ABSTRACT

In Ireland, there is no specific legislation governing the issue of consent in general, except in relation to the right to refuse to undergo any procedure on grounds of conscience/religious belief and the age of consent. In Ireland, all pharmacological research is controlled by the Control of Clinical Trials Act, 1987, as amended by the Control of Clinical Trials and Drugs Act, 1990. Only registered medical or dental practitioners are allowed to conduct clinical trials in Ireland, prior permission for which must be obtained from the Irish Medicines Board. The statutory framework within which pharmacological research in Ireland must be carried out gives rise to practical problems common to all such research. A major area of uncertainty related to the liability of ethics committees where a pharmacological trial was allowed to take place without provisions for adequate compensation for the subjects of the trial who suffered personal injury or death as a result of participating in it.