Table Of ContentThe International Library of Ethics, Law and Technology 14
Deborah Mascalzoni Editor
Ethics, Law and
Governance of
Biobanking
National, European and International
Approaches
Ethics, Law and Governance of Biobanking
The International Library of Ethics, Law and Technology
VOLUME 14
Editors
Anthony Mark Cutter, Lancashire, UK
Bert Gordijn, Ethics Institute, Dublin City University, Ireland
Gary E. Marchant, Center for the Study of Law, Science, and Technology, Arizona State
University, USA
Colleen Murphy, University of Illinois at Urbana-Champaign, Urbana, IL, USA
Alain Pompidou, European Patent Office, Munich, Germany
Sabine Roeser, Dept. Philosophy, Delft University of Technology, Delft, The Netherlands
Editorial Board
Dieter Birnbacher, Institute of Philosophy, Heinrich-Heine-Universität, Germany
Roger Brownsword, King’s College London, UK
Ruth Chadwick, ESRC Centre for Economic & Social Aspects of Genomics, Cardiff, UK
Paul Stephen Dempsey, Institute of Air & Space Law, Université de Montréal, Canada
Michael Froomkin, University of Miami Law School, FL, USA
Serge Gutwirth, Vrije Universiteit, Brussels, Belgium
Henk ten Have, Duquesne University, Pittsburgh, USA
Søren Holm, University of Manchester, UK
George Khushf, Center for Bioethics, University of South Carolina, USA
Justice Michael Kirby, High Court of Australia, Canberra, Australia
Bartha Maria Knoppers, Université de Montréal, Canada
David Krieger, The Waging Peace Foundation, CA, USA
Graeme Laurie, AHRC Centre for Intellectual Property and Technology Law, UK
René Oosterlinck, European Space Agency, Paris
Edmund Pellegrino, Kennedy Institute of Ethics, Georgetown University, USA
John Weckert, School of Information Studies, Charles Sturt University, Australia
More information about this series at http://www.springer.com/series/7761
Deborah Mascalzoni
Editor
Ethics, Law and Governance
of Biobanking
National, European and International
Approaches
1 3
Editor
Deborah Mascalzoni
Centre for Biomedicine
European Academy Bolzano
Bolzano
Italy
ISSN 1875-0044 ISSN 1875-0036 (electronic)
The International Library of Ethics, Law and Technology
ISBN 978-94-017-9572-2 ISBN 978-94-017-9573-9 (eBook)
DOI 10.1007/978-94-017-9573-9
Library of Congress Control Number: 2014959850
Springer Dordrecht Heidelberg New York London
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Acknowledgments
This book has a very long and complex story. I wish to thank all the authors for their
great work and even greater patience. I am also very grateful to Mirko Ancillotti for
his support and help.
v
Contents
Ethics Law and Governance of Biobanking: A Very Complex
Normative Puzzle .............................................. 1
Deborah Mascalzoni
Biobanks: A Definition .......................................... 15
Barbara Parodi
A Participatory Space Beyond the “Autonomy Versus
Property” Dichotomy ........................................... 21
Mariachiara Tallacchini
Intellectual Property and Biobanks ............................... 39
Naomi Hawkins
Consent, Privacy and Property in the Italian Biobanks
Regulation: A Hybrid Model Within EU? .......................... 53
Matteo Macilotti, Simone Penasa and Marta Tomasi
Data Protection Principles and Research in the Biobanks Age ......... 79
Roberto Lattanzi
The New General Data Protection Regulation—Where Are
We Are and Where Might We Be Heading? ......................... 95
Jane Reichel and Anna-Sara Lind
The Tension Between Data Sharing and the Protection
of Privacy in Genomics Research ................................. 101
Jane Kaye
vii
viii Contents
Incidental Findings: The Time Is not yet Ripe for a Policy
for Biobanks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Jennifer Viberg, Mats G. Hansson, Sophie Langenskiöld
and Pär Segerdahl
Biobanking Across Borders: The Challenges of Harmonisation ........ 133
Ruth Chadwick and Heather Strange
Governing Biobanks Through a European Infrastructure ............. 139
Emmanuelle Rial-Sebbag and Anne Cambon-Thomsen
EU Governance for Research and Ethics in Biobanks ................ 153
Jane Reichel
A Bold Experiment: Iceland’s Genomic Venture ..................... 187
David Winickoff
The Estonian Genome Center, University of Tartu ................... 211
Aime Keis
Management of the Ethical Aspects of a Local Mental
Diseases Biobank for Research Purposes: The Italian Experience ...... 219
Corinna Porteri
Biobank Governance in Spain: From the Autonomy
of Research Ethics Committees to the Autonomy of Lay People ........ 227
Antonio Casado da Rocha
Public Deliberation and the Role of Stakeholders as a New
Frontier in the Governance of Science: The British Columbia
Biobank Deliberation and the DePGx Project ....................... 241
Claudio Corradetti and Gillian Bartlett
Making Researchers Moral ...................................... 261
Linus Johnsson, Stefan Eriksson, Gert Helgesson and Mats G. Hansson
Ethics Law and Governance of Biobanking:
A Very Complex Normative Puzzle
Deborah Mascalzoni
The Food and Drug Administration in the US recently granted premarket c learance
for a DNA sequencing platform with increased diagnostic power. Francis Collins
et al. stated in an editorial in the New England Journal of Medicine that this
approval may open the door “for the development and use of innumerable new
genome-based tests” (Collins et al. 2013). Collins et al. called the approval “a
landmark move that will finally open the way to realize the promise of personal-
ized medicine” (Collins et al. 2013).
