Revised Laws of Saint Lucia (2021)

Schedule 1

(Section 11(2)(c))

PARTICULARS AND DOCUMENTS FOR APPLICATION FOR OPINION OF ETHICS COMMITTEE PARTICULARS

1.     Particulars identifying the clinical trial including the full and short title of the clinical trial.

2.     The following particulars relating to the trial design —

1.  

   (a)     a summary of the clinical trial, including justification and relevance, and the methodology to be used;

1.  

   (b)     the primary, and any secondary, research hypothesis;

1.  

   (c)     statistical analysis and justification for the numbers of subjects to be recruited for the clinical trial; and

1.  

   (d)     details of the process for peer review of the scientific value of the clinical trial.

3.     The name and address of the sponsor.

4.     Details of any arrangements under which the sponsor has delegated any of his or her responsibilities in relation to the proposed clinical trial.

5.     The financial arrangements for the clinical trial, in particular —

1.  

   (a)     sources of funding for the clinical trial and information on financial or other interests of the applicant relevant to the clinical trial;

1.  

   (b)     the arrangements for remuneration of, or re-imbursement of expenses incurred by, subjects;

1.  

   (c)     any provision for compensation in the event of injury or death attributable to the clinical trial;

1.  

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

1.  

   (e)     summary details of any financial arrangements between —

   1.  

      (i)     the sponsor or person funding the clinical trial and the investigator, and

   1.  

      (ii)     the sponsor or person funding the clinical trial and the owner or occupier of the trial site.

6.     Arrangements for the recruitment of subjects, including the materials to be used.

7.     The criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups including individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate such as —

1.  

   (a)     individuals with lack of or loss of autonomy due to immaturity or through mental disability;

1.  

   (b)     persons in nursing homes;

1.  

   (c)     minors;

1.  

   (d)     impoverished persons;

1.  

   (e)     persons in emergency situations;

1.  

   (f)     ethnic minority groups;

1.  

   (g)     homeless persons;

1.  

   (h)     nomads;

1.  

   (i)     refugees;

1.  

   (j)     pregnant women;

1.  

   (k)     those incapable of giving informed consent;

1.  

   (l)     members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

8.     Methods for recording and verifying health status for healthy volunteers.

9.     Procedures for checking simultaneous or recent involvement of potential subjects in other trials.

10.     Details of any relationship between subject and investigator which may be relevant for the purposes of an ethical opinion.

11.     Details of —

1.  

   (a)     any proposed additional investigational procedures or other interventions over and above those required for normal clinical care;

1.  

   (b)     any aspect of normal clinical care to be withheld or other deviation from normal treatment; and

1.  

   (c)     the plan for treatment or care of subjects once their participation in the clinical trial has ended.

12.     The procedures for —

1.  

   (a)     providing information to potential subjects, including a contact point where additional information can be obtained about the clinical trial and the rights of subjects;

1.  

   (b)     providing subjects with updated information during and where relevant after the clinical trial; and

1.  

   (c)     obtaining informed consent.

13.     Details of the arrangements for access to confidential data about the subjects and the arrangements to protect subjects' privacy.

14.     The rules for terminating or concluding the clinical trial before —

1.  

   (a)     the date for the conclusion of the clinical trial specified in the protocol; or

1.  

   (b)     the event specified in the protocol as the event which indicates that the end of the clinical trial has occurred.

15.     Any agreement on —

1.  

   (a)     the access by the investigator or his or her team to the data produced by the clinical trial; and

1.  

   (b)     the policy for publication of that data.

16.     An assessment of the ethical issues relating to the clinical trial, including —

1.  

   (a)     the importance of the clinical trial and of the new knowledge to be gained;

1.  

   (b)     an assessment of the potential benefits; and

1.  

   (c)     an assessment of the possible risks for the subject.

17.     details relating to the chief investigator and each investigator, including —

1.  

   (a)     experience in conducting research; and

1.  

   (b)     any potential conflicts of interest.

18.     Details of any proposed trial site and its suitability for conducting the clinical trial.

DOCUMENTS

1.     A document containing the particulars specified in paragraphs 1 to 4 and 6 to 9 of Part 2 of Schedule 3.

2.     The following documents —

1.  

   (a)     the protocol;

1.  

   (b)     the investigator's brochure for the proposed clinical trial or, where the investigational medicinal product or investigational medical device has a marketing authorization and the product is to be used in accordance with the terms of that authorization, the summary of product characteristics relating to that product;

1.  

   (c)     any document providing evidence of any insurance to cover the liability of the sponsor and investigator;

1.  

   (d)     copies of the advertisement material for recruitment of subjects;

1.  

   (e)     in the case of advertising contained on video or audio cassettes, a copy of the script for that advertising;

1.  

   (f)     a copy of any letter inviting a subject to participate in the clinical trial;

1.  

   (g)     a copy of any questionnaire, diary or sample card to be completed by the subject in writing;

1.  

   (h)     a copy of all written information to be given to a potential subject or his or her legal representative prior to seeking informed consent;

1.  

   (i)     a copy of the form to be used to record the consent of a subject or their legal representative;

1.  

   (j)     a copy of any letters or other written information to be sent to any person who normally provides a subject's clinical care;

1.  

   (k)     a summary curriculum vitae for the chief investigator and each investigator.