Table of Contents
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Front Matter	i-xx
Summary	1-24	(skim)
1 Introduction	25-57	(skim)
2 The Necessity and Challenges of Clinical Research Involving Children	58-92	(skim)
3 Regulatory Framework for Protecting Child Participants in Research	93-112	(skim)
4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children	113-145	(skim)
5 Understanding and Agreeing to Children's Participation in Clinical Research	146-210	(skim)
6 Payments Related to Children's Participation in Clinical Research	211-228	(skim)
7 Regulatory Compliance, Accreditation, and Quality Improvement	229-245	(skim)
8 Responsible Research Involving Children	246-276	(skim)
References	277-308	(skim)
Appendix A: Study Origins and Activities	309-319	(skim)
Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis	320-387	(skim)
Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research	388-393	(skim)
Appendix D: Glossary, Acronyms, and Laws and Regulations	394-401	(skim)
Appendix E: Committee Biographical Statements	402-408	(skim)
Index	409-425	(skim)

Description

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. 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 and accelerating rate 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 participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Reviews

"...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. ... The report is both welcome and timely. ... The report does not merely stress the need to protect children from being exploited in research but correctly emphasizes the ethical importance of such pediatric research. ... The committee should be commended on its willingness to make important recommendations on difficult issues. The report contains a wealth of information and suggestions for all who are concerned with clinical research that involves children, and it should receive wide dissemination and discussion."
-- New England Journal of Medicine, August 12, 2004

Authoring Organizations

• Board on Health Sciences Policy (HSP)
• Institute of Medicine (IOM)
• More Titles from HSP
• More Titles from IOM

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