Consent and Assent in Pediatric Research

Abstract

Research involving pediatric populations has important ethical and regulatory considerations. As children generally cannot consent to research, there are special protections put in place to ensure that the decisional vulnerability is protected, including parental permission and often the child's assent. Assent is an ethically important part of the research because it allows the child to participate in the process of agreeing to research, develop their autonomy, and express their values. This article explores a case where the child and parent disagree about the child's participation. In doing so, the regulatory requirements of pediatric research are outlined and the process and product of obtaining assent from a minor is described.

Keywords: Assent; Common rule; Pediatric research; Therapeutic misconception.