Governing Genetic Databases Project
The purpose of this project is to develop models for the governance of human genetic databases in England and Wales. However these will only be useful to researchers and clinicians if they are based on an understanding of current practice and the current law, as well as regulatory theory and normative principles.
The growth in genetic research has led to the establishment of a variety of genetic databases with different purposes, such as UK Biobank, ENSEMBL and sample collections established for single research projects. Despite this growth, there are no accepted definitions of ‘genetic databases’ and no clear or accepted models for their organisational, procedural or security mechanisms to be found in the law, guidelines or codes of practice of England and Wales. Currently researchers and clinicians have to ‘re-invent the wheel’ when creating genetic databases, and often rely on the shared cultural practices of their professions to develop structures and procedures for managing these collections. It is unclear whether these collections are being established in compliance with legal requirements.
There is a possibility that many genetic databases may be operating unlawfully, although they are following accepted practice. The lack of uniform systems to facilitate the sharing of data and samples while protecting the interests of those involved in the research also does not maximise the research potential of these resources.
Population genetic database proposals, such as the Icelandic Health Sector Database, have attracted much attention and have led to an extensive international debate over the principles that should be applied to genetic databases. However, not all of these principles necessarily have relevance for all types of genetic databases; nor would it be appropriate simply to transplant them into the UK context without considering carefully their potential implications and fit.
For instance, a blanket requirement that all genetic databases should have an independent oversight body, such as UK Biobank will have, may be unduly burdensome if applied to a collection of several hundred samples, maintained by one research group, for a single research project.