International ethical guidelines for the choice of control in clinical trials Extracted from CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects

Abstract

As a general rule, research subjects in the control group of a biomedical research involving human subjects should receive an established effective intervention. In some circumstances, however, it may be ethically acceptable to use an alternative comparator, such as placebo, “no treatment” or other effective alternative. This article discusses these special circumstances in detail, and puts forward means of minimizing harm to placebo control subjects.