IOM Report Recommends More Regulation in Pediatric Studies
Pediatric medical research is "supervised in a disorganized and sometimes contradictory way, which could increase hazards for some pediatric subjects," according to an Institute of Medicine report released on Thursday, the Baltimore Sun reports. The report found large differences in the review of proposed pediatric studies by institutional review boards -- committees of experts established by universities, hospitals, federal agencies and private organizations to determine whether research is ethical -- in part because members of the boards may not have expertise in pediatric health. In response, the report recommended that HHS Office for Human Research Protections take "more aggressive" efforts to enforce federal regulations on pediatric studies and called for the rules "to be extended to all privately funded pediatric research," the Sun reports. The regulations currently apply only to studies that use federal funds or involve medications that require FDA approval. The report also called for at least three pediatric experts to review pediatric studies and increased communication among IRBs.
Marilyn Field, lead author of the report, estimated that the number of children in pediatric studies has more than tripled over the past seven years, in large part because of a 1997 federal law that provides pharmaceutical companies with incentives to test their medications on children (Kohn, Baltimore Sun, 3/26). Richard Behrman, chair of the IOM committee that prepared the report, said that "involving more children in clinical research today will benefit the health and well-being of countless children in the future." However, he said that "children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf." Dr. Charles Prober, of the Elizabeth Glaser Pediatric AIDS Foundation, added, "Children are physiologically different than adults. They are developing day by day and year by year and you cannot extrapolate" the proper dosages of medications that they require (AP/Long Island Newsday, 3/26).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.