Ethical Research The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation

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.

Ulf Schmidt is Professor of Modern History and Director of the Centre for the History of Medicine, Ethics and Medical Humanities at the University of Kent, Canterbury, Kent. He studied modern history at the Universities of Hamburg and Oxford. He is a Fellow of the Royal Historical Society, and was previously Wellcome Trust Post-Doctoral Research Fellow and Senior Associate Member of St Antony's College, Oxford University.

Andreas Frewer is Professor at the Institute for History of Medicine and Medical Ethics. He studied medicine, philosophy, and the history of medicine in Munich, Erlangen, Berlin, Vienna, Oxford, and Jerusalem. Dissertation at the Free University of Berlin (scl) and European Master in Bioethics (scl). 1994-1998 Physician in Berlin, 1998-2002 Assistant Professor Goettingen, 2002-2006 Professor in Hanover. Since 2007 IRB and CEC at FAU/University Hospital Erlangen.

Dominique Sprumont is Adjunct Professor of Health Law, founder and deputy-director of the Institute of Health Law at the University of Neuch?tel, Switzerland and invited Professor at the Institute of Social and Preventive Medicine, Faculty of Biology and Medicine, University of Lausanne, Switzerland. He is the President of the Research Ethics Committee of the Canton of Vaud, Lausanne, Switzerland. He is a Swiss School of Public Health (SSPH+) Fellow.

About the Contributors
Abbreviations

1. Introduction: The Limits of Altruism - Ulf Schmidt, Dominique Sprumont, Andreas Frewer

Part 1: What Can We Know? History of Human Rights in Human Experimentation
2. The Declaration of Helsinki and the Foundations of Global Bioethics - Robert Baker
3. From Nuremberg to Helsinki: The Prosecution of Medical War Crimes at the Struthof Medical Trials, France 1952-4 - Christian Bonah, Florian Schmaltz
4. In the Absence of Alternatives: The Origins and Success of the Declaration of Helsinki, 1947-82 - Ulf Schmidt
5. Conflicts of Interest? The World Medical Association, Research Ethics, and Industry in the 1950s and 1960s - Andreas Frewer
6. Doctors and Research behind the "Nylon Curtain": Medical Ethics Debates and the Declaration of Helsinki in East Germany, 1961-89 - Schmidt, Markus Wahl
7. Secret Trials behind Walls: The Role of the State Security Service in East German Human Experiments, 1961-89 - Rainer Erices, Antje Gumz, Andreas Frewer

Part 2: How Should We Act? Reflecting about Theory and Practice of Research Ethics
8. Ideas of Human Rights in Human Experimentation - Ruth Macklin
9. Agreements and Disagreements about the Placebo Rule - Eugenijus Gefenas
10. Research Ethics Regulations: Rules versus Responsibilities - Dominique Sprumont
11. The Declaration of Helsinki and Transparency: When International Ethics Standards Face National Implementation Challenges - Trudo Lemmens, Gregory Ringkamp
12. Conflicts of Interest in Human Subject Research: Best Practices, International Standards, and Challenges in Implementing U.S. Regulations - Marc Rodwin
13. The Helsinki Declaration and the "American Stamp" - Jonathan Moreno

Part 3: What May We Hope for the Future? International Experiences and Challenges in Research Ethics
14. The Declaration of Helsinki: A European Perspective - Henriette D.C. Roscam Abbing
15. The Helsinki Declaration in Brazil: Research Ethics and the Right to Public Health - Dirceu Greco
16. The Helsinki Declaration in South Africa: Vulnerability in Health Research - Ames Dhai
17. The Helsinki Declaration in West and Central Africa: Case Studies - Odile Ouwe Missi Oukem, Godfrey B. Tangwa
18. The Helsinki Declaration in China: An Example of the Tension between International Guidelines and Native Cultural Values - Qiu Renzong, Xiaomei Zhai
19. The Future of Research Ethics - Johannes van Delden

Part 4: The Art of Compromise: Negotiating Change in Modern Research Ethics
20. The Declaration of Helsinki 1964-Witnesses, Observations and Participation - Juhana Id?np??n-Heikkil?
21. Contextualizing the Declaration of Helsinki, 1964-2008 - John Williams
22. Reflections on the Revisions to the Declaration of Helsinki from 2000 to 2013 - Robert J. Levine
23. A New Declaration 50 Years On: Presenting the 2013 Revision Process - Urban Wiesing, Ramin Parsa-Parsi

Part 5: Conclusion and Outlook
24. Some Reflections on Research Ethics - Dominique Sprumont, Andreas Frewer, Ulf Schmidt

Appendix
Draft and typed versions of the Declaration of Helsinki 1964
Index