Ethical Conduct of Clinical Research Involving Children

In recent decades, advances in biomedical research have helped save orlengthen the lives of children around the world. With improved therapies,child and adolescent mortality rates have decreased significantly in the lasthalf century. Despite these advances, pediatricians and others argue thatchildren have not shared equally with adults in biomedical advances. Eventhough we want children to benefit from the dramatic and acceleratingrate of progress in medical care that has been fueled by scientific research,we do not want to place children at risk of being harmed by participatingin clinical studies.Ethical Conduct of Clinical Research Involving Children considers the necessitiesand challenges of this type of research and reviews the ethical andlegal standards for conducting it. It also considers problems with the interpretationand application of these standards and conduct, concluding thatwhile children should not be excluded from potentially beneficial clinicalstudies, some research that is ethically permissible for adults is not acceptablefor children, who usually do not have the legal capacity or maturity tomake informed decisions about research participation. The book looks atthe need for appropriate pediatric expertise at all stages of the design,review, and conduct of a research project to effectively implement policiesto protect children. It argues persuasively that a robust system for protectinghuman research participants in general is a necessary foundation forprotecting child research participants in particular. Table of ContentsFront MatterSummary1 Introduction2 The Necessity and Challenges of Clinical Research Involving Children3 Regulatory Framework for Protecting Child Participants in Research4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children5 Understanding and Agreeing to Children's Participation in Clinical Research6 Payments Related to Children's Participation in Clinical Research7 Regulatory Compliance, Accreditation, and Quality Improvement8 Responsible Research Involving ChildrenReferencesAppendix A: Study Origins and ActivitiesAppendix B: State Regulation of Medical Research with Children Adolescents: An Overview and AnalysisAppendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in ResearchAppendix D: Glossary, Acronyms, and Laws and RegulationsAppendix E: Committee Biographical StatementsIndex