To send content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about sending content to .
To send content items to your Kindle, first ensure email@example.com
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about sending to your Kindle.
Note you can select to send to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
The advances in computer technology and high-throughput DNA sequencing have led to a substantial increase in the amount of genetic research being conducted throughout Europe. This, in turn, has led to the establishment of many different kinds of genetic databases. Population genetic databases, which have been the focus of the ELSAGEN project, represent one kind of human genetic database that is currently being developed in Europe. There are many more genetic databases that are not as well known and have not been subjected to the same intense international scrutiny and debate. Examples include web-based digital collections such as Ensembl, collections made as ‘add-ons’ for clinical trials or genetic databases established for one-off, specific research projects. Scientists have expressed concern that the current regulatory framework for human genetic databases within Europe is inadequate. In May 2004 the EC Expert Group on Genetic Testing recommended that ‘action be taken at the EU level … to follow and address regulatory issues related to collections of human biological material and associated data and their uses’. The concern is that the lack of standardized guidelines inhibits co-operation amongst researchers and the sharing of samples from genetic databases across national borders. The research of the ELSAGEN legal team has shown that there are significant obstacles to achieving a uniform European regulatory system for human genetic databases. The purpose of this chapter is to discuss some of the preliminary issues that would need to be addressed before such a regulatory system could be developed within Europe.
The legal research in the ELSAGEN project demonstrates that the governance structures for population genetic databases are not uniform or harmonious across Europe. The issues that have been raised by population genetic databases are not always addressed in the legal documents of each of the jurisdictions, and are often treated differently in the law of each jurisdiction. This is because countries have a ‘margin of appreciation’ in implementing European directives and conventions but also because there is currently no European instrument that specially relates to population genetic databases. As a result, new legislation has been written; the courts have been forced to develop the law; and existing governance structures have been used for population genetic databases. This section will highlight some of the common issues that have been raised in part III regarding the nature of the current governance structure for population genetic databases within Europe.
The lack of uniform implementation
An example of the lack of uniform implementation is the European Union Directive 95/46/EC on data protection which has been implemented into Icelandic, Swedish, Estonian and UK national law. The Directive requires that any use of health data must only be carried out with explicit consent, although there are a number of exceptions to this rule. The Directive allows data to be processed without consent ‘to protect the vital interests of the data subject or of another person’; or in cases where the ‘processing of the data is required for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services’; in cases of ‘substantial public interest’ laid down in law; and in cases were research does not involve personally identifiable data.
Email your librarian or administrator to recommend adding this to your organisation's collection.