Revised Laws of Saint Lucia (2021)

12.   Opinion of Ethics Committee

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   (1)   Subject to subsections (3) and (4), the Ethics Committee shall within 90 days following receipt of an application, give an opinion in relation to the clinical trial to which the application relates.

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   (2)   Where following receipt of an application it appears to the Ethics Committee that further information is required in order to give an opinion on a clinical trial, the Ethics Committee may, before giving an opinion, send a notice in writing to the applicant requesting that he or she furnishes the information.

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   (3)   Where the Ethics Committee sends a request under subsection (2), the period specified in subsection (1) is suspended pending receipt of the information requested.

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   (4)   Where any subject of the clinical trial is a minor and the Ethics Committee does not have a member with professional expertise in paediatric care, the Ethics Committee shall, before giving an opinion, obtain advice on the clinical, ethical and psychosocial problems in the field of paediatric care which may arise in relation to that clinical trial.

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   (5)   Where any subject to the clinical trial is an adult incapable by reason of physical and mental incapacity to give informed consent to participation in the clinical trial and the Ethics Committee does not have a member with professional expertise in the treatment of —

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      (a)     the disease to which the clinical trial relates; and

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      (b)     the patient population suffering from that disease;

the Ethics Committee shall, before giving its opinion, obtain advice on the clinical, ethical and psychosocial problems in the field of that disease and patient population which may arise in relation to that clinical trial.

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   (6)   The Ethics Committee shall consider, and give an opinion on, any other issue relating to the clinical trial, where —

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      (a)     the Ethics Committee has been asked by the applicant to consider the issue;

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      (b)     it is, in the opinion of the Ethics Committee, relevant to the other matters considered under this section.

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   (7)   An opinion by the Ethics Committee must include —

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      (a)     the relevance of the clinical trial and its design;

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      (b)     whether the evaluation of the anticipated benefits and risks as required under paragraph 2 of Part 2 of Schedule 2 is satisfactory and whether the conclusions are justified;

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      (c)     the protocol;

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      (d)     the suitability of the investigator and supporting staff;

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      (e)     the investigator's brochure;

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      (f)     the quality of the trial site for the clinical trial;

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      (g)     the adequacy and completeness of the written information to be given, and the procedure to be followed, for the purpose of obtaining informed consent of the subject to participate in the clinical trial;

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      (h)     if the subject includes a person incapable of giving informed consent, whether the research is justified having regard to the conditions and principles specified in Part 5 of Schedule 2;

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      (i)     details of provision for indemnity or compensation in the event of injury or death attributable to the clinical trial;

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      (j)     details of any insurance or indemnity to cover the liability of the investigator or sponsor;

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      (k)     the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects;

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      (l)     the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in paragraph (k); and

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      (m)     the arrangements for the recruitment of subjects.

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   (8)   Where the Ethics Committee gives an opinion under this section, it shall make a summary of that opinion available on the electronic database under section 8.