How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both.

Conclusion: In most instances, the goals of human subjects research and quality improvement projects do not intersect, and quality improvement projects are generally not subject to US Department of Health and Human Services (HHS) regulatory protections. However, some projects are both quality improvement and human subjects research, and sometimes, a quality improvement project develops into a human subjects research project. Investigators must be aware of the criteria defining human subjects research to ensure that HHS regulations for the protection of human subjects are applied when necessary. PMID: 32284684 [PubMed]
Source: Ochsner Journal - Category: General Medicine Tags: Ochsner J Source Type: research