SPECIAL SECTION: ETHICAL LIMITS IN HUMAN SUBJECTS RESEARCH | |
Informed Consent in Pediatric Research
LAINIE FRIEDMAN
ROSS
a1
a1 Lainie Friedman Ross, M.D., Ph.D., is
Associate Professor in the Department of Pediatrics and Assistant
Director of the MacLean Center for Clinical Medical Ethics at the
University of Chicago, Chicago, Illinois
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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. a
Footnotesa 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).
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