The ethical safeguards and NHS red tape following the Alder Hey body parts scandal are stifling research into new medicines, according to researchers//. With restrictions on approaching study volunteers, excessive paperwork, and seemingly arbitrary judgments by ethics committees many doctors have been deterred from getting studies up and running.
Jenny Hewison, a clinical researcher at Leeds University said, "That's a disaster and it is absolutely not in the public interest."
She and Andy Haines at the London School of Hygiene and Tropical Medicine, has written to the British Medical Journal criticising the regulations connected with consent from research volunteers.
The ‘opt in’ system for patients participating in research has especially come under criticism. This system allows researchers to only approach those patients who have previously told their doctor they are willing to be contacted to ask if they are prepared to take part in research. The researchers cannot contact patients without prior notice to ask them if they would be willing to take part.
This would lead to a dramatic cut down of the number of people that would be available for a study and thereby biases the study group rendering research invalid. Professor Hewison said, "It's not just cost or time, it is affecting the quality of the work," said. According to her most people would be happy to be contacted when they hear that the study might help to develop new treatments. "We are not double glazing salesmen," she added.
Several doctors feel that after the Alder Hey hospital scandal in Liverpool, where children's body parts were retained illegally between 1988 and 1996 the ethics committee had swung out of control. In 2004 the BMJ produced an issue that listed several ethics committee horror stories, including a 64-page form which took 40 hours to fill in.
Stephen Dealler, a consultant microbiologist, said in the NHS several desp
erate colleagues had opted to break the rules and bypass ethics committees. He said, "If they asked the ethics committee it would take six months, they may well say no for no good reason, and so there's no bloody point."
Janet Darbyshire, head of the Medical Research Council's clinical trials unit, said: "There have certainly been a number of bureaucratic hurdles that have made it difficult to do research."
However she claimed that the NHS had recognised the problem and was taking steps to streamline research.
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