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PLoS ONE study – I’d go further: poor quality information undermines rights of clinical trial participants
On my recent visit to Newcastle, my afternoon was spent talking to, and answering questions from, the public about research. Clinical trials featured heavily. The most common theme was their frustration over the poor quality information given to trial participants before, during and after a trial had finished.
The journal, PloS ONE, has today published a study by researchers from the University of Southampton (UK), Harvard Medical School and Northern Arizona University (US) in which they conclude that the information given to trial participants about ‘placebos’ is often incomplete and inaccurate. In their study they looked at 45 trial leaflets for participants. They go so far as to suggest that the poor nature of the information provided undermines the principle of ‘informed consent.’ (Medical News Today also cover it here).
Whether it is cock-up or conspiracy that researchers fail to do this I don’t know. But this sort of stuff really gets to me. Why isn’t this stuff being picked-up in the trial design at the time of ethics approval? Why does it seem so difficult to get such simple things right? Why does it need another ‘test’ or ‘trial’ to put it into practice?
The broader issue it points too is the need to codify the rights – and responsibilities! – of trial participants. I can feel a letter brewing to the HRA. Hence my headline.