rules urged for research involving children
WASHINGTON -- With increasing
emphasis put on medical research involving children, the government is
being urged to broaden and clarify its rules designed to protect
youngsters from risky or unethical studies.
While current regulations
cover research that receives federal funding, the prestigious Institute of
Medicine said Thursday those rules should be extended to cover all
Physicians are allowed to
prescribe medicines approved for adults to children, but a lack of studies
in children has meant they were often forced to estimate an appropriate
dose for youngsters of various sizes and ages.
That resulted in the deaths of
some newborns whose livers were unable to process an adult antibiotic. In
another case it was discovered that children needed a larger dose than
adults of another medicine because it passed through their bodies faster
than it did adults.
Children are not just small
adults, said Dr. Charles Prober of the Elizabeth Glaser Pediatric AIDS
"Children are physiologically
different than adults, they are developing day by day and year by year and
you cannot extrapolate" the dose needed, Prober said.
Prober said many research
centers follow federal ethics guidelines voluntarily, and welcomed the IOM
report because it stresses the need for more research involving
Richard E. Behrman, chairman
of the Institute committee that prepared the report, said "involving more
children in clinical research today will benefit the health and well-being
of countless children in the future.
"But unlike most adults,
children usually lack the legal right and the intellectual and emotional
maturity to consent to research participation on their own behalf," said
Behrman, executive chair of the Pediatric Education Steering Committee of
the Federation of Pediatric Organizations.
The Institute report urges the
government to provide better guidance to help review boards interpret the
federal rules, which are more restrictive for children than adults. In
turn, review boards studying whether to allow research should be more
thorough and explicit in judging whether research involving children meets
the highest ethical and scientific standards, the report said.
In general, rules aimed at
protecting people in research trials require that the risks to
participants be minimized, that risks be outweighed or balanced by
anticipated benefits, that research participants be equitably recruited
and that investigators obtain informed consent from them.
The rules call for parents or
guardians to grant permission before children can participate in research
and they say that, when appropriate, researchers should seek from children
themselves their agreement to participate in clinical studies.
When considering the risks
from an experiment, the report said, the review board should compare it
with the risks that are normally encountered by healthy, average children.
That doesn't mean, the report said, that it is acceptable to expose a
child to a higher risk merely because the youngster is already threatened
by illness or by living in an unsafe neighborhood.
The report also said that it
is permissible to reimburse families for expenses related to research,
such as parking fees at research facilities, and to give token gifts of
appreciation. But it is never acceptable to offer higher payments for
enrolling children in more risky research, the report said.
In an effort to increase
participation by children in research studies some institutions have
offered youngsters gift certificates at toy stores and others provide
payments to families ranging from $200 to $1,000.
© Copyright 2004
Associated Press. All rights reserved.
© 2004 The New York Times