Title Ethical conduct of clinical research involving children / Marilyn J. Field and Richard E. Behrman, editors ; Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine of the National Academies

Published Washington, D.C. : National Academies Press, [2004] ©2004

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Description 1 online resource (xviii, 425 pages) : illustrations Series Online access: NCBI NCBI Bookshelf Contents 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 Summary 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. The Ethical Conduct of 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 thatis 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 Bibliography Includes bibliographical references and index Notes Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL Print version record digitized 2010 HathiTrust Digital Library committed to preserve pda MiAaHDL Subject Pediatrics -- Research -- Moral and ethical aspects Human experimentation in medicine. Children. Institutional review boards (Medicine) Risk assessment. Biomedical Research -- ethics Child Human Experimentation Research Subjects Minors Research Subjects -- economics Adolescent Comprehension Ethics Committees, Research Fees and Charges Government Regulation Human Experimentation -- ethics Human Experimentation -- legislation & jurisprudence Risk Assessment children (people by age group) risk assessment. MEDICAL -- Ethics. Risk assessment Institutional review boards (Medicine) Children Human experimentation in medicine Pediatrics -- Research -- Moral and ethical aspects Kindergeneeskunde. Medisch onderzoek. Experimenten. Beroepsethiek. SUBJECT United States Form Electronic book Author Field, Marilyn J. (Marilyn Jane) Behrman, Richard E., 1931- Institute of Medicine (U.S.). Committee on Clinical Research Involving Children. ISBN 030953125X 9780309531252

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