The Quality Improvement Review Committee (QuIRC) is responsible for determining whether a proposed project meets the criteria for quality improvement, program evaluation, or public health surveillance in lieu of an Institutional Review Board (IRB) determination. The QuIRC is intended to facilitate QI work, including publication of results, by making rapid and consistent determinations on whether proposed projects are or are not human subjects' research that requires IRB review. Of course, whether an activity is human subjects' research or not, all of our work must be executed in a manner that is ethical and respects the rights and welfare of our patients and community members.
As a learning health system, Denver Health routinely conducts data-guided investigations using quality improvement, program evaluation, clinical effectiveness, and related methods. These activities are an important component of our operations and we should encourage them, learn from them, and publish our results when others might find them to be of value. Yet, because these activities are data-driven and can involve human participants, they sometimes overlap with the activities and methods of human subjects' research. Where overlap exists between QI and research methodologies, the federal regulations that protect human subjects research participants may apply, including IRB review.