Human Biomedical Research Regulations 2017 · 2025 Revised Edition · Part 2 · Research Institutions
10B. Management of contamination of human biological material
Feedback & supportEvery research institution must establish a system to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any human biological material used in transplantational human biomedical research conducted under the supervision and control of that research institution.
The research institution must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the human biological material used in transplantational human biomedical research conducted under the supervision and control of the research institution that is or may be contaminated or infected in any other way:
the traceability of the human biological material;
the traceability of the equipment and material used in the processing of the human biological material;
the processing and preservation of the human biological material;
the recall procedure for the human biological material.
A research institution 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 (b)in any other case, to a fine not exceeding $20,000.
Subregulation 1
Every research institution must establish a system to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any human biological material used in transplantational human biomedical research conducted under the supervision and control of that research institution.
Subregulation 2
The research institution must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the human biological material used in transplantational human biomedical research conducted under the supervision and control of the research institution that is or may be contaminated or infected in any other way:
the traceability of the human biological material;
the traceability of the equipment and material used in the processing of the human biological material;
the processing and preservation of the human biological material;
the recall procedure for the human biological material.
Subregulation 3
A research institution 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 (b)in any other case, to a fine not exceeding $20,000.