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Between Moral Hazard and Legal Uncertainty: Ethical, Legal and Societal Challenges of Human Genome Editing

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Abstract

Genome Editing Techniques are seen to be at the frontier of current research in the field of emerging biotechnologies. The latest revolutionary development, the so-called CRISPR technology, represents a paradigmatic example of the ambiguity of such techniques and has resulted in an international interdisciplinary debate on whether or not it is necessary to ban the application of this technique by means of a moratorium on its use for human germline modifications, particularly in human embryos in the reproduction process. However, given that other germline engineering techniques like mitochondrial (mt) DNA transfer techniques are already permitted and applied, the question arises what lies at the root of the apparent social unease about the modification of the human germline by Genome Editing Techniques like CRISPR. Against this background, the book seeks to make a substantial contribution to the current debate about a responsible and participatory framework for research on emerging biotechnologies by analysing underlying perceptions, attitudes, arguments and the reasoning on Genome Editing Techniques
Reihe herausgegeben von
A. Grunwald, Karlsruhe, Deutschland
R. Heil, Karlsruhe, Deutschland
C. Coenen, Karlsruhe, Deutschland
Technikzukünfte, Wissenschaft und
Gesellschaft / Futures of Technology,
Science and Society
Diese interdisziplinäre Buchreihe ist Technikzukünften in ihren wissenschaftli-
chen und gesellschaftlichen Kontexten gewidmet. Der Plural „Zukünfte“ ist dabei
Programm. Denn erstens wird ein breites Spektrum wissenschaftlich-technischer
Entwicklungen beleuchtet, und zweitens sind Debatten zu Technowissenschaften
wie u.a. den Bio-, Informations-, Nano- und Neurotechnologien oder der Robotik
durch eine Vielzahl von Perspektiven und Interessen bestimmt. Diese Zukünfte
beeinflussen einerseits den Verlauf des Fortschritts, seine Ergebnisse und Fol-
gen, z. B. durch Ausgestaltung der wissenschaftlichen Agenda. Andererseits sind
wissenschaftlich-technische Neuerungen Anlass, neue Zukünfte mit anderen
gesellschaftlichen Implikationen auszudenken. Diese Wechselseitigkeit reflektie-
rend, befasst sich die Reihe vorrangig mit der sozialen und kulturellen Prägung
von Naturwissenschaft und Technik, der verantwortlichen Gestaltung ihrer Ergeb-
nisse in der Gesellschaft sowie mit den Auswirkungen auf unsere Bilder vom
Menschen.
This interdisciplinary series of books is devoted to technology futures in their
scientific and societal contexts. The use of the plural “futures” is by no means
accidental: firstly, light is to be shed on a broad spectrum of developments in sci-
ence and technology; secondly, debates on technoscientific fields such as biotech-
nology, information technology, nanotechnology, neurotechnology and robotics
are influenced by a multitude of viewpoints and interests. On the one hand, these
futures have an impact on the way advances are made, as well as on their results
and consequences, for example by shaping the scientific agenda. On the other
hand, scientific and technological innovations offer an opportunity to conceive
of new futures with different implications for society. Reflecting this reciprocity,
the series concentrates primarily on the way in which science and technology are
influenced social and culturally, on how their results can be shaped in a responsi-
ble manner in society, and on the way they affect our images of humankind.
Weitere Bände in der Reihe http://www.springer.com/series/13596
Matthias Braun · Hannah Schickl
Peter Dabrock
Editors
Between Moral Hazard
and Legal Uncertainty
Ethical, Legal and Societal Challenges
of Human Genome Editing
Editors
Matthias Braun
Chair of Systematic Theology II (Ethics)
Friedrich-Alexander-Universität
Erlangen, Germany
Hannah Schickl
Interdisciplinary Research Group
“Gene Technology Report”
Berlin-Brandenburg Academy of
Sciences and Humanities
Berlin, Germany
Peter Dabrock
Chair of Systematic Theology II (Ethics)
Friedrich-Alexander-Universität
Erlangen, Germany
ISSN 2524-3764 ISSN 2524-3772 (electronic)
Technikzukünfte, Wissenschaft und Gesellschaft / Futures of Technology, Science and Society
ISBN 978-3-658-22659-6 ISBN 978-3-658-22660-2 (eBook)
Library of Congress Control Number: 2018962982
Springer VS
© Springer Fachmedien Wiesbaden GmbH, part of Springer Nature 2018
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https://doi.org/10.1007/978-3-658-22660-2
V
Contents
Between Moral Hazard and Legal Uncertainty: An Introduction ............ 1
Matthias Braun, Hannah Schickl and Peter Dabrock
I Mapping the Current Legal Framingg
Genome Editing and the Law. Some Remarks on Current Legal Challenges
of CRISPR-Cas9 ..................................................... 17
Stephan Rixen
Integrating Ethical Standards into the Human Rights Framework.
