[Speech]

THE UNIVERSITY OF
Pediatric Pulmonary Section A IZ NA~ 1501 N. Campbell Ave.
Respiratory Sciences CenterCENTER P.O Box 245073
College of Medicine HEALTH SCIENCES CENTER Tucson, Arizona 85724-5073
-:. ~[phone] / 6754
FAX [phone]
Benjamin Wilfond MD
University of Arizona
May 8, 1997
I would like to thank the subcommittee for inviting me to participate in these
hearings about the adequacy of informed consent for biomedical research. I have been
asked to make comments about research on children. I am an Assistant Professor of
Pediatrics in the sections of Pediatric Pulmonary and Medical and Molecular Genetics at the
University of Arizona in Tucson. I am a member of the Committee of Bioethics of the
American Academy of Pediatrics. I teach bioethics, including research issues, to medical
students and graduate students. As a pediatric pulmonologist, I care for children with lung
disorders, including asthma, cystic fibrosis, and chronic lung disease of prematurity. My
main research interests are the ethical and policy implications of new genetic technologies. I
have a particular interest in the issues of research in children. I have been a member of
Institutional Review Boards (IRB) for nine years.
Informed consent has been a central tenant of research ethics from the time of the
Nuremberg trials fifty years ago. However, consent is neither necessary nor sufficient to
make research ethical. Had the Nazis obtained consent, it would not have altered our
judgment about their medical experiments. As a legacy of Nuremberg, there was great
debate in the early seventies as to whether it was morally justified ever to conduct research
on children since they cannot give consent. This debate was considered in the Belmont
Report and expressed in the federal regulations by acknowledging that parents give
permission, not consernt, for children's participation in research. This distinction, while
subtle, is important, because it provides the conceptual justification for a greater role of the
IRB in assessing the balance of benefits and risks to which children can be exposed.
While the intent of the regulations is to place greater restrictions on research on
children, the regulations are often misinterpreted to suggest that research that otherwise
might be valuable cannot be done. In fact, as a pediatrician, there are many circumstances
where clinical judgments must be made without the benefit of sound empirical data.
Additionally, many drugs that are used in children are off-label. This problem is not
necessarily the result of regulatory restrictions but often, as a result of decisions to not
expend the resources to conduct studies in children. Once a new drug is approved,

pharmaceutical companies have few incentives to conduct other studies in children. There
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