Ethics reviewers wrestle with the issue of using placebos in research because of the fear that withholding a treatment from the controls may be denying controls access to a helpful treatment. And as our IRB members know, the IRB makes separate risk determinations for different groups in FDA-regulated investigational studies involving children, because different groups may be exposed to different levels of risk.
Placebo use in one study involving children bothered one outside researcher so much that he complained to the National Heart, Lung, and Blood Institute. His complaint prompted some changes in the study, although judging from the study’s clinicaltrials.gov listing, one group is still getting a placebo.
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