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Ethical Conduct of Clinical Research Involving Children (Hardcover, New)
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Ethical Conduct of Clinical Research Involving Children (Hardcover, New)
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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. 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. Table of Contents Front Matter Summary
1 Introduction 2 The Necessity and Challenges of Clinical Research
Involving Children 3 Regulatory Framework for Protecting Child
Participants in Research 4 Defining, Interpreting, and Applying
Concepts of Risk and Benefit in Clinical Research Involving
Children 5 Understanding and Agreeing to Children's Participation
in Clinical Research 6 Payments Related to Children's Participation
in Clinical Research 7 Regulatory Compliance, Accreditation, and
Quality Improvement 8 Responsible Research Involving Children
References Appendix A: Study Origins and Activities Appendix B:
State Regulation of Medical Research with Children Adolescents: An
Overview and Analysis Appendix C: Health Care Privacy and
Conflict-of-Interest Regulations Relevant to Protection of Human
Participants in Research Appendix D: Glossary, Acronyms, and Laws
and Regulations Appendix E: Committee Biographical Statements Index
General
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