Medical Law International - From Priciples to Practice: Implementing Genetic Database Governance

FROM PRINCIPLES TO PRACTICE: IMPLEMENTING GENETIC DATABASE GOVERNANCE
SUSAN M C GIBBONS (*)
University of Oxford

ABSTRACT
   This paper provides a short introduction to four articles published as a special collection under the title, ‘Implementing Genetic Database Governance’. It describes the background context and the need for genetic databases and biobanks to be governed appropriately and effectively. It notes the current lack of any coordinated governance frameworks, whether at the national, regional or international levels. It identifies certain core guiding principles and key issues relevant to governing genetic databases. It then draws out and reflects on five cross-cutting themes that emerge from the articles.

1. INTRODUCTION
   We live in exciting times. Human genetics and genomics research is burgeoning. The next decade may well witness significant breakthroughs in our understanding of, and ability to predict, treat and prevent, many serious common diseases and disorders. Much of this vital scientific work depends upon the use of human genetic databases or biobanks. These systematically organised collections typically contain stored human tissue samples, extracted DNA or other genetic material, that is linked to personal, medical, genealogical and lifestyle data on individuals and their family members. Traditionally, such collections tended to be relatively small-scale and diseasespecific. However, over recent years very large-scale collections have begun to emerge, covering substantial numbers of individuals.(1) Some initiatives - for example, the Estonian Genome Project Gene Bank(2) - even aspire to include millions of participants.
   With technological advances, the already huge diversity of biobanking and collaborative research enterprises continues to expand.(3) Through this, researchers can harness increasingly statistically powerful datasets. Two key developments have been the emergence of population-scale genetic databases or population biobanks – such as the Icelandic Health Sector Database and UK Biobank, both of which are discussed in papers herein – and the ability to interlink multiple databases, including internationally via virtual networks and transborder movements of data and samples.(4)
   This flourishing of research, proliferation of genetic databases of highly varied forms, rapid technological and computing advances, and the growing demand for international data-sharing and collaboration raise a host of challenging issues. These challenges span a broad spectrum, from ethical, legal and social concerns – for example, to do with safeguarding individuals’ privacy and autonomy, maximising public health gains, and ensuring justice and equitable benefit-sharing – through to technical problems associated with harmonising standards and procedures to achieve interoperability and facilitate collaboration. Additional concerns relate to economic, strategic, institutional and political factors.
   All such issues underscore the pressing need for an appropriate and effective framework (or frameworks) to govern genetic databases at the national, regional and international levels. This is important to safeguard – and, where necessary, balance or prioritise – significant rights, interests, principles and values; facilitate beneficial research for the public good; and maintain public confidence and support. Good governance dictates and scientific progress both demand a regulatory strategy that is sound in principle, pragmatically workable, and reflective of, and responsive to, key stakeholders’ legitimate interests and concerns.
   Thus, among the most fundamental challenges requiring urgent attention from policy-makers and lawmakers – both in the UK and globally – are issues to do with genetic database governance. Many difficult questions arise. How might biobanks best be governed to facilitate beneficial research whilst safeguarding against potential harms to individual participants, family members, communities and the public? How should we supervise biobanking activities to ensure that biobank creators, operators and users steward these precious resources appropriately, maximising their benefits without violating public trust or exceeding proper limits? What are ‘proper’ limits, and who should decide? Are specifically tailored, formal legal rules necessary, or are informal mechanisms such as flexible, non-binding guidelines and the inculcation of ethically sensitive professional cultures preferable? Who, if anyone, should authorise, approve, vet, oversee, report on, license, record and/or monitor biobanking activities? What normative and practical issues or potential pitfalls arise when governance measures are implemented? How should competing factors be prioritised or traded-off? In short, what principles and policies should underpin and guide the regulation and use of genetic databases, and how best might we implement and enforce these in practice?
   The four socio-legal papers contained in this special collection seek to tackle such questions. In simple terms, designing an appropriate, workable genetic database governance regime may be said to entail two steps: (1) identifying a set of core guiding norms, values, principles and/or policies; and (2) selecting those mechanisms, tools, procedures, strategies and actors that seem most capable of implementing them in the best manner possible (however ‘best’ is defined). By addressing selected key topics, critically analysing realworld experiences, presenting empirical evidence and engaging with theoretical debates, the papers collected here illuminate important aspects of this two-step process. They highlight a range of emerging norms, principles and fundamental interests at stake. They suggest some practical approaches, models and measures that perhaps should – or should not – be used to improve the regulation of biobanks and related research. Importantly, they also draw out and reflect on invaluable insights and lessons from experience; one of the primary benefits of socio-legal methodologies.

NOTES
Researcher in Law, Ethox Centre, University of Oxford.
1. FP Perera and IB Weinstein, 'Molecular Epidemiology: Recent Advances and Future Directions' (2002) 21(3) Carcinogenesis 517 and references cited therein; R Tutton and O Corrigan, 'Introduction: Public Participation in Genetic Databases' in R Tutton and O Corrigan (eds), Genetic Databases: Socio-Ethical Issues in the Collection and Use of DNA (London: Routledge, 2004).
2. http://www.geenivaramu.ee/ (last accessed 09/05/08).
3. A Cambon-Thomsen et al, 'An Empirical Survey on Biobanking of Human Genetic Material and Data in Six EU Countries' in BM Knoppers (ed), Populations and Genetics: Legal and Socio-Ethical Perspectives (Lieden/Boston: Martinus Nijhoff Publishers, 2003) 141; N Palmour, 'A Survey of the Variability of DNA Banks Worldwide' in BM Knoppers (ed), Populations and Genetics: Legal and Socio- Ethical Perspectives, ibid, 123.
4. MA Majumder, 'Cyberbanks and Other Virtual Research Repositories' (2005) 33 Journal of Law, Medicine and Ethics 31.

2. Core Principles and Key Issues >>