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/