The Emergence of Biobanks in the Legal Landscape: Towards a New Model of Governance
| Author | Emmanuelle Rial‐Sebbag,Anne Cambon‐Thomsen |
| Published date | 01 March 2012 |
| Date | 01 March 2012 |
| DOI | http://doi.org/10.1111/j.1467-6478.2012.00573.x |
JOURNAL OF LAW AND SOCIETY
VOLUME 39, NUMBER 1, MARCH 2012
ISSN: 0263-323X, pp. 113±30
The Emergence of Biobanks in the Legal Landscape:
Towards a New Model of Governance
Emmanuelle Rial-Sebbag* and Anne Cambon-Thomsen*
Biobanks are increasingly seen as new tools for medical research.
Their main purpose is to collect, store, and distribute human body
materials. These activities are regulated by legal instruments which
are heterogeneous in source (national and international), and in form
(binding and non-binding). We analyse these to underline the need for
a new model of governance for modern biobanks. The protection
initially ensured by respect for fundamental rights will need to focus on
more interactions with society in order to ensure biobanks' sustain-
ability. International regulation is more oriented on ethical principles
and traces the limits of the uses of genetics, while European regulation
is more concerned with the protection of fundamental rights and the
elaboration of standards for biobanks' quality assurance. But is this
protection adequate and sufficient? Do we need to move from the
biomedical research analogy to new forms of legal protection, and
governance systems which involve citizens?
INTRODUCTION
Among the many roles and responsibilities attached to biobanking in
biomedical research, their governance is of paramount importance. As bio-
banking developed initially in the context of clinical trials or as a by-product
of clinical activities, its normative and practical framework has evolved
113
ß2012 The Author. Journal of Law and Society ß2012 Cardiff University Law School. Published by Blackwell Publishing
Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
* UMR U 1027, Inserm, Universite
Âde Toulouse 3 ± Paul Sabatier,
Epide
Âmiologie et analyses en sante
Âpublique: risques, maladies chroniques
et handicap, De
Âpartement d'e
Âpide
Âmiologie et de sante
Âpublique, Faculte
Âde
me
Âdecine, 37 alle
Âes Jules Guesde, 31073 Toulouse, France
emmanuelle.rial@univ.tlse3.fr anne.cambon-thomsen@univ.tlse3.fr
We gratefully acknowledge funding from the European Community's Seventh
Framework project, Biobanking and Biomolecular Resources Research (BBMRI), grant
no. 212111, and Biobank Standardization and Harmonization for Research Excellence in
the European Union (BioSHaRE-EU), grant no. 261433.
logically through the derivation and adaptation of existing biomedical
regulatory frameworks applying to research on people. However, the
explosive development of biobanking in the last ten years questions this
framework; new principles and tools need to be generated. Biological
samples are not persons but human materials; biological samples without
data attached to them are not very useful for research; the research time
frame for projects using biobanks is much longer than that of any individual
project, and multiple uses of biological samples over years has become the
expected destiny of biobank samples. This phenomenon has been analysed
by various disciplines: sociology,
1
philosophy,
2
philosophy of law, political
science,
3
economics,
4
and ethics.
5
So, biobanks have become the object of
much attention, most certainly with regard to the legal and ethical stakes
raised by the use of human samples
6
and of their associated data.
7
In this
article we will show why a new model for governing biobanks is needed,
using elements from different perspectives. In particular, we will insist on
the need for the elaboration of a new model of governance, to be supported
by agreed ethical principles and strong public participation. Many questions
arise regarding the relevance, or the limitation of existing frameworks that
have hitherto served as references for biobank regulation, based partly on
analogies with other kinds of biomedical research. We will describe the
context of biobanking research as part of the biotechnology landscape, the
background and origin of the most commonly used regulations, and discuss
new challenges faced when biobanks develop at the level of supra-national
research infrastructures. We will conclude by indicating possible directions
for the future.
THE LOCATION OF BIOBANKS AMONG BIOTECHNOLOGIES
Our initial assumption, in light of emerging practices in the field of
biotechnology and especially in biobanks, is that, on the one hand, the rule of
law is perhaps not the most efficient tool for regulating biotechnology. Other
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1 V. Tournay (ed.), La gouvernance des innovations me
Âdicales (2007).
2 B. Hofmann, J.H. Solbakk, and S. Holm, `Mapping the Language of Research
Biobanking: An Analogical Approach' in The Ethics of Research Biobanking, eds.
J.H. Solbakk, S. Holm, and B. Hofmann (2009) 145±58.
3 H. Gottweis and A. Petersen (eds.), B iobanks: Govern ance in comparati ve
perspective (2008).
4 I. Hirtzlin, N. Preaubert, and A. Charru, `Analyse de l'activite et du cou
Ãt des
collections de mateÂriel biologique' (1999) 17 J. d'Economie Me
Âdicale 3±11.
5 A. Cambon-Thomsen, E. Rial-Sebbag, and B.M. Knoppers, `Trends in ethical and
legal frameworks for the use of human biobanks' (2007) 30 European Respiratory J.
373±82.
6 Most of the time these elements are legally seen as the entire human person.
7 These data raised questions related to protection of private life and confidentiality.
ß2012 The Author. Journal of Law and Society ß2012 Cardiff University Law School
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