Warning over unfair terms for patients in clinical trials

Letter: Compensation for non-negligent harm in trials remains shaky; BMJ Volume 332, pp 489-90

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 Laurence 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 Laurence 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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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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