Singapore legislation

Regulation 5

of Human Biomedical Research (Requirements for Appropriate Consent — Exemption) Regulations 2019

Regulation 5

Exemption from need for appropriate consent if tissue collected before 1 November 2019

Subregulation 1

Sections 12 and 37 of the Act do not apply in relation to the storage of tissue for use in research, the supply of tissue for use in research and the use of tissue for research where —

(a)

the tissue was removed from a human body, whether living or dead, at any time before 1 November 2019;

(b)

there is documentary evidence indicating that the donor or the person authorised to give consent mentioned in paragraph (2) —

(i)

had given relevant consent in writing before 1 November 2019 for the use of the tissue in research; and

(ii)

had been informed of the matters in section 12(2)(a), (f) and (i) of the Act, before the relevant consent was obtained; and

(c)

the relevant consent was not withdrawn at any time before 1 November 2019.

Subregulation 2

In paragraph (1), “relevant consent”, in relation to a donor who is a minor or an adult who lacks mental capacity or was deceased when the tissue was removed, means the consent given on behalf of the donor by any of the following individuals:

(a)

the donee or deputy of the donor;

(b)

the spouse of the donor;

(c)

an adult son or daughter of the donor;

(d)

either parent or a guardian of the donor;

(e)

an adult brother or sister of the donor.