Children And Clinical Research

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 48,9 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.

Author : Eric Kodish,Robert M. Nelson
Publisher : Oxford University Press, USA
Page : 345 pages
File Size : 48,9 Mb
Release : 2018-12-14
Category : Medical
ISBN : 9780190647254

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Ethics and Research with Children by Eric Kodish,Robert M. Nelson Pdf

Fundamental questions about the morality of pediatric medical research persist despite years of debate and the establishment of strict codes of ethics. Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research involving their children? Should children or their parents be paid for participation in research? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? Promoting more thoughtful attention to the complex ethical problems that arise when research involves children, this fully updated new edition of Ethics and Research with Children presents 14 case studies featuring some of the most challenging and fascinating ethical dilemmas in pediatric research. Each chapter begins with a unique case vignette, followed by rich discussion and incisive ethical analysis. Chapters represent a host of current controversies and are contributed by leading scholars from a variety of disciplines that must grapple with how to best protect children from research risk while driving innovation in the fight against childhood diseases. Chapters end with questions for discussion, providing faculty and students with accessible starting points from which to explore more in depth the thorny issues that are raised. In the final chapter, the editors provide a synthesis and summary that serve as a capstone and companion to the case-based chapters. Unique in its specific focus on research, Ethics and Research with Children provides a balanced and thorough account of the enduring dilemmas that arise when children become research subjects, and will be essential reading for those involved with pediatric research in any context.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 446 pages
File Size : 42,9 Mb
Release : 2004-08-09
Category : Medical
ISBN : 9780309091817

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 221 pages
File Size : 44,6 Mb
Release : 2015
Category : Electronic
ISBN : 1904384315

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Children and Clinical Research by Anonim Pdf

Author : Geoffrey Miller
Publisher : Cambridge University Press
Page : 305 pages
File Size : 43,9 Mb
Release : 2010
Category : Business & Economics
ISBN : 9780521517980

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Pediatric Bioethics by Geoffrey Miller Pdf

This volume offers a theoretical and practical overview of the ethics of pediatric medicine. It serves as a fundamental handbook and resource for pediatricians, nurses, residents in training, graduate students, and practitioners of ethics and healthcare policy. Written by a team of leading experts, Pediatric Bioethics addresses those difficult ethical questions concerning the clinical and academic practice of pediatrics, including an approach to recognizing boundaries when confronted with issues such as end of life care, life-sustaining treatment, extreme prematurity, pharmacotherapy, and research. Thorny topics such as what constitutes best interests, personhood, or distributive justice and public health concerns such as immunization and newborn genetic screening are also addressed.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 55,9 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

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Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Author : David Oppenheim,Douglas F. Goldsmith
Publisher : Guilford Press
Page : 273 pages
File Size : 47,7 Mb
Release : 2007-03-08
Category : Psychology
ISBN : 9781606237496

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Attachment Theory in Clinical Work with Children by David Oppenheim,Douglas F. Goldsmith Pdf

Attachment research has tremendous potential for helping clinicians understand what happens when parent–child bonds are disrupted, and what can be done to help. Yet there remains a large gap between theory and practice in this area. This book reviews what is known about attachment and translates it into practical guidelines for therapeutic work. Leading scientist-practitioners present innovative strategies for assessing and intervening in parent–child relationship problems; helping young children recover from maltreatment or trauma; and promoting healthy development in adoptive and foster families. Detailed case material in every chapter illustrates the applications of research-based concepts and tools in real-world clinical practice.

Author : Françoise Baylis,Angela Ballantyne
Publisher : Springer
Page : 301 pages
File Size : 49,8 Mb
Release : 2017-01-02
Category : Medical
ISBN : 9783319265124

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Clinical Research Involving Pregnant Women by Françoise Baylis,Angela Ballantyne Pdf

This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.

Author : Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Evaluation of Children's Health
Publisher : National Academies Press
Page : 336 pages
File Size : 52,5 Mb
Release : 2004-10-18
Category : Social Science
ISBN : 9780309166607

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Children's Health, the Nation's Wealth by Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Evaluation of Children's Health Pdf

Children's health has clearly improved over the past several decades. Significant and positive gains have been made in lowering rates of infant mortality and morbidity from infectious diseases and accidental causes, improved access to health care, and reduction in the effects of environmental contaminants such as lead. Yet major questions still remain about how to assess the status of children's health, what factors should be monitored, and the appropriate measurement tools that should be used. Children's Health, the Nation's Wealth: Assessing and Improving Child Health provides a detailed examination of the information about children's health that is needed to help policy makers and program providers at the federal, state, and local levels. In order to improve children's health-and, thus, the health of future generations-it is critical to have data that can be used to assess both current conditions and possible future threats to children's health. This compelling book describes what is known about the health of children and what is needed to expand the knowledge. By strategically improving the health of children, we ensure healthier future generations to come.

