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 pediatric studies.
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 Foundation.
“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.
Most researchers welcome regulations
Prober said many research centers follow federal ethics guidelines voluntarily, and welcomed the IOM report because it stresses the need for more research involving children.
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.
Higher payments to child volunteers prohibited
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.
