Four years in the making, Biobank is financed by the government and the pillars of Britain's scientific establishment — the Wellcome Trust, a $20 billion charity that dominates biomedical research, and the Medical Research Council, which awards science grants. Still, it is creeping to a start because of the ethical issues it poses.
The nation's health secretary, Alan Milburn, calls it a "flagship project on molecular epidemiology for the new century." But others are considerably less optimistic.
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Some people worry that they will be exploited and their privacy invaded. Critics are calling for its suspension, saying it has yet to answer crucial questions about access by the courts and pharmaceutical companies and the type of studies will be allowed.
"We would like to see it shelved until safeguards are added," said Dr. Helen Wallace, deputy director of GeneWatch U.K., a public interest group concerned about genetic research. The government has rejected GeneWatch's request for an independent review of Biobank's value.
Instead, Biobank backers are consulting with ethicists, doctors, scientists, drug companies and the public before issuing final plans. This, they hope, will rally Britain around the plan and prevent the outrage that greeted Iceland's database and doomed another in Tonga.
Biobank is to be ready for study in 2014. At the touch of a few computer keys, international researchers should be able to tap into its storehouse to see what genetic variants exist in Britain's population and how Britons' patterns of everyday life affect their risk for disease.
The researchers say their project will focus on the way genes interact with one another and with environmental influences to alter genetic susceptibility to disease. The task of searching for disease genes is expected to be performed by the Iceland project and its rivals.
Major diseases like heart disease and cancer are well known to have many causes and to involve cascades of interactions among many genes.
Sir George of the Medical Research Council said he hoped that in several decades doctors would be able to tell a patient with a particular genetic mutation and habits that his risk of stroke was, say, 40 percent.
Conclusions like this could emerge from clusters of volunteers with common traits. Researchers might cull smokers with ischemic heart disease to test the hypothesis that smoking elevates the disease risk by affecting the variants of certain key genes.
Cancer and heart disease are "the first two where we will begin to get some useful information," Sir George said, information that doctors could use to persuade patients to change their diets or behavior, or to take a drug, to lower their risk.
Biobank, which is expected to choose its chief executive soon, will be owned by a charity controlled by the British government, the Wellcome Trust and the Medical Research Council.
The need for public ownership was a lesson learned from Iceland. There, the parliament's decision to allow a commercial company to create its database and use anonymous patients' records without their consent created a furor.
Five years ago, evaluating the respective contributions of genes and environment to common diseases was impossible. Only in the last year or two have researchers begun to find some genetic mutations involved.
The recent progress and the prospect of cheaply reading an individual's genome on superfast machinery by 2014, make this kind of immense study feasible.
Still, some researchers doubt that Biobank will succeed. Last year in The Lancet, a medical journal based in Britain, David Clayton at Cambridge and Prof. Paul McKeigue at the London School of Hygiene and Tropical Medicine argued that its design was flawed.
The objectives of Wellcome and the Medical Research Council could be achieved more quickly and cheaply by laying down a bank of anonymous DNA samples from a few thousand cases of each disease, Professor McKeigue said. "U.K. Biobank will take more than l5 years to achieve its targets," he added.
Certainly, its success hinges on the accuracy of doctors' diagnoses, which can be tricky in heart disease and asthma, among others.
Biobank is a gamble, said Sir David Weatherall, a geneticist at Oxford, who was also the lead author of a World Health Organization report on genomics and world health. Issued in the spring, the report included a warning of a worldwide controversy over the desirability of big medical and DNA databases.
He cautioned that mistakes in diagnoses could send researchers after the wrong genes, and ultimately, the wrong medicines.
Biobank believes it can minimize the risk by having its research nurses check doctors' diagnoses but not re-examine patients.
Dr. Christopher O'Donnell, the associate director of the Framingham Heart Study, the gold standard in epidemiology in the United States, cautioned that even a 10 percent to 20 percent error rate in classification of disease could corrupt outcomes.
Dr. Vivienne Nathanson of the British Medical Association, said, "We give it a cautious welcome."
"The caution around it is simply that we do make sure we have proper public buy-in," Dr. Nathanson added. "DNA will give very powerful amounts of information about individuals." Generally, she said, the public is greatly reluctant to give too much information to the government "to use as they will."
Dr. Mike Dexter, director of the Wellcome Trust, said, "The insurance companies wouldn't be allowed access to any individual's data, the police wouldn't, of course, unless there is a major court order and so on."
But the ambiguity over any sort of court order issued to the database is worrisome, Dr. Nathanson said.
Before recruitment of volunteers can start, the project must pass an ethics review by the National Health Service.
An oversight body is planned with veto power over access and ethics.
"The public consultations held so far have all been positive, said Lord Hunt of King's Heath, the parliamentary under secretary of state for health, "but it is still too early to tell how widespread this feeling is amongst the broader general public and medical profession."
