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Author: Klaus Rose
Publisher: Ethics International Press
ISBN: 1804411361
Category : Medical
Languages : en
Pages : 306
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Book Description
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Author: Klaus Rose
Publisher: Ethics International Press
ISBN: 1804411361
Category : Medical
Languages : en
Pages : 306
Get Book Here
Book Description
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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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.
Author: Randell Alexander
Publisher: STM Learning
ISBN: 9781936590742
Category :
Languages : en
Pages : 439
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Book Description
The second edition of Medical Response to Child Sexual Abuse is revised and updatedto reflect contemporary best practices for the pediatric approach to childhood sexualabuse. This text is specifically developed to equip physicians, nurses, and othermedical professionals with the necessary tools to identify cases of child sexual abuseand to effectively treat and examine sexually abused patients. Professionals who work with sexually abused children face a great challenge innot only treating the immediate outcomes of sexual abuse but also safeguardingtheir patients' long-term recovery. To meet their needs and the needs of those intheir care, Medical Response to Child Sexual Abuse, Second Edition offers a wealthof evidence-based research and practical guidelines to the evaluation of childhoodsexual abuse.
Author: John R. Lutzker
Publisher: Springer Science & Business Media
ISBN: 9780306456596
Category : Medical
Languages : en
Pages : 624
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Book Description
The causes of child abuse and neglect have been major topics of study since the 1960s, but treatment strategies, research, and legal issues have only received concentrated attention since the '80s. The leading figures in these efforts have contributed to this handbook, a state-of-the-art compilation of their findings that also includes writings on associated cultural issues , youth violence, sexual abuse, and child development. Both a text and a reference, the volume is uniquely founded on empirical research.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309285151
Category : Social Science
Languages : en
Pages : 376
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Book Description
Each year, child protective services receive reports of child abuse and neglect involving six million children, and many more go unreported. The long-term human and fiscal consequences of child abuse and neglect are not relegated to the victims themselves-they also impact their families, future relationships, and society. In 1993, the National Research Council (NRC) issued the report, Under-standing Child Abuse and Neglect, which provided an overview of the research on child abuse and neglect. New Directions in Child Abuse and Neglect Research updates the 1993 report and provides new recommendations to respond to this public health challenge. According to this report, while there has been great progress in child abuse and neglect research, a coordinated, national research infrastructure with high-level federal support needs to be established and implemented immediately. New Directions in Child Abuse and Neglect Research recommends an actionable framework to guide and support future child abuse and neglect research. This report calls for a comprehensive, multidisciplinary approach to child abuse and neglect research that examines factors related to both children and adults across physical, mental, and behavioral health domains-including those in child welfare, economic support, criminal justice, education, and health care systems-and assesses the needs of a variety of subpopulations. It should also clarify the causal pathways related to child abuse and neglect and, more importantly, assess efforts to interrupt these pathways. New Directions in Child Abuse and Neglect Research identifies four areas to look to in developing a coordinated research enterprise: a national strategic plan, a national surveillance system, a new generation of researchers, and changes in the federal and state programmatic and policy response.
Author: Thomas A. Roesler
Publisher:
ISBN: 9781581101362
Category : Family & Relationships
Languages : en
Pages : 0
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Book Description
Thomas A. Roesler, MD, FAAP and Carole Jenny, MD, MBA, FAAP make the case that the term Munchausen syndrome by proxy should be retired permanently and replaced with a commonsense appreciation that children can be abused by their parents in the medical environment. Physicians who find themselves providing unnecessary and harmful medical care can see the abuse for what it is, another way parents can harm children. the book offers the first detailed and comprehensive description of treatment for this form of child maltreatment.
Author: Kimberly Hoagwood
Publisher: Routledge
ISBN: 1317824601
Category : Psychology
Languages : en
Pages : 334
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Book Description
Studies involving children with mental, emotional, or behavioral problems--or their families--have to meet certain standards of research ethics. This book contains chapters on the kinds of ethical dilemmas that typically occur in different types of studies of children, and then presents 65 real-world cases from experts who study children's mental health. These experts offer practical suggestions for how to handle these dilemmas. Chapters on the perspectives of parents, regulators, and bioethicists provide additional points of view on these issues. Written in down-to-earth language, this book will be useful for professionals who study children, for those who train students in research methods, and for parents who are thinking about participating in research studies. In attempting to bridge the apparent gap between ethics and science, the editors close this volume on a note commonly sounded by researchers: more research is needed. Yet in this area, a new kind of research is required. The science of scientific ethics must be developed and expanded, and better understanding of the determinants and circumstances under which children can comprehend and evaluate risks and benefits is needed. Likewise, fuller knowledge of the contextual factors affecting children's and families' consent to participate in research is essential. In particular, development of scales to assess children's ability to comprehend risk-benefit issues, studies of families' reactions to research procedures, and empirical data on the impact of various forms of participant reimbursement will advance both science and ethics. This volume should spur further research, serving as a guide for current investigators, participating families, institutional review boards, and policymakers who shape the research enterprise.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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Book Description
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: Paul E. Mullen
Publisher: SAGE Publications
ISBN: 1452221529
Category : Psychology
Languages : en
Pages : 147
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Book Description
Childhood Sexual Abuse critically reviews research into and provides a concise and clear guide to our current knowledge on the topic. The issues covered include: the prevalence of child sexual abuse; who molests children; the effects of such abuse, both immediate and long-term; the risk factors for abuse; and the influences and interventions that may amplify or ameliorate the impact of child sexual abuse on the victim. Areas of debate, such as the false memory syndrome, are approached in terms of the research data relevant to their resolution. This volume sets out to inform rather than advocate, discusses the methodologies of research as well as their results, highlights the limitations and the extent of current information, and points out how we can learn more about child sexual abuse.
Author: Marilyn J. Field
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 456
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Book Description
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. 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 rate of progress in medical care, we do not want to place children at risk of being harmed by participating in clinical studies. This book consideres the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also looks at the need for appropriate pediatric expertise al all stages of the design, review, and conduct of a research project to effecively implement policies to protect children.
