With £45 million ($66 million) in funding ints coffers from the Wellcome Trust, the Medical Research Council, and the Department of Health, the UK biobank got the go-ahead last week to begin building what it says will be the world’s largest public repository of genetic, medical, and lifestyle information.
Under the plan, several regional centers will recruit 500,000 volunteers between the ages of 45 and 69 who are willing to provide medical history records and a DNA sample. The MRC is now accepting expressions of interest from regional centers as well as potential coordinating centers for the project.
Frances Rawle, strategy and liaison manager at the MRC, has been coordinating the initiative so far, but said the search is on for a project director who will head up the biobank as part of a non-profit organization that will be set up to run the resource. The project director will report to the three funding bodies. In addition, an independent body will be put in place to ensure that the samples and the data collected are used responsibly and within the terms of consent obtained from the volunteers.
Academic and commercial researchers worldwide will have access to the information contained within the biobank, but Rawle noted that the resource would be more restricted than Genbank and other data sources due to the personal nature of the information. Users will need to sign a license agreement to ensure they remain within the terms of patient consent, although the terms of this licensing agreement have not yet been finalized, Rawle said. Also under discussion are intellectual property issues. Although the companies the MRC has been in contact with “are envisaging using the resource for pre-competitive research,” a clear policy on the terms of commercial access will be required before the biobank gets rolling.
The scope of the undertaking is enormous. By comparison, DeCode Genetics’ database of healthcare information on the Icelandic population covers only around 280,000 people and Genomics Collaborative’s Global Repository contains healthcare data on around 100,000 patients. Furthermore, as commercial efforts, each of these projects is driven by economic pressure to quickly and efficiently supply quality data to its clients. Getting the UK’s general practitioners — of whom only 25 percent are completely paperless right now — to comply with the yet-to-be standardized submission protocols of the biobank project will not be an easy process.
Furthermore, according to Rawle, there are three practice systems in use by the UK’s general practitioners. The centralized database that will be set up to query patient records will have to work with all three types of systems and also link out to hospital records. While everyone in the UK has a National Health System identifier code that will help standardize primary care records, hospitals tend to use their own identifier codes, Rawle said, which further complicates the process.
Initial plans don’t call for each of the 500,000 volunteers to be genotyped due to the high costs associated with the process. However, Rawle said the infrastructure of the system would be designed to adapt to the storage requirements that such a project would demand if it becomes economically feasible within the next decade.
Perhaps the most difficult technical issue is the degree of security required to support the system. Rawle said that a hierarchy of accessibility will be necessary — some users will need to link back to patient names and addresses, but this information would be off-limits to other users. Setting up such a system is one thing, but setting it up in such a way that volunteers are confident that their personal data is in good hands is quite another.
Those who have walked down this technology road before agreed that security would be the primary hurdle for the biobank project. Eric Krause, director of operations at Genomics Collaborative, noted that the lack of ethical and technological standards in acquiring and delivering healthcare data requires organizations working in the field to be “moreso above the law than anyone else.”
Arthur Holden, CEO of First Genetic Trust, said, “It’s easy to identify 500,000 people, but if you don’t have the right mechanism to aggregate that data, the right mechanism by which you can consent and reconsent based on specific projects that may be done, then it’s a challenging thing to do.” Holden noted that the centralized nature of the UK’s National Health Service should give the project a head start, but much work will need to be done to provide the level of security necessary to ensure the privacy of volunteers. But, he added, “I think that’s something the UK biobank project well understands and will deal with.”