Human Biomedical Research Act 2015 · 2020 Revised Edition · Part 8 · Enforcement Powers
42. Immediate stoppage of human biomedical research or tissue banking activity, etc.
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Where the Director‑General is of the opinion that any human biomedical research or tissue banking activity —
has given rise or is likely to give rise to a serious adverse event or to such other matter as may be prescribed;
is in contravention of —
any provision of this Act; or
any relevant code of practice or code of ethics issued or approved under section 40;
is not being or has not been properly reviewed by an institutional review board appointed by the research institution; or
is contrary to the public interest,the Director‑General may, in writing, order the researcher and other persons conducting the human biomedical research or tissue banking activity to immediately stop all activities, or any part of the activities, relating to the human biomedical research or tissue bank, and direct the research institution, institutional review board, tissue bank or researcher (as the case may be) to take such precautionary, remedial or other measures as the Director‑General may specify.
Where the Director‑General is of the opinion that an institutional review board is not discharging its duties in a proper or satisfactory manner, the Director‑General may do one or more of the following:
institutional review board
“institutional review board” means a board or committee appointed by a research institution under section 15 or 16 to conduct an ethics review of proposed human biomedical research;
direct the research institution to suspend any human biomedical research for which the institutional review board was the reviewing authority;
direct the research institution to assign another appointed institutional review board to review any human biomedical research for which the institutional review board was the reviewing authority;
direct the research institution which appointed the institutional review board to —
remove or replace any member of the institutional review board; or
dissolve the institutional review board.
Where the Director‑General is of the opinion that a research institution or tissue bank is not discharging its duties under this Act, or as prescribed in regulations made under this Act, in a proper or satisfactory manner, the Director‑General may, by notification in the Gazette, prohibit the further conduct of any, all or specified types of human biomedical research or tissue banking activities (as the case may be) under the supervision and control of that research institution or tissue bank.
research institution
“research institution” means a body of persons, whether corporate or unincorporate or other organisation, or ministry or department of the Government who or which —(a)engages, directly or indirectly (either through contractual or other arrangements), one or more researchers to conduct human biomedical research in Singapore; and(b)exercises supervision and control over human biomedical research conducted in Singapore by the researchers the institution has engaged;
Any person who contravenes an order, direction or notification given to him or her under subsection (1), (2) or (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both and, in the case of a continuing offence, to a further fine not exceeding $2,000 for every day or part of a day during which the offence continues after conviction.