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Ireland – Control of Clinical Trials Act 1987
a person registered in the Register of Pharmaceutical Chemists for Ireland maintained under the Pharmacy Acts, 1875 to 1977.
SECTION 7. Revocation of permission to undertake clinical trial.
The Minister may, at any time and after consultation with the National Drugs Advisory Board, revoke a permission granted under this Act to undertake a clinical trial if he is of the opinion that
(a) the trial or any part thereof is being conducted in a manner which is not in accordance with the permission, or
(b) for any other reason, the trial should not continue, and he shall communicate the reason for his revocation of the permission to the person who had been granted the, permission.
SECTION 8. Ethics committees.
(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;
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