Dan Neville
Question:120 Mr. Neville asked the Minister for Health and Children if clinical trials were conducted in psychiatric hospitals on people who were mentally handicapped. [7267/01]
Written Answers. - Clinical Trials.
Mental handicap, or intellectual disability as it is alternatively described, is a condition of delayed or incomplete development of the mind which is present at birth or acquired before the age of 18. It results in a greater than average difficulty in learning and can occur with or without any other medical, mental or physical disorder.
As the Deputy is aware the Irish Medicines Board has approved clinical trials in patients with mental illness over the years. The majority of these trials were conducted in psychiatric hospitals. Although these patients would not be classified as mentally handicapped, as defined in the above definition, they may have some degree of cognitive impairment. However, the Irish Medicines Board has not approved of any specific trials on persons who were mentally handicapped as defined above.
As the Deputy is aware the Control of Clinical Trials Acts, 1987 and 1990, require that all clinical trials are approved by the appropriate ethics committee and that informed consent is given by all persons participating in the trials. There are special provisions applying under the Act in the case of patients who, for practical and other reasons, are unable to give their written and signed consent. These provisions require (a) where the patient is capable of comprehending the significance of his consent, he can give his consent to the doctor treating him for that illness in any other manner provided it is clearly given and in the presence of two witnesses who are present at the same time. In such cases the consent must be expressed in writing and be attested by the signature of the two witnesses; (b) where the patient is incapable of comprehending the significance of the consent to be given, he can only participate in the trial if written and signed consent to such participation is obtained from a person, or persons, who in the opinion of the ethics committee is or are competent to give such consent on his behalf. Such a person or persons must be independent of the person arranging the trial and of the doctor or dentist conducting the trial.
It should be noted that in both these instances it is not permissible to conduct a clinical trial unless the substance or preparation under trial is to be administered for the purpose of saving the life of the patient, restoring his health, alleviating his condition or relieving his suffering.