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Mother, may I? Obtaining consent in pediatric clinical trials

Tara R. Krieg ( is a Director at Ankura and is located in Springfield, OH.

Children are notorious for asking questions, aren’t they? “Mom, can I do this?” “Dad, can I go here?” Parents are tasked with the responsibility and obligation to lead and protect their children; they are expected to do what is in their child’s best interest.

But parents are not always the only ones who hold this responsibility. Sadly, and all too often, children become sick and require knowledge and intervention from medical experts. Once healthcare professionals are involved in the child’s care, they now also share in this solemn responsibility.

And the stakes are especially high when a child with fragile health is involved and difficult medical decisions must be made.

The great news for children with delicate medical conditions is that pediatric research has made great strides in recent history. In fact, participation in a clinical trial can be some patients’ best treatment option.[1] However, despite growing acceptance and popularity noticed by the author, pediatric clinical trials continue to have very distinctive challenges and characteristics, in part due to their unique subject population.

In this article, we will discuss informed consent and assent and the associated implications for the institutional review board (IRB), the parent(s) or legal guardian(s), the child, and the investigator.

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