Singapore legislation

Section 8

of Human Biomedical Research Act 2015

Section 8

Consent for research involving minors

(1)

Where the prospective research subject is a minor, the appropriate consent must be obtained from the following persons in the following circumstances:

(a)

where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research, consent is obtained from both the minor and at least one adult parent or guardian of the minor;

(b)

where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research and an institutional review board has, in accordance with section 13, waived the requirement to obtain the consent of at least one adult parent or guardian of the minor, consent is obtained from the minor;

(c)

where the minor does not have sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research and there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of the class of minors to which the minor belongs, consent is obtained from at least one adult parent or guardian of the minor;

(d)

where the minor lacks mental capacity and there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of the class of minors to which the minor belongs, consent is obtained from —

(i)

a deputy who is authorised to give consent to the biomedical research on behalf of the minor; or

(ii)

at least one adult parent or guardian of the minor.

(2)

For the purposes of subsection (1), the deputy, adult parent or guardian of a minor must, in determining whether to give consent under subsection (1), have regard to such matters, considerations and procedures as may be prescribed.

Section 8 — Human Biomedical Research Act 2015 | laws.sg