Ethical Conduct of Clinical Research Involving Children

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Author :
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Safe and Effective Medicines for Children

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Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Attachment Theory in Clinical Work with Children

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Author :
Publisher : Guilford Press
ISBN 13 : 1606237497
Total Pages : 273 pages
Book Rating : 4.6/5 (62 download)

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Book Synopsis Attachment Theory in Clinical Work with Children by : David Oppenheim

Download or read book Attachment Theory in Clinical Work with Children written by David Oppenheim and published by Guilford Press. This book was released on 2007-03-08 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Children in Medical Research

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Publisher : OUP Oxford
ISBN 13 : 0191534218
Total Pages : 300 pages
Book Rating : 4.1/5 (915 download)

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Book Synopsis Children in Medical Research by : Lainie Friedman Ross

Download or read book Children in Medical Research written by Lainie Friedman Ross and published by OUP Oxford. This book was released on 2006-02-09 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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'.

Children's Health, the Nation's Wealth

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Publisher : National Academies Press
ISBN 13 : 0309166608
Total Pages : 336 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Children's Health, the Nation's Wealth by : Institute of Medicine

Download or read book Children's Health, the Nation's Wealth written by Institute of Medicine and published by National Academies Press. This book was released on 2004-10-18 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pediatric Bioethics

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Publisher : Cambridge University Press
ISBN 13 : 0521517982
Total Pages : 305 pages
Book Rating : 4.5/5 (215 download)

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Book Synopsis Pediatric Bioethics by : Geoffrey Miller

Download or read book Pediatric Bioethics written by Geoffrey Miller and published by Cambridge University Press. This book was released on 2010 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Children and Clinical Research

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Author :
Publisher :
ISBN 13 : 9781904384311
Total Pages : 221 pages
Book Rating : 4.3/5 (843 download)

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Book Synopsis Children and Clinical Research by :

Download or read book Children and Clinical Research written by and published by . This book was released on 2015 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Research Involving Pregnant Women

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Publisher : Springer
ISBN 13 : 3319265121
Total Pages : 301 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Clinical Research Involving Pregnant Women by : Françoise Baylis

Download or read book Clinical Research Involving Pregnant Women written by Françoise Baylis and published by Springer. This book was released on 2017-01-02 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pediatric Lymphomas

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Publisher : Springer Science & Business Media
ISBN 13 : 354068753X
Total Pages : 296 pages
Book Rating : 4.5/5 (46 download)

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Book Synopsis Pediatric Lymphomas by : Howard J. Weinstein

Download or read book Pediatric Lymphomas written by Howard J. Weinstein and published by Springer Science & Business Media. This book was released on 2007-01-20 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive textbook of Hodgkin's and non-Hodgkin's lymphomas written by leaders in the field of childhood lymphomas. It includes clinical, pathologic and molecular biology of each subtype of lymphoma. The pathology chapters are comprehensive and include excellent photographs. The book is at the level of subspecialists in pediatric hematology and oncology, radiation oncology, pediatric surgery and hematopathology.

Clinical Trials

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Publisher : Oxford University Press
ISBN 13 : 0199750599
Total Pages : 208 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis Clinical Trials by : Lorna Speid, Ph.D

Download or read book Clinical Trials written by Lorna Speid, Ph.D and published by Oxford University Press. This book was released on 2010-07-30 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.

Ethics and Research with Children

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Publisher : Oxford University Press, USA
ISBN 13 : 0190647256
Total Pages : 345 pages
Book Rating : 4.1/5 (96 download)

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Book Synopsis Ethics and Research with Children by : Eric Kodish

Download or read book Ethics and Research with Children written by Eric Kodish and published by Oxford University Press, USA. This book was released on 2018-12-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Oxford Textbook of Clinical Research Ethics

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Publisher : OUP USA
ISBN 13 : 0199768633
Total Pages : 848 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel

Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Critical Thinking in Clinical Research

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Publisher : Oxford University Press
ISBN 13 : 0199324492
Total Pages : 537 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis Critical Thinking in Clinical Research by : Felipe Fregni

Download or read book Critical Thinking in Clinical Research written by Felipe Fregni and published by Oxford University Press. This book was released on 2018 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Ethical and Regulatory Aspects of Clinical Research

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Publisher :
ISBN 13 :
Total Pages : 532 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Psychosocial Care of Children in Hospitals

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Author :
Publisher : Ingram
ISBN 13 : 9780937821701
Total Pages : 159 pages
Book Rating : 4.8/5 (217 download)

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Book Synopsis Psychosocial Care of Children in Hospitals by :

Download or read book Psychosocial Care of Children in Hospitals written by and published by Ingram. This book was released on 1990 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Rocket Boys of NIH :.

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (123 download)

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Book Synopsis The Rocket Boys of NIH :. by : Don Luckett

Download or read book The Rocket Boys of NIH :. written by Don Luckett and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Informed Consent in Medical Research

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Publisher : BMJ Books
ISBN 13 : 9780727914866
Total Pages : 0 pages
Book Rating : 4.9/5 (148 download)

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Book Synopsis Informed Consent in Medical Research by : Len Doyal

Download or read book Informed Consent in Medical Research written by Len Doyal and published by BMJ Books. This book was released on 2000-12-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive discussion of the ethical issues involved in informing patients on their rights and participation in medical research and treatment. With 30 chapters contributed by internationally recognised medical ethicists, Informed Consent provides an authoritative reference on a subject of major importance in medical ethics