Section 31

that the Director should be notified of the conduct of such restricted human biomedical research;

that the restricted human biomedical research should be carried out only under, and in accordance with the conditions of approval obtained from the Director or a public officer authorised by the Minister;

that the restricted human biomedical research should be reviewed by an institutional review board, or such other committee as may be prescribed, comprising members with certain specified qualifications;

that the restricted human biomedical research should be conducted only by certain specified persons;

that the appropriate consent in a restricted human biomedical research be obtained from the research subject who has capacity to give consent in person and not from a person authorised under Part 3 to give consent on the subject’s behalf;

that the restricted human biomedical research should be carried out only at certain specified premises;

that the restricted human biomedical research should or should not be conducted in any specified manner.

one of the following types of consent for the tissue to be used for the particular restricted human biomedical research has been obtained:

in a case where the donor is not a minor and has capacity to give consent, appropriate consent obtained from the donor in person and not from a person authorised under Part 3 to give consent on the donor’s behalf;

in a case where the donor is a minor who has sufficient understanding and intelligence to enable the minor to understand what is proposed in the procedure, appropriate consent obtained from both the minor and, unless waived under section 13(2), at least one adult parent or guardian of the minor;

in the case of human tissue imported from a place outside Singapore, consent obtained in accordance with the legal or ethical requirements of that place; and

the use is in accordance with any conditions or restrictions specified as part of the consent.