The Ethical Limits of Children's Participation in Clinical Research.

Abstract

This essay reflects on arguments by Paul Ramsey, in The Patient as Person: Explorations in Medical Ethics (1970) and elsewhere, that continue to challenge policy-makers and those doing clinical and translational research involving children. Ramsey argued that parents cannot morally authorize their child's participation in research unless the research is designed to benefit the child. He acknowledged that abiding by this position could have adverse impacts on improving child health, and he concluded, in a 1976 Hastings Center Report piece, that researchers must "sin bravely." Many philosophers and theologians, including Richard McCormick, have argued against Ramsey. The Ramsey-McCormick debate played out in the bioethics literature and, by invitation, at the deliberations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with developing an ethics framework and policies for human subjects protections. Although in its final recommendations, the commission sided with McCormick, the strict limitations on risks and harms to which a child can be exposed were clearly influenced by Ramsey.