Biosafety Guidelines For Research On Genetically Modified ...

SECTION 2: PURVIEW - EXTENT AND EXEMPTIONS
2.1 EXTENT OF GUIDELINES
2.1.1 These guidelines cover experiments that involve the construction and/or
propagation of all biological entities (cells, organisms, prions, viroids or
viruses) which have been made by genetic manipulation and are of a
novel genotype* and which are unlikely to occur naturally, or which could
cause public health or environmental hazards.
The categories of experiments which fall under these guidelines are described
in Section 3. A list of other relevant documents is included in Appendix1.
2.1.2 Intentional release of genetically manipulated organisms must adhere to the
“Singapore Guidelines on the Release of Agriculture-related Genetically
Modified Organisms” (GMAC).
2.1.3 Work with GMOs derived from biological agents and toxins known to be
hazardous to human heath are regulated, under Section 2(c) of the Biological
Agents and Toxins Act (Act 36 of 2005).
2.1.4 Work in the field of human health such as gene therapy, or other genetic
manipulations on humans involving stem cells, whole organs or individuals will
be assessed by MOH or its designated agency(ies). These investigations
include the introduction of nucleic acids (genetically manipulated or chemically
synthesised and their derivates), or genetically manipulated micro-organisms,
or cells into human subjects for the purposes of gene therapy, cell marking, or
for stimulating an immune response against a subject's own cells, as used for
the treatment of some cancers. For exemptions, refer to 2.1.6.
2.1.5 Research proposals where the introduction into human subjects of nucleic acids
(genetically manipulated or chemically synthesised), or genetically manipulated
micro-organisms, or cells, is designed to stimulate an immune response to
antigenic determinants of infectious agents, as in the case of classical vaccine,
should be submitted to the appropriate Bioethics committees. If necessary,
advice from GMAC could also be obtained.
2.1.6 Vaccines which have been approved for use in Singapore, as well as the
transfer of non-genetically manipulated autologous host cells, organ and tissue
transplants are exempt from Sections 2.1.4, and 2.1.5.
2.1.7 If an investigator is unsure whether their research proposal falls within these
guidelines, a description of their proposed research should be submitted, in
writing, to their Institutional Biosafety Committee(s) (IBC) for clarification, before
the commencement of their research work.
The responsibilities of GMAC, IBCs and principal investigators (laboratory
leaders) are defined in Section 5.
* In the case of multicellular organisms, ‘novel genotype’ refers to any of the cells which make up the
organism.
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