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From principles to practice: implementing genetic database governance

02 June 2008

By Dr Sue Gibbons

Researcher in Law, Ethox Centre, University of Oxford.

Appeared in BioNews 460
Biobanking is flourishing. Techniques and technologies are evolving rapidly. Demand for harmonised standards, especially to facilitate cross-border data and biosample sharing and database interoperability, is mounting. Within this changing environment, the need to develop appropriate, legitimate and effective human genetic database governance frameworks - at national, regional and international levels - is both palpable and urgent. But setting policies and priorities, and actually designing and implementing suitable governance frameworks, present huge challenges. These span a broad spectrum, including ethical, legal and social concerns, practical and technical issues, and economic, strategic, institutional and political factors. In striving to meet such challenges, governance measures must not only safeguard the sometimes competing rights and interests of a huge and diverse range of stakeholders, but also foster beneficial research for the public good whilst maintaining public confidence and support. No simple tasks indeed.

Various organisations are striving to achieve international harmonisation of norms, standards and procedures (1). A seemingly relentless stream of laws, declarations, guidance documents, recommendations and so forth continues to emanate from a vast range of bodies. To date, however, no specifically tailored, widely accepted biobanking or human genetic research database governance frameworks have emerged. Meantime, existing laws and guidelines-particularly in the UK - remain uncoordinated, confusing, complex, inconsistent and incomplete.

Until recently, most scholarly attention, and most legal and policy-related initiatives, concentrated on identifying core guiding norms, standards or principles. But equally important is the need to determine which governance mechanisms, tools, procedures, actors and so forth best might be used to implement whatever norms, standards and principles are eventually accepted. Unfortunately, this crucial second limb has been somewhat neglected - both in terms of establishing sound theoretical foundations for regulation, and exploring possible implementation models.

To help plug this yawning gap, a special issue of Medical Law International is being published this month (2) - see 'Recommends' for details. Under the heading 'Implementing Genetic Database Governance', it contains four socio-legal articles prefaced by an introductory paper, plus a book review by Gertz of 'The Ethics and Governance of Human Genetic Databases: European Perspectives', a substantial new work edited by Hayry, Chadwick, Arnason and Arnason. Taken together, these six papers engage with relevant theoretical debates, outline key developments within the contemporary research landscape, present new empirical evidence and research findings, critically analyse real-world experiences of genetic database governance initiatives, and expose invaluable insights and lessons.

The introductory paper by Gibbons sets the scene. After describing the background context and identifying core principles and issues fundamental to genetic database governance, it comments critically on five cross-cutting themes drawn from the articles. The first of these - perhaps unsurprisingly - is the pressing need for a properly constructed governance regime for biobanks and related biomedical research and forensic activities. The second is the urgent need for more socio-legal and empirical research in the field. A third theme is whether concepts of 'ownership' and 'property rights' should or should not be used - a hotly debated issue. A fourth is the desirability of taking a plurality of viewpoints into account when consulting on and formulating genetic database governance models. The final cross-cutting theme is the need to ensure that governance-related questions are classified accurately (especially as being 'policy' or 'technical' in nature), so that decisions are made early enough and by the correct bodies.

The article by Kaye and Gibbons uses the 'regulatory space' metaphor as an analytical tool, to map out and understand better the current biomedical governance framework in England and Wales. It probes the sometimes surprising roles and powers of many different bodies - notably, the Human Tissue Authority, Information Commissioner, research ethics committees, professional bodies and research funders.

Reporting on a qualitative study into the views of family members of children with cancer and health professionals, Dixon-Woods et al argue that systems of governance and regulation should respect and reflect donors' values. Rather than introducing individual 'property rights' or continuing to use the traditional 'gift' metaphor to describe tissue donations, their findings suggest that a charitable trust model of governance might be better.

Drawing in part on first-hand knowledge of the abortive Icelandic Health Sector Database project, Helgason and Gibbons tell the story of its conception through to its demise from a novel perspective. This focuses on the problems that can arise where regulators try to meet legal requirements for information security using technical information security standards.

Smart et al, meanwhile, examine how the drive to include minority ethnic groups in biomedical research raises thorny problems for genetic database governance. Once again presenting findings from a qualitative study, this time with biobank researchers, their article highlights a significant potential clash between the twin imperatives of achieving just representation ('social inclusivity') and maintaining scientific accuracy and precision ('analytical acuity').

These four substantive articles arose 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 (3,4). That series followed an earlier one, reported in BioNews last year (5). The papers from the previous series also were published (6). It is hoped that both special issues will aid lawmakers and policy-makers, especially in the UK, in designing and implementing appropriate, effective and legitimate governance frameworks for biobanking and human genetic databases, both in the immediate and long-term future.

SOURCES & REFERENCES
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2) Medical Law International, Vol. 9, No. 2 (2008).
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5) SMC Gibbons, 'Commentary: Governing Genetic Databases - Collection, Storage and Use' BioNews 413: 25 June 2007
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6) King's Law Journal, Vol. 18, No. 2 (2007), pp. 201 ff.
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