Abstract

KIE: The Association of the British Pharmaceutical Industry's guidelines on compensating patients for injuries incurred in clinical trials of drugs are published here, followed by a commentary co-authored by two ethics committee members who have reviewed such trials. Among the issues covered by the guidelines and clarified by the commentary are provision for compensation without proof of negligence; payment only for injuries caused by the drug under investigation and not by other factors; payment to patients involved in trials, but not to healthy volunteers; and the amount of compensation.