Author : Lainie Friedman Ross
Publisher : OUP Oxford
Page : 300 pages
File Size : 42,8 Mb
Release : 2006-02-09
Category : Philosophy
ISBN : 9780191534218

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Children in Medical Research by Lainie Friedman Ross Pdf

Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook (where mentally retarded children were infected with hepatitis) are evidence that before the policy shift protection was not always adequate, even for the most vulnerable groups. Additional safeguards for children were first implemented in many countries in the 1970s and 1980s; more recent policies and guidelines are trying to promote greater participation. Ross considers whether the safeguards work, whether they are fair, and how they apply in actual research practice. She goes on to offer specific recommendations to modify current policies and guidelines. Ross examines the regulatory structures (e.g. federal regulations and institutional review boards), the ad hoc policies (e.g. payment in pediatric research and the role of schools as research venues), the actual practices of researchers (e.g. the race/ethnicity of enrolled research subjects or the decision to enroll newborns) as well as the decision-making process (both parental permission and the child's assent), in order to provide a broad critique. Some of her recommendations will break down current barriers to the enrolment of children (e.g. permitting the payment of child research subjects; allowing healthy children to be exposed to research that entails more than minimal risk without requiring recourse to 407 panels); whereas other recommendations may create new restrictions (e.g., the need for greater protection for research performed in schools; restrictions on what research should be done in the newborn nursery). The goal is to ensure that medical research is done in a way that promotes the health of current and future children without threatening, to use the words of Hans Jonas, 'the erosion of those moral values whose loss . . . would make its most dazzling triumphs not worth having'.

Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller
Publisher : OUP USA
Page : 848 pages
File Size : 45,9 Mb
Release : 2011-02
Category : Medical
ISBN : 9780199768639

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The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Pdf

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

Author : Dorothee Heemskerk,Maxine Caws,Ben Marais,Jeremy Farrar
Publisher : Springer
Page : 66 pages
File Size : 42,6 Mb
Release : 2015-07-17
Category : Medical
ISBN : 9783319191324

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Tuberculosis in Adults and Children by Dorothee Heemskerk,Maxine Caws,Ben Marais,Jeremy Farrar Pdf

This work contains updated and clinically relevant information about tuberculosis. It is aimed at providing a succinct overview of history and disease epidemiology, clinical presentation and the most recent scientific developments in the field of tuberculosis research, with an emphasis on diagnosis and treatment. It may serve as a practical resource for students, clinicians and researchers who work in the field of infectious diseases.

Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Page : 1220 pages
File Size : 51,7 Mb
Release : 2019-12-16
Category : Medical
ISBN : 9781119413417

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Pharmacoepidemiology by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy Pdf

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Author : Thomas H. Ollendick,Jerome A. Cerny
Publisher : Springer Science & Business Media
Page : 362 pages
File Size : 50,8 Mb
Release : 2013-03-08
Category : Medical
ISBN : 9781468411041

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Clinical Behavior Therapy with Children by Thomas H. Ollendick,Jerome A. Cerny Pdf

As noted by its title, the focus of this book is centered on an examination of behavior therapy with children in clinical settings. Throughout, our goal has been to examine theoretical underpinnings, review empirical research, and illustrate clinical utility for a variety of behavioral proce dures with children. In pursuing this goal, we have described child behavior therapy as an approach based on empirical methodology, de rived from behavioral principles, and focused upon adjustment disor ders of children. The hallmark of such an approach is its accountability the extent to which the procedures and techniques presented in this text are demonstrably accountable must be determined at least partially by the reader. As students of child behavior, we have become sensitized to two trends in behavior therapy with children during the preparation of this book. First, we have been concerned with the simple application of behavioral procedures to children, irrespective of developmental con siderations. All too frequently, assessment strategies and treatment pro cedures found to be useful with adults have been applied to children in an indiscriminate fashion. For example, some recent studies have examined and assessed the very same social skill deficits in children as in adults (e. g. , lack of eye contact, delayed latency of response, and absence of positive commendatory responses). Surely, skill deficits differ from age to age just as they differ from situation to situation.

Author : Bernard Lo
Publisher : Lippincott Williams & Wilkins
Page : 302 pages
File Size : 54,6 Mb
Release : 2012-03-28
Category : Medical
ISBN : 9781451152777

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Ethical Issues in Clinical Research by Bernard Lo Pdf

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.