Ethical Research The Declaration of Helsinki, and the Past,

Present, and Future of Human Experimentation - 1st Edition

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Let us not forget that progress is an optional goal, not an uncondi-
tional commitment, and that its tempo in particular, compulsive as
it may become, has nothing sacred about it.
(Hans Jonas, “Philosophical Reflections on Experimenting with
Human Subjects,” DAEDALUS, vol. 98, 1969, p. 245)
 Contents

Acknowledgments xi
Editors and Contributors xiii
Abbreviations xix
1. Introduction: The Limits of Altruism 1
Ulf Schmidt, Dominique Sprumont, Andreas Frewer

A : W HAT C A N W E K N OW ? H I S T O RY O F H UM A N
R IG H T S I N H UM A N E X P E R I M E N TAT IO N

2. The Declaration of Helsinki and the Foundations of Global Bioethics 47

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
Christian Bonah, Florian Schmaltz
4. In the Absence of Alternatives: The Origins and Success of the
Declaration of Helsinki, 1947–​82 101
Ulf Schmidt
5. Conflicts of Interest? The World Medical Association, Research
Ethics, and Industry in the 1950s and 60s 131
Andreas Frewer
6. Doctors and Research behind the “Nylon Curtain”: Medical Ethics
Debates and the Declaration of Helsinki in East Germany,
1961–​89 167
Ulf Schmidt, Markus Wahl
7. Secret Trials behind Walls: The Role of the State Security Service
in East German Human Experiments, 1961–​89 190
Rainer Erices, Antje Gumz, Andreas Frewer
viii Contents

B : W HAT SHO U L D W E D O ? R E F L E C T I N G A B OU T
T H E O RY A N D P R AC T IC E O F R E SE A R C H E T H IC S

8. Ideas of Human Rights in Human Experimentation 209

Ruth Macklin
9. Agreements and Disagreements about the Placebo Rule 227
Eugenijus Gefenas
10. Research Ethics Regulation: Rules versus Responsibility 241
Dominique Sprumont
11. The Declaration of Helsinki and Transparency: When International
Ethics Standards Face National Implementation Challenges 284
Trudo Lemmens, Gregory Ringkamp
12. Conflicts of Interest in Human Subject Research: Best Practices,
International Standards, and Challenges in Implementing
US Regulations 310
Marc A. Rodwin
13. The Declaration of Helsinki and the “American Stamp” 351
Jonathan D. Moreno

C : W HAT M AY W E HO P E F O R T H E F U T U R E ?
I N T E R NAT IO NA L E X P E R I E N C E S
A N D C HA L L E N G E S I N R E SE A R C H E T H IC S

14. The Declaration of Helsinki, a European Perspective: A Health

Lawyer’s View 369
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
Dirceu Greco
16. Developing Safeguards for Research Participants in
South Africa: The Influence of the Declaration of Helsinki 399
Ames Dhai
17. Applying the Declaration of Helsinki in African Contexts:
Some Examples and Challenges from Francophone West and
Central Africa 416
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
Xiaomei Zhai, Renzong Qiu
 Contents ix

19. The Future of Research Ethics 468

Johannes van Delden

D : T H E A RT O F C OM P R OM I SE : N E G O T IAT I N G
C HA N G E I N M O D E R N R E SE A R C H E T H IC S

20. The Declaration of Helsinki, 1964—​Witnesses, Observations,

and Participation 479
Juhana E. Idänpään-​Heikkilä
21. Contextualizing the Declaration of Helsinki, 1964–​2008 482
John R. Williams
22. Reflections on the Revisions to the Declaration of Helsinki
from 2000 to 2013 495
Robert J. Levine
23. The New Declaration of Helsinki, Adopted in Fortaleza in 2013 519
Urban Wiesing, Ramin Parsa-​Parsi

E : C O N C LU SIO N A N D OU T L O O K

24. Some Reflections on Research Ethics 551

Dominique Sprumont, Ulf Schmidt, Andreas Frewer

F : A P P E N D IC E S : O R IG I N S O F T H E D E C L A R AT IO N
O F H E L SI N K I , 1 9 5 3 –​6 4

1a. World Medical Association, “Principles of Human Experimentation,”

