Avoidable harm to people participating in research

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Failure to assess all relevant, reliable evidence can also result in avoidable harm to people who participate in research.

Researchers continue to be commissioned and allowed to do studies that involve withholding treatments known to be effective. For example, long after reliable evidence was available showing that giving antibiotics to patients having bowel surgery reduced their chances of dying from complications of the operation, researchers continued to do comparison studies that involved withholding antibiotics from half the patients participating in controlled trials.

The researchers’ failure to review systematically what was already known deprived half the participants in their studies of a known beneficial treatment. This serious lapse was evidently overlooked by the funding bodies who financed their research, and by the research ethics committees which reviewed the protocols and failed to challenge the researchers.

It is not only patients requiring treatment who can be put at risk if researchers do not assess systematically what is already known about the effects of the treatments they will be given.  Healthy volunteers can be harmed too.

The first phase of testing some treatments often involves a very small number of healthy volunteers. In 2006, six young men volunteers at a private research facility in West London were given infusions of a drug that had not previously been used in people. They all suffered life-threatening complications – one of them losing fingers and toes – and their long-term health has been compromised.

This tragedy could most probably have been avoided [13] if a report of a severe reaction to a similar drug had been submitted for publication, [14] and if the researchers had assessed systematically what was already known about the effects of such drugs. [15] Had they done so, they might not have proceeded with their study at all, or if they had decided to go ahead, they might have injected the volunteers one at a time rather than simultaneously; and they could and should have warned the healthy young volunteers about the possible dangers. [16]

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