An amendment to the Health and Social Care Bill passed by parliament last week should clear the way for health registries in the United Kingdom to continue collecting data on public health without patients' consent, the General Medical Council has said.
Guidance produced by the council on patient confidentiality and informed consent caused a furore throughout the medical and research communities when it was issued last year (BMJ 2000;321:849).
It said that it was illegal for doctors and hospitals to supply personal information on their patients to research projects or registries without first obtaining the permission of their patients. Doctors claimed, however, that the guidance was unworkable because to ask patients for their consent immediately after telling them they had a serious disease, such as cancer, would be inappropriate in many cases.
An estimated 15 trusts immediately banned doctors from passing on patients' personal details to cancer registries for fear they would be breaking human rights and data protection laws. The viability of the UK national cancer registration system—considered one of the best in the world—was put in jeopardy. The bans were temporarily lifted, however, when the GMC announced that it would delay introduction of its guidance until October this year.
Speaking at a meeting last week to raise awareness of the threat to future research, Professor Richard Peto, a director of the clinical trial service and epidemiological studies unit in Oxford, said: “Every UK citizen has the right to medical care, but those rights also involve responsibilities. Better treatments that save more lives come from research into previous patients' experience.”
The GMC thinks that a permanent solution to the problem will be made possible, however, by a new body that is being set up under the Health and Social Care Bill, called the Patient Information Advisory Group. Individual registries who want to be exempt from the council's guidance on informed consent can appeal to this group, which will decide whether to recommend to the secretary of state that they be exempt. The secretary of state will then pass a “simple regulation” to grant exemption (see article below).
David Forman, deputy chairman of the UK Association of Cancer Registries, said that researchers were not against informed consent but were concerned that if some patients refused to let their details go to the cancer registries then the epidemiological picture of the disease would be distorted.
However, there was still a danger that the registries would collapse if the new law did not come into force before October, when the GMC's guidance would be imposed, said Professor Michel Coleman, head of the cancer and public health unit at the London School of Hygiene and Tropical Medicine.
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IMPERIAL CANCER RESEARCH FUND
Richard Peto: “ rights also involve responsibilities”