NUS-IRB: Overview of Guidelines

All human biomedical research conducted in Singapore is governed by the Human Biomedical Research Act (HBRA) 2015, which mandates that any proposed human biomedical research should undergo review and be approved or exempted by an Institutional Review Board (IRB).


Please see the MOH website for more information on the HBRA and related guidelines.

The meaning of “human biomedical research” is defined by section 3, HBRA, which provides:

      "Meanings of “human biomedical research” and “supervision and control"
      3.—(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 —
        (i) 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;
        (ii) the use of any individually-identifiable human biological material; or
        (iii) 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.”

 

However, please note the following exclusions as delineated in the First and Second Schedules of the HBRA:

First Schedule

HUMAN BIOLOGICAL MATERIAL EXCLUDED FROM DEFINITION OF HUMAN TISSUE

1. Hair shaft, cut without dermal hair root or follicle.
2. Nail plate, cut without underlying dermal tissue.
3. Naturally excreted bodily fluids and waste products such as saliva, sweat, urine and faeces.
4. — (1) Any other human biological material that is not individually-identifiable and has been processed in such a manner that its functional, structural and biological characteristics are substantially manipulated as compared to the time of collection.

(2) For the purposes of and without prejudice to the generality of sub‑paragraph (1), human biological material is not deemed to be substantially manipulated merely because it has been processed by any of, or any combination of, the following methods:

    (a) cutting;
    (b) grinding;
    (c) shaping;
    (d) centrifugation;
    (e) soaking in antibiotic or antimicrobial solutions;
    (f) sterilization;
    (g) low-level irradiation;
    (h) cell separation, concentration or purification;
    (i) filtering;
    (j) lyophilisation;
    (k) freezing;
    (l) cryopreservation;
    (m) vitrification.

Sections 2 and 62(1)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Second Schedule

RESEARCH, STUDIES AND MATTERS EXCLUDED FROM DEFINITION OF HUMAN BIOMEDICAL RESEARCH

1. Research and studies on normal human psychological responses and behaviours —

    (a) which are not designed or intended to study psychiatric or psychological disorders; and
    (b) which involve no more than minimal risk to the research subject.
2. Research, studies and tests to measure human intelligence —
    (a) which are not designed or intended to study mental or intellectual disability; and
    (b) which involve no more than minimal risk to the research subject.
3. Public health research on infectious diseases conducted for the purposes of and in accordance with section 59A of the Infectious Diseases Act (Cap. 137).
4. Collection and compilation by the National Registry of Diseases of health information for epidemiological or statistical purposes in accordance with the National Registry of Diseases Act (Cap. 201B).
5. Collection and compilation of health information for statistical purposes in accordance with the Statistics Act (Cap. 317).
6. Clinical trials of health products conducted in accordance with the Health Products Act (Cap. 122D).
7. Clinical trials of medicinal products conducted in accordance with the Medicines Act (Cap. 176).

Sections 3(4) and 62(1)
 
 
 
 
 
 
 
 
 


Research studies that do not fall under the purview of HBRA will generally be categorised as "Social, Behavioural and Educational Research (SBER)" for the purposes of NUS-IRB review.

However, the final decision will be made by the IRB and affected PIs will be informed if further documents are required.

 

Please determine if your study is HBR or SBER and click on the corresponding links for the relevant guidelines:

 

HBR
Guidelines
Forms
 
SBER
Guidelines
Forms
   
 
Note: Guidelines and Forms are accessible to NUS researchers only.
For non-NUS researchers, please contact irb@nus.edu.sg.