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Quality Improvement Activities

Institutions engage in “quality improvement” projects or activities which are designed to evaluate outcomes and determine appropriate institutional practices. In most cases, these activities do not qualify as “human subject research” that would require IRB review and approval under the Federal Regulations. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care. In these situations, prospective IRB approval is needed prior to engagement in the activity. Investigators CANNOT assume that their protocol is “quality improvement” simply because the ultimate goal of their research is to improve the quality of specific aspects of patient care.