1953–4​ 557
1b. World Medical Association, “Principles for those in Research and
Experimentation,” 1954 559
2a. World Medical Association, Summary of Activities, 1961 560
2b. World Medical Association, Report of the Committee
on Medical Ethics, May, 1962 561
2c. World Medical Association, “Draft Code of Ethics on Human
Experimentation,” October, 1962 564
2d. World Medical Association, Minutes, October 31, 1963 565
2e. World Medical Association, Minutes, June 14, 1964 566
3. World Medical Association, Typed Draft of the Declaration of
Helsinki, 1964 568
Index 571
 Acknowledgments

“I am really quick climbing this mountain,” the six-year-old son of one of the
editors said as the two approached Carn Llidi near St Davids in Wales. “No, take
your time, and don’t rush it,” the editor replied, inadvertently summing up the
essential issue with which this book has had to grapple: time. We are indebted
to all the authors of this volume for the time they have invested in this volume.
Without them, and their commitment, this book would not have materialized.
All of our contributors have embraced the process of its production as a journey
in which the structure and chapters of the book have reflected profound changes
in the ethical and regulatory landscape. This meant not only that the drafting
and re-drafting process took considerably longer than originally anticipated,
but also that it required a degree of perseverance from everyone involved that
went far beyond the call of duty. It would be wrong to assume that this book did
not test the patience of our contributors. The chapters in this book, however, are
testament to their extraordinary resilience and belief in the importance of this
project.
Many have supported us along the way. We are extremely grateful to the
Brocher Foundation, Geneva, especially to Cécile Caldwell Vulliéty, Anyck
Gérard, Marie Grosclaude, and Elliot Guy, for having provided us with the facil-
ities and financial support for the initial conference that started this journey.
Their organizational support and friendship over the years has been unpar-
alleled. We are greatly indebted to the Wellcome Trust, and to the Thyssen
Foundation, which provided us with core funding to turn the event into a truly
international meeting of experts. Special thanks also go to the Brocher Visiting
Researchers, Richard Cookson, Felicitas Holzer, and Joanne Mishtal especially,
for their advice and encouragement in the final stages of the project. Our insti-
tutional support has been second to none. We would like to mention especially
Jackie Waller and James Farley from the professional service staff of the School
of History, Rutherford College, University of Kent, and Kerstin Franzò, Frauke
Scheller, and Anja Koberg from the secretariat of the Professorship for Ethics
in Medicine at the Friedrich Alexander University, Erlangen-Nürnberg. We are
grateful to all the organizations which contributed to the success of this book,
xii Acknowledgments

especially to the World Medical Association (WMA), Ferney-Voltaire, near

Geneva, where Otmar Kloiber, Julia Tainijoki-Seyer, Lamine Smaali, and Radhia
Smaali went out of their way to support the project. Andreas Reis and Marie-
Charlotte Bouësseau from the World Health Organization (WHO), Geneva,
were likewise on hand to share a wealth of information with us. We are also
grateful to the staff of the Archives of the WMA, of the Archives of the Finnish
Medical Association in Helsinki, and of the Archives of the WHO, and to the of-
fice of the Bundesbeauftragte für die Stasi-Unterlagen (Federal Commissioner
for Stasi Records) for granting us access to hitherto unpublished records.
Patrick Durich and Alice Kohli from Public Eye, Switzerland, supplied us
with much relevant contextual information. Our colleagues Juhana Idänpään-
Heikkilä, Helsinki, Sev Fluss, Geneva, Vladislava Talanova, Neuchâtel, Andrea
Jost, Erlangen, Charlie Hall and Katja Schmidt-Mai, Canterbury, and Sarah
Patey, Norwich, provided us with essential editorial support and good counsel
throughout the project.
Our last word of thanks has to go to our publisher and to those who turned
our text into a book. We have been extremely fortunate to have had, in Oxford
University Press, a publisher who supported our project from the outset. We
would like to thank Peter Ohlin, Madeleine Freeman, and Suthan Raj from
Oxford University Press for their great professionalism and expertise in
shepherding such sizeable and complex project to its successful conclusion. Their
advice and patience during the production process was exceedingly helpful. Our
final gratitude goes to our copy-editor Virginia Catmur, Névache, who, like no
other, improved our manuscript to an extent that is rarely, if ever, seen these days.
As if further proof were needed, her meticulous copy-editing demonstrated yet
again the relative nature of time, since the only thing that counts at the end is
the quality of the text before of us. It is thanks to her and all our friends and
colleagues that we climbed what initially seemed like an insurmountable moun-
tain after all.

