A substantial part of the MRC's plans for its increased funding comes under the umbrella of the "post-genome challenge." According to this scheme, the MRC is to support large-scale, systematic approaches to revealing gene function, which will capitalize on the mass of sequence information generated by the Human Genome Project. To do this, it is focusing on four programs—two that target training in bioinformatics and related disciplines to bolster the scientific base and two that promote genetic studies in mice and humans.

Under the latter program, £12 million ($20 million) has been set aside to 'kickstart' the creation of a national genetic database. The aim is to collect a representative sample of around 100,000 individuals that, using high-throughput technologies, will be systematically studied to discover genes that contribute to many common diseases and allow identification of factors that affect responsiveness to drugs—pharmacogenomics. This venture will most likely be undertaken in collaboration with various medical charities and the National Health Service.

David Porteous

David Porteous of the MRC's Human Genetics Unit in Edinburgh, who has been instrumental in setting up the program, says that the money will be used to conduct studies on 60,000 existing tissue samples beginning next year, and thereafter to promote the collection of new samples and to establish technical centers that can undertake the type of industrial-scale analysis that is the project's aim.

As with other DNA database projects, however, there are many ethical issues that await resolution before the MRC can proceed. Patient confidentiality and informed consent are critical and of immediate importance, as the project will begin with genetic analysis of samples from existing patient cohorts. Although some of these patients have consented to broad-based genetic analysis of their samples, in other cases retrospective agreements will have to be reached.

Even murkier is the issue of what procedures should be followed once results of studies are obtained. Is it appropriate, for instance, to inform supposedly anonymous sample donors that they have a disease susceptibility? This may be acceptable if adequate prevention and treatment options are available, but the appropriate action is unclear regarding conditions for which there is no effective therapy.

The most controversial issue is the question of ownership, both of biological material and access to data, and the role of the pharmaceutical industry. Iceland is currently grappling with the same questions, and debate continues over a parliamentary bill which will allow one Icelandic biotechnology company (deCODE) exclusive rights to the health records of every citizen for its own genetic studies or for licensing to third parties.

Porteous envisages a somewhat different situation for the UK, based primarily on a relationship between academia and the NHS, which he insists "will in no way compromise patient confidentiality or incur any of the not unreasonable concerns about ownership of information and proprietary rights over particular patient sample sets." From this basis non-exclusive licenses for broad and general use by the pharmaceutical industry may be granted.

"If we don't have these [industrial] collaborations we will have failed. We must ensure that the best treatments come through the pharmaceutical industry, it is very much a partnership," Porteous told Nature Medicine. Within the context of such collaborations, he added, "maybe government agencies and charities can play a stronger role in setting the agenda rather than [have it shaped primarily by the pharmaceutical industry]."