To protect the rights and welfare of children participating in clinical studies, federal agencies including the Food and Drug Administration (FDA) and the National Institute of Health (NIH), oversee much of the medical research in the US. The FDA also has an office in pediatric therapeutics that monitors the growing number of clinical studies in the United States involving children.

Institutional Review Boards (IRBs) oversee the centers we are clinical studies are conducted. IRBs review and approve study protocols to ensure that a clinical study is ethical and that your child’s rights are protected.

The written permission of the parent or legal guardian is required before your child enrolls in a clinical study. Once your child is enrolled, both of you will be able to ask questions of the doctor and staff about the study.

Many drugs and treatments prescribed to children may not have been studied in children. So, clinical studies are conducted to see if a study medication, therapy or device is safe and efficient for children to use.

They are also conducted:

• To find new treatments and improve upon existing treatments for children
• To compare existing treatments and learn more about them
• To determine the appropriate dosage for children

A pediatric clinical study is also known as a”clinical research study”, a “research study”, or a “clinical trial”, and aims to answer specific questions about children’s health.

A pediatric clinical study is conducted according to a plan called a protocol which describes:

• What types of volunteers may enter the study
• The schedules of tests and procedures, study medications and dosages
• Length of the study
• Number of study visits

The parents or guardian of each child volunteer participating in the clinical study must agree in writing to the follow the protocol. This is called giving informed consent. Participating in a clinical study is voluntary, and your child may decide to stop participating for any reason, at any time.

• Study volunteers get access to new research treatments that are not available to the wider public
• Study volunteers’ treatment and progress can be monitored more closely than the usual treatment process
• Study volunteers can plan a more active role in their own healthcare because they can get more information about treatments and disease by being part of a clinical trial
• Study volunteers can receive care not covered by their insurance when enrolled in a clinical trial
• Study volunteers feel empowered knowing that their contributions to clinical research will help advance medical treatments for future generations

• Study volunteers who receive the new research treatment may turn out to be no better, or worse, than the standard treatment
• Study volunteers may experience unexpected side effects
• Study volunteers may have to visit the place of treatment more often, or have more tests and treatments than the standard treatment of care

• Your child may have access to potentially new study medications, therapies or devices that are not otherwise available
• Your child will receive study-related medical care for the condition being studied
• You and your child may feel pride in helping other children by contributing to medical research