Singapore legislation
Regulation 2
of Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019
Regulation 2
Exemption from need for witness to research subject’s consent
Subregulation 1
The requirement in section 6(d) of the Act that appropriate consent must be obtained in the presence of a prescribed witness does not apply to the appropriate consent of a research subject where the research —
is not invasive;
is not interventional; and
is not restricted human biomedical research.
Subregulation 2
For the purposes of paragraph (1), research that comprises solely of a survey or collection of information from the research subjects is treated as not invasive and not interventional.
Subregulation 3
Despite paragraph (1), the requirement in section 6(d) of the Act that appropriate consent must be obtained in the presence of a prescribed witness does not apply to the appropriate consent of a research subject where —
the research is interventional but the intervention involves no more than minimal risk to the research subject;
the research subject is able to read and sign the appropriate consent form; and
the research is not restricted human biomedical research.
Subregulation 4
The requirement in section 6(d) of the Act does not apply to any consent to human biomedical research given by a research subject before 1 November 2017.
Subregulation 5
In this regulation, research is interventional if the research involves 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.