FrontMatter -- Contents -- Preface -- Acknowledgments -- Reviewers -- Summary -- 1 Introduction -- 2 The Necessity and Challenges of Clinical Research Involving Children -- 3 Regulatory Framework for Protecting Child Participants in Research -- 4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children -- 5 Understanding and Agreeing to Children's Participation in Clinical Research -- 6 Payments Related to Children's Participation in Clinical Research -- 7 Regulatory Compliance, Accreditation, and Quality Improvement -- 8 Responsible Research Involving Children -- References -- Appendices -- A Study Origins and Activities -- B State Regulation of Medical Research with Children and Adolescents: An Overview and Analysis -- C Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research -- D Glossary, Acronyms, and Laws and Regulations -- E Committee Biographical Statements -- Index.