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.

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'.

Practical Research with Children

Practical Research with Children PDF Author: Jess Prior
Publisher: Routledge
ISBN: 1317384040
Category : Psychology
Languages : en
Pages : 309

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Book Description
Practical Research with Children is designed to help the reader understand techniques for research with children, based on real world experience. The book describes a wide range of research methods, focusing equally on quantitative and qualitative approaches, and considers how different methods can be integrated. It highlights the benefits and challenges of each method and gives emphasis to best practice, with expert guidance on how to avoid potential pitfalls in order to obtain valuable insights into how children develop. The volume includes fifteen chapters arranged over three sections. Each chapter explores a particular method, or combination of methods, and discusses both theoretical and practical issues, using a diversity of domains, including different ages, cultures, populations and settings. Uniquely, the book includes newer methods (such as eye tracking and digital technologies) alongside well-established behavioural methods which are used for research with children. With contributions from internationally renowned researchers and practitioners from a range of disciplines, the book will be indispensable reading for a wide audience, including for students in psychology, education and nursing undertaking research projects with children, and also for anyone looking to understand the research behind current theories in child development.

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.

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.

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.

Informed Consent in Medical Research

Informed Consent in Medical Research PDF Author: Len Doyal
Publisher: BMJ Books
ISBN: 9780727914866
Category : Medical
Languages : en
Pages : 334

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Book Description
This is a comprehensive discussion of the ethical issues involved in informing patients on their rights and participation in medical research and treatment. With 30 chapters contributed by internationally recognised medical ethicists, Informed Consent provides an authoritative reference on a subject of major importance in medical ethics

Ethical Issues in Mental Health Research With Children and Adolescents

Ethical Issues in Mental Health Research With Children and Adolescents PDF Author: Kimberly Hoagwood
Publisher: Routledge
ISBN: 1317824601
Category : Psychology
Languages : en
Pages : 334

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Book Description
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.

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.