Ethical Research

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.

About the ContributorsAbbreviations1. Introduction: The Limits of Altruism - Ulf Schmidt, Dominique Sprumont, Andreas FrewerPart 1: What Can We Know? History of Human Rights in Human Experimentation2. The Declaration of Helsinki and the Foundations of Global Bioethics - Robert Baker3. From Nuremberg to Helsinki: The Prosecution of Medical War Crimes at the Struthof Medical Trials, France 1952-4 - Christian Bonah, Florian Schmaltz4. In the Absence of Alternatives: The Origins and Success of the Declaration of Helsinki, 1947-82 - Ulf Schmidt5. Conflicts of Interest? The World Medical Association, Research Ethics, and Industry in the 1950s and 1960s - Andreas Frewer6. Doctors and Research behind the "Nylon Curtain": Medical Ethics Debates and the Declaration of Helsinki in East Germany, 1961-89 - Schmidt, Markus Wahl7. Secret Trials behind Walls: The Role of the State Security Service in East German Human Experiments, 1961-89 - Rainer Erices, Antje Gumz, Andreas FrewerPart 2: How Should We Act? Reflecting about Theory and Practice of Research Ethics8. Ideas of Human Rights in Human Experimentation - Ruth Macklin9. Agreements and Disagreements about the Placebo Rule - Eugenijus Gefenas10. Research Ethics Regulations: Rules versus Responsibilities - Dominique Sprumont11. The Declaration of Helsinki and Transparency: When International Ethics Standards Face National Implementation Challenges - Trudo Lemmens, Gregory Ringkamp12. Conflicts of Interest in Human Subject Research: Best Practices, International Standards, and Challenges in Implementing U.S. Regulations - Marc Rodwin13. The Helsinki Declaration and the "American Stamp" - Jonathan MorenoPart 3: What May We Hope for the Future? International Experiences and Challenges in Research Ethics14. The Declaration of Helsinki: A European Perspective - Henriette D.C. Roscam Abbing15. The Helsinki Declaration in Brazil: Research Ethics and the Right to Public Health - Dirceu Greco16. The Helsinki Declaration in South Africa: Vulnerability in Health Research - Ames Dhai17. The Helsinki Declaration in West and Central Africa: Case Studies - Odile Ouwe Missi Oukem, Godfrey B. Tangwa18. The Helsinki Declaration in China: An Example of the Tension between International Guidelines and Native Cultural Values - Qiu Renzong, Xiaomei Zhai19. The Future of Research Ethics - Johannes van DeldenPart 4: The Art of Compromise: Negotiating Change in Modern Research Ethics20. The Declaration of Helsinki 1964-Witnesses, Observations and Participation - Juhana Id?np??n-Heikkil?21. Contextualizing the Declaration of Helsinki, 1964-2008 - John Williams22. Reflections on the Revisions to the Declaration of Helsinki from 2000 to 2013 - Robert J. Levine23. A New Declaration 50 Years On: Presenting the 2013 Revision Process - Urban Wiesing, Ramin Parsa-ParsiPart 5: Conclusion and Outlook24. Some Reflections on Research Ethics - Dominique Sprumont, Andreas Frewer, Ulf SchmidtAppendixDraft and typed versions of the Declaration of Helsinki 1964Index