Schedule 2
(Section 12(7)(b) and (h))
CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS
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.
PART 2
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation Good Clinical Practice Guideline
1. Clinical trials shall be conducted in accordance with the ethical principles that are consistent with good clinical practice and the requirements of this Act.
2. Before the clinical trial is started, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial should be started and continued only if the anticipated benefits justify the risks.
3. The rights, safety, and well-being of the subjects are the most important considerations and prevails over interests of science and society.
4. The available non-clinical and clinical information on an investigational medicinal product or investigational medical device must be adequate to support the clinical trial.
5. Clinical trials must be scientifically sound, and described in a clear, detailed protocol.
6. A clinical trial shall be conducted in compliance with the protocol that has a favourable opinion from the Ethics Committee.
7. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified health practitioner.
8. Each individual involved in conducting a clinical trial shall be qualified by education, training, and experience to perform his or her respective task.
9. Subject to the other provisions of this Schedule relating to consent, freely given informed consent shall be obtained from every subject prior to clinical trial participation.
10. All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
11. The confidentiality of records that could identify subjects shall be protected, respecting the privacy and confidentiality rules in accordance with the requirements of any law relating to data protection or confidentiality.
12. Investigational medicinal products or investigational medical devices used in the clinical trial must be —
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(a) manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice; and
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(b) used in accordance with the approved protocol.
13. Systems with procedures that assure the quality of every aspect of the clinical trial must be implemented.
14. A clinical trial shall be started only if the Ethics Committee and the National Competent Authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.
15. The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with any law relating to data protection are safeguarded.
16. Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.
PART 3
CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY
1. The subject has had an interview with the investigator, or another member of the investigating team, in which he or she has been given the opportunity to understand the objectives, risks and inconveniences of the clinical trial and the conditions under which it is to be conducted.
2. The subject has been informed of his or her right to withdraw from the clinical trial at any time.
3. The subject has given his or her informed consent to taking part in the clinical trial.
4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent.
5. The subject has been provided with a contact point where he or she may obtain further information about the trial.
PART 4
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
Conditions
1. Subject to paragraph 6, a parent of the minor or, if by reason of the emergency nature of the treatment provided as part of the clinical trial no such person can be contacted prior to the proposed inclusion of the subject in the trial, a guardian for the minor has had an interview with the investigator, or another member of the investigating team, in which he or she has been given the opportunity to understand the objectives, risks and inconveniences of the clinical trial and the conditions under which it is to be conducted.
2. That parent or guardian has been provided with a contact point where he or she may obtain further information about the clinical trial.
3. That parent or guardian has been informed of the right to withdraw the minor from the clinical trial at any time.
4. That parent or guardian has given his informed consent to the minor taking part in the clinical trial.
5. That parent or guardian may, without the minor being subject to any resulting detriment, withdraw the minor from the clinical trial at any time by revoking his or her informed consent.
6. The minor has received information according to his or her capacity of understanding, from staff with experience with minors, regarding the clinical trial, its risks and its benefits.
7. The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in paragraph 6 to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.
8. No incentives or financial inducements are given —
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(a) to the minor; or
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(b) to a parent of the minor or the guardian of the minor, except provision for compensation in the event of injury or loss.
9. The clinical trial relates directly to a clinical condition from which the minor suffers or is of such a nature that it can only be carried out on minors.
10. Some direct benefit for the group of patients involved in the clinical trial is to be obtained from that clinical trial.
11. The clinical trial is necessary to validate data obtained —
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(a) in other clinical trials involving persons able to give informed consent; or
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(b) by other research methods.
Principles
12. Informed consent given by a parent or guardian to a minor taking part in a clinical trial shall represent the minor's presumed will.
13. The clinical trial has been designed to minimize pain, discomfort, fear and any other foreseeable risk in relation to the disease and the minor's stage of development.
14. The risk threshold and the degree of distress have to be specially defined and constantly monitored.
15. The interests of the patient always prevail over those of science and society.
PART 5
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
Conditions
1. The subject's guardian has had an interview with the investigator, or another member of the investigating team, in which he or she has been given the opportunity to understand the objectives, risks and inconveniences of the clinical trial and the conditions under which it is to be conducted.
2. The guardian has been provided with a contact point where he or she may obtain further information about the clinical trial.
3. The guardian has been informed of the right to withdraw the subject from the clinical trial at any time.
4. The guardian has given his informed consent to the subject taking part in the clinical trial.
5. The guardian may, without the subject being subject to any resulting detriment, withdraw the subject from the clinical trial at any time by revoking his or her informed consent.
6. The subject has received information according to his or her capacity of understanding regarding the clinical trial, its risks and its benefits.
7. The explicit wish of a subject who is capable of forming an opinion and assessing the information referred to in paragraph 6 to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.
8. No incentives or financial inducements are given to the subject or their guardian, except provision for compensation in the event of injury or loss.
9. There are grounds for expecting that administering the medicinal product or medical device to be tested in the trial will produce a benefit to the subject outweighing the risks or produce no risk at all.
10. The clinical trial is essential to validate data obtained —
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(a) in other clinical trials involving persons able to give informed consent; or
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(b) by other research methods.
11. The clinical trial relates directly to a life-threatening or debilitating clinical condition from which the subject suffers.
Principles
12. Informed consent given by a guardian to an incapacitated adult in a clinical trial shall represent that adult's presumed will.
13. The clinical trial has been designed to minimize pain, discomfort, fear and any other foreseeable risk in relation to the disease and the cognitive abilities of the patient.
14. The risk threshold and the degree of distress have to be specially defined and constantly monitored.
15. The interests of the patient always prevail over those of science and society.