Clinical trials and children

Children can be participants in clinical trials. However, children are different from adults both developmentally and physiologically and children’s responses to medical interventions and tests cannot always be predicted from information collected in clinical trials that only include adults.

Until recently, children were rarely included in trials of medical interventions and much is still unknown about how children respond to some medications, medical devices and tests. Therefore, clinical trials that are designed to test the effectiveness of interventions for children are important to ensure that children, too, can receive appropriate, safe and effective treatment and care.

Why enrol a child in a clinical trial?

Parents and guardians choose to enrol their children in clinical trials for a range of reasons, including a desire to provide optimal care for their child and to contribute to improving the treatment and care of other children.

A parent’s/guardian’s consent and the child’s assent

If you are thinking of enrolling your child in a clinical trial, it is important that you understand what is involved so that you can make informed choices — together with your child, if they are old enough. Your child’s health and safety is always a top priority and should be considered before agreeing to enrol them in any trial.

Children under 16 cannot give legal consent, which has to be given by a parent or guardian, but they can and should be involved in the decision as far as possible. Children benefit from knowing what will happen, having a say and being listened to, even though they do not have the legal authority to make the decision to participate.

Young people over 16 can give legal consent to medical treatment; however, they usually cannot provide legal consent to participate in research until they are 18. Nonetheless, some Human Research Ethics Committees (HRECs) do allow mature young people under 18 to give their consent for some kinds of research.

When you are approached to give informed consent for your child to take part, your child may also be asked for their permission or agreement to take part in the clinical trial. This agreement is sometimes referred to as the child's 'assent.' Assent should be obtained when the child is considered to have sufficient maturity to be able to express a view on whether they would like to take part in the research.

Both informed consent and assent require that children understand the research process and are informed about what they are expected to do or what will happen to them during the trial. In considering whether to agree to participate, children can express their views and any worries about participating in a trial and have their questions answered. Children should always be given information in a form that they can understand.

Getting information

Before a parent or guardian can give consent for a child to take part in a trial, it is important that the parent or guardian is given enough information to make an informed choice and an opportunity to ask as many questions as necessary. Staff cannot enter a child in a trial if the parent or guardian does not give their informed consent. There should never be any pressure placed on parents or guardians to give consent for their children to take part in a clinical trial.

Parents who are considering enrolling a child in a trial will be invited to talk with a scientist or health care professional on the research team. They may also wish to discuss their child’s participation in the trial with other family members and with the child’s local doctor about the decision.