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  4. What do we owe our placebo group subjects?

What do we owe our placebo group subjects?

In a randomized, blinded trial, when one group gets the test article and the other a placebo, what happens when the intervention turns out to be wildly effective?

From an ethical standpoint, it would make sense to halt the study and offer the placebo group the intervention. But from a scientific perspective, that greatly complicates the ability to study the intervention’s long-term effects.

That’s the dilemma now facing researchers and participants in COVID19 vaccine trials, as this article in the New York Times discusses. Subjects in this blinded study were asked to sign a revised consent form indicating that those in the placebo group might have to wait up to 2 years to get the vaccine. As one of these study subjects points out, she always has the option to quit the research and get the vaccine on her own, once it’s available. Read the whole article to see what else is being considered.

 

Posted by Edith Paal on December 4, 2020

Filed Under: Institutional Review Board Members

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