Clinical trials - confusion over compensation for injured participants
27/02/2006
May I thank you for the way my accident claim has been handled, after my accident my confidence was very low indeed but the sympathetic handling of my case restored my confidence.
John, Sheffield
Clinical trial patients may mistakenly believe they would be compensated for accidental harm because of badly worded contracts, a senior doctor has warned.
University of London Professor Desmond Laurence told the British Medical Journal (BMJ) that injury pay-out decisions were at the trial sponsor's discretion.
The government, which vets contracts said patients are fully informed of the risks.
There have been reports of heart problems and damage to blood cells after adverse reactions to drugs.
Professor
Laurence said patients who took part in trials deserved to have the
consumer contracts adequately explained to them. He said documents were
not written in plain language, and therefore did not meet the legal requirement of fairness and openness under consumer law.
In the statement it says that, '[The sponsor] will pay compensation for [non-negligent harm]. Any payment would be without legal commitment.'
'If
the law were to be observed patients would be told frankly, in words
lay people could readily understand, that they might be seriously injured but with merely discretionary compensation.'
The answer, he argues, would be to introduce more humane compensation arrangements.
'The issues Professor Laurence
raises are very worrying. Patients should have things fully explained
to them. It is naive of the government and trial sponsors to think they
do not have to do this. It sounds like it is very confusing for patients,' said Partner Louise Hunt, commenting on the BBC.
'Patients have a right to know what their rights are when volunteering for trials,' added Louise.
The Department of Health said that patients were not being misled.
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