Abstract

The Ethical Use of Placebo in Pediatric Research

Rita A. Gómez-Díaz, Niels Wacher, Susana Castañón, Carlos A. Aguilar-Salinas, Susan Drier-Jonas and Alberto Lifshitz-Gϋinzberg

The use of placebo remains one of the more hotly debated elements of this facet of medicine. Therefore, the objective of this document is to raise some reflections about its use in children. The World Medical Association, Nuremberg Proceedings, and, in many countries, local regulations consider the principles of non-malfeasance and justice, which consist in offering the best therapies available to children, as long as they are previously evaluated, regardless of race, economic level or social status. However, the special ethical dilemmas of children are not adequately addressed. This article suggests a list of considerations for the use of children in placebo-controlled trials, recommends ethical guidelines, and offers an algorithm based on that proposed for adults for evaluating the ethics of a placebo-controlled trial.