- guardian.co.uk, Sunday January 5 2003 10.35 GMT
Crucial medical research which could save the lives of thousands of cancer sufferers is being threatened by new rules to make patients' records more confidential.
Scientists are warning they may have to abandon investigations into key areas of research because of the legal and bureaucratic hurdles they face.
The country's largest medical charity, Cancer Research UK, has asked Ministers to give them a full exemption from regulations in the Data Protection Act, which mean they must gain consent from individuals for every separate piece of research.
Some of the studies now running into trouble include:
· an investigation into women who have had a benign breast lump to see why some go on to become malignant;
· a study of new methods of cervical screening, in order to speed up detection of cancerous cells;
· a trial looking at the success rates of different prostate cancer treatments.
Professor Jack Cuzick of Cancer Research UK said that the law on keeping private records confidential was never drafted with the intention of harming medical research.
'We want to have the full consent from patients when we embark on research, but the new regulations are actively harming the very science that is going to help them,' he said. 'There needs to be a sensible way forward through all of this, both to protect the rights of patients and to safeguard scientific investigation.'
The Data Protection Act, passed in 1998, was designed to protect consumers from having personal information, such as bank details, used in unscrupulous ways by companies. But the law has had important ramifications for other areas of life, with schools and social services also being affected.
As it stands, the current rules require that every single use of medical information must be agreed by the patients. That can be prob lematic for science, because sometimes researchers need to go back and look at other aspects of the study that were not originally planned.
One example is a study conducted by Guy's Hospital which involves thousands of women who had benign breast disease, dating back to the 1950s. Many of the patients have since died, but scientists would like to go back to see which of them wenton to develop breast cancer. But although the original study won full ethical approval, the women did not give their specific consent for the new investigation, and it may now not be possible for scientists to do a retrospective investigation.
'This is a really important area of research, but we are being told that it may have to be abandoned beause we haven't got that individual consent,' said Prof Cuzick.
Another breast cancer study affected by the regulations is the ATAC (Arimidex, Tamoxifen and Combination) trial which recently showed that the drug Arimidex can significantly reduce a patient's chances of suffering a relapse.
Scientists would like to know whether there are specific characteristics in the tumours which did occur among the thousands of women who took part to see if they are the kind that could be prevented. But as this was not mentioned on the original consent form, it may not be possible to investigate it because the costs of returning to each patient to ask permission would be prohibitive.
Also in jeopardy is a national study of prostate cancer patients who were diagnosed between five and 10 years ago to look at how successful their treatments were.
An exemption clause does allow the Secretary of State for Health to approve the use of data for research in some circumstances where there is not consent. However, the medical charities want their research to be granted a blanket exemption rather than having to apply for it on a case-by-case basis.
