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 —

(a)

the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body;

(b)

the restoration, maintenance or promotion of the aesthetic appearance of human individuals through clinical procedures or techniques; or

(c)

the performance or endurance of human individuals,where the research involves —

(d)

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;

(e)

the use of any individually‑identifiable human biological material; or

(f)

the use of any individually‑identifiable health information.

(3)

Any research that involves —

(a)

human gametes or human embryos;

(b)

cytoplasmic hybrid embryos;

(c)

the introduction of any human-animal combination embryo into an animal or a human;

(d)

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

(e)

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.

Terms defined in s 2

health information
Defined · s 2
“health information” means information pertaining to an individual —(a)obtained in the course of or in connection with providing healthcare services; or(b)relating to the study, prevention, prognostication, diagnosis, or alleviation of a disease, disorder, or injury;
Open s 2
human biological material
Defined · s 2
“human biological material” or “biological material” means any biological material obtained from the human body that consists of, or includes, human cells;
Open s 2
human biomedical research
Defined · s 2
“human biomedical research” has the meaning given by section 3;
Open s 2
individually‑identifiable
Defined · s 2
“individually‑identifiable”, in relation to human biological material or health information pertaining to an individual, means that the individual can be identified —(a)from the human biological material or health information; or(b)from that human biological material or health information and other information to which the person, research institution, tissue bank or other organisation has or is likely to have access;
Open s 2
institutional review board
Defined · s 2
“institutional review board” means a board or committee appointed by a research institution under section 15 or 16 to conduct an ethics review of proposed human biomedical research;
Open s 2
research
Defined · s 2
“research” means any systematic investigation with the intention of developing or contributing to generalisable knowledge;
Open s 2
research institution
Defined · s 2
“research institution” means a body of persons, whether corporate or unincorporate or other organisation, or ministry or department of the Government who or which —(a)engages, directly or indirectly (either through contractual or other arrangements), one or more researchers to conduct human biomedical research in Singapore; and(b)exercises supervision and control over human biomedical research conducted in Singapore by the researchers the institution has engaged;
Open s 2