Children In Medical 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 : 54,8 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 : Lainie Friedman Ross
Publisher : OUP Oxford
Page : 300 pages
File Size : 45,9 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 : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 446 pages
File Size : 46,5 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 : 46,9 Mb
Release : 2015
Category : Electronic
ISBN : 1904384315

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Children and Clinical Research by Anonim Pdf

Author : Richard J. Altenbaugh
Publisher : Springer
Page : 355 pages
File Size : 45,9 Mb
Release : 2018-08-02
Category : History
ISBN : 9783319963495

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Vaccination in America by Richard J. Altenbaugh Pdf

The success of the polio vaccine was a remarkable breakthrough for medical science, effectively eradicating a dreaded childhood disease. It was also the largest medical experiment to use American schoolchildren. Richard J. Altenbaugh examines an uneasy conundrum in the history of vaccination: even as vaccines greatly mitigate the harm that infectious disease causes children, the process of developing these vaccines put children at great risk as research subjects. In the first half of the twentieth century, in the face of widespread resistance to vaccines, public health officials gradually medicalized American culture through mass media, public health campaigns, and the public education system. Schools supplied tens of thousands of young human subjects to researchers, school buildings became the main dispensaries of the polio antigen, and the mass immunization campaign that followed changed American public health policy in profound ways. Tapping links between bioethics, education, public health, and medical research, this book raises fundamental questions about child welfare and the tension between private and public responsibility that still fuel anxieties around vaccination today.

Author : Richard H. Nicholson
Publisher : Oxford University Press, USA
Page : 296 pages
File Size : 40,7 Mb
Release : 1986
Category : Children
ISBN : UOM:39015010144122

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Medical Research with Children by Richard H. Nicholson Pdf

Should children be excluded from medical research? Some child rights activists argue that no child should ever be used for research, while many physicians claim that health care for children will not improve without such experimentation. This informative study examines the legal and ethical basis for carrying out research on children, discussing such factors as the distinction between therapeutic and nontherapeutic research, the nature of risk in medical research, and the degree to which children can make responsible decisions regarding research on themselves. A thoughtful, lucid consideration of an important issue in medical ethics, this book will be of interest to all doctors working in medical research, and to pediatricians, moral philosophers, family lawyers, child welfare proponents, and interested lay people.

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children
Publisher : National Academies Press
Page : 525 pages
File Size : 48,8 Mb
Release : 2016-11-21
Category : Social Science
ISBN : 9780309388573

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Parenting Matters by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children Pdf

Decades of research have demonstrated that the parent-child dyad and the environment of the familyâ€"which includes all primary caregiversâ€"are at the foundation of children's well- being and healthy development. From birth, children are learning and rely on parents and the other caregivers in their lives to protect and care for them. The impact of parents may never be greater than during the earliest years of life, when a child's brain is rapidly developing and when nearly all of her or his experiences are created and shaped by parents and the family environment. Parents help children build and refine their knowledge and skills, charting a trajectory for their health and well-being during childhood and beyond. The experience of parenting also impacts parents themselves. For instance, parenting can enrich and give focus to parents' lives; generate stress or calm; and create any number of emotions, including feelings of happiness, sadness, fulfillment, and anger. Parenting of young children today takes place in the context of significant ongoing developments. These include: a rapidly growing body of science on early childhood, increases in funding for programs and services for families, changing demographics of the U.S. population, and greater diversity of family structure. Additionally, parenting is increasingly being shaped by technology and increased access to information about parenting. Parenting Matters identifies parenting knowledge, attitudes, and practices associated with positive developmental outcomes in children ages 0-8; universal/preventive and targeted strategies used in a variety of settings that have been effective with parents of young children and that support the identified knowledge, attitudes, and practices; and barriers to and facilitators for parents' use of practices that lead to healthy child outcomes as well as their participation in effective programs and services. This report makes recommendations directed at an array of stakeholders, for promoting the wide-scale adoption of effective programs and services for parents and on areas that warrant further research to inform policy and practice. It is meant to serve as a roadmap for the future of parenting policy, research, and practice in the United States.

