Human Biomedical Research (Tissue Banking) Regulations 2019 · 2025 Revised Edition · Part 2 · Tissue Banks Generally
18. Safety and welfare of donors
Feedback & supportEvery tissue bank, who or which is involved in the removal of tissue from tissue donors for use in research, must establish a system to ensure the safety and welfare of the tissue donors.
The tissue bank must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the tissue donors:
the qualifications of and training to be received by the personnel involved in the removal of tissue;
the measures to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any tissue;
the management of quality control and maintenance of instruments and equipment used for the removal of tissue.
A tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —
in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or
in any other case, to a fine not exceeding $20,000.
Subregulation 1
Every tissue bank, who or which is involved in the removal of tissue from tissue donors for use in research, must establish a system to ensure the safety and welfare of the tissue donors.
Subregulation 2
The tissue bank must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the tissue donors:
the qualifications of and training to be received by the personnel involved in the removal of tissue;
the measures to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any tissue;
the management of quality control and maintenance of instruments and equipment used for the removal of tissue.
Subregulation 3
A tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —
in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or
in any other case, to a fine not exceeding $20,000.