Dáil Éireann díospóireacht -
Wednesday, 28 Feb 2001

Vol. 531 No. 4

Written Answers. - Drug Trials.

Jan O'Sullivan

Ceist:

104 Ms O'Sullivan asked the Minister for Health and Children the investigation which has been held into claims that drugs trials may have been carried out on psychiatric patients without appropriate consent; and if he will make a statement on the matter. [5964/01]

Minister for Health and Children (Mr. Martin)

The Control of Clinical Trials Acts, 1987 and 1990, impose strict regulatory controls on the conducting of clinical trials in Ireland. These controls include a requirement that informed consent be obtained from all persons participating in the trials.

For the purpose of ensuring that the consent is valid, the Act requires (1) the consent must be given in writing and signed by the person who is to be the participant in the trial; (2) the person consenting is capable of comprehending the nature, significance and scope of his consent; and (3) the consent is obtained by or on behalf of the person conducting the trial.

The Act requires that in obtaining informed consent the participant is made aware of the following matters: the objectives of the trial; the manner in which the substance or preparation is proposed to be administered; the risks and any discomfort involved in and the possible side effects of the trial; and whether or not the trial will involve the administration of placebos.

In relation to the Deputy's particular concern about psychiatric patients, I assure her that there are special provisions applying under the Act in the case of all patients who are unable, for practi cal and other reasons, 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; and (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 to conduct 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. These safeguards were specifically provided to protect the interests of all patients, particularly those with a mental illness, referred to by the Deputy.

If the Deputy is aware of any instances of clinical trials being carried out on psychiatric patients without appropriate consent having being obtained, I would be grateful if she could supply me with the relevant details. I can assure the Deputy that upon receipt of such information the matter will be investigated.