The Editors
Canterbury, Erlangen, Fribourg
January, 2020
 Editors and Contributors

The Editors

ULF SCHMIDT is Professor of Modern History and founding Director of

the Centre for the History of Medicine, Ethics and Medical Humanities at the
University of Kent, and a Fellow of the Royal Historical Society. His research
interests are in the history of modern medical ethics, warfare, policy, and society
in twentieth-​century Europe and the United States. He has published widely on
the history of modern Germany and post-​war Europe (East/​West), the history of
the Cold War, the history of medicine and medical ethics, the history of human
experimentation and human rights, the Nuremberg Doctors’ Trial and the
Nuremberg Code, the history of eugenics and euthanasia, the history of chem-
ical and biological warfare, and the history of propaganda and conflict.
Professor Schmidt is or has been associated with the following professional
bodies and funding panels: Member of the Wellcome Trust History of Medicine
and Medical Humanities Funding Committee; Research Associate at the
Wellcome Unit for the History of Medicine, Oxford; Research Associate of Green
College, Oxford; Member of the German History Society (GHS) Committee;
Member of the Harvard Sussex Program on Chemical and Biological Warfare
at the Foreign and Commonwealth Office (by invitation only). More recently, he
has worked with the Organisation for the Prohibition of Chemical Weapons and
Non-​Governmental Organizations (NGOs) to highlight the role of civil society
in meeting the challenges presented by current and future chemical weapons
development.
Professor Schmidt is the author of, among other works, Medical Films, Ethics
and Euthanasia in Nazi Germany (2002), Justice at Nuremberg: Leo Alexander
and the Nazi Doctors’ Trial (2004), (together with Andreas Frewer, eds), History
and Theory of Human Experimentation. The Declaration of Helsinki and Modern
Medical Ethics (2007), and Karl Brand: The Nazi Doctor. Medicine and Power in
the Third Reich (2007), published in German as Hitlers Arzt Karl Brandt. Medizin
und Macht im Dritten Reich (2009). He was the Principal Investigator (PI) of
the Wellcome Trust-​funded project on “Cold War at Porton Down: Medical
Ethics and the Legal Dimension of Britain’s Biological and Chemical Warfare
Programme, 1945–​ 1989.” Professor Schmidt has recently published Secret
Science. A Century of Poison Warfare and Human Experiments (OUP, 2015),
and is one of the editors of the book on Propaganda and Conflict: War, Media
xiv Editors and Contributors

and the Shaping of the Twentieth Century (Bloomsbury, 2019). He is also one
of the PIs of the recent European Research Council (ERC) Synergy Award
(2019) on Taming the European Leviathan: The Legacy of Post-​War Medicine
and the Common Good (https://blogs.kent.ac.uk/history/2019/10/28/schmidt-
taming-the-european-leviathan/).

