Governing Genetic Databases: Challenges Facing Research Regulation and Practice

Authors


  • The authors wish to express their thanks to the anonymous JLS referees for providing invaluable feedback.

Abstract

This paper reports on the initial findings of an interdisciplinary research project on the governance of human genetic databases in England and Wales. The number of biosample and information collections has expanded, yet considerable legal uncertainty surrounds their definition, collection, storage, management, and use which could inhibit research and clinical practice, while failing to protect the rights and interests of all stakeholders. We report some initial findings from the legal research and identify major challenges associated with defining ‘genetic databases’. We identify a wide range of relevant instruments and regulatory actors, and suggest that none adequately addresses the challenges posed by contemporary research techniques or the‘corporeal’and‘informational’materials used in the genetic databases context. This preliminary analysis seriously questions the efficacy of the current regulatory framework and concludes that developing an appropriate governance framework for the creation, maintenance, and use of genetic databases requires the bringing together of legal analysis with good quality empirical evidence.

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