Singapore legislation

Regulation 3

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

Regulation 3

Exemption from need for witness to tissue donor’s consent

Subregulation 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 tissue donor whose tissue —

(a)

is to be removed primarily for a therapeutic or diagnostic purpose; and

(b)

is not to be used for restricted human biomedical research.

Subregulation 2

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 tissue donor where —

(a)

the removal of the tissue involves no more than minimal risk to the tissue donor;

(b)

the tissue donor is able to read and sign the appropriate consent form; and

(c)

the appropriate consent is not for the purpose of restricted human biomedical research.

Subregulation 3

The requirement in section 6(d) of the Act does not apply to any consent to the removal, storage, supply or use of tissue given by a tissue donor before 1 November 2019.