Ethical Conduct of Clinical Research Involving Children

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Author :
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Author :
Publisher : OUP Oxford
ISBN 13 : 0191534218
Total Pages : 300 pages
Book Rating : 4.1/5 (915 download)

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Book Synopsis Children in Medical Research by : Lainie Friedman Ross

Download or read book Children in Medical Research written by Lainie Friedman Ross and published by OUP Oxford. This book was released on 2006-02-09 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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'.

Vaccination in America

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Author :
Publisher : Springer
ISBN 13 : 331996349X
Total Pages : 355 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Vaccination in America by : Richard J. Altenbaugh

Download or read book Vaccination in America written by Richard J. Altenbaugh and published by Springer. This book was released on 2018-08-02 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Research Involving Pregnant Women

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Author :
Publisher : Springer
ISBN 13 : 3319265121
Total Pages : 301 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Clinical Research Involving Pregnant Women by : Françoise Baylis

Download or read book Clinical Research Involving Pregnant Women written by Françoise Baylis and published by Springer. This book was released on 2017-01-02 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.

The Ethics of Research with Children and Young People

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Author :
Publisher : SAGE Publications
ISBN 13 : 0857021370
Total Pages : 177 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis The Ethics of Research with Children and Young People by : Priscilla Alderson

Download or read book The Ethics of Research with Children and Young People written by Priscilla Alderson and published by SAGE Publications. This book was released on 2011-02-09 with total page 177 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 and Clinical Research

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Author :
Publisher :
ISBN 13 : 9781904384311
Total Pages : 221 pages
Book Rating : 4.3/5 (843 download)

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Book Synopsis Children and Clinical Research by :

Download or read book Children and Clinical Research written by and published by . This book was released on 2015 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Research Involving Children

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Author :
Publisher :
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Research Involving Children by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book Research Involving Children written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1977 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Against Their Will

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Publisher : St. Martin's Press
ISBN 13 : 1137363452
Total Pages : 284 pages
Book Rating : 4.1/5 (373 download)

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Book Synopsis Against Their Will by : Allen M. Hornblum

Download or read book Against Their Will written by Allen M. Hornblum and published by St. Martin's Press. This book was released on 2013-06-25 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

America's Children

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Publisher : National Academies Press
ISBN 13 : 0309173930
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis America's Children by : Institute of Medicine and National Research Council

Download or read book America's Children written by Institute of Medicine and National Research Council and published by National Academies Press. This book was released on 1998-10-27 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: America's Children is a comprehensive, easy-to-read analysis of the relationship between health insurance and access to care. The book addresses three broad questions: How is children's health care currently financed? Does insurance equal access to care? How should the nation address the health needs of this vulnerable population? America's Children explores the changing role of Medicaid under managed care; state-initiated and private sector children's insurance programs; specific effects of insurance status on the care children receive; and the impact of chronic medical conditions and special health care needs. It also examines the status of "safety net" health providers, including community health centers, children's hospitals, school-based health centers, and others and reviews the changing patterns of coverage and tax policy options to increase coverage of private-sector, employer-based health insurance. In response to growing public concerns about uninsured children, last year Congress voted to provide $24 billion over five years for new state insurance initiatives. This volume will serve as a primer for concerned federal policymakers and regulators, state agency officials, health plan decisionmakers, health care providers, children's health advocates, and researchers.

Clinical Trials in Vulnerable Populations

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Author :
Publisher : BoD – Books on Demand
ISBN 13 : 1789232007
Total Pages : 226 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Clinical Trials in Vulnerable Populations by : Milica Prostran

Download or read book Clinical Trials in Vulnerable Populations written by Milica Prostran and published by BoD – Books on Demand. This book was released on 2018-05-09 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.

Protecting Data Privacy in Health Services Research

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Publisher : National Academies Press
ISBN 13 : 0309071879
Total Pages : 208 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Protecting Data Privacy in Health Services Research by : Institute of Medicine

Download or read book Protecting Data Privacy in Health Services Research written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-13 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.

The Rocket Boys of NIH :.

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (123 download)

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Book Synopsis The Rocket Boys of NIH :. by : Don Luckett

Download or read book The Rocket Boys of NIH :. written by Don Luckett and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ethics and Research with Children

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Author :
Publisher : Oxford University Press
ISBN 13 : 0190671939
Total Pages : 408 pages
Book Rating : 4.1/5 (96 download)

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Book Synopsis Ethics and Research with Children by : Eric Kodish

Download or read book Ethics and Research with Children written by Eric Kodish and published by Oxford University Press. This book was released on 2018-11-26 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Informed Consent in Medical Research

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Publisher : BMJ Books
ISBN 13 : 9780727914866
Total Pages : 0 pages
Book Rating : 4.9/5 (148 download)

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Book Synopsis Informed Consent in Medical Research by : Len Doyal

Download or read book Informed Consent in Medical Research written by Len Doyal and published by BMJ Books. This book was released on 2000-12-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Medical Research with Children

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Publisher : Oxford University Press, USA
ISBN 13 :
Total Pages : 296 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Medical Research with Children by : Richard H. Nicholson

Download or read book Medical Research with Children written by Richard H. Nicholson and published by Oxford University Press, USA. This book was released on 1986 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Research Involving Children

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Author :
Publisher :
ISBN 13 :
Total Pages : 630 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Research Involving Children by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book Research Involving Children written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1977 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt:

MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)

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Author :
Publisher :
ISBN 13 : 9781568870717
Total Pages : 0 pages
Book Rating : 4.8/5 (77 download)

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Book Synopsis MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) by : Paul S. Appelbaum

Download or read book MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) written by Paul S. Appelbaum and published by . This book was released on 2001 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The MacCAT-CR provides a structured format for capacity assessment that is adaptable to the particulars of any given research project. With the introduction of the MacCAT-CR, researchers enrolling human participants in their studieshave available for the first time a reliable and valid means of assessing their potential subject's capacity to consent to participation. The MacCAT-CR can typically be administered in 15-20 minutes. Beginning with project-specific disclosures to potential participants, the MacCAT-CR measures the four generally accepted components of decision-making competence: understanding, appreciation, reasoning, and the ability to express a choice. Quantification of subjects' responses permits comparisons across subjects and subject groups, and allows the MacCAT-CR to be used for not only for screening individual participants but also for conducting research on the characteristics of subject populations and for assessing the effectiveness of interventions designed to increase subjects' capacities.