Human Biomedical Research Regulations 2017 · 2025 Revised Edition · Part 2 · Research Institutions
10C. Safety and welfare of research subjects
Feedback & supportEvery research institution that is involved in the removal of human biological material from research subjects for use in research, must establish a system to ensure the safety and welfare of the research subjects.
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 research subjects:
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 human biological material;
the management of quality control and maintenance of instruments and equipment used for the removal of 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 that is involved in the removal of human biological material from research subjects for use in research, must establish a system to ensure the safety and welfare of the research subjects.
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 research subjects:
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 human biological material;
the management of quality control and maintenance of instruments and equipment used for the removal of 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.