Abstract
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.
Highlights
The use of placebo is a standard component of medical research
[1] Nuremberg Proceedings [2] and, in many countries, local regulations consider the principles of nonmalfeasance 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
At the end of this paper is a proposed algorithm, based on that proposed for adults by RJ Amdur and CJ Biddle, to determine the ethical use of placebocontrolled trials with children [7]
Summary
The use of placebo is a standard component of medical research. some of its indications remain controversial to this day. Studies controlled with placebo are considered to be necessary, at least when there is high risk of life-threatening or irreversible morbidity associated with current treatment Another aspect is that if an effective treatment is available, the use of placebo should be prohibited. Placebo seems to function in cases where the risks are minimum (e.g.: in studies for the treatment of allergic rhinitis); that is why the Canadian Institutes of Health Research, reached the following conclusion: “The best proof that the inclusion of a placebo in a study is adequate, will be the decision of the patient to participate in agreement that the physician’s request is based on a state of moral equilibrium and clinical justification” [13]. These characteristics force analysis of clinical research studies in children from a different perspective Because children and their parents are vulnerable for trials that investigate therapies for diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are significant. Unanswered questions include: 1. Definitions of the pediatric populations in which placebo is acceptable
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