Author : National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on the Science of Children Birth to Age 8: Deepening and Broadening the Foundation for Success
Publisher : National Academies Press
Page : 706 pages
File Size : 41,9 Mb
Release : 2015-07-23
Category : Social Science
ISBN : 9780309324885

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Transforming the Workforce for Children Birth Through Age 8 by National Research Council,Institute of Medicine,Board on Children, Youth, and Families,Committee on the Science of Children Birth to Age 8: Deepening and Broadening the Foundation for Success Pdf

Children are already learning at birth, and they develop and learn at a rapid pace in their early years. This provides a critical foundation for lifelong progress, and the adults who provide for the care and the education of young children bear a great responsibility for their health, development, and learning. Despite the fact that they share the same objective - to nurture young children and secure their future success - the various practitioners who contribute to the care and the education of children from birth through age 8 are not acknowledged as a workforce unified by the common knowledge and competencies needed to do their jobs well. Transforming the Workforce for Children Birth Through Age 8 explores the science of child development, particularly looking at implications for the professionals who work with children. This report examines the current capacities and practices of the workforce, the settings in which they work, the policies and infrastructure that set qualifications and provide professional learning, and the government agencies and other funders who support and oversee these systems. This book then makes recommendations to improve the quality of professional practice and the practice environment for care and education professionals. These detailed recommendations create a blueprint for action that builds on a unifying foundation of child development and early learning, shared knowledge and competencies for care and education professionals, and principles for effective professional learning. Young children thrive and learn best when they have secure, positive relationships with adults who are knowledgeable about how to support their development and learning and are responsive to their individual progress. Transforming the Workforce for Children Birth Through Age 8 offers guidance on system changes to improve the quality of professional practice, specific actions to improve professional learning systems and workforce development, and research to continue to build the knowledge base in ways that will directly advance and inform future actions. The recommendations of this book provide an opportunity to improve the quality of the care and the education that children receive, and ultimately improve outcomes for children.

Author : Institute of Medicine,Board on Health Care Services,Committee on the Future of Emergency Care in the United States Health System
Publisher : National Academies Press
Page : 360 pages
File Size : 54,7 Mb
Release : 2007-05-08
Category : Medical
ISBN : 9780309133760

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Emergency Care for Children by Institute of Medicine,Board on Health Care Services,Committee on the Future of Emergency Care in the United States Health System Pdf

Children represent a special challenge for emergency care providers, because they have unique medical needs in comparison to adults. For decades, policy makers and providers have recognized the special needs of children, but the system has been slow to develop an adequate response to their needs. This is in part due to inadequacies within the broader emergency care system. Emergency Care for Children examines the challenges associated with the provision of emergency services to children and families and evaluates progress since the publication of the Institute of Medicine report Emergency Medical Services for Children (1993), the first comprehensive look at pediatric emergency care in the United States. This new book offers an analysis of: • The role of pediatric emergency services as an integrated component of the overall health system. • System-wide pediatric emergency care planning, preparedness, coordination, and funding. • Pediatric training in professional education. • Research in pediatric emergency care. Emergency Care for Children is one of three books in the Future of Emergency Care series. This book will be of particular interest to emergency health care providers, professional organizations, and policy makers looking to address the pediatric deficiencies within their emergency care systems.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 48,5 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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.

Author : Eric Kodish M.D.
Publisher : Oxford University Press
Page : 376 pages
File Size : 47,7 Mb
Release : 2005-03-10
Category : Philosophy
ISBN : 019803833X

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Ethics and Research with Children by Eric Kodish M.D. Pdf

In this edited volume, a diverse group of scholars present and discuss challenging cases in the field of pediatric research ethics. After years of debate and controversy, fundamental questions about the morality of pediatric research persist: Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research that involves young children? What should be the role of the older child in decisions about research participation? How do the dynamics of hope and desperation influence decisions about research involving dying children? Should children or their parents be paid for participation in research? What about economic incentives for doctors, researchers and the pharmaceutical industry? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? Following an introductory overview by editor Eric David Kodish, the book is divided into three sections of case studies: Research Involving Healthy Children, Research Involving At Risk Children, and Research Involving Children with Serious Illness. Each case raises compelling ethical issues, and the analysis presented in each chapter illuminate the challenges posed across a wide spectrum of both research protocols and stories of individual case-based approach, this book provides a balanced and through account of the enduring dilemmas that arise when children become research subjects.