Considerations towards the Future Regulation of Genome Editing
on an International Level ............................................. 31
Fruzsina Molnár-Gábor
II eoretical Challenges
Prospects of Human Germline Modication by CRISPR-Cas9 –
an Ethicist’s View .................................................... 53
Dieter Birnbacher
Genome Editing, Non-Identity and the Notion of Harm .................. 67
Alina Omerbasic
VI Contents
Genome Editing and the Transgression of the Species Boundary.
Does Species Aliation Have an Ethical Relevance? ...................... 83
Markus Rothhaar
Germline Modications as a Severe Intervention into Human Nature ...... 99
Nadia Primc
Is Genome Editing Unnatural? Nature in Bioethics, the Politics
of Bioethics, and the Political Dimension of Nature ..................... 111
Eva Odzuck
Transition and Care. eological Concepts of Dynamic Creation
and the Ethics of Genome Editing ..................................... 129
Mathias Wirth
Human Germline Genome Editing in the Clinical Context.
e Case of Disease Prevention ....................................... 149
Giovanni Rubeis
III Towards a Governance Frame in Dealing with Genome Editing
Who? What? How? Why? If You Don’t Ask You’ll Never Know.
On Criticism of the New Uproar about Germline Editing –
Discourse Analytical and Socioethical Metaperspectives ................. 163
Peter Dabrock
Debating Genome Editing Technologies. Questioning the Role
of Public Discussion ................................................. 187
Lukas Kaelin
A Path rough the (Moral) Morass. Genome Editing, Reproduction
and Broad Conversations ............................................ 203
Giulia Cavaliere
VII
Authors
Authors
Dieter Birnbacher, Univ.-Prof. i. R. Dr. Dr. h.c., is Professor Emeritus of Practical
Philosophy at the Heinrich-Heine University Düsseldorf and President of the Ger-
man Societ y for Dying with Dignity. His main elds of research are concerned with
ethical and anthropological issues in modern medicine as well as anthropology
and neurophilosophy, e.g. theories of emotions.
Matthias Braun, Dr., is Assistant Professor at the Chair of Systematic eology
II (Ethics), Friedrich-Alexander University Erlangen-Nuremberg. His research is
focused on theological, philosophical and socio-political concepts in dealing with
emerging biotechnologies at the science-society interface (with special regard to
genome editing, synthetic biology, stem cell research and big-data medicine) on the
one hand as well as concepts of recognition and vulnerability and its implications
for ethics on the other hand.
Giulia Cavaliere is a PhD student at the Department of Global Health & Social
Medicine, King’s College London. Her research interests concern philosophical
and sociological approaches to bioethics, particularly the intersection between
moral and social questions surrounding reproductive genetic technologies and
the history of eugenics.
Peter Dabrock, Prof. Dr., is Professor of Systematic eology (Ethics) at the Fried-
rich-Alexander University Erlangen-Nuremberg and Chair of the German Ethics
Council. From 2011 until 2016 he was also member of the “European Group on
Ethics in Science and New Technologies”. His research focuses on concrete ethics
from a Protestant perspective, foundational t heology and bioethics as theologically
based social ethics (with special regard to healthcare, human genomics, synthetic
biology, big data and biobanks).
VIII Authors
Lukas Kaelin, Dr., is Assistant Professor at the Institute of Practical Philosophy
and Ethics, Catholic Private University of Linz. His research interests encompass
social and political philosophy (especially the notion of the ‚public sphere‘) as well
as bioethics and medical ethics.
