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Approval for restricted research starting on or after 1 November 2017

Human Biomedical Research (Restricted Research) Regulations 2017

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—(1) This regulation applies to any restricted research which starts on or after 1 November 2017.(2) The researcher must, before starting any restricted research mentioned in paragraph (1) ensure that the conduct of the restricted research is approved by all of the following:(a)an institutional review board of the research institution under whose supervision or control the restricted research is to be conducted by the researcher;(b)an institutional animal care and use committee where any living postnatal animal, living animal foetus or a living animal embryo is to be used in the restricted research;(c)the Director‑General.(3) The application to the Director‑General for approval mentioned in paragraph (2)(c) for any restricted research must —(a)contain the following information and particulars:(i)particulars of the principal researcher and any other individual who is involved in the restricted research;(ii)the title of the research proposal;(iii)the name of the research institution under whose supervision or control the restricted research is to be conducted by the researcher;(iv)the location or facility where the restricted research will be carried out;(v)any other information or particulars specified in the electronic application system on the Internet website at https://elis.moh.gov.sg/tiaras;(b)be accompanied by the approvals or certified true copies of the approvals mentioned in paragraph (2)(a) and if applicable, (b); and(c)be submitted through the research institution.(4) A research proposal for or involving restricted research must not be reviewed by an institutional review board through an expedited process, and not be exempted from review by an institutional review board.(5) In determining whether to grant approval under paragraph (2)(c), the Director‑General may consult an advisory committee established under section 5(2) of the Act.(6) The Director‑General’s approval under paragraph (2)(c) is valid for the period determined by the Director‑General.

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