Governing Genetic Databases: Challenges Facing Research Regulation and Practice
| Author | Catherine Heeney,Susan M.C. Gibbons,Andrew Smart,Jane Kaye,Michael Parker |
| Date | 01 June 2007 |
| Published date | 01 June 2007 |
| DOI | http://doi.org/10.1111/j.1467-6478.2007.00387.x |
JOURNAL OF LAW AND SOCIETY
VOLUME 34, NUMBER 2, JUNE 2007
ISSN: 0263-323X, pp. 163±89
Governing Genetic Databases: Challenges Facing Research
Regulation and Practice
Susan M.C. Gibbons,* Jane Kaye,* Andrew Smart,**
Catherine Heeney,* Michael Parker*
This paper reports on the initial findings of an interdisciplinary
research project on the governance of human genetic databases in
England and Wales. The number of biosample and information collec-
tions has expanded, yet considerable legal uncertainty surrounds their
definition, collection, storage, management, and use which could
inhibit research and clinical practice, while failing to protect the rights
and interests of all stakeholders. We report some initial findings from
the legal research and identify major challenges associated with
defining `genetic databases'. We identify a wide range of relevant
instruments and regulatory actors, and suggest that none adequately
addresses the challenges posed by contemporary research techniques
or the `corporeal' and `informational' materials used in the genetic
databases context. This preliminary analysis seriously questions the
efficacy of the current regulatory framework and concludes that
developing an appropriate governance framework for the creation,
maintenance, and use of genetic databases requires the bringing
together of legal analysis with good quality empirical evidence.
163
ß2007 The Author. Journal Compilation ß2007 Cardiff University Law School. Published by Blackwell Publishing Ltd,
9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
*Ethox Centre, University of Oxford, Gibson Building/Block 21, Radcliffe
Infirmary, Woodstock Road, Oxford OX2 6HA, England
sue.gibbons@ethox.ox.ac.uk jane.kaye@ethox.ox.ac.uk
catherine.heeney@ethox.ox.ac.uk michael.parker@ethox.ox.ac.uk
** Bath Spa University, Newton Park, Newton St Loe, Bath BA2 9BN,
England
a.smart@bathspa.ac.uk
The authors wish to express their thanks to the anonymous JLS referees for providing
invaluable feedback.
INTRODUCTION
Developments in information technology and high-throughput DNA
sequencing have substantially altered genetic research activity. There has
been a dramatic expansion in the types of research that scientists can pursue,
the tools and methods available to them, and the number of actual, virtual or
potential libraries of genetic materials.
1
These innovations challenge existing
regulations ± not least, the current governance provisions that apply to
biomedical research. Historically, United Kingdom medical research regula-
tions only had to cover traditional, one-off research projects and relatively
small-scale, single-gene or disease-specific biosample collections. While
research tools and resources have proliferated and diversified, the law lags
far behind the changes in practice and technology.
If legal standards are unclear and inaccessible, this could leave research
participants without adequate protection, place researchers at risk of criminal
or civil liability, and inhibit the progress of research. Despite these concerns,
no sustained effort has been made to ascertain precisely what sorts of
collections of genetic materials (whether genetic information, biosamples or
both) exist within the United Kingdom, what they contain, where they are
located, how they are used, by whom, or for what purposes. Without such
basic empirical knowledge and an informed understanding of key issues and
needs associated with different collection types, formulating appropriate,
effective, meaningful, and proportionate governance structures will not be
possible.
In this paper we begin to address these gaps in knowledge and under-
standing by presenting some initial findings from the legal research arm of an
interdisciplinary research project on the governance of human genetic
databases in England and Wales.
2
Our purpose is to identify, and to start to
unpack, important legal issues surrounding collections of genetic materials
that may be used in biomedical science. We begin by reviewing the changes
in research activities that pose particular challenges for regulators, including
the shift from genetic to genomic science, and the growing numbers and types
of studies that use genetic or biological samples and/or information to address
their research questions. In section 2 we introduce our interdisciplinary
research project and discuss the research design and methodologies being
using to explore the issues around governing genetic databases in our project.
164
1 F.P. Perera and I.B. Weinstein, `Molecular Epidemiology: Recent Advances and
Future Directions' (2002) 21 Carcinogenesis 517 (and references cited therein); R.
Tutton and O. Corrigan, `Introduction: Public Participation in Genetic Databases' in
Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA, eds. R.
Tutton and O. Corrigan (2004).
2 The Governing Genetic Databases Project (
project (November 2005±October 2008) funded by the Wellcome Trust Biomedical
Ethics Unit (award ref: 076070/Z/04/Z). We outline its purpose, aims, and rationale in
section 2 below.
ß2007 The Author. Journal Compilation ß2007 Cardiff University Law School
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