Human Biomedical Research Regulations 2017 · 2025 Revised Edition · Part 4 · Miscellaneous
25. Witness to appropriate consent
Feedback & supportFor the purposes of section 6(d) of the Act, any appropriate consent must be taken in the presence of a witness —
who is 21 years of age or older;
who has mental capacity; and
who must not be the same individual taking the appropriate consent.
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.
The witness must take reasonable steps to ascertain —
the identity of the individual giving the appropriate consent; and
that the consent was given voluntarily without any coercion or intimidation.
Subregulation 1
For the purposes of section 6(d) of the Act, any appropriate consent must be taken in the presence of a witness —
who is 21 years of age or older;
who has mental capacity; and
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 —
the identity of the individual giving the appropriate consent; and
that the consent was given voluntarily without any coercion or intimidation.