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. »-- Quatrième de couverture cover Half title Ethical Research The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation Copyright Contents Acknowledgments Editors and Contributors Abbreviations 1. Introduction: The Limits of Altruism A: What Can We Know? History of Human Rights in Human Experimentation 2. The Declaration of Helsinki and the Foundations of Global Bioethics 3. From Nuremberg to Helsinki: The Preparation of the Declaration of Helsinki in the Light of the Prosecution of Medical War Crimes at the Struthof Medical Trials, France, 1952–​4 4. In the Absence of Alternatives: The Origins and Success of the Declaration of Helsinki, 1947–​82 5. Conflicts of Interest? The World Medical Association, Research Ethics, and Industry in the 1950s and 60s 6. Doctors and Research behind the “Nylon Curtain”: Medical Ethics Debates and the Declaration of Helsinki in East Germany, 1961–​89 7. Secret Trials behind Walls: The Role of the State Security Service in East German Human Experiments, 1961–​89 B: What Should We Do? Reflecting about Theory and Practice of Research Ethics 8. Ideas of Human Rights in Human Experimentation 9. Agreements and Disagreements about the Placebo Rule 10. Research Ethics Regulation: Rules versus Responsibility 11. The Declaration of Helsinki and Transparency: When International Ethics Standards Face National Implementation Challenges 12. Conflicts of Interest in Human Subject Research: Best Practices, International Standards, and Challenges in Implementing US Regulations 13. The Declaration of Helsinki and the “American Stamp” C: What May We Hope for the Future? International Experiences and Challenges in Research Ethics 14. The Declaration of Helsinki, a European Perspective: A Health Lawyer’s View 15. Research Ethics and the Right to Public Health: Care and Treatment of Clinical Trial Participants from the Perspective of Achieving Universal Access to Adequate Public Health 16. Developing Safeguards for Research Participants in South Africa: The Influence of the Declaration of Helsinki 17. Applying the Declaration of Helsinki in African Contexts: Some Examples and Challenges from Francophone West and Central Africa 18. The Declaration of Helsinki in China: An Example of the Tension between International Guidelines and Native Cultural Values 19. The Future of Research Ethics D: The Art of Compromise: Negotiating Change in Modern Research Ethics 20. The Declaration of Helsinki, 1964—​Witnesses, Observations, and Participation 21. Contextualizing the Declaration of Helsinki, 1964–​2008 22. Reflections on the Revisions to the Declaration of Helsinki from 2000 to 2013 23. The New Declaration of Helsinki, Adopted in Fortaleza in 2013 E: Conclusion and Outlook 24. Some Reflections on Research Ethics F: Appendices: Origins of the Declaration of Helsinki, 1953–​64 1a. World Medical Association, “Principles of Human Experimentation,” 1953–4​ 1b. World Medical Association, “Principles for those in Research and Experimentation,” 1954 2a. World Medical Association, Summary of Activities, 1961 2b. World Medical Association, Report of the Committee on Medical Ethics, May, 1962 2c. World Medical Association, “Draft Code of Ethics on Human Experimentation,” October, 1962 2d. World Medical Association, Minutes, October 31, 1963 2e. World Medical Association, Minutes, June 14, 1964 3. World Medical Association, Typed Draft of the Declaration of Helsinki, 1964 Index "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"-- Provided by publisher