Trials for ADHD in Children
As a parent of a child with ADHD, you may look constantly to find a better treatment for him or her. Perhaps your pediatrician has told you about new research conducted in children with ADHD to find a solution for this condition. You may wonder whether or not your child should be involved in this study. Here are a few things to consider before becoming involved in a trial for ADHD.
Types of Studies
A variety of research studies are now in progress to help doctors understand hundreds of medical conditions, including ADHD. Not all studies involve a new drug to be tested. For example, some studies will evaluate the learning styles, language, social skills and literacy of children with ADHD.
Children belong to the “vulnerable population of human subjects" because they have special physical needs, and their ability to understand a treatment and make decisions is different from an adult. Special rules and regulations have been created to support the welfare of the child in these studies.
When it comes to research involving children, the studies can be classified as:
- Minimal risk research. Observational studies that evaluate a child in the classroom, or performing certain tests or
- Greater than minimal risk research. When new drugs are tested, or the child performs new and experimental techniques to learn.
Safety Comes First
Before deciding to enroll your child in a study, think first about his or her well-being and safety. The best way to keep your child safe is to learn as much as you can about the study. Read the information provided by the investigators carefully, talk to your pediatrician and ask questions.
You know your child and his needs better than the doctor, or anyone else. It is your responsibility as a parent to evaluate whether or not the study is right for our child, and to fully understand the risks and benefits.
Questions Before Enrollment
Talk to the doctor about your child’s involvement in the study; what does he or she have to do, or what drugs does he or she have to take during the research? Evaluate the risks and benefits of the therapy and ask yourself whether the benefits outweigh the risks. How serious are the possible risks associated with the study?
You should also consider the length of the study, and the frequency of follow-ups as your child may become uncomfortable. Does this study require that your child to miss time from school? If so, how many hours?
Legal Aspects
Federal regulations require that clinical researchers address the measures taken to protect the rights and welfare of children participating in research. If the participant of the study is a child (younger than age 18), the assent of the child is required. In addition, the permission of both parents is also required. Other legal details vary based on the circumstances.