We are moving into a world where whole-genome scanning of individual DNA
samples will start to become routine in medical research and clinical practice;
proposals for routine screening of genomic profiles have already appeared in the
public policy arena. The borders between medical research and clinical practice
are to a certain extent blurring, so that research sequencing platforms are starting
to gain clinical validity and clinical practice is beginning to rely more immediately
and more closely on research results.
Biobank research and genomic information are reshaping our notions of health
and medicine and offering the promise of more tailored medical treatment. The
cost effectiveness of these treatments and of pharmacogenomics in general are
part of this conversation, but it has been claimed that the way forward relies on
bio-specimen research.
In Europe, the investments in research infrastructure and the linkages between
existing biobanks and biomedical projects are extensively supported by public
funding. The EU Seventh Framework funding programme invested heavily in the
D. Mascalzoni (*)
Centre for Biomedicine, European Academy of Bolzano, Bolzano, Italy
e-mail: [email protected]
© Springer Science+Business Media Dordrecht 2015 1
D. Mascalzoni (ed.), Ethics, Law and Governance of Biobanking,
The International Library of Ethics, Law and Technology 14,
DOI 10.1007/978-94-017-9573-9_1
2 D. Mascalzoni
creation of network infrastructures and working consortia in order to facilitate the
genomics movement on a large scale, and the research and innovation programme
Horizon 2020 seems to be following the same philosophy.
The rapid pace of technology development in genome sequencing has an
impact on how we think about biobank-based research regulation and health
regulation. Thus, for example, the advances in bioinformatics and the augmented
power of computing technologies together with the availability of widespread
access to different network facilities have completely reshaped our notion of infor-
mational risk, leading to the conclusion that the very idea of anonymity in research
may be a fairy tale.
How should these developments impact the current regulatory approaches,
which rely heavily on anonymity and confidentiality in research? In the European
parliament, the fear that the increased computer processing power associated with
Web 2.0 internet technologies could impact individual privacy interests led to
the proposal for a General Data Protection Regulation (GDPR) in January 2013,
which initially suggested very strict rules for research. This proposal was severely
criticised by patient associations, and there were widespread comments from
scientists, scholars and professional associations who feared its possible impact on
research.
While the first impression is that regulations follow scientific development,
in fact, there are very complex dynamics in the co-production of bio-objects and
regulatory approaches. Just as regulations impact research, research impacts regu-
lation and governance approaches. Bottom-up approaches and self-regulation are
constantly informing scientific practice. In a highly complex relationship, social
values, existing rules, health expectations and science each play a role in reshaping
the regulatory context.
The existing wealth of regulations on local, regional, national and interna-
tional levels creates a complex picture that must be deciphered in order to c onduct
research. Binding legal rules need to be acknowledged together with ethical
requirements and non-binding professional guidelines that sometimes overlap and
diverge.
This book outlines the current developing situation with respect to biobanking
regulations. The very definition of what constitutes a biobank is not unequivocal.
Barbara Parodi explains the differences in the lexicon. She has explored the main
literature in the field to provide a glossary that will help to map the complexity
of the existing reality. It appears that the terms biorepository, biological resource
centre and biobank can refer to very different structured collections of biologi-
cal samples and associated data. They can include human tissues, animal tissues,
cells, bacterial cultures and even environmental samples. These terms are often
confused and sometimes misplaced in the literature. The associated regulations
pertain to the kind of materials collected and the possible uses of those materi-
als. Therefore human tissues collected for clinical use will be associated with a
different legal and ethical framework than animal cell lines collected for research
purposes. Relevant aspects such as proprietary rights, patenting, etc. will therefore
have a very different basis. Barbara Parodi looks at how the various biobanks and
