Subscribe to the BioNews newsletter for free

Login
Advanced Search

Search for
BioNews

Like the Progress Educational Trust on Facebook


 


 

Governing genetic databases - collection, storage and use

25 June 2007

By Dr Sue Gibbons

Researcher in Law, Ethox Centre, University of Oxford

Appeared in BioNews 413
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 (5,6).

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.

SOURCES & REFERENCES
1) Third Report, 'Human Genetics: The Science and its Consequences' (London: HMSO, 1995) paras 2 and 3.
| 
 
| 
 
| 
 
4) Dr Jane Kaye and I co-edited the symposium articles and co-authored the introductory paper.
| 
 
| 
 
| 
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

05 December 2011 - by Professor Barbara Prainsack and Dr Alena Buyx 
What do research biobanks, social media and the NHS have in common?...
01 June 2010 - by Dr Lux Fatimathas 
The DNA of up to four million newborn babies is being stored in UK hospitals without proper parental consent....

HAVE YOUR SAY
Be the first to have your say.

You need to or  to add comments.

By posting a comment you agree to abide by the BioNews terms and conditions


- click here to enquire about using this story.

Published by the Progress Educational Trust

CROSSING FRONTIERS

Public Conference
London
8 December 2017

Speakers include

Professor Azim Surani

Professor Magdalena Zernicka-Goetz

Professor Robin Lovell-Badge

Sally Cheshire

Professor Guido Pennings

Katherine Littler

Professor Allan Pacey

Dr Sue Avery

Professor Richard Anderson

Dr Elizabeth Garner

Dr Andy Greenfield

Dr Anna Smajdor

Dr Henry Malter

Vivienne Parry

Dr Helen O'Neill

Dr César Palacios-González

Philippa Taylor

Fiona Fox

Sarah Norcross

Sandy Starr


BOOK HERE

Good Fundraising Code

Become a Friend of PET HERE and give the Progress Educational Trust a regular donation