ANDREAS FREWER is Professor at the Institute for the History of Medicine

and Medical Ethics, University of Erlangen-Nürnberg (Germany). He studied
medicine, philosophy, and the history of medicine in Munich, Erlangen, Berlin,
Vienna, Oxford, and Jerusalem. His dissertation on medical ethics and the his-
tory of medicine at the Free University of Berlin was received summa cum laude
and he holds a European Master in Bioethics qualification from the universities
of Leuven, Nijmegen, Basel, and Padua (summa cum laude). Between 1994 and
1998 he worked as a physician at the Virchow Hospital and the Charité Medical
Faculty of Humboldt University (Berlin) in the clinical medicine, nephrology,
and oncology departments, and in the intensive care unit.
From 1998 to 2002, he was Assistant Professor at the Institute of Ethics
and History of Medicine at the University of Göttingen and a member of the
university’s Institutional Review Board/​ Research Ethics Committee (IRB/​
REC). Between 2002 and 2006 he was Professor of Medical Ethics at the
Institute for History, Ethics, and Philosophy of Medicine at Hanover Medical
School (MHH), and in 2004 Managing Director of the Institute for the History
and Ethics of Medicine at the Goethe University, Frankfurt-​am-​Main. In 2007,
he took up the Professorship of Medical Ethics at the Friedrich-​Alexander
University, Erlangen-Nürnberg. He holds official positions in the IRB/​REC
and as Managing Director of the Clinical Ethics Committee (CEC) at Erlangen
University Hospital.
Professor Frewer is member of the following scientific societies: Akademie
für Ethik in der Medizin (AEM), Society for the History of Sciences, Medicine
and Technology (GWMT), European Society for Philosophy of Medicine
and Health Care (ESPMH). He serves on the editorial boards of the journals
Theoretical Medicine and Bioethics, Philosophy of Medical Research and Practice,
and HealthCare Ethics Committees Forum etc.
Among his publications are more than 250 articles and several books on med-
ical ethics and the history of medicine (e.g. Medizin und Moral in Weimarer
Republik und Nationalsozialismus, 2000), ethics committees, research ethics,
end-​of-​life-​issues, and on clinical ethics generally. Professor Frewer is editor of
the series Kultur der Medizin. Geschichte—​Theorie—​Ethik (42 vols), Geschichte
und Philosophie der Medizin/​History and Philosophy of Medicine (14 vols),
Medizin und Menschenrechte/​Medicine and Human Rights (6 vols), Klinische
Ethik/​Clinical Ethics (Peter Lang, 7 vols), Menschenrechte in der Medizin/​Human
 Editors and Contributors xv

Rights in Healthcare (7 vols) and the Jahrbuch Ethik in der Klinik/​Yearbook Ethics
in Clinics (12 vols).

DOMINIQUE SPRUMONT is Professor of Health Law, University of

Neuchâtel (Switzerland). As Founder and Deputy Director of the Institute
of Health Law of the University of Neuchâtel, he collaborated in the drafting
of several laws in the field of health and healthcare for the federal and can-
tonal governments. He is regularly invited by scientific and professional asso-
ciations to develop their guidelines in those fields. For instance, he coordinated
the drafting of the Olympic Movement Medical Code for the International
Olympic Committee in 2006 and its 2016 revision and contributed to the 2008
and 2013 revisions of the Declaration of Helsinki as well as to the drafting
of 2016 Declaration of Taipei on Ethical Considerations regarding Health
Databases and Biobanks of the World Medical Association. He is currently the
Chair of the Research Ethics Committee of the Canton of Vaud (Switzerland)
(www.cer-​vd.ch) and was from 2015 to 2018 the Vice-​director of the Swiss
School of Public Health+ (SSPH+).
Professor Sprumont is an expert in the field of patients’ rights and public
health law, with a special interest in the regulation of research with human
subjects, patients’ rights, the regulation of healthcare professionals, and phar-
maceutical and food stuff regulation. He has published more than 140 articles
and book chapters on these issues. He has provided expert assistance to several
national and international organizations working in the field of health law and
ethics (e.g. Swiss Academy of Medical Sciences, Council of Europe, European
Union, Council of the International Organizations of Medical Science, World
Medical Association, World Health Organization), collaborating in the drafting
of several ethical guidelines for the Swiss Academy of Medical Sciences such as
those on biomedical research (1997) and biobanks (2006). He was elected presi-
dent from 2001 to 2008 of the “Coordination of the Evaluation of Clinical Trials”
working group established by the Swiss Academy of Medical Sciences, the Swiss
Agency for Therapeutic Products (Swissmedic), the Swiss Federal Office of
Public Health, RECs and the cantonal health authorities.
At the European and international level, he participated as an expert in the
Demo-​Droit Ethical Review of Biomedical Research Activity (DEBRA) pro-
ject of the Council of Europe in Bulgaria, Slovenia, and Estonia. He is one of the
founders of the European Network of Research Ethics Committees supported
by the European Commission (www.eurecnet.org). Since 2006, he has been
the coordinator of the EU-​funded Training and Resources in Research Ethics
Evaluation (TRREE) project, which aims to provide e-​resources on research
ethics and regulation as well as an online training program in the field (http://​
elearning.trree.org).
xvi Editors and Contributors

