the Office for Human Research Protections--as they felt that this was a research project requiring Institutional Review Board approval and informed consent--put the data collection on hold for lack of approval by the Institutional Review Board at the participating hospitals in Michigan as well as for not having obtained informed consent from each patient and clinician involved in the project. This article documents the recent events surrounding the Keystone Project and the response to the actions taken by the Office for Human Research Protections in the lay press and the new media (Internet and blogs), articulates how a determination can be made if a project is quality-improvement, human-subjects research, or both, and proposes some solutions to create a structured approach to this kind of research in the future.