Control of Clinical Trials Act, 1987

Conducting of clinical trial.

6.—(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 a person registered in the Register of Pharmaceutical Chemists for Ireland maintained under the Pharmacy Acts, 1875 to 1977.