BOARD urges FDA to waive parental consent for some medical experiments
Tuesday, July 31st 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ A government panel is recommending that the Food and Drug Administration let certain teen-agers participate in medical experiments without their parents' consent.
The FDA regulates all testing of drugs and medical devices. FDA attorneys say federal law governing the agency mandates that only adults can consent to medical experiments and that such consent can be waived only in a medical emergency.
However, the Department of Health and Human Services has rules allowing some teens with certain conditions, such as pregnancy or the AIDS virus, to participate in federal studies without parental permission. Teens may participate if an oversight board rules that telling parents would be detrimental to the study _ and if the exceptions don't violate any state or federal law. Because of the FDA law, the exceptions typically have been reserved for behavioral studies, such as surveys about teen sexual history.
On Monday, advisers to the HHS Office of Human Research Protections recommended that FDA allow waivers of parental consent for certain teens, such as HIV patients, who wish to participate in certain treatment studies.
The committee ``asked us to see if there are other interpretations of that law to allow some flexibility,'' explained FDA senior science adviser David LePay.
The FDA will consider the recommendation, along with other comments recently submitted regarding children's medical research, but officials said changing FDA's operating law would take congressional action.