When do quality improvement activities become human subject research?
The Office for Human Research Protections (OHRP) has guidance (FAQs) regarding the relationship between quality improvement activities and human subject research – http://answers.hhs.gov/ohrp/categories/1569 The guidance begins by noting that OHRP “recognizes that most quality improvement activities are not research subject to the HHS protection of human subjects 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, and in these cases the regulations for the protection of subjects in research (45CFR46) may apply”. In addition, the guidance acknowledges that other laws or regulations may apply to quality improvement activities independent of whether the HHS regulations for the protection of human subjects in research apply. The following categories are considered to be activities that do not meet the definition of research and therefore are not subject to 45CFR46: • Qualit
