Human Biomedical Research Act 2015 · 2020 Revised Edition · Part 6 · Regulation of Human Tissue Activities and Tissue Banks
36. Declaration of compliance by tissue bank
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The declaration of compliance that a tissue bank is required to submit to the Director‑General under section 35(1) for all tissue banking activities conducted under the supervision and control of the tissue bank must be in such form and submitted in such manner and within such time as may be prescribed and must be accompanied by —
declaration of compliance
“declaration of compliance” means a declaration by a research institution or a tissue bank of its compliance with the requirements of this Act;
such particulars, information and documents as may be prescribed;
if required by the Director‑General, a statutory declaration by the tissue bank verifying any information contained in or related to the declaration of compliance; and
such fee as may be prescribed.
A tissue bank must notify the Director‑General —
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;
of any change in the information submitted under subsection (1)(a), within 30 days after the occurrence of the change or such longer period as the Director‑General may allow in any particular case; and
of its intention to cease operating as a tissue bank at least 30 days before the cessation of operation or such shorter period as the Director‑General may allow in any particular case.
Any person who, in submitting a declaration of compliance referred to in subsection (1) or any notification referred to in subsection (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.
Any person who contravenes subsection (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.