As the world’s largest medical study, the UK Biobank, roll outs across the country, the project’s Ethics and Governance Council (EGC) has held a public meeting in Manchester to restate its aims and allay fears about the way the collected data will be used.
UK Biobank hopes to recruit some 500,000 people aged 40-69 over the next four years as part of a £61 million project to determine how genes, lifestyle and the environment come together in the development of killer conditions such as cancer, heart disease, diabetes, dementia and joint disease. A successful pilot study to check the feasibility of this undertaking took place in Altrincham, south Manchester last year and assessment centres have now been established in Manchester, Oxford and Glasgow, while another centre is due to open in Cardiff soon.
Before volunteers complete a touch-screen questionnaire, have a face-to-face interview and have their blood pressure and some body measurements taken, they have to complete a written consent, and most questions from the floor at the meeting focused on this point. The consent form notes that participants give permission for access to medical records, and for long-term storage and use of this information “for health-related research purposes” and they also “relinquish all rights” to blood and urine samples. The volunteers also need to sign a section of the form which states that “none of my results will be given to me…and that I will not benefit financially from taking part, eg if research leads to commercial development of a new treatment”.
Attendees expressed concerns as to who will have access to the data and Rory Collins, chief executive and principal investigator of UK Biobank, explained that the most stringent security measures are in place, and are being added to. Also, the project has charity status which strengthens its position against companies or organisations, such as the police, who want to sequester data. He added that the anonymous nature of the data collected acts as another security protection, reiterating that there is also no individual feedback. “It sounds strange but we are not actually interested in individuals,” as scientists, he added.
Usefulness of resource lies long into the future
Prof Collins also pointed out that the data is only going to be useful in, at a very generous estimate, 10 years’ time and that the resource will chiefly be used for a series of case-control studies of different outcomes within the cohort (using anonymised data sets and/or samples). A timetable will be developed to indicate when sufficient cases of each condition are likely to have occurred and researchers can then develop proposals against this indicative timetable. “There will be no preferential access for anyone – it will be open to all scientists,” he added.
It is far too early to talk about the commercialisation strategy for UK Biobank, but the EGC is already laying down the principles by which access to data will be permitted and William Lowrance, who was chairman of the interim advisory group that established UK Biobank’s Ethics and Governance Framework, told PharmaTimes World News that a level of trust from all sides is required so that this innovative project can succeed.
Speaking at the Manchester meeting, he noted that there are other biobanks in operation, notably in Iceland, Estonia, Japan, but not all have full, high-quality data plus specimens, and several have suffered serious setbacks. However, UK Biobank “is perhaps the most ambitious true biobank initiative _ in its scientific scale and comprehensiveness, its de novo prospective design, and its tending to openness, ethics and governance”.
Prof Lowrance noted that “inevitably, UK Biobank will have a very, very, very long startup lag-time and demand great patience _ on the part of its sponsors, managers, scientific partners, participants, the EGC, and everybody else”. However, he concluded that “we mustn't lose sight of the purpose of all this”! By Kevin Grogan