The Gray Zone Between Quality Improvement and Human Subject Research

The Journal of Clinical Ethics 2026

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Authors: Baddr A. Shakhsheer, Michael O’Connor, Bita Makarachi, Peter Angelos
DOI: 10.1086/739010
Cited by: 0
References: 11

Abstract

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?

Fields of Study & Subjects

Ethics in Clinical Research Ethics and bioethics in healthcare Healthcare Quality and Management

Publication details

Journal / source
The Journal of Clinical Ethics
Volume
37
Issue
1
Pages
34–37
Publication date
16 February 2026
Language
EN