GOVERNING
GENETIC DATABASES - COLLECTION, STORAGE AND USE:
http://www.BioNews.org.uk,
Human
genetics research is undergoing rapid and dramatic growth.
Over recent
years, human genetic databases, or 'biobanks', have burgeoned
in number, size
and sophistication. Many countries are developing population-scale
collections,
such as UK Biobank, to investigate complex common diseases.
Meanwhile, both
biomedical researchers and criminal forensic scientists
are seeking greater
collaboration, including through multinational networking
and interlinking of
datasets.
Such developments - the explosion in genetics and genomic
research,
proliferation of biobanks of many different forms, technological
innovations,
and mounting pressure for transborder data and sample sharing
- starkly
demonstrate the need for an appropriate and effective framework
to govern
genetic databases, both nationally and internationally.
This is vital to
safeguard fundamental rights and interests, facilitate beneficial
research for
the public good, and maintain public confidence and support.
As far back as
1995, the House of Commons Science and Technology Committee
identified human
genetics as a field 'ripe for review and regulation' (1).
Yet, still no
specifically tailored framework exists. UK laws and guidelines
remain
incoherent, confusing, uncoordinated and incomplete. Various
international
consortia, such as P3G (2), are attempting to achieve international
harmonisation of norms, principles, standards and procedures.
But, given
widespread national variations and acute legal uncertainty,
their task is
daunting.
It is timely, then, that the King's Law Journal is publishing
an inaugural
special symposium issue entitled 'Governing Genetic Databases
- Collection,
Storage and Use' (3). This special issue contains five articles
(together with
an introductory paper (4)), written by eminent scholars
drawn from the UK and
abroad. The articles emerged from a seminar series hosted
by the Ethox Centre,
University of Oxford, as part of an ongoing socio-legal
research project
looking into genetic database governance (5).
Between them, the five papers address a range of challenging
topics, many of
which test traditional legal concepts, governance measures
and bioethical
principles. Often, they present differing perspectives.
Key cross-cutting
issues and themes explored or raised include consent, data-sharing
and data
protection, special concerns around population biobanks
and criminal forensic
databases, controlling third party access, international
disagreement over
terminology and definitions, ownership, community participation,
feedback and
benefit-sharing, commercialisation, managing intellectual
property rights,
genetic exceptionalism, genetic discrimination, balancing
potential conflicts
between values or rights (especially the 'public good' and
individual
interests), and international consensus-building and harmonisation.
Highlighting two major cross-cutting themes gives a flavour
of the breadth
and depth of analysis. First, notably all five papers tackle
aspects of
consent. Alastair Campbell and Timothy Caulfield each explore
its ethical
foundations, particularly in autonomy, and consider various
implications of
this. Like them, Bartha Maria Knoppers questions the legitimacy
(or otherwise)
of 'blanket' or 'generic' forms of consent - a pressing
but highly contentious
issue, especially within the international population biobanking
debate.
Tellingly, all three authors' conclusions differ. Deryck
Beyleveld stresses the
centrality of consent under data protection law, revisits
anonymisation, and
questions how far data protection exemptions from consent
for medical and
genetics research in the public interest may be justified.
Provocatively, Roger
Brownsword asks whether we should introduce compulsory,
universal participation
in national genetic databases that serve both forensic and
public health
purposes. While all authors agree that there should be consent,
then, their
papers reflect a spectrum of opinion over its proper form
and when it should be
required.
Secondly, although the principal focus of the collection
is on biomedical
research databases, forensic databases are also discussed
in considerable
depth. This analysis, too, is timely. The use of bioinformation
for forensic
purposes and its governance are currently under active review
in the UK. One
particularly controversial issue here is whether, or how
far, police and
security agencies should be able to access and search non-forensic
databases.
Several authors caution that supposed 'public good' (or
public perception)
justifications must not become a licence to commandeer or
exploit genetic
databases in ways that improperly violate individual rights.
Clearly, the
'public good' concept requires further development, not
least within the
biobanking context. The authors' calls for a full public
debate - and to embed
within the governance framework now all necessary safeguards,
oversight
mechanisms and accountability structures to prevent future
misuses or abuse -
arguably should be heeded as a matter of urgency.
Overall, the articles published in the King's Law Journal
special symposium
issue underscore not only the tremendous value and importance
of facilitating
top quality genetic and genomic research, but also the range
of issues that any
properly constructed framework for governing genetic databases
must address.
They show that our decisions about governance potentially
carry serious
implications - not only for individuals, stakeholders and
the public good, but
for the very nature and fabric of society. As biobanking
activities continue to
proliferate and diversify, policymakers and lawmakers simply
must act.
Helpfully, these papers contribute by advancing our awareness
and
understanding. Significantly, they also suggest possible
ways to progress the
domestic and global quests to formulate a practically workable,
normatively
sound, appropriate and effective governance framework for
biobanks.
- Dr Sue Gibbons, Researcher in Law, Ethox Centre, University
of Oxford
References:
(1) Third Report, 'Human Genetics: The Science and its Consequences'
(London:
HMSO, 1995) paras 2 and 3.
(2) Public Population Project in Genomics Consortium,
http://www.p3gconsortium.org/.
(3) King's Law Journal, Vol. 18, No. 2 (2007), pp. 201 ff.
See
http://www.hartjournals.co.uk/klj/volumes/18/issues/2/index.html.
(4) Dr Jane Kaye and I co-edited the symposium articles
and co-authored the
introductory paper.
(5) See http://www.ggd.org.uk/ and http://www.ethox.org.uk/