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Human Biomedical Research Act 2015 PART 7 — CODES OF PRACTICE AND ETHICS

s 40–s 41 · 2 sections

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Codes of practice or ethics

s 40

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40.—(1) The Director‑General may, from time to time —(a) issue one or more codes of practice for the purpose of providing guidance with respect to the requirements of this Act relating to the taking of consent, safety and research practices and for standards; (b) issue one or more codes of practice for the protection of the identity of individuals in relation to individually‑identifiable human biological material and health information; (c) issue one or more codes of ethics for the ethical conduct of human biomedical research or tissue banking activity; (d) approve as a code of practice or a code of ethics any document prepared by another person or body of persons other than the Director‑General, if the Director‑General considers the document as suitable for this purpose; and[Act 11 of 2023 wef 01/05/2023] (e) amend or revoke the whole or part of any code of practice or code of ethics issued under paragraph (a), (b) or (c) or approved under paragraph (d).[Act 11 of 2023 wef 01/05/2023] (2) The Director‑General must publish any code of practice or code of ethics issued or approved under subsection (1), including any amendment or revocation of the code, in such manner as the Director‑General thinks fit.[Act 11 of 2023 wef 01/05/2023] (3) Any code of practice or code of ethics issued or approved under this section does not have any legislative effect and need not be published in the Gazette.

Use of codes of practice or ethics

s 41

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41.—(1) A person is not liable to any criminal proceedings by reason only that the person has failed to observe any code of practice or code of ethics issued or approved under section 40. (2) In any proceedings for an offence under this Act, a code of practice or code of ethics issued or approved under section 40 that is relevant to any matter which it is necessary for the prosecution to prove in order to establish the commission of the offence is admissible in evidence in the proceedings. (3) In determining for the purposes of any provision of this Act as to whether any activity or practice in or in relation to the conduct of human biomedical research or tissue banking activity is reasonable and in accordance with the generally accepted practices and principles of ethical conduct, regard must be had to any relevant code of practice or code of ethics issued or approved under section 40.

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