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Clearly argued and written in nontechnical language, this book provides a definitive account of informed consent. It begins by presenting the analytic framework for reasoning about informed consent found in moral philosophy and law. The authors then review and interpret the history of informed consent in clinical medicine, research, and the courts. They argue that respect for autonomy has had a central role in the justification and function of informed consent requirements. Then they present a theory of the nature of informed consent that is based on an appreciation of its historical roots. An important contribution to a topic of current legal and ethical debate, this study is accessible to everyone with a serious interest in biomedical ethics, including physicians, philosophers, policy makers, religious ethicists, lawyers, and psychologists. This timely analysis makes a significant contribution to the debate about the rights of patients and subjects.
One of the most challenging tasks facing clinicians today is the assessment of patients' capacities to consent to treatment. The protection of a patient's right to decide, as well as the protection of incompetent patients from the potential harm of their decisions, rests largely on clinicians' abilities to judge patients' capacities to decide what treatment they will receive. However, confusing laws and the complicated ethical issues surrounding the concept of competence to consent have made the process of competence assessment intimidating for many clinicians. Health professionals--physicians, medical students, residents, nurses, and mental health practitioners--have long needed a concise guidebook that translates the issues for practice. That is what this book accomplishes. This volume is the product of an eight-year study of patients' capacities to make treatment decisions--the most comprehensive research of its kind. The authors describe the place of competence in the doctrine of informed consent, analyze the elements of decision-making, and show how assessments of competence to consent to treatment can be conducted within varied general medical and psychiatric treatment settings. The book explains how assessments should be conducted and offers detailed, practice-tested interview guidelines to assist medical practitioners in this task. Numerous case studies illustrate real-life applications of the concepts and methods discussed. Grisso and Appelbaum also explore the often difficult process of making judgments about competence and describe what to do when patients' capacities are limited. A timely, practical handbook relevant to every medical specialty, Assessing Competence to Consent to Treatment will benefit a wide array of medical practitioners--including physicians, medical students, residents, nurses, and other allied health professionals--who need to assess the mental competence of patients in their everyday practice. It will also interest ethicists and moral philosophers, as well as geriatricians and clinical psychologists working with cognitively impaired patients.
Despite having been revised and criticised over the years, the Declaration of Helsinki remains one of the most important and internationally known ethics codes worldwide. Yet we know relatively little about its historical origins or about the prolonged revision process which accompanied this ôliving documentö. The chapters presented in this volume look at the history and theory of human experimentation, assess the role of the Helsinki Declaration in an international context, and illustrate specific issues about the history and practice of research ethics through a number of case studies in the United States, Asia and Europe. To this day, the Declaration is one of the most important landmarks in human subject research which is aimed at protecting experimental subjects in society. The current volume offers a better and historically-informed understanding of the Declaration to ensure that the existing safeguards are not only preserved but developed and improved in the future. Die 1964 veröffentlichte Deklaration zu Helsinki ist einer der wichtigsten und international bekanntesten Kodizes zur Forschungsethik, dessen Entstehungsgeschichte von steter Kritik und zahlreichen Ã_berarbeitungen begleitet wurde. Dennoch weiá man relativ wenig ber die historischen Wurzeln und Novellierungsprozesse dieses ägewachsenen Dokumentsô der Medizingeschichte. Bis zum heutigen Tag ist die Deklaration einer der bedeutendsten Wegweiser f r die Forschung am Menschen, deren grundsätzliches Ziel es ist, Versuchspersonen in medizinischen Experimenten zu sch tzen. Der Band beleuchtet Geschichte und Theorie der Experimente am Menschen, untersucht die Rolle der Deklaration im internationalen Kontext und illustriert spezifische Themen zur Geschichte und Praxis der Forschungsethik anhand von Fallstudien zu den USA, Asien und Europa. Auáerdem geben die Studien Einblick in die Entstehungsgeschichte der Deklaration - nicht nur um die bestehenden Standards zum Schutz von Versuchspersonen zu bewahren, sondern auch um diese zuk nftig weiterzuentwickeln und zu verbessern. Aus dem Inhalt Ulf Schmidt / Andreas Frewer: History and Ehtics of Human Experimentation: the Twisted Road to Helsinki. An Introduction History and Theory of Medical Research Ethics Ulrich Tröhler: The Long Road of Moral Concern: Doctors' Ethos and Statute Law Relating