Fruzsina Molnár-Gábor, Dr., is group leader at the Heidelberg Academy of Sciences
and Humanities and at the BioQuant Centre of the University of Heidelberg, as well
as lecturer at the Faculty of Law at the University of Heidelberg. Her research focuses
on the regulation of biomedicine, including the legal elds of public international
law, the law of the European Union, and comparative public law.
Eva Odzuck, Dr., is Assistant Professor at the Chair of Political Science II, Fried-
rich-Alexander Universit y Erlangen-Nuremberg. Her research is focused on political
philosophy, political theory, and history of political thought, as well as ethics and
politics of the life sciences.
Alina Omerbasic, M.A., is Research Assistant at the Chair of Applied Ethics, De-
partment of Philosophy, University of Potsdam. Her main elds of research are
applied ethics and political philosophy.
Nadia Primc, Dr., is Research Assistant at the Institute of History and Ethics of
Medicine, Medical Department, University of Heidelberg. Her research is con
-
cerned with philosophy of science as well as bio-, medical and nursing ethics and
moral philosophy.
Stephan Rixen, Prof. Dr., is Professor at the Chair of Public Law I, Public Law,
Social Economy Law and Health Law, University of Bayreuth. His research is
focused on constitutional and administrative law (especially public commercial
law), German and European social law (including children and youth welfare law)
as well as health law.
Markus Rothhaar, Prof. Dr., is Endowed Chair for Bioethics at the Catholic Uni-
versity of Eichstätt-Ingolstadt. His research is focused on medicine and bioethics,
especially the status of human embryos, bioethics and political philosophy, notions
of life and justice in public health service.
Authors IX
IX
Giovanni Rubeis, Dr., is Research Assistant at the Institute of the History, Philo-
sophy and Ethics of Medicine, University of Ulm. His research focuses mainly on
ethics in prenatal and reproductive medicine, philosophy of science of biology and
theory of medicine.
Hannah Schickl, State Examination, is currently Research Assistant at the Inter-
disciplinary Research Group “Gene Technology Report”, Berlin-Brandenburg
Academy of Sciences and Humanities, Berlin, and PhD student at the Institute for
Ethics, History and eory of Medicine, University of Münster. Her research is
focused on analytic bioethics, particularly gene technologies like stem cell research,
reproductive medicine and animal ethics.
Mathias Wirth, Dr., is an Assistant Professor (tenure track) of Systematic eology/
Ethics at the School of eology at the University of Bern (Switzerland). Prior to this
position, he was a Feodor Lynen Postdoc at the Yale Divinity School (USA) (2017-
2018) and a research associate and lecturer at the Department of Medical History
and Ethics at the University Medical Center Hamburg-Eppendorf (2012–2017). His
research is on medical ethics, trans*phenomena and religious ethics.
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With CRISPR/Cas9 and other genome-editing technologies, successful somatic and germline genome editing are becoming feasible. To respond, an American Society of Human Genetics (ASHG) workgroup developed this position statement, which was approved by the ASHG Board in March 2017. The workgroup included representatives from the UK Association of Genetic Nurses and Counsellors, Canadian Association of Genetic Counsellors, International Genetic Epidemiology Society, and US National Society of Genetic Counselors. These groups, as well as the American Society for Reproductive Medicine, Asia Pacific Society of Human Genetics, British Society for Genetic Medicine, Human Genetics Society of Australasia, Professional Society of Genetic Counselors in Asia, and Southern African Society for Human Genetics, endorsed the final statement. The statement includes the following positions. (1) At this time, given the nature and number of unanswered scientific, ethical, and policy questions, it is inappropriate to perform germline gene editing that culminates in human pregnancy. (2) Currently, there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications of gene editing. There should be no prohibition on making public funds available to support this research. (3) Future clinical application of human germline genome editing should not proceed unless, at a minimum, there is (a) a compelling medical rationale, (b) an evidence base that supports its clinical use, (c) an ethical justification, and (d) a transparent public process to solicit and incorporate stakeholder input. Copyright © 2017 American Society of Human Genetics. All rights reserved.
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