History and Theory of Human Experimentation

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)

• Edited by Ulf Schmidt
• Edited by Andreas Frewer