Frequently Asked Questions

To protect the rights and welfare of children in clinical trials, government regulatory agencies oversee that medical research in children follows strict safety and ethical guidelines. These agencies often have additional guidelines and requirements for clinical trials in children. Institutional Review Boards (IRBs) and Ethics Committees (ECs) oversee the centers where clinical trials take place. IRBs and ECs review and approve clinical trial protocols to ensure that a clinical trial is ethical, and that participants’ rights are protected.

Yes, children can take part in clinical trials, but only with informed consent from their parents or legal guardians. Depending on their age, they may be asked to give their own “assent”. That means the children show that they understand and agree to join the clinical trial.

Some diseases or conditions only happen in children, such as childhood cancers or being born too early (premature birth). Clinical trials are needed to learn more about childhood diseases and how to treat them. Vaccines also need to be tested in children once they are found to be safe and effective in adults.

Clinical trials in children are also called pediatric clinical trials. Pediatric trials are designed to answer specific questions about the effects of a treatment on children’s health. These clinical trials are important for:

• Learning how new drugs and treatments may affect children
• Finding the best doses and treatment options for children at different ages
• Developing different ways for children to get or take a treatment (for example, chew tablets or drink a liquid rather than swallow a pill)

Pediatric clinical trials are designed to answer specific questions about the effects of a treatment on children’s health. Children and teenagers may respond differently to treatment than adults, so it’s important to test treatments in different age groups. Many times, treatments that have been approved for use in adults have not yet been tested in children. So, more clinical trials are done to make sure new medicines or treatments work and are safe for children.

If you are thinking about a clinical trial as an option for a child in your care, ask questions of your child’s doctor and the clinical trial doctor. They can give you the information you need to decide if the clinical trial is the right choice.

Only people who have reached the legal age of consent can give their consent to participate in a clinical trial. The age of consent varies worldwide. Assent is when someone who is not able to give legal consent agrees to take part in an activity like a clinical trial.

If your child is younger than the legal age of consent, you as the parent or legal guardian will give permission for your child to take part in the clinical trial. You will sign the informed consent form for your child.

When a clinical trial includes children, extra precautions are needed. Here are some ways sponsors take extra precautions for these trials:

• Expert review: Have the clinical trial plan reviewed by outside experts who are knowledgeable about issues in children
• Fair recruitment: Recruit participants in a fair and ethical way with special considerations for both the parent or legal guardian and the child
• Clear explanation: Clearly explain the risks and requirements to the child’s parent or legal guardian and, when appropriate, to the child
• Informed consent and assent: Obtain informed consent from the responsible parent or legal guardian and assent from the child, if appropriate
• Minimize risk and discomfort: Design the clinical trial to minimize risk and discomfort to children through careful selection of the tests and procedures, as well as the selection and training of study staff.
• Reduce stress: Design the clinical trial to minimize distress to the participants

Learn more about clinical trials in children