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.
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 2004-08-09 with total page 446 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.
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.
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.
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.
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.
Download or read book Ethics and Research with Children written by Eric Kodish and published by Paperbackshop UK Import. This book was released on 2018-12-24 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 306 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.
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.
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.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Download or read book Children As Research Subjects Science Ethics and Law written by Program in Medical Ethics Michael A. Grodin Director and published by Oxford University Press, USA. This book was released on 1994-02-08 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is using children as research subjects ever justified? Are there limits to such use? Does the fact that children are medically and psychosocially different from adults have implications for research? What can we learn from the history of the use and abuse of children as research subjects? Do parents have the authority to volunteer their children for research projects? How should children participate in the decision to be involved in research? How should research risks be assessed and balanced? These perplexing questions and others are addressed by a distinguished group of experts in the field of biomedical and behavioral research with children. This book adopts an integrated multidisciplinary approach which uses science, ethics, and law as guides for exploring these most difficult issues. The tension between acquiring important new knowledge and fulfilling the obligation to protect children from exploitation and harm is a recurring theme. As the first book to be devoted solely to the science, ethics, and law of research with children, it is an indispensable resource to physicians, psychologists, educators, lawyers, ethicists, Institutional Review Board members, child advocates and others involved in performing or reviewing research with children.
Download or read book Clinical Ethics in Pediatrics written by Douglas S. Diekema and published by Cambridge University Press. This book was released on 2011-09-08 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a practical overview of the ethical issues arising in pediatric practice. The case-based approach grounds the bioethical concepts in real-life situations, covering a broad range of important and controversial topics, including informed consent, confidentiality, truthfulness and fidelity, ethical issues relating to perinatology and neonatology, end-of-life issues, new technologies, and problems of justice and public health in pediatrics. A dedicated section also addresses the topics of professionalism, including boundary issues, conflicts of interests and relationships with industry, ethical issues arising during training, and dealing with the impaired or unethical colleague. Each chapter contains a summary of the key issues covered and recommendations for approaching similar situations in other contexts. Clinical Ethics in Pediatrics: A Case-Based Textbook is an essential resource for all physicians who care for children, as well as medical educators, residents and scholars in clinical bioethics.
Download or read book Ethical Issues in Clinical Research written by Bernard Lo and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pocket Book of Hospital Care for Children written by World Health Organization and published by World Health Organization. This book was released on 2013 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.
Download or read book Clinical Behavior Therapy with Children written by Thomas H. Ollendick and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
