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El. knyga: Ethical Research: The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation

Edited by (Professor, Institute for History of Medicine and Medical Ethics, University of Erlangen-Nuremberg-), Edited by , Edited by (Professor of Modern History and Director of the Centre for the History of Medicine, Ethics and Medical Humanities, University of Kent)
  • Formatas: 496 pages
  • Išleidimo metai: 21-Apr-2020
  • Leidėjas: Oxford University Press Inc
  • Kalba: eng
  • ISBN-13: 9780190224189
  • Formatas: 496 pages
  • Išleidimo metai: 21-Apr-2020
  • Leidėjas: Oxford University Press Inc
  • Kalba: eng
  • ISBN-13: 9780190224189

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"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"--

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.
Acknowledgments xi
Editors and Contributors xiii
Abbreviations xix
1 Introduction: The Limits of Altruism
1(46)
Ulf Schmidt
Dominique Sprumont
Andreas Frewer
A WHAT CAN WE KNOW? HISTORY OF HUMAN RIGHTS IN HUMAN EXPERIMENTATION
2 The Declaration of Helsinki and the Foundations of Global Bioethics
47(22)
Robert Baker
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
69(32)
Christian Bonah
Florian Schmaltz
4 In the Absence of Alternatives: The Origins and Success of the Declaration of Helsinki, 1947--82
101(30)
Ulf Schmidt
5 Conflicts of Interest? The World Medical Association, Research Ethics, and Industry in the 1950s and 60s
131(36)
Andreas Frewer
6 Doctors and Research behind the "Nylon Curtain": Medical Ethics Debates and the Declaration of Helsinki in East Germany, 1961-89
167(23)
Ulf Schmidt
Markus Wahl
7 Secret Trials behind Walls: The Role of the State Security Service in East German Human Experiments, 1961--89
190(19)
Rainer Erices
Antje Gumz
Andreas Frewer
B WHAT SHOULD WE DO? REFLECTING ABOUT THEORY AND PRACTICE OF RESEARCH ETHICS
8 Ideas of Human Rights in Human Experimentation
209(18)
Ruth Macklin
9 Agreements and Disagreements about the Placebo Rule
227(14)
Eugenijus Gefenas
10 Research Ethics Regulation: Rules versus Responsibility
241(43)
Dominique Sprumont
11 The Declaration of Helsinki and Transparency: When International Ethics Standards Face National Implementation Challenges
284(26)
Trudo Lemmens
Gregory Ringkamp
12 Conflicts of Interest in Human Subject Research: Best Practices, International Standards, and Challenges in Implementing US Regulations
310(41)
Marc A. Rodwin
13 The Declaration of Helsinki and the "American Stamp"
351(18)
Jonathan D. Moreno
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
369(16)
Henriette D.C. Roscam Abbing
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
385(14)
Dirceu Greco
16 Developing Safeguards for Research Participants in South Africa: The Influence of the Declaration of Helsinki
399(17)
Ames Dhai
17 Applying the Declaration of Helsinki in African Contexts: Some Examples and Challenges from Francophone West and Central Africa
416(27)
Odile Ouwe Missi Oukem-Boyer
Godfrey B. Tangwa
18 The Declaration of Helsinki in China: An Example of the Tension between International Guidelines and Native Cultural Values
443(25)
Xiaomei Zhai
Renzong Qiu
19 The Future of Research Ethics
468(11)
Johannes van Delden
D THE ART OF COMPROMISE: NEGOTIATING CHANGE IN MODERN RESEARCH ETHICS
20 The Declaration of Helsinki, 1964---Witnesses, Observations, and Participation
479(3)
Juhana E. Idanpaan-Heikkila
21 Contextualizing the Declaration of Helsinki, 1964--2008
482(13)
John R. Williams
22 Reflections on the Revisions to the Declaration of Helsinki from 2000 to 2013
495(24)
Robert J. Levine
23 The New Declaration of Helsinki, Adopted in Fortaleza in 2013
519(32)
Urban Wiesing
Ramin Parsa-Parsi
E CONCLUSION AND OUTLOOK
24 Some Reflections on Research Ethics
551(6)
Dominique Sprumont
Ulf Schmidt
Andreas Frewer
F APPENDICES: ORIGINS OF THE DECLARATION OF HELSINKI, 1953---64
1a World Medical Association, "Principles of Human Experimentation," 1953--4
557(2)
1b World Medical Association, "Principles for those in Research and Experimentation," 1954
559(1)
2a World Medical Association, Summary of Activities, 1961
560(1)
2b World Medical Association, Report of the Committee on Medical Ethics, May, 1962
561(3)
2c World Medical Association, "Draft Code of Ethics on Human Experimentation" October, 1962
564(1)
2d World Medical Association, Minutes, October 31, 1963
565(1)
2e World Medical Association, Minutes, June 14, 1964
566(2)
3 World Medical Association, Typed Draft of the Declaration of Helsinki, 1964
568(3)
Index 571
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 Univerity 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 Neuchātel, 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.