Ireland – Control of Clinical Trials Act 1987

(2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon

(a) in the case of a proposed clinical trial, until the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 8(2),

(b) in the case of a clinical trial which has been approved by the ethics committee

(i) until the committee has given its approval to the amendment, and

(ii) in respect of each person to whom one or more substances or preparations are to be administered, until the person who has given or gives his consent in accordance with section 9 has been made aware of such matters (if any) as the committee considers he should be made aware of having regard to the amendment.

SECTION 6. Conducting of clinical trial.

(1) A person shall not conduct a clinical trial unless

(a) he is a registered medical practitioner or a registered dentist,

(b) there is a subsisting permission granted by the Minister under section 4 in respect of the trial, and

(c) the provisions of section 4 (2) (a) or 5 (2) (a), as the case may be, have been complied with.

(2) In this section

"conduct a clinical trial" means

the conducting of a systematic investigation or series of investigations for the purpose of ascertaining the effects (including kinetic effects) of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect, but does not include the conducting of such a systematic investigation or series of investigations as aforesaid

(a) where

(i) the administration of one or more substances or preparations, as the case may be, is on a patient in the ordinary course of medical practice (in the case of a registered medical practitioner) or of dental practice (in the case of a registered dentist) and

(ii) the principal purpose of that administration is the welfare of the patient, or

(b) where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or as a registered dentist or as a registered pharmaceutical chemist and where it is to be administered as part of such a course of training, or

(c) for the purpose of examining the nutritional effect of the substance or preparation concerned where that substance or preparation is a normal dietary constituent;

"registered pharmaceutical chemist" means