The Contributors

Professor Robert Baker, William D. Williams Professor of Philosophy at Union College

(NY) and Founding Director of the Union Graduate College-​Icahn School of Medicine at
Mount Sinai Bioethics Program, United States

Professor Christian Bonah, Director of the Department for Social Studies and
Humanities in Medicine and Health at the University of Strasbourg Institute for Advanced
Studies, France

Professor Ames Dhai, Director of the Steve Biko Centre for Bioethics at the Faculty of
Health Sciences, University of the Witwatersrand, South Africa

PD Dr Rainer Erices, Research Fellow, Professorship of Ethics in Medicine, Institute

for the History of Medicine and Medical Ethics at the University of Erlangen-Nürnberg,
Germany

Professor Andreas Frewer, European Master in Bioethics, Institute for the History of
Medicine and Medical Ethics, Professor for Ethics in Medicine, University of Erlangen-
Nürnberg, Germany

Professor Eugenijus Gefenas, Professor and Director, Department of Medical History

and Ethics, University of Vilnius, Lithuania

Professor Dirceu Greco, School of Medicine, Federal University of Minas Gerais, Belo
Horizonte, Brazil

Professor Antje Gumz, Berlin University of Psychology (PHB), and Department of

Psychosomatic Medicine and Psychotherapy, University Medical Center, Hamburg-​
Eppendorf, Germany

Professor Juhana Idänpään-​Heikkilä, former Secretary-​

General of CIOMS and
Professor of Medicine at Helsinki University, Finland

Professor Trudo Lemmens, Associate Professor, Scholl Chair in Health Law and Policy,
Faculty of Law, University of Toronto, Canada

Professor Robert J. Levine, Professor of Medicine, Yale University and Former Chair of
a World Medical Association (WMA) Working Group for Revision of the Declaration,
United States

Professor Ruth Macklin, Department of Epidemiology and Population Health, Albert

Einstein College of Medicine of Yeshiva University, New York, United States

Professor Jonathan D. Moreno, Professor of Medical Ethics and the History and
Sociology of Science at the University of Pennsylvania, United States

Dr Odile Ouwe Missi Oukem-​ Boyer, Cameroon Bioethics Initiative (CAMBIN),

Yaoundé, Cameroon; Fondation Mérieux, Bamako, Mali
 Editors and Contributors xvii

Dr Ramin Walter Parsa-​

Parsi, Director of International Affairs, German Medical
Association, Germany

Professor Renzong Qiu, Institute of Philosophy/​Center for Applied Ethics, Chinese

Academy of Social Sciences, Beijing, China

Gregory Ringkamp, Research Assistant and Juris Doctor Student at the Faculty of Law of
the University of Toronto, Canada

Professor Marc A. Rodwin, Professor of Law, Suffolk University Law School, United States

Professor Henriette D.C. Roscam Abbing, Emerita of Health Law in the Universities of
Maastricht and Utrecht, The Netherlands

Dr Florian Schmaltz, Research Program Coordinator, Senior Research Scholar, Max

Planck Institute for the History of Science, Berlin, Germany

Professor Ulf Schmidt, Fellow of the Royal Historical Society, Professor of Modern
History, University of Kent, United Kingdom

Professor Dominique Sprumont, Institute of Health Law, Professor at the Law Faculty of
the University of Neuchâtel, Switzerland

Dr Godfrey B. Tangwa, Cameroon Bioethics Initiative (CAMBIN), University of

Yaoundé, Yaoundé, Cameroon

Professor Johannes van Delden, President of the Council for International Organizations
of Medical Science (CIOMS) and Professor of Medical Ethics at the University of Utrecht,
The Netherlands

Dr Markus Wahl, Researcher at the Institute for the History of Medicine at the Robert
Bosch Stiftung, Stuttgart, Germany

Professor Urban Wiesing, Institute for Ethics and History of Medicine, Tübingen,
Germany

Professor John R. Williams, formerly Director of Ethics, WMA, Ferney-​Voltaire, France;

currently Director, TRREE Initiative and Adjunct Professor, Department of Medicine,
University of Ottawa, Canada

Professor Xiaomei Zhai, School of the Humanities and Social Sciences/​Center for
Bioethics, Peking Union Medical College, Beijing, China