GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA
APPENDIX E
DISCLOSURE OF CONFLICTING INTERESTS3

  1. A member of the Board or of the staff or of any committee of the Authority, may not vote at, attend or in any other manner participate in the proceedings of any meeting or hearing of the Board or any committee of the Authority if:

  • in relation to an application for the registration of a medicine, complementary medicine, veterinary medicine, clinical trial or device, that member or that member’s immediate family member or business partner is a director, member or business partner of or has an interest in the business of the applicant of any person who made representations in relation to the application; or

  • in relation to any matter before the Authority, has any interest which precludes or may be perceived as to preclude that member from performing that member’s functions as a member of the Authority in fair, unbiased and proper manner.

  1. For the purpose of this section, "interest" includes, but is not limited to, any consultancy, paid or unpaid, any research grant from which the member directly or indirectly benefits, or any equity holding or any executive or non-executive directorship or any other payment or benefit in kind.

  2. If at any stage during the course of any proceedings of the Board or committee of the Authority has an interest contemplated in subsection (1), that member:

  1. must forthwith and fully disclose the nature of that member’s interest and leave the meeting or hearing in question so as to enable the remaining members of the Board or any committee of the Authority to discuss the matter and determine whether that member should be preclude from participating in such proceedings by reason of a conflict of interests, and

  2. such disclosure and the decision taken by the remaining members of the Board or any committee of the Authority regarding such determination, must be recorded in the minutes of the proceedings in question.

Footnote

[3] Office of the President (1998)  No. 132 of 1998: South African Medicines and Medical Devices Regulatory Authority Act, 1998.  Gazette Number:  19615, Part 1 of 2.  Volume 402.  Notice Number:  1634.  Date: 18 December 1998

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