s 23 Functions and duties of research institutions
23.—(1) Every research institution must, in respect of any human biomedical research to be conducted under its supervision and control —(a) submit a notification in such form and manner, and within such time as may be prescribed, before the commencement of the first human biomedical research conducted under that research institution’s supervision and control; (b) submit, in accordance with section 24(1), a declaration of compliance in respect of all human biomedical research conducted under its supervision and control in the preceding 12 months, or such other period of time as the Director‑General may require; and[Act 11 of 2023 wef 01/05/2023] (c) ensure that there is in force an approval for the human biomedical research under section 17(1) issued by an institutional review board which the research institution had appointed or is an exemption under section 17(2) of the requirement for that research to be approved by the institutional review board appointed by the research institution. (2) Every research institution must, in respect of any human biomedical research which is carried out under its supervision and control —(a) supervise, review and proactively monitor the conduct of the research; (b) designate a principal person in charge to be responsible for ensuring that the research institution complies with this Act; (c) formulate and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the research; (d) establish a data and safety monitoring board if its institutional review board considers that it is necessary for the purposes of any particular research proposal; (e) investigate any areas of concern and take such remedial measures as appropriate; (f) ensure that the research —(i) is in compliance with the requirements of this Act; and (ii) is conducted in accordance with its standards, policies and procedures referred to in paragraph (c); (g) ensure that, where the human biomedical research is conducted jointly or in collaboration with more than one research institution, 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; and (h) perform such other functions and duties as may be prescribed by the Minister. (3) Every research institution must notify the Director‑General, in such form and manner as may be prescribed, of —(a) the commission of any suspected offence or contravention under this Act or the regulations; (b) the occurrence of any serious adverse event; and (c) such other matters as may be prescribed.[Act 11 of 2023 wef 01/05/2023] (4) The designation of a principal person in charge by a research institution under subsection (2)(b) does not absolve or relieve the institution of any of its obligations or duties under this Act. (5) To avoid doubt, the delegation of any obligation or duty under this Act to another person or service provider under a contract or other arrangement does not absolve or relieve the research institution of any of its obligations or duties under this Act. (6) Any person who contravenes subsection (1)(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 contravenes subsection (1)(c) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 5 years or to both. (8) Any person who contravenes subsection (3) 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.