Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?
Yes. In certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations.
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?
