Confusion reigns as data law continues to threaten research

LONDON It has been a turbulent few months for UK researchers and government regulators at loggerheads over the interpretation of the 1998 Data Protection Act.Biomedical researchers have been fighting for their professional lives, claiming that guidance from the General Medical Council (GMC) on how the Act should be implemented would destroy the future of British research and put public health unnecessarily at risk.Meanwhile champions of patients' rights have stuck to their guns, saying that to deny patients the option of refusing to pass on their personal details for research purposes was an infringement of human rights.By Friday 11 May a certain calm — or was it confusion — had settled over the debate. On Thursday night the Health and Social Care Bill had passed through Parliament with the crucial clause 65 intact. This meant that a new statutory body, the Patient Information Advisory Group (PIAG), would be created giving the Secretary of State the power to exempt specific research projects from the GMC's guidance. A GMC spokesperson described the PIAG as "a good solution to the problem," giving scientists a means of opting out of the Act while still providing patient safeguards. Hilary Thomas, Professor of oncology at Surrey Postgraduate Medical School, who chaired the GMC working group that prepared the guidelines called it "a good interim measure that resolves the conflict between scientists and the law." She added that in the future data protection will become increasingly important as more and more people seek genetic tests for disease risk, therefore what is really needed is a more comprehensive look at the data protection law and clause 65 provides a good stepping stone to enable that process to begin.Michel Coleman, head of the Cancer and Public Health Unit at the London School of Hygiene and Tropical Medicine, who has been a vociferous opponent of the GMC's interpretation of the Act said the creation of the PIAG was "a positive development." He admitted, however, that it was still too early to predict whether the proposed scheme would work or not. "The existence of a statutory body that will have more durability should give the issues a higher profile and provide more resources to carry out a review of the technical issues involved," he said. "But it is still too early to say what the outcome of the PIAG will be as the membership and structure of the group has not yet been decided."Coleman predicts that the GMC, Medical Research Council, Department of Health, Patients' Association, British Medical Association and various Royal Colleges will all have a say as to how the system will run. But an essential element will be to categorise research projects in some way to ensure that the volume of applications expected to come the group's way does not clog the system.There is an enormous amount of research carried out in the UK using patient identifiable data and for the moment its future remains uncertain. Coleman believes that asking scientists to improve public health without access to patient records is rather like asking the police to protect the public against criminals without allowing them to have a register of their crimes. Hence, the fight against the guidance.Despite the fact that the GMC issued a one-year moratorium on its guidance last October, much research has already been blocked or delayed, says Coleman. When the guidance was first issued back in September the data flow to cancer registries stopped abruptly after 15 National Health Service trusts swiftly instructed their doctors they were breaking the law by passing on patient details. Although the data stream was repaired after the GMC agreed to delay the imposition of its guidance Professor Coleman fears that if the PIAG is not up and running by the time the moratorium expires in October there will be devastating consequences for research in this country. "If the GMC fails to modify its guidance or if it fails to extend its moratorium and if the PIAG cannot deliver its regulations by October then a great body of research will cease and cease permanently," said Coleman. "There will be a huge loss for the nation. We will not know how effective cancer screening is, how effective treatments are and much more."He is adamant that without research that uses patient identifiable data society would suffer. But he is also convinced that because scientists have had to confront the issue of patient confidentiality for at least a decade the whole process is meticulously managed and controlled. "There has not been a single breach of confidentiality for 40 years when the cancer registries were first set up. Cancer registries have set the standards on these issues and for this process to be interfered with in this way really feels like telling a grandmother how to suck eggs," said Coleman.For Martin Bobrow, professor of medical genetics at the University of Cambridge, the biggest danger of the new approval system is its impact on small research projects. Very large, high-profile and well run studies, such as the UK Biomedical Collection, which Bobrow is helping to develop, are unlikely to be greatly affected. "But the new set-up is really a disincentive to people who are doing highly valuable small projects — say someone looking at three cases of a disease who wants to extract data from the hospital diagnosis index. If they have to apply to the new body for approval then the UK could find itself a very unattractive place to conduct clinical research," said Bobrow.He says the UK Biomedical Collection should not have any problems because adults who take part in the study will be asked for their consent from the start. If family doctors were being fastidious about applying the new data protection rules, however, they could refuse access to the names and ages of their patients — information the researchers would require to recruit the 500,000 people needed for the project.Professor Bobrow takes issue with the very essence of the Data Protection Act and questions whether the public really needs this level of in-built safety against the medical community. He believes that few people whose details have been passed onto cancer registries feel they have been misused. What they really fear is whether the information will get into the wrong hands. "I would like to see research that gives us some factual basis on which to base this legislation — a 'reality check' if you like, on whether the law is in line with what people on the streets think," he said. "And if it's out of line the law should be changed to exempt medical research."

Confusion reigns as data law continues to threaten research

Biomedical researchers in the UK breathed a sigh of relief this week as a new law lifted the threat of the data protection regulations. But can research without patient consent continue as before?

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