WASHINGTON -- Federal rules to protect children from risky or unethical clinical research should be extended to cover all pediatric research in the public and private sectors, says a new report from the Institute of Medicine of the National Academies. Currently, the rules apply primarily to studies that are supported by the U.S. Department of Health and Human Services or regulated by the Food and Drug Administration. Some research institutions voluntarily apply them to their studies.

The report also says that the government should offer better guidance and in more accessible formats to clinical researchers and institutional review boards (IRBs) to help them interpret the federal rules, which are more restrictive for children than adults. In turn, IRBs which are responsible for approving human research should be more thorough and explicit in judging whether research involving children meets the highest ethical and scientific standards. On the whole, as clinical research has grown in scope and complexity, implementing human-research protection policies consistently and effectively has become more challenging.

"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 committee chair Richard E. Behrman, executive chair of the Pediatric Education Steering Committee of the Federation of Pediatric Organizations, Palo Alto, Calif., and clinical professor of pediatrics at both the University of California, San Francisco, and George Washington University, Washington, D.C. "Their vulnerability demands additional protections beyond those provided to mentally competent adults."

THE GROWTH OF RESEARCH INVOLVING CHILDREN

Congress, the National Institutes of Health, and FDA have taken steps in rec
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Contact: Vanee Vines
news@nas.edu
202-334-2138
The National Academies
26-Mar-2004

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