Human Biomedical Research (Tissue Banking) Regulations 2019

No. S 702

Human Biomedical Research Act 2015

(ACT 29 OF 2015)

Human Biomedical Research
(Tissue Banking) Regulations 2019

In exercise of the powers conferred by section 63 of the Human Biomedical Research Act 2015, the Minister for Health makes the following Regulations:

PART 1

PRELIMINARY

Citation and commencement

1. These Regulations are the Human Biomedical Research (Tissue Banking) Regulations 2019 and come into operation on 1 November 2019.

Definitions

2. In these Regulations, unless the context otherwise requires —

“human tissue transplantation” means the transplantation or grafting of any tissue —

(a)	from one part to the same part of a body of an individual;
(b)	from one part to another part of the same body of an individual; or
(c)	from the body of one individual to the body of another individual or the bodies of other individuals;

“non‑identifiable”, in relation to tissue, means tissue which has been rendered non‑identifiable within the meaning of section 27(3) of the Act;

“principal person in charge designated”, for a tissue bank, means the individual designated by the tissue bank under section 35(2)(b) of the Act;

“recipient” means a person (including a researcher or research institution) who receives any human tissue directly or indirectly from a tissue bank but excludes the individual to whose body the tissue is transplanted or grafted;

“relevant website” means the website at https://elis.moh.gov.sg/tiaras;

“untoward occurrence” means an occurrence associated with the removal of human tissue primarily for research that —

(a)	results in, or contributes to, death;
(b)	is life‑threatening;
(c)	requires in‑patient hospitalisation or results in prolongation of existing hospitalisation;
(d)	results in or contributes to persistent or significant disability or incapacity;
(e)	results in the transmission of a communicable disease;
(f)	results in any misidentification or mix‑up of any type of tissue, gametes or embryo; or
(g)	results in or contributes to a congenital anomaly or birth defect.

Made on 21 October 2019.

CHAN HENG KEE

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:69; AG/LEGIS/SL/131C/2015/3 Vol. 2]

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