Appointment and notification of institutional review boards
Open ↗15.—(1) A research institution must appoint one or more institutional review boards for the purpose of reviewing human biomedical research conducted under the supervision and control of that research institution and in accordance with such requirements as may be prescribed.
(2) To avoid doubt, a person may be appointed as a member concurrently of 2 or more institutional review boards appointed by the same research institution or different research institutions.
(3) A person who is appointed as a member concurrently of 2 or more institutional review boards is not disqualified from sitting on the different boards which are reviewing proposals for human biomedical research that are part of the same research or are otherwise connected or related.
(4) A research institution must notify the Director‑General of —(a)
any institutional review board which it has appointed under this section or section 16; or
(b)
any institutional review board which appointment it has revoked,
as the case may be.
[Act 11 of 2023 wef 01/05/2023]
(5) A notification for the purposes of subsection (4) must be submitted to the Director‑General in such form and manner and within such time as the Director‑General may require, and must be accompanied by such fee as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(6) Any person who contravenes subsection (4)(a) or (b) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(7) Any person who, in submitting a notification for the purposes of subsection (4) —(a)
makes any statement or furnishes any document which that person knows to be false or does not believe to be true; or
(b)
by the intentional suppression of any material fact, furnishes information which is misleading,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Appointment of institutional review boards by multiple research institutions
Open ↗16.—(1) This section applies where human biomedical research is conducted jointly or in collaboration with more than one research institution and there is an agreement among the research institutions for one research institution to be appointed as the lead research institution for the purpose of coordinating the research (called in this section the lead research institution).
(2) For the purposes of their common human biomedical research, the research institutions may, instead of appointing the institutional review boards appointed by them under section 15, appoint a common institutional review board which may be the institutional review board appointed by the lead research institution or such other institutional review board as may be agreed among the institutions.
(3) This Act applies, with the necessary modifications, to the common institutional review board designated by the research institutions under subsection (2) in the same manner as it applies to the institutional review board appointed by the research institution under section 15.
Functions and duties of institutional review boards
Open ↗17.—(1) The functions and duties of an institutional review board are —(a)
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;
(b)
to carry out a review of the progress of the proposed research on ethical grounds at such times as may be prescribed;
(c)
to assess the suitability and qualifications of the researcher for the proposed research;
(d)
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;
(e)
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;
(f)
to assess that the requirements in Part 3 of the Fifth Schedule are fulfilled before approving any proposed emergency research;
(g)
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;
(h)
to assess if a data and safety monitoring board is necessary for the purposes of the proposed research;
(i)
to assess the suitability and adequacy of the system of oversight of the research institution conducting the particular research proposal;
(j)
to assess the suitability of the premises for the proposed research;
(k)
if the board considers appropriate —(i)
to grant its approval for the research to be conducted or continued, as the case may be;
(ii)
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
(iii)
to disallow the conduct or continuation of the proposed research (as the case may be) with written justifications; and
(l)
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 —(a)
exempt the proposed research from the requirement to be approved by an institutional review board; or
(b)
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.
Composition, quorum and proceedings of institutional review board
Open ↗18.—(1) The composition, quorum and proceedings of an institutional review board must be in accordance with regulations made under section 63.
(2) The office of a member of an institutional review board becomes vacant if the member —(a)
dies;
(b)
resigns his or her office;
(c)
becomes subject to any of the disqualifications specified in the regulations;
(d)
becomes subject to a disqualification order made under the regulations; or
(e)
has his or her appointment revoked before the expiry of the term for which he or she has been appointed.
(3) If any vacancy arises in the institutional review board, the research institution may appoint any person who is eligible under the regulations to fill the vacancy.
(4) An institutional review board may act despite any vacancy in the board, except that where the number of members of the board becomes less than 5, the board is dissolved.
(5) The validity of any proceedings of an institutional review board is not affected —(a)
by any defect in the appointment or qualification of any member of the board;
(b)
by any contravention of section 19(1) by any member of the board; or
(c)
by any contravention of the regulations relating to the procedures of institutional review boards except for the requirements relating to the quorum for meetings of the board.
Conflicts of interest
Open ↗19.—(1) A member of an institutional review board must declare at every meeting of the board the nature and extent of all conflicts of interest or potential conflicts of interest in relation to a matter under consideration by the board at that meeting, including such circumstances as may be prescribed in regulations made under section 63.
(2) A person who is a member concurrently of 2 or more institutional review boards which are reviewing proposals for human biomedical research that are part of the same research or are otherwise connected or related —(a)
is not disqualified from participating in the proceedings of the boards on the ground of conflicts of interests by reason only of such concurrent memberships; but
(b)
must disclose his or her participation in each board’s proceedings to all the other boards.
Application to institutional review board for review
Open ↗20. Every application to an institutional review board for the review of human biomedical research must be made by one or more researchers responsible for the conduct and supervision of the research in accordance with such requirements as may be prescribed.
Appeal against decision of institutional review board
Open ↗21.—(1) Any researcher who, having submitted an application to an institutional review board for initial review, is aggrieved by the decision of the institutional review board (called in this section the first board) not to grant approval for the research to be conducted or continued (as the case may be) may within 30 days after the decision of the first board, submit an appeal to the research institution which appointed the first board.
(2) The research institution receiving an appeal under subsection (1) may —(a)
dismiss the appeal;
(b)
direct the first board to reconsider and review its decision; or
(c)
direct the researcher to submit the research to another institutional review board appointed by the research institution (called in this section the second board) for a second initial review.
(3) No appeal under subsection (1) is allowed unless the first board has confirmed in writing that it has disallowed the conduct or continuation of the research.
(4) To avoid doubt, there is no appeal against the decision of the research institution or the second board referred to in subsection (2).
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
