2. Exemption from need for witness to research subject’s consent

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.