G. Pascuzzi, U. Izzo, M. Macilotti (Eds.)
Comparative Issues in the Governance of Research Biobanks
Property, Privacy, Intellectual Property, and the Role of Technology
Springer
ISBN: 978-3-642-33115-2
Anno: 2013
In the last few years, the boom in biobanking has prompted a lively debate on a host of interrelated legal issues, such as the Gordian knot of the ownership of biological materials, as well as privacy concerns. The latter are due to the difficulty of accepting that biological samples must be completely anonymous without making it practically impossible to exploit their information potential. The issues also include the delicate role and the changing content of the donor’s “informed consent” as the main legal tool that may serve to link the privacy and property interests of donors with the research interests and the set of principles that should be at the core of the biobanking practice. Lastly, the IP issues and the patentability of biological samples as well as the protection of databases storing genetic information obtained from the samples are covered. Collecting eighteen essays written by eminent scholars from Italy, the US, the UK and Canada, this book provides new solutions to these problems. From a comparative viewpoint, it explores the extent to which digital technology may assist in tackling the numerous regulatory issues raised by the practice of biobanking for research purposes. These issues may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property.
Contents
1 Introduction: A Law and Technology Approach to the Law of Biobanking . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Umberto Izzo, Matteo Macilotti, and Giovanni Pascuzzi
Part I Property and Privacy in Biobanking
2 Research Biobanks Meet Synthetic Biology: Autonomy and Ownership . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Stephen R. Munzer
3 Regulating Biobanks: Another Triple Bottom Line . . . . . . . . . . . . . 41
Roger Brownsword
4 Health Insurance, Employment, and the Human Genome: Genetic Discrimination and Biobanks in the United States . . . . . . . . . . . . . 63
Eric A. Feldman and Chelsea Darnell
5 Ownership of Biomedical Information in Biobanks . . . . . . . . . . . . 77
Naomi Hawkins, Nadja Kanellopoulou, Jane Kaye, Karen Melham, Paula Boddington, Liam Curren, and Heather Gowans
6 Human Tissues in the “Public Space”: Beyond the Property/Privacy Dichotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Mariachiara Tallacchini
7 Should Privacy Be Abolished in Genetics and Biobanking? . . . . . . 105
Amedeo Santosuosso
8 Biobanks and Electronic Health Records: Open Issues . . . . . . . . . . 131
Paolo Guarda
9 Informed Consent and Research Biobanks: A Challenge in Three Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Matteo Macilotti
Part II Intellectual Property and Biobanks
10 The Challenges of Achieving Open Source Sharing of Biobank Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Donna M. Gitter
11 Beyond Open Source: Patents, Biobanks and Sharing . . . . . . . . . . 191
E. Richard Gold and Dianne Nicol
12 Opening Research Biobanks: An Overview . . . . . . . . . . . . . . . . . . 209
Roberto Caso and Rossana Ducato
13 The Roles of Material Transfer Agreements in Genetics Databases and Bio-Banks . . . .. . . . . . . . . . . . . . . . . . . . . . 231
Thomas Margoni
14 Quasi-Patents and Semi-Patents in Biobanking . . . . . . . . . . . . . . . 251
Gideon Parchomovsky and Michael Mattioli
15 Accessing Accessions: Biobanks and Benefit-Sharing . . . . . . . . . . . 267
Mark Perry
16 Conveying Information, Generating Trust: The Role of Certifications in Biobanking . . . . . . . . . . . . . . . . . . . . . . . 281
Matteo Ferrari
Part III Biobanks: The Perspective of Biobanker’s
17 Scientific and Managerial Premises and Unresolved Issues in Tumour Biobanking Activities . . . .. . . . . . . . . . . . . 301
Mattia Barbareschi, Silvia Fasanella, Chiara Cantaloni,
and Silvia Giuliani
18 The Italian Prototype Networks of Research Biobanks . . . . . . . . . . 311
Giuliano D’Agnolo and Elena Bravo
19 Governance of Biobanks for Cancer Research: Proposal for a Material Transfer Agreement . . . . . . . . . . . . . . . . . 327
Barbara Parodi, Paola Visconti, Tiziana Ruzzon, and Mauro Truini
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333