The Ethical Problems with Sham Surgery in Clinical Research

Abstract

The recent use of sham surgery in randomized, controlled trials raises three critical questions about research involving human subjects. The first question concerns the tension between the highest standard of research design and the highest standard of ethics.¹ When these two standards come into conflict and researchers cannot simultaneously meet both, which should prevail, and how should a balance be struck? The second question points to ongoing uncertainties and disagreements in assessing the risks and benefits of research protocols. When reasonable people — the members of well-established institutional review boards or the sponsors of research — disagree in their risk–benefit . . .