Quality Improvement Activities do not need to be submitted to the IRB for review.
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The Office of Health and Human Services has outlined the parameters of Quality Improvement Activities. Principal investigators should carefully read and understand these parameters before making the determination that their research project constitutes quality improvement. Principal investigators should maintain high ethical standards for all research activities, regardless of the type of research. The links below to the Office for Human Research Protection [OHRP] should clarify for principal investigators the parameters of quality improvement activities.