title: Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics.
abstract: We argue that the current ethical and regulatory framework for permissible risk levels in pediatric research can be helpfully understood in terms of children's moral right to adequate protection from harm. Our analysis provides a rationale for what we propose as the highest level of permissible risk in pediatric research without the prospect of direct benefit: what we call "relatively minor" risk. We clarify the justification behind the usual standards of "minimal risk" and "a minor increase over minimal risk" and explain why it is permissible to impose any risks at all on child participants who do not stand to benefit directly from enrollment in research. Finally, we illuminate some aspects of the concept of "best interests."
authors.affiliation: George Washington University, Washington, District of Columbia, USA.|National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: David
authors.initials: D
authors.lastname: DeGrazia
authors.affiliation: The Greenwall Foundation, New York, New York, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Groman
authors.affiliation: Presidential Commission for the Study of Bioethical Issues, Washington, District of Columbia, USA.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Lee
mesh_terms: D002648:Child; D032984:Ethics, Research; D006801:Humans; D028701:Patient Rights / Q000941:ethics*; D035842:Research Subjects; D012306:Risk
keywords: adequate protection; best interests; moral rights; parental obligations; pediatric research ethics; research risks