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This report from the Institute of Medicine Committee on Clinical Research Involving Children comprehensively discusses the conflicting objectives of scientific research that involves children: ensuring that children benefit from the progress in medical care made possible by such research while minimizing the risks from their participation. It is divided into eight sections that review the need for and challenges of clinical research involving children and the existing regulatory framework for protecting children who participate in research. The requirements of both parental consent and children's assent to participate are described in detail, as are the appropriate riskbenefit ratios. Important issues such
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