Singapore legislation
Section 3
Section 3
Meanings of “human biomedical research” and “supervision and control”
(1)
In this Act, “human biomedical research” means the research specified in subsection (2) or (3) but subject to subsection (4).
(2)
Any research that is intended to study —
the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body;
the restoration, maintenance or promotion of the aesthetic appearance of human individuals through clinical procedures or techniques; or
the performance or endurance of human individuals,where the research involves —
subjecting an individual to any intervention (including any wilful act or omission) that has a physical, mental or physiological effect (whether temporary or permanent) on the body of the individual;
the use of any individually‑identifiable human biological material; or
the use of any individually‑identifiable health information.
(3)
Any research that involves —
human gametes or human embryos;
cytoplasmic hybrid embryos;
the introduction of any human-animal combination embryo into an animal or a human;
the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into an animal at any stage of development (including a prenatal animal foetus or animal embryo); or
any entity created as a result of any process referred to in paragraph (c) or (d).
(4)
Subsections (2) and (3) do not apply to such research, studies or activities that are specified in the Second Schedule.
(5)
For the purposes of this Act, human biomedical research is treated as conducted under the supervision and control of a research institution if the research institution is identified as the research institution for that research and that research has been reviewed by an institutional review board appointed by that research institution.