UK Biobank is now open for business, with researchers able to access biological samples from over 500,000 Britons. It is undeniably an amazing resource but there are still issues that could cause problems ahead…
It might be the first biobank to open in England, but the idea is nothing new and similar resources are available across Europe and indeed the world. The first biobank founded was in 1975 by Ohio State University. Their Human Tissue Resource Network collected and provided tissue specimens from malignant and benign solid tumours. It now forms part of the Cooperative Human Tissue Network which was established by the National Cancer Institute in 1987.
Biobanks really came into their own in the late 1990s when researchers realised that although many diseases have a genetic component contribute to their cause, few are triggered by a single defective gene. Researchers began collecting much larger amounts of genetic information, and since performing genome-wide scans had become as cost-effective as examining a single gene, multiple teams of researchers were able to analyse data from a large number of people for numerous purposes.
However, it wasn’t until 2006 that trials for UK Biobank were underway and it was only in March this year that UK Biobank opened its doors to scientists, having collected samples from 500,000 individuals over a period of four years.
Although there appeared to be no shortage of volunteers – only 22 of 35 regional centres were required to reach the half a million target – how UK Biobank recruited participants came under fire. They sent a letter of invitation to potential contributors based on names, addresses and date of birth provided by the NHS. Although compliant with data protection, some objected to the NHS passing information onto a third party – in this case a non-profit private institution – without explicit consent.
The issue of consent has also been a contentious one – participants must give permission for their information and samples to be included but concerns have been raised about how much they really know about how their specimens will be used. Many biobanks require participants to give written consent, but this doesn’t necessarily cover new and future uses of the sample and with the potential for specimens to be used by multiple researchers in several different experiments, you have to wonder how much participants really know.
Another concern is that of anonymity. A certain amount of information is needed to ensure each specimen is identifiable – in case someone wants results or to withdraw from the biobank – but researchers working on these samples should not be able to identify participants. However, computer scientists in 2009 showed that even when information like names have been removed from records, people could still be identified from a few key pieces of information. Users of the UK Biobank will have to enter into a legal agreement not to make any attempt to identify participants.
And then there is the question of who will have access to the biobank. Although there is no restriction on scientists accessing the resource, they will be subjected to checks that the research is health-related and in the public interest. Scientists will have to register, and then submit a preliminary and main application before being granted access to samples. Some have said this is a few too many hoops to jump through – particularly as this is supposed to be a widely available resource – but this is surely a small price to pay to ensure participants’ information is safe and the resource is not depleted too quickly. A robust governance system needs to be in place to ensure that data is not misused, but it is interesting to note that there is no internationally-accepted set of guidelines.
Another contentious issue is how biobanks are funded and maintained, and who will have ownership of samples and research. deCODE, a biobank funded by a biopharmaceutical company in Iceland has never made a profit and recorded losses of over $85.5m in 2006. UK Biobank was funded by the Wellcome Trust, the Department of Health, the Scottish Government and the Medical Research Council (MRC) and will be funded by the MRC and Wellcome Trust until 2015. Who will foot the bill for the upkeep after this is as yet unclear – it might be that since scientists are expected to pay for access to the resource on a cost-recovery basis, this will used.
All results are expected to be returned to the biobank so that they are available for other researchers to use, but scientists are not expected to collaborate with the biobank. UK Biobank retains ownership of samples and the database, but will have no financial claim over inventions resulting from research.
Although UK Biobank has had to contend with these initial hurdles, the universal consensus is that it can promote good research provided they are governed well. As you will see on page 21, UK Biobank will provide a valuable health resource that will allow researchers to study what causes disease – particularly as we age – and opens up the possibility of wider collaborations with researchers across the globe, which can only be a good thing. I believe scientists should be making use of this resource – although the idea is not unique – the data it offers is unique to this country and will provide an important insight into the health of a nation.