Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children PDF 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.

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

Get Book Here

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.

The Belmont Report

The Belmont Report PDF Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614

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Book Description


Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309164923
Category : Social Science
Languages : en
Pages : 216

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Book Description
Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

Appendix to Report and Recommendations, Research Involving Children

Appendix to Report and Recommendations, Research Involving Children PDF Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Children
Languages : en
Pages : 442

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Book Description


Parenting Matters

Parenting Matters PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309388570
Category : Social Science
Languages : en
Pages : 525

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Book Description
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.

New Directions in Child Abuse and Neglect Research

New Directions in Child Abuse and Neglect Research PDF 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.

A Roadmap to Reducing Child Poverty

A Roadmap to Reducing Child Poverty PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309483980
Category : Social Science
Languages : en
Pages : 619

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Book Description
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.

International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans PDF Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0

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Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Transforming the Workforce for Children Birth Through Age 8

Transforming the Workforce for Children Birth Through Age 8 PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309324882
Category : Social Science
Languages : en
Pages : 587

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Book Description
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.

Depression in Parents, Parenting, and Children

Depression in Parents, Parenting, and Children PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309121787
Category : Medical
Languages : en
Pages : 488

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Book Description
Depression is a widespread condition affecting approximately 7.5 million parents in the U.S. each year and may be putting at least 15 million children at risk for adverse health outcomes. Based on evidentiary studies, major depression in either parent can interfere with parenting quality and increase the risk of children developing mental, behavioral and social problems. Depression in Parents, Parenting, and Children highlights disparities in the prevalence, identification, treatment, and prevention of parental depression among different sociodemographic populations. It also outlines strategies for effective intervention and identifies the need for a more interdisciplinary approach that takes biological, psychological, behavioral, interpersonal, and social contexts into consideration. A major challenge to the effective management of parental depression is developing a treatment and prevention strategy that can be introduced within a two-generation framework, conducive for parents and their children. Thus far, both the federal and state response to the problem has been fragmented, poorly funded, and lacking proper oversight. This study examines options for widespread implementation of best practices as well as strategies that can be effective in diverse service settings for diverse populations of children and their families. The delivery of adequate screening and successful detection and treatment of a depressive illness and prevention of its effects on parenting and the health of children is a formidable challenge to modern health care systems. This study offers seven solid recommendations designed to increase awareness about and remove barriers to care for both the depressed adult and prevention of effects in the child. The report will be of particular interest to federal health officers, mental and behavioral health providers in diverse parts of health care delivery systems, health policy staff, state legislators, and the general public.