SUPERMARKETS and banks have been doing it for years. Increasingly, medical scientists are doing it too: digging into the vast amounts of data they routinely collect from the public in search of useful insights.
Last week, data-mining experts met at the University of Plymouth, UK, to hear of the latest advances in applying such methods to medical records. The idea is to scour patient data collected in hospitals for clues into the risk factors and early diagnosis of conditions such as Alzheimer鈥檚 disease and cancer.
Many of those at the were involved with 鈥� a pan-European project set up in 2004 to assess the challenges of performing such data mining on patient records across the European Union. The vast scale of the undertaking has naturally led to a focus on the technological challenges involved. The work of the dozens of research teams suggests that such a project may well be feasible, and could offer huge healthcare benefits.
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My own involvement in Biopattern, however, leads me to believe that such projects risk being scuppered by an issue currently receiving far less attention. It centres on the fact that most of us prefer to be asked before our details are used for medical research, no matter how worthy its aims. This seems like common sense to most people, but some in the research community have yet to accept it.
The issue of consent in research has prompted plenty of tension over the years, mainly between the purists who insist that obtaining explicit informed consent is an indispensable ingredient of ethical research, and the pragmatists who argue the issue should not be allowed to threaten the greater good of a research project.
It鈥檚 true that demanding explicit consent has had dire consequences on databases designed to probe specific diseases. Medical registries in Canada, Australia and Germany have all been weakened by this requirement, with most patients deciding, for whatever reason, not to give consent. Demanding consent can also lead to subtle biases in databases since certain groups, often the poor, are less likely to agree. This can lead to misleading inferences about the links between sociological class, for example, and diseases such as cancer.
Yet brushing aside the issue of consent can be even worse. In the 1990s, Iceland became the focus of a pioneering project under which the medical and genetic records of the whole population would be stored on databases and mined for medical treasure. The analysis was to be done by the company , which planned to sell the fruits of its discoveries to drug companies.
In 1998, the Icelandic government passed legislation allowing the project to proceed on the basis of presumed consent. That is, every Icelander alive or dead was presumed to be happy to be included in the databases, once their records had been anonymised. It proved a false presumption. Bitter criticism from ethicists was followed by legal challenges, culminating in the collapse of the project in 2004. A similar project, set up by an Australian biotech company in the Pacific Tonga islands, suffered the same fate that year, again over issues of consent.
Surveys have repeatedly shown that the public does not buy the argument that the medical ends justify the research means. In 2005, a poll conducted by the British Medical Association found that 77 per cent of people in the UK believe their explicit consent should be required even for the basic act of storing their health records on a national computer network.
鈥淭he public does not buy the argument that the medical ends justify the research means鈥�
Yet many in the medical research community still seem convinced that consent can and should be bent to suit the circumstances. Last year, by the UK鈥檚 Academy of Medical Sciences on the use of patient information in research declared that 鈥渦ndue emphasis鈥� on the need for explicit consent has impeded research. The power of inadequate emphasis on consent to ruin major research projects seems to have passed the academy by.
Consent will be central to the success of huge projects such as those envisaged by Biopattern and similar efforts in the US and Canada. Yet despite clear lessons, there is a serious risk that this issue will be overlooked. Of 13 programmes funded by Biopattern, for example, just two include any consideration of the consent issues involved.
It doesn鈥檛 have to be this way. Over the last few months, the has been collecting health data from thousands of people. Set up in 2000 and backed by government and charitable funding, Biobank has been notable for asking the public鈥檚 opinion on their participation, rather than taking a guess. This led to explicit consent being adopted as standard, with fresh consent being sought whenever new uses for the data emerge. The project has been rewarded by positive media coverage and impressive levels of participation.
Whether Biobank makes a major contribution to healthcare remains to be seen, but it has already shown that in medical research, as in life, it pays to treat people with respect 鈥� and to ask before taking.
