Abstract
Is an activity quality improvement (QI), or is it research? And why does the distinction make a difference? While national leaders deliberate on how to answer these questions, healthcare organizations must act to ensure patient safety in both QI and research activities. The current system used by researchers for more than 30 years has not always protected human subjects. The result has been patient injuries and even death. Could QI activities result in patient injuries and death? This article offers healthcare quality professionals information that will better equip them to ensure safe practice and protect human subjects.
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