Assent | IRB | Randomization |
Blinding or Masking | Placebo | |
Informed Consent | Protocol |
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.