Control of Clinical Trials Act, 1987

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Ethics committees.

8.—(1) Where the Minister is satisfied that a proposed ethics committee for a clinical trial is competent to consider the justification for conducting the proposed clinical trial and the circumstances under which it is to be conducted, he shall give his approval of the proposed committee, which shall thereupon become the ethics committee for the proposed clinical trial and, where the ethics committee gives its approval in accordance with subsection (2), for the clinical trial.

(2) The ethics committee for a proposed clinical trial shall consider the justification for conducting the proposed trial and the circumstances under which it is proposed to be conducted and, where the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval to the conducting of the proposed trial and the person who is arranging for the conducting of the proposed trial shall communicate such approval to the Minister in writing.

(3) For the purposes of subsection (2), the ethics committee shall not consider the proposed clinical trial justified unless it is satisfied that the risks to be incurred by participants would be commensurate with the objectives of the trial.

(4) Without prejudice to the generality of subsection (2), the ethics committee for a proposed clinical trial shall, in considering the circumstances under which the proposed trial is to be conducted, have regard to the following matters:

(a) the objectives of the proposed trial and its planning and organisational structure;

(b) the qualifications and competence of each person who would conduct the clinical trial and, where appropriate, the resources available to him;

(c) the criteria to be used for the recruitment and the selection of participants;

(d) the procedures proposed for compliance with section 9 ;

(e) the extent and nature of the medical examination that persons selected as participants are to undergo before participating in the clinical trial;

(f) the extent to which the health of participants is proposed to be monitored during and after the clinical trial;

(g) whether or not the persons selected as participants are to undergo independent medical examination before, during or after the clinical trial;

(h) details of the proposed method or methods by which participants are to be recruited;

(i) details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant;

(j) any payments, whether monetary or otherwise, to be made to a person for conducting the clinical trial or any part of the trial;

(k) the criteria to be used to ensure that the identity of each participant remains confidential;

(l) any payments, whether monetary or otherwise, to be made to any person for facilities used for the purposes of the clinical trial;

(m) such other matters as may be prescribed by regulations made by the Minister under this Act.

(5) The composition of the ethics committee may at any time be changed with the approval of the Minister.