Author : David Wendler
Publisher : Oxford University Press
Page : 352 pages
File Size : 48,6 Mb
Release : 2010-03-01
Category : Medical
ISBN : 0199749507

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The Ethics of Pediatric Research by David Wendler Pdf

Millions of children suffer from diseases and illnesses that do not have adequate treatment, and many other children are harmed by medicines intended to help them. In order to protect and help these children, society must conduct pediatric research to identify safer and more effective medical treatments. This research requires exposing some children to risks for the benefit of others. Yet, critics and courts have argued that it is unethical to expose children to research risks for the benefit of others, and this practice seems to violate our obligation to protect children from harm and exploitation. In this way, clinical research with children presents us with what appears to be an irresolvable dilemma: either we can protect pediatric subjects from exploitation, or we can protect pediatric patients from dangerous medicines, but not both. The Ethics of Pediatric Research is the first work to systematically evaluate this dilemma, and David Wendler offers an original justification for pediatric research based on an in-depth analysis of when it is in our interests to help others. It will be of interest primarily to scholars in pediatric ethics and clinical research ethics.

Author : Allen M. Hornblum,Judith L. Newman,Gregory J. Dober
Publisher : St. Martin's Press
Page : 284 pages
File Size : 53,8 Mb
Release : 2013-06-25
Category : Science
ISBN : 9781137363459

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Against Their Will by Allen M. Hornblum,Judith L. Newman,Gregory J. Dober Pdf

During the Cold War, an alliance between American scientists, pharmaceutical companies, and the US military pushed the medical establishment into ethically fraught territory. Doctors and scientists at prestigious institutions were pressured to produce medical advances to compete with the perceived threats coming from the Soviet Union. In Against Their Will, authors Allen Hornblum, Judith Newman, and Gregory Dober reveal the little-known history of unethical and dangerous medical experimentation on children in the United States. Through rare interviews and the personal correspondence of renowned medical investigators, they document how children—both normal and those termed "feebleminded"—from infants to teenagers, became human research subjects in terrifying experiments. They were drafted as "volunteers" to test vaccines, doused with ringworm, subjected to electric shock, and given lobotomies. They were also fed radioactive isotopes and exposed to chemical warfare agents. This groundbreaking book shows how institutional superintendents influenced by eugenics often turned these children over to scientific researchers without a second thought. Based on years of archival work and numerous interviews with both scientific researchers and former test subjects, this is a fascinating and disturbing look at the dark underbelly of American medical history.

Author : Eric Kodish,Robert M. Nelson
Publisher : Oxford University Press
Page : 408 pages
File Size : 54,6 Mb
Release : 2018-11-26
Category : Psychology
ISBN : 9780190671938

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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 : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Board on Children, Youth, and Families,Committee on Building an Agenda to Reduce the Number of Children in Poverty by Half in 10 Years
Publisher : National Academies Press
Page : 619 pages
File Size : 53,7 Mb
Release : 2019-09-16
Category : Social Science
ISBN : 9780309483988

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A Roadmap to Reducing Child Poverty by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Board on Children, Youth, and Families,Committee on Building an Agenda to Reduce the Number of Children in Poverty by Half in 10 Years Pdf

The strengths and abilities children develop from infancy through adolescence are crucial for their physical, emotional, and cognitive growth, which in turn help them to achieve success in school and to become responsible, economically self-sufficient, and healthy adults. Capable, responsible, and healthy adults are clearly the foundation of a well-functioning and prosperous society, yet America's future is not as secure as it could be because millions of American children live in families with incomes below the poverty line. A wealth of evidence suggests that a lack of adequate economic resources for families with children compromises these children's ability to grow and achieve adult success, hurting them and the broader society. A Roadmap to Reducing Child Poverty reviews the research on linkages between child poverty and child well-being, and analyzes the poverty-reducing effects of major assistance programs directed at children and families. This report also provides policy and program recommendations for reducing the number of children living in poverty in the United States by half within 10 years.