Human Biomedical Research (Tissue Banking) Regulations 2019

Human Biomedical Research Act 2015

(Section 63)

Human Biomedical Research
(Tissue Banking) Regulations 2019

2025 REVISED EDITION

(2 June 2025)

[1 November 2019]

PART 1

PRELIMINARY

Citation

1.  These Regulations are the Human Biomedical Research (Tissue Banking) Regulations 2019.

Definitions

2.  In these Regulations —

“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.