Singapore legislation

Regulation 10C

of Human Biomedical Research Regulations 2017

Regulation 10C

Safety and welfare of research subjects

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:

(a)

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;

(b)

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 —

(a)

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.