Singapore legislation
Section 13
Section 13
Waiver of appropriate consent by institutional review board
(1)
Despite anything in this Part, an institutional review board which is the reviewing authority of a human biomedical research proposal may waive the requirement —
for the appropriate consent obtained for the participation of a person as a research subject or for the use of human tissue (as the case may be) to be in writing, in such circumstances as are specified in Part 1 of the Fifth Schedule;
to obtain appropriate consent for the use of human biological material or health information (as the case may be) in such circumstances as are specified in Part 2 of the Fifth Schedule; or
to obtain appropriate consent for the participation of a person as a research subject for emergency research in such circumstances as are specified in Part 3 of the Fifth Schedule.
(2)
Despite sections 8 and 10, an institutional review board which is the reviewing authority of a human biomedical research proposal may waive the requirement to obtain the appropriate consent of at least one adult parent or guardian for the participation of a minor as a research subject if the board is satisfied that —
the proposed research involves no more than minimal risk to the research subjects;
the waiver of parental consent will not adversely affect the research subject’s rights and welfare; and
the proposed research may not practicably be carried out unless there is such a waiver, and the research proposal —
is designed for conditions or for a research subject population for which parental or guardian consent is not a reasonable requirement to protect the research subjects (such as neglected or abused minors), and an appropriate mechanism for protecting the minors is substituted;
is of such a private and sensitive nature that it is not reasonable to require permission, (such as adolescents in studies concerning treatment of sexually transmitted diseases); or
is within the description of such circumstances as may be prescribed.
(3)
To avoid doubt —
subsection (1) does not apply to the waiver of consent for the removal of human tissue from a person;
a waiver under subsection (1) or (2) does not affect a person’s duty to protect individually‑identifiable information from unauthorised disclosure under sections 29 and 39 or imposed by law; and
nothing in this section provides immunity to the custodian of any individually‑identifiable information for such information if disclosed, unless the disclosure was done in accordance with this Act.
(4)
A waiver under subsection (1) or (2) has effect despite any obligation as to confidentiality or other restriction upon the disclosure or use of information imposed by law, contract or rules of professional conduct.
(5)
A researcher who conducts human biomedical research pursuant to a waiver under subsection (1) or (2) is not treated as being in breach of any obligation as to confidentiality or other restriction upon the disclosure or use of information or material imposed by law, contract or rules of professional conduct.