Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2008
The recent article by Scott et al1 presents valuable scientific results concerning the relationship between placebo and nocebo effects and the endogenous opioid and dopaminergic systems. From an ethical perspective, however, it can be characterized as deceptive research, deceptively described. Participants were deceived about the experimental design. It is reported that they were informed that “We are studying the effect of a pain relief medication” and that they would receive either this medication or placebo. In reality, they received only a placebo in connection with a pain stimulus. Additional deception derived from informing participants about possible adverse effects of the analgesic study medication, which was actually a placebo. Furthermore, it appears that participants were not told that the purpose of the study was to understand placebo and nocebo effects. The deceptive description of the research is reflected in 2 statements reported in the article. First, it is stated that “Written informed consent was obtained in all cases.” Unless “written informed consent” merely designates the signing of a consent document, informed consent was not obtained. The research involved deception about a key study intervention and probably also about the purpose of the research—2 basic elements of informed consent. Second, Scott et al reported in the “Methods” section that the disclosure to the participants was similar to typical placebo-controlled trials. In the “Comment” section, this point is repeated along with enumerating the basic elements of placebo-controlled trials, including “no deception” and “subjects who were aware that either an active or inactive drug could be administered.” Unlike placebo-controlled trials, this placebo mechanism experiment deceived the subjects by only administering placebo, despite telling them that they could receive either a pain medication or a placebo. The ethics of research using deception is controversial.2 All the more problematic is deceptive research that is misleading about the use of deception.
Miller FG. Deceptive Research. Arch Gen Psychiatry. 2008;65(10):1225-1226. doi:10.1001/archpsyc.65.10.1225-b