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Terms You Should Know: Main

Assent IRB Randomization
Blinding or Masking Placebo  
Informed Consent Protocol  

Placebo

"Placebo is a pill, liquid or powder that has no active medicine in it. It's a fake."

"We did find out that she wasn't on [the study drug]. But even if she was...that's part of a study now...she is already part of a different statistic that's going to help other babies..."
Nicole, mother of child in heart defect study
There are lots of questions parents have about a placebo. A placebo can be a sugar pill or a look-alike procedure or device that has no curative effects. Parents might worry that their child is going to be denied effective treatment if a placebo is part of a study.

But it is important to know that there are ethical rules that help researchers decide if a placebo is okay to use in a study with children. A placebo must pose little risk to participants and the harms and benefits of being in the placebo group should be similar to those in the treatment group.

A lot of times, studies compare a new treatment to an older treatment. But sometimes it is necessary to see if a new treatment is better than doing nothing. This isn't as silly as it sounds because some treatments have side effects that are harmful. And believe it or not, some patients who get the placebo in studies do improve.

Sometimes there is a standard therapy and researchers want to see what happens if a new therapy is added. This is commonly done in child cancer studies where all children get the standard therapy and half get a new treatment and half get the placebo to see if adding a drug will have more benefits or not.

Most importantly, risks must be minimal.
"In any sort of life threatening situation, placebo would be inappropriate and people wouldn't use that."
Dr. Renee Jenkins, Pediatrician, American Academy of Pediatrics President, 2007-2008



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