The line between human research, which generally is given oversight by Institutional Review Boards, and quality improvement (QI) practices, which generally are not, is blurry and troublesome.
A group of 21 medical ethicists, health planners and administrators considers the situation and its consequences and suggests a method to analyze and oversee the ethics of QI activities.
An editorial writer says that the degree of “scrutiny and oversight for an activity should vary, regardless of whether the activity is called QI or human subjects research,” and suggests an “oversight triage system” to decide what kind of review each activity requires.