PART 1
APPLICATION AND INTERPRETATION
1. (1) The conditions and principles specified in Part 2 apply to all clinical trials.
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(2) If any subject of a clinical trial is —
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(a) an adult able to give informed consent, or
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(b) an adult who has given informed consent to taking part in the clinical trial prior to the onset of incapacity, the conditions and principles specified in Part 3 apply in relation to that subject.
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(3) If any subject of a clinical trial is a minor, the conditions and principles specified in Part 4 apply in relation to that subject.
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(4) If any subject —
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(a) is an adult unable by virtue of physical or mental incapacity to give informed consent; and
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(b) did not, prior to the onset of incapacity, give or refuse to give informed consent to taking part in the clinical trial,
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the conditions and principles specified in Part 5 apply in relation to that subject.
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(5) If any person —
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(a) is an adult unable by virtue of physical or mental incapacity to give informed consent; and
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(b) has, prior to the onset of incapacity, refused to give informed consent to taking part in the clinical trial,
that person cannot be included as a subject in the clinical trial.
2. In this Schedule —
“guardian” means a tutor or curator appointed under the Civil Code of Saint Lucia, Cap. 4.01;
“good manufacturing practice” means an international quality standard for manufacturing practices which ensures the quality of investigational medicinal products and investigational medical devices that provides assurance that active substances meet the requirements for quality and purity that the investigational medical products and investigational medical devices purport or represent to possess;
“person connected with the conduct of the trial” means —
(a) the sponsor of the trial;
(b) a person employed or engaged by, or acting under arrangements made with, the sponsor and who under-
takes activities in connection with the management of the trial;
(c) an investigator for the trial;
(d) a health service worker who is a member of an investigator's team for the purposes of the clinical trial; or
(e) a person who provides health services under the direction or control of a person referred to in paragraphs (c) and (d) above, whether in the course of the clinical trial or otherwise;
“health service provider” includes —
(a) a person or body providing a health service;
(b) a person who manages a health care institution;
(c) any clinic, public hospital, private hospital, community health centre, mental health hospital; and
(d) the chief executive officer or person holding a similar position of a body listed in paragraph (c).
3. (1) For the purposes of this Schedule, a person gives informed consent to take part, or that a subject is to take part, in a clinical trial only if his decision —
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(a) is given freely after that person is informed of the nature, significance, implications and risks of the clinical trial; and
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(b) either —
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(i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his or her consent, or
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(ii) if the person is unable to sign or to mark a document so as to indicate his or her consent, is given orally in the presence of at least one witness and recorded in writing.
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(2) For the purposes of this Schedule, references to informed consent —
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(a) shall be construed in accordance with paragraph (1); and
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(b) include references to informed consent given or refused by an adult unable by virtue of physical or mental incapacity to give informed consent, prior to the onset of that incapacity.