By Scarlet Pruitt, IDG News Service
November 15, 2003 | LONDON -- Some four years after the idea was introduced, the UK Biobank is rapidly becoming reality, with the appointment of a CEO, an initial round of funding, and the release of an ethics and governance framework.
The ambitious project plans to collect biological samples and medical data from up to half a million Britons aged 45 to 69, creating the world’s largest repository of information for ethically and scientifically approved research. The goal is to create a database that can help researchers diagnose genetic and environmental factors contributing to major diseases, including heart disease and cancer, and possibly prolong lives.
“In terms of scope, this project is unprecedented,” says the Biobank’s CEO, John Newton. Newton joins the Biobank from the University of Oxford’s Department of Public Health and Primary Care, where he was a consultant epidemiologist for 11 years.
Mike Pringle, deputy chair of the Biobank’s Science Committee, sees the project as building upon the scientific progress in cracking the human genome. “What we have to do now is benefit from the mapping in terms of patient health, and the only way to do that is to build a large database and look at the variance in (genetic) codes,” he says.
Although originally proposed in June 1999, the Biobank’s foundation is only now being poured, with about $100 million (about £60 million) in initial funding from the Medical Research Council, The Wellcome Trust, and the Department of Health. The University of Manchester has been selected to host the Biobank Coordinating Centre, reflecting its investment in genetics, data links, and infrastructure.
But Pringle, a general practitioner and professor at the University of Nottingham with an interest in health informatics, recognizes that the biggest challenges lie ahead, as collecting and performing genetic analysis on so many samples is an enormous task, requiring large-scale data storage and tracking. A pilot data collection program is set to begin next year, with full volunteer recruitment in 2005. In the meantime, key ethical and practical issues are still being addressed, including what kind of technical systems to put in place.
In September, the project’s Interim Advisory Group on Ethics and Governance released an ethics framework, putting in place safeguards for patient privacy, consent, and access. All sensitive patient data will be anonymized, according to the ethics group chair, William Lowrance. “It’s important to remember that we are creating a resource and not just a single study,” Lowrance says, noting that the framework had to include long-term patient privacy issues. Access to the data will be granted only when rigorous ethical and scientific criteria are met.
The database is planned to be usable for decades to come, allowing scientists and researchers to query a wealth of patient information to dissect the biological and environmental factors contributing to major diseases. With numerous researchers expected to seek access to such a rich medical resource, establishing those parameters is another key consideration.
“We will assuredly do it online, with data entry using portable computers, PDAs, and possibly mobile phones,” Newton says, adding that researchers in Sweden, France, and Canada have also expressed interest in accessing the data and are keen on using mobile devices.
Professor John Bell, a geneticist at the University of Oxford and chair of the Biobank’s Science Committee, said that linking Biobank data to similar efforts around the world would lead to “a globalization of medical research.” But expansion plans beyond the United Kingdom are a distant priority, as questions about how to link all the U.K. practices have yet to be resolved.
The main challenge will be linking general practice primary care records to the Biobank center on a continuing basis, according to Pringle. Adding to the difficulty, some 12 percent of U.K. patients switch practices every year, he says.
To avoid losing track of participants, the system must be dynamic and widespread. Fortunately, 98 percent of British general practices are already using informatics, Pringle says, and one-third of the practices are “paper light,” meaning that they keep all their records in electronic files. However, that does not mean that the data are networked. Although exact IT requirements are still being considered, Newton says sophisticated tracking software and hardware will be needed and the project will “almost certainly” use bar-coding.
Newton adds that “many, many IT vendors” are already offering to help, but he concedes that he is keeping them at arm’s length while they study and evaluate the resources already available in the scientific world: “We aren’t that far advanced in the IT planning, and although we know we will need additional partners, because of the industrial nature of our work we’ll be looking to the scientific community.”
In addition to data storing and tracking, the actual sample collection process is also under evaluation. Automated and robotic retrieval systems are being considered, according to Bell, but given the scope of the project, it depends on which technical advances become available.
While many practical questions still remain, the project leaders say that the public has already expressed wide support. “People want to participate -- they want to be part of developments toward a better life,” Newton says.