This title was first published in 2003: As new medical technologies and treatments develop with increasing momentum, the legal and ethical implications of research involving human participants are being called into question as never before. Human Experimentation and Research explores the philosophical foundations of research ethics, ongoing regulatory dilemmas, and future challenges raised by the rapid globalisation and corporatisation of the research endeavour. This volume brings together some of the most significant published essays in the field. The editors also provide an informative introduction, summarizing the area and the relevance of the articles chosen.
The author finds that these committees are predominantly influenced by members of research institutions and by the researchers themselves. Yet researchers, and their institutions, stand to gain considerable benefits from the experiments they conduct. Dr McNeill argues that committees of review, as they are presently constituted, cannot be relied on to ensure an equitable balance between the interests of researchers and the interests of the human subjects experimented on. He proposes a radically different rationale and model for committee review.
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 "living document". 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 veroffentlichte Deklaration zu Helsinki ist einer der wichtigsten und international bekanntesten Kodizes zur Forschungsethik, dessen Entstehungsgeschichte von steter Kritik und zahlreichen Uberarbeitungen begleitet wurde. Dennoch weiss man relativ wenig uber die historischen Wurzeln und Novellierungsprozesse dieses "gewachsenen Dokuments" der Medizingeschichte. Bis zum heutigen Tag ist die Deklaration einer der bedeutendsten Wegweiser fur die Forschung am Menschen, deren grundsatzliches Ziel es ist, Versuchspersonen in medizinischen Experimenten zu schutzen. 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. Ausserdem 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 zukunftig 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 Trohler: 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 Barnighausen: Communicating "Tainted Science" 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 Myllymaki: 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) - The Nuremberg Code (1947) - World Medical Association: Declaration of Helsinki I (1964) - World Medical Association: Declaration of Helsinki II (Tokyo, 1975) - Council of Europe: Convention on Human Rights and Biomedicine (Oviedo, 1997) - World Medical Association: Declaration of Helsinki (2004)
Debates on the ethics of human subjects research meet with an increasing interest both within the medical profession and the broader public. Frequently, historical arguments are used to propagate or attack certain positions within these debates. However, there is a tendency to oversimplify the complexities of the past for present day purposes, and at the same time a lack of awareness of the historical dimension implicit in today's value preferences. Twentieth Century Ethics of Human Subjects Research brings together leading historians of medicine to reconstruct and analyse the history of actual experimental practices, the debates on human subjects research, and the attempts to regulate such research during the twentieth century. The volume addresses cases of medical research in France, Britain, Israel, the United States, and Germany, including the Nazi period; the major developments of ethical debates in these and further national contexts, such as the Soviet Union, the Czech Republic, and Japan. It also explores religious views (Catholic, Jewish) on human experimentation, and the origins and contexts of international codes and declarations. "Volker Roelckes Uberblick uber die Geschichte der Menschenversuche im Dritten Reich sei jedem empfohlen, der sich kurz und pragnant uber dieses dustere Kapitel deutscher Geschichte informieren mochte." FAZ.
At the heart of research with human beings is the moral notion that the experimental subject is altruistic, and is primarily concerned for the welfare of others. Beneath the surface, however, lies a very different ethical picture. Individuals participating in potentially life-saving research sometimes take on considerable risks to their own well-being. Efforts to safeguard human participants in clinical trials have intensified ever since the first version of the World Medical Association's Declaration of Helsinki (1964) and are now codified in many national and international laws and regulations. However, a comprehensive understanding of how this cornerstone document originated, changed, and functions today does not yet exist in the sphere of human research. Ethical Research brings together the work of leading experts from the fields of bioethics, health and medical law, the medical humanities, biomedicine, the medical sciences, philosophy, and history. Together, they focus on the centrality of the Declaration of Helsinki to the protection of human subjects involved in experimentation in an increasingly complex industry and in the government-funded global research environment. The volume's historical and contemporary perspectives on human research address a series of fundamental questions: Is our current human protection regime adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science? How important has the Declaration been in non-Western regions, for example in Eastern Europe, Africa, China, and South America? Why has the bureaucratization of regulation led to calls to pay greater attention to professional responsibility? Ethical Research offers insight into the way in which philosophy, politics, economics, law, science, culture, and society have shaped, and continue to shape, the ideas and practices of human research.
This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.
This collection of essays looks at the dark medical research conducted during and after World War II. Contributors describe this research, how it was brought to light, and the rationalisations of those who perpetrated and benefited from it.
The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. "[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine "Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine "You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal "Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology
