Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-07-09

Total Pages: 445

ISBN-13: 0309133386

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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

Safe and Effective Medicines for Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-10-13

Total Pages: 432

ISBN-13: 0309225493

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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 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.


Ethics and Research with Children

Ethics and Research with Children

Author: Eric Kodish

Publisher: Paperbackshop UK Import

Published: 2018-12-24

Total Pages: 345

ISBN-13: 0190647256

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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.


Ethics in Pediatrics

Ethics in Pediatrics

Author: Ian Mitchell

Publisher: Springer Nature

Published: 2020-01-01

Total Pages: 464

ISBN-13: 3030226174

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This book offers easy access to the everyday ethics problems that occur in the medical care of children. It contains practical guidance on how physicians and other healthcare practitioners may manage both straightforward and complex ethics problems. The book provides a readable and comprehensive introduction to ethics issues for beginners and is also extremely valuable to experienced practitioners.This work covers important "classical" ethical issues such as privacy, confidentiality, truth telling, and discusses the elements of the relationships that might exist between parents and healthcare providers. However, the book also provides a resource for new and emerging areas of bioethics. These include issues arising in the new population of children who are beginning to survive the neonatal and infant periods with a multitude of problems – “children with medical complexity". Finally, it also includes a section on the advantages and pitfalls of social media use.


Pediatric Ethics: Theory and Practice

Pediatric Ethics: Theory and Practice

Author: Nico Nortjé

Publisher: Springer

Published: 2022-12-03

Total Pages: 0

ISBN-13: 9783030861841

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This book assists health care providers to understand the specific interplay of the roles and relationships currently forming the debates in pediatric clinical ethics. It builds on the fact that, unlike adult medical ethics, pediatric ethics begins within an acutely and powerfully experienced dynamic of patient-family-state-physician relationship. The book provides a unique perspective as it interacts with established approaches as well as recent developments in pediatric ethics theory, and then explores these developments further through cases. The book first focuses on setting the stage by introducing a theoretical framework and elaborating how pediatric ethics differ from non-pediatric ethics. It approaches different theoretical frameworks in a critical manner drawing on their strengths and weaknesses. It helps the reader in developing an ability to engage in ethical reasoning and moral deliberation in order to focus on the wellbeing of the child as the main participant in the ethical deliberation, as well as to be able to identify the child’s moral claims. The second section of the book focuses on the practical application of these theoretical frameworks and discusses specific areas pertaining to decision-making. These are: the critically ill child, new and enduring ethical controversies, and social justice at large, the latter of which includes looking at the child’s place in society, access to healthcare, social determinants of health, and vaccinations. With the dynamic changes and challenges pediatric care faces across the globe, as well as the changing face of new technologies, no professional working in the field of pediatrics can afford not to take due note of this resource.


Clinical Ethics in Pediatrics

Clinical Ethics in Pediatrics

Author: Douglas S. Diekema

Publisher: Cambridge University Press

Published: 2011-09-08

Total Pages: 263

ISBN-13: 1139501836

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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.


Pediatric Bioethics

Pediatric Bioethics

Author: Geoffrey Miller

Publisher: Cambridge University Press

Published: 2010

Total Pages: 305

ISBN-13: 0521517982

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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, Ethics, and Modern Medicine

Children, Ethics, and Modern Medicine

Author: Richard B. Miller

Publisher:

Published: 2003-06-18

Total Pages: 342

ISBN-13:

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Utilizing a form of medical ethnography to investigate a variety of pediatric contexts, Richard B. Miller tests the fit of different ethical approaches in various medical settings to arrive at a new paradigm for how best to care for children. Miller contends that the principle of beneficence must take priority over autonomy in the treatment of children. Yet doctors alone cannot decide what is best for the child. Determining and implementing such decisions, Miller argues, doctors must become part of a "therapeutic alliance" with families and the child undergoing medical care to arrive at the best course of treatment.Children, Ethics, and Modern Medicine combines strong philosophical argumentation with firsthand knowledge of the issues facing children and families in pediatric care. This book will be an invaluable resource for medical ethicists and practitioners in pediatric care, as well as parents struggling with ethical issues in the care and treatment of their children.


Pediatric Ethics

Pediatric Ethics

Author: Alan R. Fleischman

Publisher: Oxford University Press

Published: 2016

Total Pages: 257

ISBN-13: 0199354472

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This work examines the many ethical issues related to health care in children. It explores the moral obligations of families and clinicians facing hard choices for critically ill and dying children, ranging from neonates to adolescents. It also addresses the ethical concerns in research, genetic testing and screening, and surgical and medical enhancement


Ethical Issues in Mental Health Research With Children and Adolescents

Ethical Issues in Mental Health Research With Children and Adolescents

Author: Kimberly Hoagwood

Publisher: Routledge

Published: 2014-06-03

Total Pages: 334

ISBN-13: 1317824601

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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.