Singapore legislation

Regulation 18

of Human Biomedical Research (Tissue Banking) Regulations 2019

Regulation 18

Safety and welfare of donors

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:

(a)

the qualifications of and training to be received by the personnel involved in the removal of tissue;

(b)

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;

(c)

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 —

(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.

Regulation 18 — Human Biomedical Research (Tissue Banking) Regulations 2019