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Bodies that oversee medical research are harming public health by imposing constraints on the use of patients' data that go further than the law demands, doctors were told at a meeting last week organised by the cardiothoracic section of the Royal Society of Medicine.
Charles Warlow, professor of medical neurology at Edinburgh University, quoted David Smith, deputy information commissioner at the UK Information Commissioner's Office, as saying that the Data Protection Act did not necessarily require consent for the use of health information in medical research. Mr Smith had also approved comments by the medical law expert Philip Havers QC that “researchers should be bolder,” Professor Warlow said.
Mr Havers had said at a symposium in 2006: “The courts are likely to be highly receptive to arguments that the law justifies breaches of confidence and privacy with regard to secondary data research, provided [that] the infringements are no more than is necessary.”
The success of such arguments, Mr Havers added, would depend on demonstrating the strength of the public interest in using the data and “that it was simply not practicable to obtain the consent of the patient or to provide the patient with information about the research.”
Yet guidelines from the General Medical Council and NHS on confidentiality were much more stringent, Professor Warlow told participants at the meeting, which was entitled “The doctor under fire.”
Excluding people from research who did not consent introduced consent bias, he said. The Scottish intracranial malformation study was one opportunity to study the effects of such bias, he added. These researchers were not able to get consent from all patients but had approval from the multicentre research ethics committee to collect baseline and follow-up data on the whole cohort from GPs' and hospital records. The study showed that consenters were systematically different from those who hadn't consented in unpredictable ways and that these differences could not have been estimated in advance.
Professor Warlow said that insistence on consent might get the wrong result, which would damage individual and public health and waste public money on research and practice. “What better way to waste money and damage patients?”
Richard Smith, a former editor of the BMJ, called for better protection for doctors who blow the whistle on research misconduct. Dr Smith said he had reported researchers for misconduct possibly 20 times a year when he was an editor. “Often my experience was miserable,” he said.
In one case he had rung the district general hospital that employed the doctor, to be told that he was already suspended for clinical reasons and that the hospital would investigate the BMJ's complaint if the journal paid for it.
Whistleblowers were very seriously damaged “even when what they blew the whistle on was proved to be serious misconduct,” Dr Smith said. “We also need a way to correct the scientific record; we absolutely don't have that.”
Peter Wilmshurst, consultant cardiologist at the Royal Shrewsbury Hospital, said that conflicts of interest with potential to influence the management of patients or the performance and reporting of research could include personal relationships as well as financial conflicts. “We all know doctors cover up for each other,” he said. “If you report you will suffer almost invariably more than the person you report.”
He said that financial conflicts of interest affecting the management of patients included the system of dispensing GPs, which was “a multibillion pound legal but entirely unethical situation.”
And, he said, although medical journals expressed concern about financial conflicts of interest, they often received “hundreds of thousands of dollars from reprint sales to industry” when the journal published articles that were favourable to a drug or device.