Singapore legislation
Section 12
Section 12
Information to be provided before taking appropriate consent
(1)
In the case of human biomedical research, the appropriate consent must be obtained after the research subject or, where applicable, the person authorised to give consent under this Part, has been informed of all of the following:
the investigational nature of the biomedical research;
the purpose of the biomedical research;
the reasonably foreseeable risks, discomforts or inconveniences to a living research subject arising from this biomedical research;
the benefits which the research subject may reasonably expect from the biomedical research;
where applicable, whether there are any alternative procedures or treatments available to the research subject, and the potential benefits and risks of such alternatives;
any compensation and treatment available to the research subject in the event of injury arising from participation in the research;
any anticipated expenses the research subject is likely to incur as a consequence of participating in the biomedical research;
the extent to which information identifying the research subject will be kept confidential;
whether individually‑identifiable information obtained from the research subject will be used for future biomedical research;
where applicable, whether biological material taken from the research subject will be destroyed, discarded or stored for future biomedical research;
whether the research subject’s participation involves information in individually‑identifiable form;
the circumstances (if any) under which, the research subject or the person authorised to give consent under this Part will be contacted for further consent, including but not limited to changes in the proposed research, serious adverse events that would lead to a change in the proposed research, the development of capacity by minors to make decisions and any other circumstances which could be specific to a particular research proposal;
whether the research subject would wish to be re‑identified in the case of an incidental finding if the proposed biomedical research expressly provides for such re‑identification;
the research subject’s right to withdraw his or her consent in the circumstances specified in section 14 and the limitations of such withdrawal as specified in that section;
the person or persons to contact to obtain further information on the biomedical research and to provide feedback in relation to the biomedical research, respectively;
such other information as the institutional review board may require;
such other information as may be prescribed.
(2)
In the case of the removal, donation or use of human tissue, the appropriate consent must be obtained after the tissue donor or, where applicable, the person authorised to give consent under this Part, has been informed of all of the following:
the specific research purpose for which the tissue is intended to be used, if this information is available but if not available, the purpose for which the tissue is intended to be used may be stated as for general research;
whether the tissue will be used for any purpose other than research and if so, the specific purpose for which the tissue will be used;
the proposed areas of research approved by the institutional review board in a case where it has waived the requirement that the removal of the tissue is primarily for a therapeutic or diagnostic purpose under section 37(3);
the reasonably foreseeable risks, discomforts or inconveniences to a living donor arising from the removal of the tissue;
the donation of the tissue is voluntary and the renunciation of the donor’s rights to the tissue and any intellectual property rights that may be derived from the use of the tissue;
the donor’s right to withdraw his or her consent in the circumstances specified in section 14 and the limitations of such withdrawal as specified in that section;
any compensation and treatment available to the donor in the event of injury arising from participation in the process of tissue donation;
any anticipated expenses the donor is likely to incur as a consequence of donating tissue;
the extent to which records identifying the donor will be kept confidential;
whether individually‑identifiable information obtained from the tissue donor will be used for future research;
where applicable, whether biological material taken from the tissue donor will be destroyed, discarded or stored and used for future research;
whether, and the circumstances under which, the donor or the person authorised to give consent under this Part (as the case may be) will be contacted for further consent;
whether the tissue donation would result in the use of the donor’s tissue in an individually‑identifiable form;
whether the tissue will be used in restricted human biomedical research involving human-animal combinations;
whether the donor or the person authorised to give consent under this Part (as the case may be) would wish to be re‑identified in the case of an incidental finding if the future research expressly provides for such re-identification;
the person or persons to contact to obtain further information on the purposes for which the tissue will be used and to provide feedback in relation to such purposes, respectively;
whether the tissue will be exported or removed from Singapore to a place outside Singapore;
such other information as may be prescribed.
(3)
Where the research subject or tissue donor is a minor who has sufficient understanding and intelligence to understand what is proposed in the biomedical research or procedure (as the case may be) it is sufficient compliance with this section in respect of that minor if only such information as may be prescribed is provided to that minor.
(4)
Subsection (3) does not affect the duty to provide the information specified in this section to the adult parent or guardian of the minor where the consent of the adult parent or guardian in addition to the consent of the minor is required under this Part.