Sarah Wilson has doubts

Recent research comparing the governance frameworks of several European Biobank projects points to weaknesses in the governance structures of the UK project. (See reference 1.)

Countries such as Iceland and Estonia have developed legislation specifically to safeguard the information in the databases, and to address key issues of access.  In contrast, no such legislation exists here, and the UK Biobank will be overseen by an independent Ethics and Governance Council.  Whilst existing UK law will obviously apply, there is no direct legislation governing the project, which will instead operate to a set of standards agreed by the Council.

Police access

This mode of operation gives cause for concern, particularly in relation to state and commercial access.  There is no outright ban on access by the police (as there is in the Estonian Biobank) and it is possible that the police may obtain identifying information through a court order.

Whilst the governing framework of the Biobank spells out that such a request would be strongly resisted in the courts, precedence has been set for confidentiality to be breached in a similar case.  The group responsible for the initial Ethics and Governance framework ‘didn’t perceive any special vulnerability to police interest for UK Biobank as compared with…other databases’.

In practice it may be that the special vulnerability of the Biobank lies in the sheer size of the project, making it an easy way of checking a large number of DNA samples at one time.  Similar concerns exist in relation to insurance and employment, where there is the potential for discrimination.

Bark not bite

These concerns are compounded because the committee responsible for overseeing the Biobank’s ethical framework has little power if it identifies a breach of ethical practice, even though the White Paper on genetics had suggested the oversight Council should have the power of veto. The existing powers of the Ethics and Governance Council are limited to an advisory capacity, with the strongest action being formal resignation and public denouncement by members of the Council.

Early in the process of developing the framework, it was recommended that ‘the option of seeking legislative support be kept in mind’ and this should be re-considered.  Greater powers of sanction, and clarity in matters of access, would answer some of the criticism levelled against the UK Biobank, and may ultimately contribute to a more successful project.

Reference
1. Anthony Mark Cutter, Sarah Wilson and Ruth Chadwick (Sept 2004), Balancing Powers: Examining Models of Biobank Governance,  Journal of International Biotechnology Law, Vol 1, Issue 5, p187-192.

The support of the North West Genetics Knowledge Park and the Economic and Social Research Council of UK, is gratefully acknowledged. The work was part of the ESRC Centre for Economic and Social Aspects of Genomics (CESAGen).

Dr Sarah Wilson is research associate at CESAGen, Lancaster University.