Bernard Allen
Question:606 Mr. Allen asked the Minister for Health and Children if he will introduce guidelines in clinical trials of psychiatric patients and children. [1398/01]
Written Answers. - Clinical Trials.
Bernard Allen
Question:607 Mr. Allen asked the Minister for Health and Children if he proposes to introduce guidelines for clinical trials of medical products on psychiatric patients. [1399/01]
I propose to take Questions Nos. 606 and 607 together.
All clinical trials conducted in this country are subject to strict regulatory controls under the Control of Clinical Trials Acts, 1987 and 1990. In view of this legislative control and the extensive guidelines, both national and international, that are already in operation and in use in this country in regard to the conduct of clinical trials, it is not considered that any further guidelines are necessary at this time.
On the coming into force of the Control of Clinical Trials Act, 1987, the Department of Health published guidelines on the implementation of the Act, to assist and inform all persons that may be involved in clinical trials, whether as sponsors, investigators, members of ethics committees or as participants. These guidelines were further updated in 1990 when the Act was amended. These guidelines, inter alia, summarised the requirements of the Acts and of the safeguards provided in respect of participants, including participants who are not capable of understanding the significance of the informed consent as required under section 9 of the Act.
The National Drugs Advisory Board, now the Irish Medicines Board, also published detailed guidelines, titled "Guidelines for applications for clinical trial investigations of medicinal products for human use". While these guidelines were directed mainly at applicants, they also dealt with problem areas for obtaining informed consent, as in the case of children and persons with mental functional abnormality including psychiatric disorders and mental deficiency. All of these guidelines continue to be in operation today via the Irish Medicines Board under the Control of Clinical Trials Acts, 1987 and 1990.
Since the coming into force of the 1987 Act, no clinical trial may be conducted unless the person who proposes to conduct the trial holds a permission under the Act. Currently application for permission must be made to the Irish Medicines Board. All proposals to carry out trials are evaluated by the board in consultation with an expert sub-committee on clinical trials which then makes its recommendation to the board and to the Advisory Committee on Human Medicines. On receipt of the recommendation from the clinical trial sub-committee, the board grants the required permission under the Acts. All trials are required to be conducted according to internationally recognised standards of good clinical practice, in particular those adopted within the International Conference on Harmonisation, including the EU Committee on Proprietary Medicinal Products.
In parallel to the permission granted by the Irish Medicines Board, it is also necessary under Section 8 of the Control of Clinical Trials Acts, 1987, for the approval of the relevant Ethics Committees to be obtained. The composition of these Ethics Committees is approved by the Irish Medicines Board when it grants the required per mission. The matters which must be taken into account by these committees are set out in detail in Section 8(4) of the 1987 Act. These matters include the recruitment of participants, financial inducements, selection of volunteers and informed consent.
The need for trials to be conducted in accordance with internationally required standards of good clinical practice (GCP) is a matter which must also be taken into account by the Ethics Committees in their deliberations. Compliance with standards of good clinical practice provides a public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. These also provide assurance that the clinical data provided by these trials is credible.
The Mental Health Bill currently before the Oireachtas will prohibit the conduct of clinical trials on patients who are held involuntarily for psychiatric care and treatment.