Prohibited and Restricted HBR (rHRB)

 

Prohibited human biomedical research is defined in the Third Schedule of HBRA, and these include:

  1. Human biomedical research involving the development of human-animal combination embryos referred to in paragraph 2(a)(i) or (iii) of the Fourth Schedule beyond 14 days or the appearance of the primitive streak, whichever is the earlier.

  2. Human biomedical research involving the implantation of any human-animal combination embryo into the uterus of an animal or a human.

  3. Human biomedical research involving the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brain of living great apes whether prenatal or postnatal.

  4. Human biomedical research involving the breeding of animals which have had any kind ​of pluripotent stem cells (including induced pluripotent stem cells) introduced into them.​


Restricted human biomedical research (rHBR) is defined in the Fourth Schedule of HBRA, and these include:

  1. Human biomedical research involving human eggs or human embryos.

  2. Human biomedical research involving —

    (a) the following types of human-animal combination embryos:

    (i) cytoplasmic hybrid embryos;
    (ii) human-animal combination embryos created by the incorporation of human stem cells (including induced pluripotent stem cells);
    (iii) human-animal combination embryos created in-vitro by using —
          - human gametes and animal gametes; or
          - one human pronucleus and one animal pronucleus;

    (b) the introduction of human stem cells (including induced pluripotent stem cells) into a prenatal animal foetus or animal embryo;

    (c) the introduction of human pluripotent stem cells (including induced pluripotent stem cells) into a living postnatal animal but excludes the introduction of such human pluripotent stem cells into immunodeficient mice solely for the analysis of teratoma induction;

    (d) the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brain of a living postnatal animal; or

    (e) any entity created as a result of any process referred to in sub paragraphs (b), (c) and (d).​


Update: Research involving the implantation of glioblastoma stem cells into the brain of postnatal animals is not considered rHBR. Similar to glioblastoma neural cells, glioblastoma stem cells are considered abnormal cancerous cells that are unlikely to cause humanisation in animals. 


MOH approval must be obtained for all research involving rHBR prior to starting work, and require Full Board review. PI would have to submit rHBR application together with NTU-IRB approval to MOH via TIARAS. Please inform IRB admin ([email protected]) for the access to TIARAS system if you are going to conduct any restricted HBRA research.​