Vol. 530 No. 3
172 Mr. Neville asked the Minister for Health and Children the procedure under the Control of the Clinical Trials Act, 1987; the procedures to appoint members of ethic committees in hospitals; the guidelines under which they operate; the number of such committees; and the names of the members of each committee. [3858/01]
The Control of Clinical Trials Acts, 1987 and 1990 impose strict regulatory controls on the conducting of clinical trials in Ireland. Under these Acts a person who proposes to arrange for the conducting of a clinical trial must make application to the Irish Medicines Board for permission. Every such application must be accompanied by the name, address and description of the applicant; sufficient information to enable a scientific evaluation to be made of the proposed clinical trial and of the substance or preparation which it is proposed to administer in the course of that trial; the identity, which includes the qualifications of each member, of the ethics committee; the name, address and qualifications of each person who would conduct the clinical trial; the criteria to be used for the recruitment and the selection of participants; details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant; such further information, evidence, documents, samples and other materials as may be necessary to indicate the nature of the trial; and the appropriate fee, if any, specified by the Minister by virtue of section 16 of the Act.
In addition, the approval of the appropriate ethics committee for the trial must also be obtained. Under the Acts it is incumbent on the applicant in making application to identify the proposed ethics committees and to provide the names, addresses and qualifications of each member. Guidelines prepared by my Department on the implementation of the Acts require that in determining the membership of ethics committees the following principles should apply: committees must command the technical competence and judgment to attempt to reconcile the physical and psychological consequences of participation with both the welfare of the participants and the objectives of the investigation and they should also, with advantage, accommodate respected lay opinion in a manner that provides effective representation of community as well as medical interests.
The guidelines also recommend that the membership should, as far as possible, include both sexes and comprise both lay and medical members. The following was proposed as the minimum membership for an ethics committee:
"(i)Medical
Three medical practitioners, at least one of whom should be independent of the institution in which the study is to be considered and one, at least, who should be personally familiar with the conduct of clinical trials generally. In the event of a practitioner being personally involved in the study to be conducted, that fact should be disclosed to the other members of the Committee and there should be a sufficient number of other practitioners who are not so involved in order to maintain a balance.
(ii)Paramedical
A person actively involved in patient care.
(iii)One professional non-medical person who is involved in administration or business.
(iv)One person with legal experience.
(v)One member of the lay public whose competence and integrity the public could be expected to respect."
