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FDA Urged to Broaden Study Rules
Current Policy Prevents Teens From Enrolling Without Parents' Consent

_____From Today's Post_____
"Patient #10" Expresses No Regrets
U.S. May Relax Rules for Teenagers in Studies
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Death Heightens Scrutiny of Clinical Tests (The Washington Post, Jun 25, 2001)

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By Susan Okie
Washington Post Staff Writer
Tuesday, July 31, 2001; Page A02

An ethics advisory committee of the Department of Health and Human Services agreed yesterday to urge the Food and Drug Administration to allow teenagers, in some circumstances, to enroll in studies of experimental treatments without their parents' knowledge or consent.

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.

2001 The Washington Post Company

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