Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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.
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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 Ethics of Research with Children and Young People
Author: Priscilla Alderson
Publisher: SAGE Publications
ISBN: 0857021370
Category : Education
Languages : en
Pages : 177
Book Description
Ethical questions are at the centre of research with children and young people. This clear and practical text informs students and researchers about the relevant laws and guidelines and current debates in research ethics. Priscilla Alderson and Virginia Morrow cover ethics at every stage of research, and with all kinds of young research participants, particularly those who are vulnerable or neglected. They break down the process of research into ten stages, each with its own set of related questions and problems, and they show how these need to be addressed. This practical book is essential reading for anyone who conducts or reviews research with children or young people. Priscilla Alderson is Emerita Professor of Childhood Studies at the Institute of Education University of London. Virginia Morrow is Senior Research Officer in the Department of International Development, University of Oxford.
Publisher: SAGE Publications
ISBN: 0857021370
Category : Education
Languages : en
Pages : 177
Book Description
Ethical questions are at the centre of research with children and young people. This clear and practical text informs students and researchers about the relevant laws and guidelines and current debates in research ethics. Priscilla Alderson and Virginia Morrow cover ethics at every stage of research, and with all kinds of young research participants, particularly those who are vulnerable or neglected. They break down the process of research into ten stages, each with its own set of related questions and problems, and they show how these need to be addressed. This practical book is essential reading for anyone who conducts or reviews research with children or young people. Priscilla Alderson is Emerita Professor of Childhood Studies at the Institute of Education University of London. Virginia Morrow is Senior Research Officer in the Department of International Development, University of Oxford.
Children in Medical Research
Author: Lainie Friedman Ross
Publisher: OUP Oxford
ISBN: 0191534218
Category : Philosophy
Languages : en
Pages : 300
Book Description
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'.
Publisher: OUP Oxford
ISBN: 0191534218
Category : Philosophy
Languages : en
Pages : 300
Book Description
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'.
Pediatric Bioethics
Author: Geoffrey Miller
Publisher: Cambridge University Press
ISBN: 0521517982
Category : Business & Economics
Languages : en
Pages : 305
Book Description
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.
Publisher: Cambridge University Press
ISBN: 0521517982
Category : Business & Economics
Languages : en
Pages : 305
Book Description
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.
Research with Children
Author: Michelle O′Reilly
Publisher: SAGE
ISBN: 1446291685
Category : Education
Languages : en
Pages : 316
Book Description
Thought-provoking, pertinent and engaging, this book provides an overview of every aspect of carrying out research with children. It is unique in its particular focus on vulnerable groups of children such as those with mental-health problems, physical health problems and learning disabilities, along with young offenders and looked after children. The book helpfully addresses each stage of the research process: -Part I introduces the main elements of doing research with children, including seeking ethical approval for sensitive research topics. -Part II guides the reader through the initial stages of the research project including recruitment issues and communicating with gatekeepers. -Part III outlines the data collection, data analysis, writing up and dissemination stages of research and covers both quantitative and qualitative methods. Filled with practical advice and useful activities for each chapter, this book is an essential resource for any student, academic or professional working with, or doing research with, children.
Publisher: SAGE
ISBN: 1446291685
Category : Education
Languages : en
Pages : 316
Book Description
Thought-provoking, pertinent and engaging, this book provides an overview of every aspect of carrying out research with children. It is unique in its particular focus on vulnerable groups of children such as those with mental-health problems, physical health problems and learning disabilities, along with young offenders and looked after children. The book helpfully addresses each stage of the research process: -Part I introduces the main elements of doing research with children, including seeking ethical approval for sensitive research topics. -Part II guides the reader through the initial stages of the research project including recruitment issues and communicating with gatekeepers. -Part III outlines the data collection, data analysis, writing up and dissemination stages of research and covers both quantitative and qualitative methods. Filled with practical advice and useful activities for each chapter, this book is an essential resource for any student, academic or professional working with, or doing research with, children.
Conflict of Interest in Medical Research, Education, and Practice
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309145449
Category : Medical
Languages : en
Pages : 436
Book Description
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Publisher: National Academies Press
ISBN: 0309145449
Category : Medical
Languages : en
Pages : 436
Book Description
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Children’s Competence to Consent
Author: Gary B. Melton
Publisher: Springer Science & Business Media
ISBN: 1468442899
Category : Psychology
Languages : en
Pages : 364
Book Description
Publisher: Springer Science & Business Media
ISBN: 1468442899
Category : Psychology
Languages : en
Pages : 364
Book Description
Women and Health Research
Author: Anna C. Mastroianni
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 268
Book Description
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 268
Book Description
Vaccination in America
Author: Richard J. Altenbaugh
Publisher: Springer
ISBN: 331996349X
Category : History
Languages : en
Pages : 349
Book Description
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.
Publisher: Springer
ISBN: 331996349X
Category : History
Languages : en
Pages : 349
Book Description
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.
Ethical Considerations for Research on Housing-Related Health Hazards Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309164923
Category : Social Science
Languages : en
Pages : 216
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.
Publisher: National Academies Press
ISBN: 0309164923
Category : Social Science
Languages : en
Pages : 216
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.