http://www.washingtonpost.com/wp-dyn/articles/A8479-2001Jul30.html
FDA
Urged to Broaden Study Rules
Current Policy Prevents Teens From Enrolling
Without Parents' Consent
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By Susan Okie
Washington Post Staff Writer
Tuesday, July 31, 2001; Page A02
The department's rules already allow mature adolescents with certain
conditions -- such as pregnancy, sexually transmitted diseases or HIV infection,
as well as abused teenagers -- to volunteer for federally funded studies
without their parents' permission, provided that an ethics committee has
approved such participation and has agreed that informing the parents is not in
the child's best interests.
But the FDA, which regulates the testing of drugs and medical devices, has
refused to adopt the HHS policy because the agency says its own rules require
study participants to give informed consent except in emergencies -- and,
legally, informed consent can be given only by an adult.
"The types of research that this is alluding to are not circumstances
in which we have the authority to waive informed consent," said Rosemary
Roberts, medical leader of the pediatric team at the FDA's Center for Drug
Evaluation and Research.
The National Human Research Protections Advisory Committee (NHRPAC) would
like the definition of informed consent broadened to include some teenagers,
said committee member Alan R. Fleischman of the New York Academy of Medicine.
In certain cases, barring teenagers from participating in studies without
parental consent could deny them experimental treatments that are likely to
help them, while involving their parents could be dangerous to the youngsters,
committee members said.
"We believe that the adolescent . . . who is mature and has the
capability, is giving informed consent," said Fleischman, who chairs a
group that is preparing the committee's comments to the FDA.
"We don't want it to be used in any wholesale way to change the role of
parents," he added, "[but] there does come a time when the interests
of adolescents may outweigh the involvement of their parents in specific
circumstances."
The HHS rule has often been invoked to allow teenagers to enroll, without
their parents' knowledge, in studies of behavioral risk factors that only
required participants to fill out questionnaires, Fleischman said.
But in the late 1980s and early 1990s, some teenagers with HIV infection
were treated with experimental drugs in federally funded studies because it was
the only way they could gain access to medicines that were prolonging the lives
of adults but had not yet been approved for children, he said. At some medical
centers, ethics committees (known as institutional review boards, or IRBs) allowed
teenagers to enroll in such studies without their parents' permission.
"Those adolescents would not have allowed the clinicians to inform
their parents about their diagnosis," Fleischman said. "I believe
IRBs did that without any knowledge that the FDA might not think this is the
right thing to do."
Lawrence J. D'Angelo, chief of adolescent medicine at Children's National
Medical Center in the District, said his hospital's institutional review board
wrestled with the issue a few years ago before deciding not to allow teenagers
to enroll in a government-funded HIV study without parental consent.
Nearly all states have laws permitting doctors to treat teenagers for
pregnancy or sexually transmitted diseases and to prescribe contraceptives for
them without informing their parents, D'Angelo said, "but that does not
necessarily extend to research studies."
"That's a much larger step," he added. "I think the
implications of it could be frightening. I'm not sure that I want 15-year-olds
making decisions that they can or should take medications that could
potentially have some adverse side effects."
Because many approved drugs have never been studied in children, Congress
passed a law in 1997 that extends pharmaceutical companies' patents on certain
drugs if they perform such studies. Companies applying for FDA approval of a
new drug with potential uses in children are also required to submit a
pediatric research plan, said Dianne Murphy, CDER's associate director for
pediatrics.
As a result, many companies are eager to test medicines on children,
increasing the pressure on pediatricians to enroll patients in drug trials.
Waiving parental consent for research participation could subject children
to increased risks, said Vera H. Sharav of the Alliance for Human Research
Protection.
"Why is there such a rush to accommodate research by diminishing the
protections that children now have?" asked Sharav, a member of the NHRPAC
working group who dissented from the majority position. "What happens when
a child is harmed? Do you bring the parent back?"
But other NHRPAC members expressed support for urging the FDA to change its
position.
"The very sorts of research that we're talking about . . . would
include children whose situations need to be better understood, so that we can care
for those children in a better way," said Mary Faith Marshall, NHRPAC
chairman and a bioethicist at the University of Kansas Medical Center.
A letter from NHRPAC is to be forwarded to the FDA and considered along with
other comments on the agency's current position, which was published as an
interim rule last April.
The FDA is not legally authorized to waive parental consent for teenagers'
participation in drug trials, said David A. LePay of HHS. Congress would
probably have to pass legislation granting such authority, he added.
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The Washington Post Company
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