Singapore legislation

Regulation 25

of Human Biomedical Research Regulations 2017

Regulation 25

Witness to appropriate consent

Subregulation 1

For the purposes of section 6(d) of the Act, any appropriate consent must be taken in the presence of a witness —

(a)

who is 21 years of age or older;

(b)

who has mental capacity; and

(c)

who must not be the same individual taking the appropriate consent.

Subregulation 2

To avoid doubt, the witness may be a member of the team carrying out the research of which the individual giving the consent is a research subject.

Subregulation 3

The witness must take reasonable steps to ascertain —

(a)

the identity of the individual giving the appropriate consent; and

(b)

that the consent was given voluntarily without any coercion or intimidation.