Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in the clinical trial, you as the parent/legal guardian of your child will be provided with an overview of the research study, including study goals, how long the study will last, benefits and risks, and the tests, procedures, and medications that your child will receive or undergo. You will have an opportunity to ask any questions you may have. If you agree that your child participate in the study, you will be asked to sign an Informed Consent Form (ICF). In addition to the ICF, your child will be provided with a separate assent form containing information about the study written in a way that is understandable to children in your child's age group. Your child will be able to ask any questions they may have about the study and can either agree or not agree to participate in the study.
Study participation usually involves visiting a clinic periodically, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time
