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

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

The Ethics of Research with Children and Young People PDF Author: Priscilla Alderson
Publisher: SAGE Publications
ISBN: 0857021370
Category : Education
Languages : en
Pages : 177

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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

Children in Medical Research PDF Author: Lainie Friedman Ross
Publisher: OUP Oxford
ISBN: 0191534218
Category : Philosophy
Languages : en
Pages : 300

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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'.

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.

Doing Research with Children and Young People

Doing Research with Children and Young People PDF Author: Sandy Fraser
Publisher: SAGE
ISBN: 9780761943815
Category : Medical
Languages : en
Pages : 308

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Book Description
Doing Research with Children and Young People introduces researchers to the key considerations involved in working with children and young people.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432

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Book Description
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.

Children As Research Subjects : Science, Ethics, and Law

Children As Research Subjects : Science, Ethics, and Law PDF Author: Program in Medical Ethics Michael A. Grodin Director
Publisher: Oxford University Press, USA
ISBN: 9780199771424
Category : Medical
Languages : en
Pages : 290

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Book Description
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.

Research Involving Children

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 : 184

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Book Description


Ethical research with children

Ethical research with children PDF Author: Ann Farrell
Publisher: McGraw-Hill Education (UK)
ISBN: 0335224989
Category : Education
Languages : en
Pages : 200

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Book Description
This book focuses on doing ethical research with children in today's climate of increased globalization, surveillance and awareness of children as competent research participants. It covers a range of conceptual, methodological and procedural issues, and provides a framework for doing ethical research with children. Written by international experts in the fields of early childhood research and ethics, this book supports students, practitioner-researchers and research gatekeepers with resources on how to conduct and evaluate ethical research with children. The contributors: Use key examples of cutting-edge research from a range of countries to examine research ethics with children and those around them Provide strategies for planning, conducting and evaluating research in an ethical way Explore theoretical approaches to children and childhood that are relevant to ethical research Ethical Research with Children is key reading for students in childhood studies, teacher education, public health, nursing, human services, legal studies, psychology and social sciences, as well as practitioner-researchers in these fields.

Ethics in Light of Childhood

Ethics in Light of Childhood PDF Author: John Wall
Publisher: Georgetown University Press
ISBN: 1589016246
Category : Philosophy
Languages : en
Pages : 216

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Book Description
Childhood faces humanity with its own deepest and most perplexing questions. An ethics that truly includes the world’s childhoods would transcend pre-modern traditional communities and modern rational autonomy with a postmodern aim of growing responsibility. It would understand human relations in a poetic rather than universalistic sense as openly and interdependently creative. As a consequence, it would produce new understandings of moral being, time, and otherness, as well as of religion, rights, narrative, families, obligation, and power. Ethics in Light of Childhood fundamentally reimagines ethical thought and practice in light of the experiences of the third of humanity who are children. Much like humanism, feminism, womanism, and environmentalism, Wall argues, a new childism is required that transforms moral thinking, relations, and societies in fundamental ways. Wall explores childhood’s varied impacts on ethical thinking throughout history, advances the emerging interdisciplinary field of childhood studies, and reexamines basic assumptions in contemporary moral theory and practice. In the process, he does not just apply ethics to childhood but applies childhood to ethics—in order to imagine a more expansive humanity.