to Human Research in Europe Dietrich von Engelhardt: The Historical and Philosophical Background of Ethics in Clinical Research Ulf Schmidt: The Nuremberg Doctors' Trial and the Nuremberg Code Till Bärnighausen: Communicating ôTainted Scienceö: The Japanese Biological Warfare Experiments on Human Subjects in China The Helsinki Declaration in an International Context Susan E. Lederer: Research Without Borders: The Origins of the Declaration of Helsinki Povl Riis: Forty Years of the Declaration of Helsinki: Progress in Medical Ethics? Kati Myllymäki: Revising the Declaration of Helsinki: An Insiders' View Robert Carlson / Kenneth Boyd / David Webb: The Interpretation of Codes of Medical Ethics: Some Lessons from the Fifth Revision of the Declaration of Helsinki David Willcox: Medical Ethics and Public Perception: The Declaration of Helsinki and its Revisions in 2000 Dominique Sprumont / Sara Girardin / Trudo Lemmens: The Helsinki Declaration and the Law: An International and Comparative Analysis History and Ethics of Research - International Perspectives Andreas Frewer: History of Medicine and Ethics in Conflict: Research on National Socialism as Moral Problem Ulf Schmidt: Medical Ethics and Human Experiments at Porton Down: Informed Consent in Britain's Biological and Chemical Warfare Experiments John Williams: The Declaration of Helsinki. The Importance of Context Jonathan D. Moreno: Helsinki into the Future. An Epilogue Key Documents on the History of Research Ethics Circular of the Reich Minister of the Interior Concerning Guidelines for New Therapy and Human Experimentation (Berlin, 1931) ù The Nuremberg Code (1947) ù World Medical Association: Declaration of Helsinki I (1964) ù World Medical Association: Declaration of Helsinki II (Tokyo, 1975) ù Council of Europe: Convention on Human Rights and Biomedicine (Oviedo, 1997) ù World Medical Association: Declaration of Helsinki (2004).
Informed consent - as an ethical ideal and legal doctrine - has been the source of much concern to clinicians. Drawing on a diverse set of backgrounds and two decades of research in clinical settings, the authors - a lawyer, a physician, a social scientist, and a philosopher - help clinicians understand and cope with their legal obligations and show how the proper handling of informed consent can improve , rather than impede, patient care. Following a concise review of the ethical and legal foundations of informed consent, they provide detailed, practical suggestions for incorporating informed consent into clinical practice. This completely revised and updated edition discusses how to handle informed consent in all phases of the doctor-patient relationship, use of consent forms, patients' refusals of treatment, and consent to research. It comments on recent laws and national policy, and addresses cutting edge issues, such as fulfilling physician obligations under managed care. This clear and succinct book contains a wealth of information that will not only help clinicians meet the legal requirements of informed consent and understand its ethical underpinnings, but also enhance their ability to deal with their patients more effectively. It will be of value to all those working in areas where issues of informed consent are likely to arise, including medicine, biomedical research, mental health care, nursing, dentistry, biomedical ethics, and law.
For many years this has been a leading textbook of bioethics. It established the framework of principles within the field. This is a very thorough revision with a new chapter on methods and moral justification.
Consent is a basic component of the ethics of human relations, making permissible a wide range of conduct that would otherwise be wrongful. Consent marks the difference between slavery and employment, permissible sexual relations and rape, borrowing or selling and theft, medical treatment and battery, participation in research and being a human guinea pig. This book assembles the contributions of a distinguished group of scholars concerning the ethics of consent in theory and practice. Part One addresses theoretical perspectives on the nature and moral force of consent, and its relationship to key ethical concepts, such as autonomy and paternalism. Part Two examines consent in a broad range of contexts, including sexual relations, contracts, selling organs, political legitimacy, medicine, and research.
Written by epidemiologists, ethicists and legal scholars, this book provides an in-depth account of the moral problems that often confront epidemiologists, including both theoretical and practical issues. The first edition has sold almost three thousand copies since it was published in 1996. This edition is fully revised and includes three new chapters:Ethical Issues in Public Health Practice, Ethical Issues in Genetic Epidemiology, and Ethical Issues in International Health Research and Epidemiology. These chapters collectively address important developments of the past decade. Three chapters from the first edition have also been reorganized: Ethicall Optimized Study Deisgns in Epidemiology, Ethical Issues in Epidemiologic Research with Children, and The Ethics of Epidemiologic Research with Older Populations. Instead of standing alone, these chapters have been integrated into chapters on informed consent, confidentiality and privacy protection, and community-based intervention studies.

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