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Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

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September 2003

Beschreibung

Beschreibung

"Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics." -- Bulletin of the World Health Organization
"This book provides excellent matieral on a broad variety of ethical topics in clinical research." -- Quality Assurance Journal
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process.

Inhaltsverzeichnis

Contents:Part I. Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and TuskegeePart II. Ethical and Regulatory Guidance for Research with HumansPart III. The Ethics of Clinical Trial DesignPart IV. The Ethics of Research Participant RecruitmentPart V. Informed Consent in ResearchPart VI. Clinical Research with Special PopulationsPart VII. Special Topics in Research EthicsPart VIII. The Behavior of Clinical Investigators: Conflicts of InterestPart IX. Scientific MisconductPart X. Challenges to the Institutional Review Board System

Portrait

Ezekiel J. Emanuel, M.D., Ph.D., is Chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center at the National Institutes of Health. Robert A. Crouch, M.A., is an Assistant Professor in the Biomedical Ethics Unit and the Department of Social Studies of Medicine at McGill University. John D. Arras, Ph.D., is Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia. Jonathan D. Moreno, Ph.D., is Director of the Center for Biomedical Ethics at the University of Virginia. Christine Grady, R.N., Ph.D., is Head, Section on Human Subjects Research in the Department of Clinical Bioethics at the National Institutes of Health.

Pressestimmen

Provides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of literature included. A lot of information is made available at a very affordable price. Quality Assurance Journal 2005 Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics. -- Leonardo D. de Castro Bulletin of the World Health Organization 2004 One word will suffice to describe the book-outstanding. -- Sanjay A. Pai Current Science 2004
EAN: 9780801878138
ISBN: 0801878136
Untertitel: Empfohlen ab 22 Jahre. New. Sprache: Englisch.
Verlag: JOHNS HOPKINS UNIV PR
Erscheinungsdatum: September 2003
Seitenanzahl: 528 Seiten
Format: kartoniert
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