The necessity and challenges of clinical research involving children -- Regulatory framework for protecting child participants in research -- Defining, interpreting, and applying concepts of risk and benefit in clinical research involving children -- Understanding and agreeing to children's participation in clinical research -- Payments related to children's participation in clinical research -- Regulatory compliance, accreditation, and quality improvement -- Responsible research involving children. In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic rate of progress in medical care, we do not want to place children at risk of being harmed by participating in clinical studies. This book consideres the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also looks at the need for appropriate pediatric expertise al all stages of the design, review, and conduct of a research project to effecively implement policies to protect children.