Human Biomedical Research Act 2015 · 2020 Revised Edition · Part 6 · Regulation of Human Tissue Activities and Tissue Banks
34. Notification of tissue bank
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A research institution must notify the Director‑General of any tissue bank which the research institution is directly or indirectly operating or which is part of the research institution.
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;
A tissue bank must notify the Director‑General of its particulars unless a research institution has made a notification of that tissue bank in accordance with subsection (1).
tissue bank
“tissue bank” means an individual or a body of persons, whether corporate or unincorporate, or other organisation, that carries on or conducts any tissue banking activity but excludes an individual, a body of persons or an organisation that conducts any tissue banking activity solely for the purpose of the person’s or organisation’s own human biomedical research approved or exempted from review by an institutional review board;
A notification for the purposes of subsection (1) or (2) must be submitted to the Director‑General in such form and manner, with such particulars and within such time as may be prescribed, and must be accompanied by such fee as may be prescribed.
Any person who contravenes subsection (1) or (2) 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.
Any person who, in submitting a notification for the purposes of subsection (1) or (2) —
makes any statement or furnishes any document which he or she knows to be false or does not believe to be true; or
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.