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Are UK genetic databases governed adequately? A comparative legal analysis

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Abstract:

Given the burgeoning of genetic research and proliferation of human genetic databases, especially in the biomedical sphere, this paper explores whether the existing laws and regulatory structures for governing genetic databases in England and Wales are adequate. Through a critical survey of relevant rules, bodies and practices, it argues that the current UK framework is far from ideal in at least five major areas: (1) forms and styles of law used, especially the separate legislative regimes for physical biomaterial and data; (2) core definitions; (3) formal regulatory bodies, licensing and notification requirements; (4) ethics committees and other advisory panels; and (5) enforcement powers and sanctions. Such shortcomings could have major implications for stakeholders, hamper efforts to achieve European or international harmonisation of genetic database principles and practices, and undermine the UK’s standing as a world leader in genetics and biotechnology. Drawing on comparative analysis of governance strategies adopted in Estonia, Iceland and Sweden, the paper identifies alternative options and lessons from experiences abroad, suggesting possible avenues for reform that may warrant serious consideration in the UK.

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1748-121X.2007.00045.x

Affiliations: Researcher in Law, Ethox Centre, University of Oxford

Publication date: June 1, 2007

bsc/lest/2007/00000027/00000002/art00007
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