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Including children in research signals new era

Warning that pediatricians must prevent Americans from "protecting our children to death," Jim Hanson, M.D., FAAP, and other AAP members are working to implement a recent victory, in the Academy's long campaign to include children in research.

The National Institutes of Health (NIH) in January announced a policy that all clinical research that could potentially affect children be required to include children as subjects—or else justify their exclusion.

The new policy breaks, with cultural and medical traditions that actually tended to do children more harm than good, according to experts.

"Children were not gaining the ordinary protections and advantages of a research program that adults get," said Dr. Hanson, special assistant to the director of the National Institute of Child Health and Human Development (NICHD). "Carried to an extreme, this would have the effect of denying care to children—sort of protecting them to death."

The NIH policy expansion is based on conclusions reached last June at a worskhop co-sponsored by the Academy and NICHD.

Edward McCabe, M.D., FAAP, physician-in-chief for the UCLA Children's Hospital, who spoke at the workshop, explained, "Our concern is that children are underrepresented in research—very much analogous to where women and minorities were underrepresented a few years ago.