Why Include Children in Research?

You may wonder why children are included in research since it involves uncertainty and may have risks. Why not ask adults only, who can decide for themselves if they want to join a study?

Research is commonly done with adults first. Many medicines and treatments have been studied only in adults. Because children’s bodies and brains are developing differently from adults, children sometimes don’t respond in the same way that adults do. For example, the correct dose of a medicine for a child cannot be decided by simply decreasing the adult dose to match the child’s size. When studies were done on a seizure medicine called Neurontin, it showed that children less than 5 years of age needed a larger dose of the medicine to prevent seizures. Also, side effects of some medicines only happen in children. For example, Tetracycline, an antibiotic when given to young children, can stain their teeth. Giving aspirin to children with viruses is linked to Reye’s syndrome.

Some problems occur only in children and cannot be tested in adults like congenital heart defects and prematurity. For children to benefit from new medicines and treatments, it’s important to include them in research studies. In 1998, the National Institutes of Health (NIH) made a policy that children should be included in all NIH-supported research unless there are good reasons to leave them out. In 2002, Congress approved the “Best Pharmaceuticals for Children Act” which urges drug companies to do studies of certain medicines that are used in children but have not been studied in children.

Research Helps Children
Many children today benefit from research that was done on children in the past. For example, the ways that doctors treat many childhood cancers and cystic fibrosis are based on past research. The Pediatric Cardiac Genomics Consortium (PCGC) was established in 2009 to conduct research in children with congenital heart defects and heart disease in order to improve their health and quality of life.

The goal for the PCGC study teams is to conduct research that will help children who have heart defects or disease, today and in the future, have better and healthier lives.

Children and Clinical Studies
The Children and Clinical Studies website is a great place to find information about research in children. There you will find videos of researchers, parents and children sharing their stories about being in a study. You will learn more about what it means to be in a study and what happens during and after a study.