IRB Manual
      7.1 Research Involving the use of Placebos
 

Subjects in any study in which a placebo is being used even under "blind" conditions, should be given appropriate treatment when any sign of significant worsening of their condition is detected.

If an investigative study is undertaken to determine the therapeutic efficacy of a new drug, device or procedure and the experimental design requires assignment of some of the subjects to "control" or "placebo" groups, such subjects should, whenever possible, receive the accepted and established form of treatment currently regarded as the most efficacious for the disease or disorder in question.

Research involving the study of "control" or "placebo" groups should only be approved if:
  1. there is no generally accepted and established form of treatment for the disease or disorder under investigation; or
  2. the nature of the disease or disorder under investigation is such that untreated subjects would not be exposed to significant risks.
    If a study which involves the use of placebos is approved, the written consent form should contain the following information.
  1. a statement that some subjects will receive a placebo rather than active medication;
  2. a definition of placebo;
  3. a description of the method of allocating subjects to the placebo group, e.g., randomization (explain what "random" means if used in the consent form);
  4. an explanation of the probability that a subject will be allocated to the placebo group, e.g., "half of the subjects will receive the placebo".
     
   


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