| Document Type
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BL
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| Record Number
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1019093
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| Doc. No
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b773463
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| Title & Author
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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.
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| Publication Statement
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Washington, D.C. :: National Academies Press,, [2004]
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, ©2004
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| Page. NO
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1 online resource (xviii, 425 pages) :: illustrations
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| ISBN
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030953125X
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: 9780309531252
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0309091810
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9780309091817
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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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.
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| Abstract
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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.
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| Subject
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Human experimentation in medicine.
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Pediatrics-- Research-- Moral and ethical aspects.
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Biomedical Research-- ethics.
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Child.
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Expérimentation humaine en médecine.
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Pédiatrie-- Recherche-- Aspect moral.
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Human experimentation in medicine.
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MEDICAL-- Ethics.
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Pediatrics-- Research-- Moral and ethical aspects.
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Human Experimentation.
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Minors.
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Research Subjects.
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Beroepsethiek.
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Experimenten.
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Kindergeneeskunde.
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Medisch onderzoek.
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Adolescent.
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Comprehension.
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Ethics Committees, Research.
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Fees and Charges.
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Government Regulation.
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Human Experimentation-- ethics.
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Human Experimentation-- legislation jurisprudence.
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Research Subjects-- economics
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Risk Assessment.
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United States.
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| Dewey Classification
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174.2/8
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| LC Classification
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RJ85.E85 2004eb
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| NLM classification
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2004 K-282
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W 20.5E838 2004
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44.02bcl
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| Added Entry
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Behrman, Richard E.,1931-
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Field, Marilyn J., (Marilyn Jane)
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| Added Entry
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Institute of Medicine (U.S.)., Committee on Clinical Research Involving Children.
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