How does HHS view quality improvement activities in relation to the regulations for human research subject protections?
Protecting human subjects during research activities is critical and has been at the forefront of HHS activities for decades. In addition, HHS is committed to taking every appropriate opportunity to measure and improve the quality of care for patients. These two important goals typically do not intersect, since most quality improvement efforts 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 (45 CFR part 46) may apply. To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order: (1) does the activity involve research (45 CFR 46.102(d)); (2) does the research activity involve human subjects (45 CFR 46.102(f)); (3) does the human subjects researc
Related Questions
- Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?
- How does HHS view quality improvement activities in relation to the regulations for human research subject protections?
- When do quality improvement activities become human subject research?
