Protecting Children in Clinical Trials

Assent Process for Children

Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law, though IRBs may require it.

To take part in the assent process, your child must be mature enough to understand the trial and what they are required to do. Some children as young as 7 years old may be able to take part. But this age varies depending on the child and the group running the trial.

As with informed consent, the assent process is meant to be an ongoing conversation between your child, your family, and the research team. This team may include doctors, nurses, social workers, and other health care providers.

During the assent process:

• You give informed permission for your child to join the clinical trial.
• The research team explains the trial to your child in language they can understand, including what it means to take part and what they can expect.
• The research team may use written forms, videos, graphics, and other visual aids to help explain the trial.
• Your child is encouraged to talk with your family and ask questions of the research team.

It may take several sessions before the research team feels that your child has a clear understanding of what the trial involves. At that point, your child is asked to show assent or dissent.

Assent must be obtained from children unless:

• Your child is not capable of assenting.
• Your child might benefit from the treatment or procedure being studied in the trial.
• The treatment or procedure that may benefit your child is only available in clinical trials.

Even if assent is not required, your child will still benefit from going through the assent process. Doing so can help them feel more in control and engaged in the trial.  It shows that they have a say in what happens to them and that their questions and input are valued.

Parental Consent

All clinical trials that involve minors require parental consent - regardless of the assent process. Usually, both parents will need to give permission for your child to take part in the trial. The only exceptions to this is when one parent:

• Has died
• Is unknown
• Is incompetent
• Is not reasonably available
• Has sole legal custody of the child