Warning Over Unfair Terms For Patients In Clinical Trials

February 24, 2006

Patients who volunteer to take part in clinical trials are currently

being left without adequate legal protection in the event of injury,

warns a senior doctor in this week's BMJ.

Professor Desmond ce argues that when patients are invited to

enter clinical trials, they are at present being induced to believe

that the trial sponsor will have a legal obligation to compensate

them in case of injury, when in fact that is not true.

Patients who volunteer for clinical trials enter a consumer contract

with the trial sponsor. Consumer law requires such contracts to be

expressed in plain language.

But Professor ce argues that the words used in clinical trial

contract documents concerning injuries to patients are not plain

language and do not therefore meet the legal requirement of fairness

and openness under consumer law.

" 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, " he

says. " The trial sponsor of course may always pay ex gratia

compensation, if it cares to, " he adds. " But if it does not, then the

cost of compensation for non-negligent harm falls upon the injured

patients themselves. "

He calls on the Department of Health to obey the law. " If patients

were told the truth, any resultant shortage of volunteers could well

lead to the introduction of more humane compensation arrangements for

injured patients, " he says. " If it simply will not, then the Office

of Fair Trading should now enforce the law. "

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