Medical research: civil liability and compensation for personal injury--a discussion paper. Ciba Foundation Study Group.

The Ciba Foundation Study Group has considered the most appropriate means of compensating participants (or their relatives) for injuries received as a consequence of medical research. The group recognises that injury may occur despite the exercise of the highest degree of skill and care by the investigator and that compensation through an action for negligence is therefore not available. At present injured participants have to rely on ex gratia payments. The group considers this unsatisfactory and recommends the establishment of a centrally operated fund with authority to provide compensation on a no-fault basis. These recommendations do not diminish the rights of the participant to bring an action in the event of negligence on the part of the investigator or an action under the law relating to product liability against the manufacturers of defective equipment or drugs.