The Gray Zone Between Quality Improvement and Human Subject Research
AbstractIt has become increasingly difficult to distinguish between human subject research and before-after quality improvement projects that do not require informed consent. Is there a boundary between human subject research and quality improvement projects? If so, is it a sharp line or a gray zone?
Authors
- Baddr A. Shakhsheer (ORCID: https://orcid.org/0000-0002-5420-6771)
- Michael O’Connor
- Bita Makarachi
- Peter Angelos
Publication Details
- Journal
- The Journal of Clinical Ethics
- Published
- 2026-02-16
- DOI
- https://doi.org/10.1086/739010
- Primary Topic
- Health Policy Implementation Science
- Type
- article
- Field-Weighted Citation Impact
- 0.00