Ethical Conduct of Clinical Research Involving Children

Released on by Institute of Medicine
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  • Ethical Conduct of Clinical Research Involving Children Book Detail

  • Author : Institute of Medicine
  • Release Date : 2004-07-09
  • Publisher : National Academies Press
  • Genre : Medical
  • Pages : 445
  • ISBN 13 : 0309133386
  • File Size : 38,38 MB
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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine PDF Summary

Book 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.

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Safe and Effective Medicines for Children

Safe and Effective Medicines for Children

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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used fo