Children and Clinical Trials

When your child has cancer, you would do anything to cure their disease. Often, parents will choose to enroll their children in a clinical trials for a new or modified cancer treatment regimen. When this happens, the parent needs to consider the amount of information that will need to be shared with the child. How much will you need to share with your child to get a legal assent for participation in the trial?

Legally, children who are under the age of 18 require parental authorization to participate in a clinical trial. This authorization process is called 'informed consent'. Because of this issue, parents may believe that they do not need to divulge information about the trial specifics to their children. Many clinicians believe that children and teens benefit from having knowledge of those specifics and, in fact, have a right to know. They believe a process of 'informed assent' should be followed for children involved in trials. Even though children cannot "consent," because true consent implies full understanding, they are now routinely asked whether they agree (assent) or do not agree (dissent) to participate.

The American Academy of Pediatrics calls this "empower[ing] children to the extent of their capacity" and talks about this issue in "Informed Consent, Parental Permission, and Assent in Pediatric Practice." The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research established age 7 as a reasonable minimum age for involving children in some kind of assent process. It is felt that most children this age can understand information tailored for their knowledge and developmental level.

Further Resources

Guide to Understanding Informed Consent - provides essential background for understanding the concept of assent and describes the process you will go through before giving permission for your child to take part in a clinical trial.

Children's Assent to Clinical Trial Participation - guide to help you better understand the concept of 'assent' as well as some of the larger issues surrounding young people's participation in trials.

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