Singapore legislation
Section 17
Section 17
Functions and duties of institutional review boards
(1)
The functions and duties of an institutional review board are —
to carry out a review (called in this Act an initial review) of any proposed human biomedical research (called in this section the proposed research) on ethical grounds;
to carry out a review of the progress of the proposed research on ethical grounds at such times as may be prescribed;
to assess the suitability and qualifications of the researcher for the proposed research;
to assess whether the minors or the class of minors (if any) who are research subjects in the proposed research are capable of giving consent to the proposed research, having regard to the ages, psychological states and maturity of the minors or class of minors involved;
to assess whether the participation by the minors who lack sufficient understanding and intelligence to give consent or the class of such minors, or the adults or minors who lack mental capacity or the class of such adults or minors (if any) in the proposed research is scientifically necessary and ethically appropriate for the conduct of the proposed research;
to assess that the requirements in Part 3 of the Fifth Schedule are fulfilled before approving any proposed emergency research;
to assess whether there are adequate provisions for taking the consent of the minors or the class of minors (if any) who are research subjects in the proposed research;
to assess if a data and safety monitoring board is necessary for the purposes of the proposed research;
to assess the suitability and adequacy of the system of oversight of the research institution conducting the particular research proposal;
to assess the suitability of the premises for the proposed research;
if the board considers appropriate —
to grant its approval for the research to be conducted or continued, as the case may be;
to require modifications to be made to the research proposal before granting its approval or allowing the proposed research to continue, as the case may be; or
to disallow the conduct or continuation of the proposed research (as the case may be) with written justifications; and
to make such other assessments or carry out such other functions or duties as may be required or imposed under this Act.
(2)
Despite subsection (1), if the chairperson of an institutional review board that is responsible for reviewing a proposed human biomedical research or another member authorised by the board is satisfied that the proposed research falls within such criteria as may be prescribed, including but not limited to the risk of harm to the research subjects, the chairperson or the authorised member may, if he or she considers appropriate —
exempt the proposed research from the requirement to be approved by an institutional review board; or
review the proposed research proposal through an expedited process by the chairperson alone or by a single member authorised by the institutional review board,subject to such conditions as may be prescribed or imposed by the board.