The values of autonomy, beneficence, nonmaleficence, and justice guide bioethics and clinical research in the United States and around the world today. The Nuremberg code established the requirement of informed consent and limited research involving children, in order to protect this vulnerable population from exploitation; however, this ruling resulted in a lack of research targeting this special population. Federal guidelines in the United States now encourage the inclusion of children in clinical research so that this population can benefit from new studies and technology. The issue of consent in pediatric research aims to reconcile the competing ideas of informed consent and research application to all, requiring both informed consent from parents and assent from children.

Informed consent necessitates disclosure by the researcher, discussion between the researcher and potential subject, and a subject’s full understanding of the proposed research. Once these requirements are fulfilled, a subject may then voluntarily wish to participate in the research protocol. By law, informed consent must be given by an autonomous individual who is younger than 18 years of age and makes independent decisions and is responsible for them. In pediatric research, parental consent permits the researcher to ask the child if he or she wants to participate in the protocol. The researcher must then ask for assent from the child. Assent should be obtained using developmentally appropriate tools.