Informed Consent in Pediatric Research

Abstract

The first principle of the Nuremberg Code (1946) requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki (1964). U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades (1983) in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health and Human Services (DHHS) to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified.I would like to thank Walter Glannon, Ph.D., for reading an earlier version of this paper. The section of this paper entitled “Parental Permission” is based on an editorial: Ross LF. How many parents should be needed to consent to a child's participation in medical research? American Academy of Pediatrics, Section on Bioethics Newsletter May 2002:1, 4. Dr. Ross's research on children in research is funded by an NIH Grant (NLM 1 G13 LM07472-01).