HIV Digest	HIV Digest Archive

An ethics advisory committee of the Department of Health and Human Services (HHS) agreed to urge the Food and Drug Administration (FDA) to allow teenagers, in some circumstances, to enter clinical trials of experimental drugs without their parents' consent.

The department's rules already allow mature adolescents with certain conditions (pregnancy, STDs, HIV, or history of abuse) to volunteer for federally funded studies without parental per- mission. But the FDA, which has its own rules for testing drugs and medical devices, has refused to adopt HHS's rules because FDA regulations require informed consent from study participants. Legally, only an adult can give informed consent.

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The National Human Research Protections Advisory Committee (NHRPAC) would like informed consent broadened to include some teenagers. "We believe that the adolescent... who is mature and has the capability, is giving informed consent," said Alan R. Fleischman of the New York Academy of Medicine. In the late 1980s and 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 treatment. At some medical centers, ethics committees allowed teenagers to enroll without parental consent.

Nearly all states have laws permitting doctors to treat teenagers for STDs and pregnancy without informing their parents, but these laws do not extend to research studies. "That's a much larger step," said Lawrence J. D'Angelo, chief of adolescent medicine at Children's National Medical Center in Washington, D.C. "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 adverse side effects."

The FDA is not legally authorized to waive parental consent for teenagers' participation in drug trials, according to David L. LePay of HHS. Congress would have to pass legislation granting such authority, he said.

Editor's Note: from the Washington Post