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Developmental Stages and Patient Assent for Research Studies or Medical Treatment

August 17, 2022

As a pediatrician and a clinical researcher, I am well aware of the requirements of when we need to obtain parental consent, and when a child needs to assent, meaning the child needs to agree.

In general, we talk about child assent for clinical studies, but there are times when medical treatment and enrollment in a clinical study are one and the same. For instance, most children with cancer are automatically enrolled in a clinical study, because we are still learning the best way to treat many of these cancers. And many children with cancer are alive today because of those before them who entered into these studies.

But what does it mean to get assent from a child?

This week, Pediatrics is early releasing a Pediatrics Perspectives by Gianna McMillan, a parent and bioethicist at Loyola Marymount University, entitled “The Parent’s Dilemma: Pediatric Assent in Research (10.1542/peds.2021-055426).

Dr. McMillan helps us understand that assent means different things at different developmental stages. At some stages, the parent should make the decision, with or without the child’s input (again, depending on the child’s developmental stage). As the child becomes more developmentally mature, it may become appropriate for the child to make the decision, with parental agreement.

As someone who works as a patient advocate and who is herself the parent of an adult survivor of childhood cancer who cannot make most health decisions independently, Dr. McMillan offers thoughtful and practical suggestions – which I would encourage you to read and perhaps incorporate into your daily practice - about how we as doctors and researchers must provide resources and education to parents, so that they know how to talk with their child, and what assent means.

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