Table Of ContentLinda F. Hogle Editor
Regenerative
Medicine Ethics
Governing Research and Knowledge
Practices
Regenerative Medicine Ethics
Linda F. Hogle
Editor
Regenerative Medicine
Ethics
Governing Research and Knowledge
Practices
Editor
Linda F. Hogle
University of Wisconsin—Madison
Madison , WI , USA
ISBN 978-1-4614-9061-6 ISBN 978-1-4614-9062-3 (eBook)
DOI 10.1007/978-1-4614-9062-3
Springer New York Heidelberg Dordrecht London
Library of Congress Control Number: 2013953877
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Pref ace
Motivation for this book came from two very different things: frustration and a
desire for reciprocity. Frustration, because it is diffi cult to fi nd teaching materials on
research ethics that are both specifi c enough to be useful to regenerative medicine
researchers and yet robust enough to be applicable to a broader audience of those who
deal with similar issues in scientifi c practice, particularly those related to the use
of human and animal cells in research. Frustration also comes from the narrow way
in which ethical and social issues in regenerative medicine have been defi ned. The
subject of much of ethical and policy writing about regenerative medicine, while
important, is often both disproportionate and out of sync with what researchers,
clinicians, patients, and others face in the lab, the classroom, the boardroom, in
exchanges within scientifi c communities, or in everyday decisions about health
care. Readers are accustomed to the debates that have dominated stem cell research
to date, fi ltered through historical and political lenses, but there are emerging issues
in the way regenerative medicine is being practiced and organized that go begging
for analysis and discussion. On the horizon are surprising changes in our ability to
manipulate biology and disruptions to the way we have organized and funded the
production of knowledge, all of which need careful consideration. But there are also
gray areas and “unknown unknowns” that come up in routine practice and need
guideposts for good judgment. This book thus has dual aims: to bring attention to a
few salient emerging issues, as well as to provide fundamental information that will
be useful for both experienced readers and those new to the fi eld. In addition, I hope
that readers will see that social, ethical, policy, and technological issues are mutu-
ally constitutive. That is, governance structures, conventions for sequestering or
sharing knowledge, research priorities and fi nancing, new scientifi c theories, and
technical tools are all informed by history, politics, and culture and all are involved
in the dynamic processes involved in producing knowledge.
Then there’s reciprocity. Much of my research and teaching has been grounded
in work previously supported by the National Science Foundation and the Greenwall
Foundation. I am deeply appreciative for the opportunities this funding provided.
It has also been my privilege to work with, learn from, and teach many researchers
v
vi Preface
working in regenerative medicine. I am grateful to the many stem cell and tissue
engineers, biologists, materials scientists, regulatory offi cers, and others who have
not only patiently endured my many questions over the years but also engaged with
me in thinking through the many challenges and paradoxes inherent in regenerative
medicine research. This book is for you, and for all of the researchers, policy-makers,
program managers, and students who must navigate constantly changing environ-
ments. I would also like to thank research assistants Jessica Von Reyn and Catherine
Turng, who made this challenging book manageable, as well as the many students
who have made the journey so rewarding.
Madison, WI, USA Linda Hogle
Contents
Part I Foresight, Hindsight and Peripheral Vision: Navigating
Contemporary Legal, Ethical and Policy Issues
in Regenerative Medicine
1 Contemporary Issues in Regenerative Medicine Research Ethics
and Governance: An Overview ................................................................ 3
Linda F. Hogle
2 Characterizing International Stem Cell Research Niches ..................... 29
Linda F. Hogle, Sean P. Palecek, David Schaffer,
and Peter W. Zandstra
3 Policies and Practices to Enhance Multi- sectorial Collaborations
and Commercialization of Regenerative Medicine ................................ 67
Tania Bubela, Amrita Mishra, and Debra Mathews
4 The Patenting Landscape for Human Embryonic Stem Cells .............. 89
Kevin E. Noonan
5 Repositories for Sharing Human Data in Stem Cell Research ............. 107
Pilar N. Ossorio
Part II Research Integrity: Updates for Regenerative
Medicine Researchers
6 Beyond the Checkboxes: Research Integrity for Regenerative
Medicine Researchers ............................................................................... 131
Jessica Von Reyn, Amritava Das, and Linda F. Hogle
7 Protecting Human Participants in the Procurement
of Materials in Regenerative Medicine Research ................................... 173
David B. Resnik
vii
viii Contents
8 Early-Stage Research: Issues in Design and Ethics ............................... 187
Nancy M.P. King
Appendix A: Global Embryonic Stem Cell Policies as of 2012 ................... 205
Appendix B: Proposed State Personhood Laws (USA) ............................... 207
Appendix C: Resources .................................................................................. 211
Appendix D: Glossary ..................................................................................... 213
Author Biographies ......................................................................................... 217
Index ................................................................................................................. 221
Part I
Foresight, Hindsight and Peripheral
Vision: Navigating Contemporary Legal,
Ethical and Policy Issues in Regenerative
Medicine
