Image: Erica P. Johnson
The UK Biobank aims to recruit 500,000 people for population studies of the interactions among lifestyle, genes, and disease, but some opponents question whether the massive effort is structured properly to do an adequate and ethical job. Ian Gibson (Labour, Norwich North), chair of the House of Commons Select Committee on Science and Technology, is to host a meeting in December of members of parliament and the project's funding bodies and critics. UK Biobank has yet to be discussed by the full select committee.
The idea for UK Biobank originated in 1997 when the Wellcome Trust was considering how best to turn the human genome sequencing efforts into medical benefits. Among the ideas: to use the resources of the National Health Service to recruit a statistically significant group of people aged between 45 and 69 (the period during which many diseases with multiple causes begin to manifest). Plans are now well under way for the recruitment, which will probably begin next year and take place over five years. Once a participant gives consent, research nurses will take biological samples, make a physical examination and ask questions about lifestyle. The information will be stored centrally, alongside health records collected by copying participants' National Health Service records on an ongoing basis.
For the next 20 to 30 years, as the numbers succumbing to disease grows, academic and industrial biomedical researchers will have access to the database. The project will cost £45 million, with the Wellcome Trust providing £20 million, the Medical Research Council paying £20 million, and the Department of Health providing £5 million.
Research groups might want to use the database to: search for clusters of disease by, say, geographic area; ask for samples to be sequenced from people fitting a certain profile (samples will be sequenced only as requested by researchers); or use the large sample size to explore statistically the relationships among different disease risk factors and genotypes. For researchers to enjoy freedom of access, their findings and supporting data also must be stored in the Biobank.
Overall the project's aim is to locate potential drug targets and develop the knowledge that could identify someone genetically predisposed to disease in certain circumstances. Slowly, though, the project is gathering opposition. In a parliamentary debate in July, Gibson challenged the basis of the project, saying, "It seems like dubious methodology to ask 50-year-olds what they had for dinner in their childhood."
Robert Terry, a senior policy advisor at the Wellcome Trust, counters, "We won't be asking people if they had three eggs for breakfast. We're interested in questions about alcohol consumption, smoking, and exercise, and there are well-tried ways of weighting answers about such questions to take account of people not being completely honest with medical professionals."
But Gibson also raised a number of significant issues concerning ethics and management and called for public consultation, even though the funding parties have consulted the public, most recently earlier this year via People Science & Policy, an independent consulting company. "The question," says a member of Gibson's staff, "is whether these consultations were a marketing exercise, trying to find out how best to sell the idea, or whether the intent was to be responsive to public concerns."
Terry says, "We can show we have been listening. Our own earlier public consultations suggested the project should be overseen by an independent board, and we changed to accommodate that idea." The most recent consultation recommends extending the process to other regions of the United Kingdom and including more socioeconomic groups. On the whole, the participants (20 each in three locations) were not opposed to the Biobank at the end of the process.
Some had been concerned about whether genetic samples could be used to clone a human being or create "designer" babies. Others stressed the importance of getting the structure of the independent supervisory board correct, though a conclusion about composition was not reached. Further consultations are to follow.
Other issues relating to ethics and management are still at different stages of being ironed out, says Terry, including the nature of the consent form, access to the database by commercial companies, access to samples by police or government, and genetic discrimination and confidentiality. There is no serious concern that confidentiality with respect to the individual will not be maintained, but Helen Wallace, from GeneWatch, a lobby group opposing UK Biobank, says that the plans should be suspended until these issues are resolved.
Some of the concerns are not confined to the Biobank. Take the ongoing concern about genetic discrimination, and the fear that research could lead to knowledge that employers could use to discriminate against people. Equally, the civil liberties concerns that affect Biobank also affect any research that uses tissue samples.
"We would refuse access without a court order," says Terry, "in exactly the same way as any other existing research program that uses biological samples." But there is no way around the fact that if the sample is not given, it cannot be subject to a court order. Commercial access remains a thorny issue, yet one aim of the Biobank is that companies able to develop therapies should have access. "Those accessing the database will pay recovery costs, but we could have a sliding scale with academic groups paying less than industry," says Terry.
In the meantime, the triad of funders is pressing ahead with recruitment of a CEO to head the not-for-profit company that will run UK Biobank. Invitations have also been sent to institutions, which can submit bids to host the central hub of the project. Decisions are expected about both the CEO and the hub's location by the end of the year, with further decisions about regional centers to be made next year.
Helen Gavaghans is a freelance writer in London.