Up to 1987 there were no provisions for the statutory control of the conduct of clinical trials. Following the establishment of the National Drugs Advisory Board in 1966, a voluntary scheme was introduced with the agreement of the pharmaceutical industry and the medical and pharmaceutical professions. This scheme involved applications to the National Drugs Advisory Board and letters of no objection from the board in respect of the proposed trials. This informal scheme, which did not have a statutory backing, continued until the coming into force of the Control of Clinical Trials Act, 1987. On the basis of the annual reports published by the National Drugs Advisory Board, it has been estimated that approximately 2,022 letters of no objection were issued by the board for the period 1966 to 1988 in respect of applications to conduct clinical trials in this country.
The Control of Clinical Trials Act, 1987, imposed strict regulatory controls on the conducting of clinical trials in this country. Under this Act, which was amended in 1990, persons were required to make application to the Minister for Health and Children for permission to conduct clinical trials. These permissions were granted on the recommendation of the National Drugs Advisory Board. On the coming into force of the Irish Medicines Board Act, 1995, in January 1996, the Irish Medicines Board became the competent authority for the granting of such permissions. Approximately 1,900 permissions to conduct clinical trials, including trials in psychiatric institutions, were granted in the period 1989 to 1997.
Neither the National Drugs Advisory Board nor the Irish Medicines Board hold specific records in regard to psychiatric institutions. Accordingly, the number of trials carried out in psychiatric institutions is not available without retrieving all the files and going through them in considerable detail. However, the IMB is compiling data concerning clinical trials which were previously requested by the Deputy and these will be forwarded to the Deputy as soon as they are available. However, this procedure may not provide reliable or meaningful data as permissions may have been granted for trials which did not subsequently take place. This would also be the case where the number of participants involved in trials is concerned.
Additional InformationSince the coming into force of the Control of Clinical Trials Acts, 1987 to 1990, it is required that informed consent be obtained from all persons participating in the trials. For the purpose of ensuring the consent is valid, the Act requires that the consent must be given in writing and signed by the person who is to be the participant in the trial, the person consenting is capable of comprehending the nature, significance and scope of his consent, and the consent is obtained by or on behalf of the person conducting the trial.
The Act also requires that the person conducting a trial shall ensure that before giving his consent every person 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 the trial will involve the administration of placebos. The consent must be given in writing and signed by the person who is to be the participant.
On the Deputy's concern about psychiatric patients, I assure him that special provisions apply 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 state that, 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. Where the patient is incapable of comprehending the significance of the consent to be given, he can participate in the trial only 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, especially those with a mental illness.
The Deputy has raised this issue on a number of occasions and I have explained the rigorous process provided for obtaining consent under the Control of Clinical Trials Act. The Deputy should be aware that the raising of these matters has caused some concerns to former patients of psychiatric institutions and their relatives and I am anxious that any unnecessary concerns should be allayed. Therefore, if the Deputy has specific concerns about an individual case or individual areas, I would be grateful if he could provide me with the details so that any necessary investigation can be carried out without further delay.
