Copyright: © 2026 by the authors. Licensee: Pirogov University.
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ORIGINAL RESEARCH

Placebo and the double standard of care in clinical trials: when inequality becomes an ethical premise using inequality as an ethical justification

Gidirim UO , Beliaeva AM
About authors

Pirogov Russian National Research Medical University, Moscow, Russia

Correspondence should be addressed: Anastasia M Beliaeva
Ostrovityanova St., 1, Moscow, 117997, Russia; moc.liamg@ztivonerug

About paper

Author contribution: Gidirim UO — concept development and text writing, Beliaeva AM — writing and editing.

Received: 2026-03-13 Accepted: 2026-04-20 Published online: 2026-05-21
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The article presents an ethical analysis of randomized placebo-controlled trials (PCTs) conducted in developing countries in situations where effective treatment already exists elsewhere in the world. The authors examine a fundamental contradiction: the use of a placebo often becomes feasible only because of global inequality in access to healthcare, whereby the actual standard of care for the local population is the complete absence of treatment. Through two case studies: trials of drugs for HIV prevention and for the treatment of infant respiratory distress syndrome (IRDS) —  the ambiguity of ethical evaluation is demonstrated. The key criterion for the acceptability of a PCT is identified as the degree of potential harm: while in the case of HIV the risk to participants was high but not fatal, in the case of IRDS the use of a placebo directly endangered the lives of infants. To provide a philosophical foundation for the problem, the authors employ John Rawls’ thought experiment of the “veil of ignorance” and Gerald Cohen’s test of interpersonal justifiability. From Rawls’ perspective, PCTs perpetuate injustice, because the standard of care cannot depend on a patient’s place of residence, and no one would agree to risk their life due to the contingency of being born in a poor country. Cohen’s test reveals the moral deficiency in the pharmaceutical companies’ reasoning: they themselves contribute to the inaccessibility of medicines and then use this as a justification for placebo controls. The conclusions argue for the necessity of a differentiated approach: prohibition of PCTs when lethal risks are involved, and permissibility only under the condition that the research is aimed at developing accessible treatment for the same vulnerable population.

Keywords: placebo-controlled trials, clinical research ethics, ethics of placebo use, global health inequality, developing countries, Cohen’s interpersonal test, Rawls’ theory of justice, vulnerable patient populations

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