TY  - BOOK
AU  - Field,Marilyn J.
AU  - Behrman,Richard E.
ED  - Institute of Medicine (U.S.).
TI  - Ethical conduct of clinical research involving children
SN  - 030953125X
AV  - RJ85 .E85 2004eb
U1  - 174.2/8 22
PY  - 2004///]
CY  - Washington, D.C.
PB  - National Academies Press
KW  - Pediatrics
KW  - Research
KW  - Moral and ethical aspects
KW  - Human experimentation in medicine
KW  - Children
KW  - Institutional review boards (Medicine)
KW  - Risk assessment
KW  - Biomedical Research
KW  - ethics
KW  - Child
KW  - Human Experimentation
KW  - Research Subjects
KW  - Minors
KW  - economics
KW  - Adolescent
KW  - Comprehension
KW  - Ethics Committees, Research
KW  - Fees and Charges
KW  - Government Regulation
KW  - legislation & jurisprudence
KW  - Risk Assessment
KW  - Pédiatrie
KW  - Recherche
KW  - Aspect moral
KW  - Expérimentation humaine en médecine
KW  - Enfants
KW  - Comités d'éthique de la recherche
KW  - Évaluation du risque
KW  - children (people by age group)
KW  - aat
KW  - risk assessment
KW  - MEDICAL
KW  - Ethics
KW  - bisacsh
KW  - fast
KW  - Kindergeneeskunde
KW  - gtt
KW  - Medisch onderzoek
KW  - Experimenten
KW  - Beroepsethiek
KW  - United States
N1  - Includes bibliographical references and index; 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; Electronic reproduction; [Place of publication not identified]; HathiTrust Digital Library; 2010
N2  - 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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ER  -