It varies by study.
The ethics and laws that govern medical practice also apply to clinical studies, and we adhere to these strict standards. However, studies, by nature, involve investigational products that might be ineffective or cause side effects.
Clinical studies are overseen by the U.S. Food and Drug Administration (FDA). Clinical studies also follow strict protocols that we adhere to, and they are reviewed by Institutional Review Boards (IRBs)—a board of highly qualified individuals who are dedicated to ensuring patients’ rights are protected.
You and your child will go through an informed consent process that explains in detail each step of the study. Our team will help clarify information regarding the specific medicine that is being studied, the number of required doctor or clinic visits, potential side effects, and many other aspects of the study and your child’s participation. You are encouraged to ask any and all questions throughout the process.