Taking of appropriate consent
Open ↗6. Any appropriate consent must for the purposes of this Act be obtained —(a)
in writing;
(b)
from the research subject or tissue donor personally or otherwise obtained in accordance with section 7, 8, 9, 10 or 11, as the case may be;
(c)
after the information referred to in section 12 has been provided and explained to the research subject or tissue donor or the persons authorised to give consent on the subject’s or donor’s behalf under this Part, as the case may be; and
(d)
in the presence of a prescribed witness and in accordance with such other procedures and requirements as may be prescribed.
Consent for research involving adults who lack mental capacity
Open ↗7.—(1) Where the prospective research subject is an adult who lacks mental capacity and there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of the class of persons to which the adult belongs, the appropriate consent for the adult must be obtained from the following persons in the following circumstances:(a)
where there is a donee or deputy who is authorised to give consent to the biomedical research on behalf of the adult, consent is obtained from the donee or deputy;
(b)
where there is no donee or deputy who is authorised to give consent to the biomedical research on behalf of the adult, consent is obtained from any of the following persons in the order of priority stated, when persons in prior classes are not available, and in the absence of actual notice of contrary indications by the adult, or actual notice of opposition of a member of the same class or a prior class:(i)
the spouse;
(ii)
an adult son or daughter;
(iii)
either parent or a guardian;
(iv)
an adult brother or sister;
(v)
any other person named by the adult as someone to be consulted on the matter in question or on matters of that kind.
(2) For the purposes of subsection (1) —(a)
an adult is assumed to have capacity to give consent unless it is established that he or she lacks capacity;
(b)
where a donee is a person specified in subsection (1)(b)(i) to (iv) but there is an express provision in the lasting power of attorney that the donee is not authorised to give consent to human biomedical research on behalf of the adult lacking mental capacity, that donee is not authorised to give consent under subsection (1)(b)(i) to (iv);
(c)
the donee or deputy of an adult lacking mental capacity or a person specified in subsection (1)(b)(i) to (iv) must, in determining whether to give consent under subsection (1), have regard to such matters, considerations and procedures as may be prescribed.
Consent for research involving minors
Open ↗8.—(1) Where the prospective research subject is a minor, the appropriate consent must be obtained from the following persons in the following circumstances:(a)
where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research, consent is obtained from both the minor and at least one adult parent or guardian of the minor;
(b)
where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research and an institutional review board has, in accordance with section 13, waived the requirement to obtain the consent of at least one adult parent or guardian of the minor, consent is obtained from the minor;
(c)
where the minor does not have sufficient understanding and intelligence to enable the minor to understand what is proposed in the biomedical research and there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of the class of minors to which the minor belongs, consent is obtained from at least one adult parent or guardian of the minor;
(d)
where the minor lacks mental capacity and there are reasonable grounds for believing that biomedical research of comparable effectiveness cannot be carried out without the participation of the class of minors to which the minor belongs, consent is obtained from —(i)
a deputy who is authorised to give consent to the biomedical research on behalf of the minor; or
(ii)
at least one adult parent or guardian of the minor.
(2) For the purposes of subsection (1), the deputy, adult parent or guardian of a minor must, in determining whether to give consent under subsection (1), have regard to such matters, considerations and procedures as may be prescribed.
Consent for removal or use of tissue for research involving adults who lack mental capacity
Open ↗9.—(1) Where the prospective tissue donor is an adult who lacks mental capacity to consent to the removal or use of any human tissue and the removal of human tissue from that adult is primarily for a therapeutic or diagnostic purpose, the appropriate consent must be obtained from the following persons in the following circumstances:(a)
where there is a donee or deputy who is authorised to give consent to the removal or use of the tissue on behalf of the adult, consent is obtained from the donee or deputy;
(b)
where there is no donee or deputy who is authorised to give consent to the removal or use of the tissue on behalf of the adult, consent is obtained from any of the following persons in the order of priority stated, when persons in prior classes are not available, and in the absence of actual notice of contrary indications by the adult, or actual notice of opposition of a member of the same class or a prior class:(i)
the spouse;
(ii)
an adult son or daughter;
(iii)
either parent or a guardian;
(iv)
an adult brother or sister;
(v)
any other person named by the adult as someone to be consulted on the matter in question or on matters of that kind.
(2) For the purposes of subsection (1) —(a)
an adult is assumed to have capacity to give consent unless it is established that he or she lacks capacity;
(b)
where a donee is a person specified in subsection (1)(b)(i) to (iv) but there is an express provision in the lasting power of attorney that the donee is not authorised to give consent to the removal or use of tissue on behalf of the adult lacking mental capacity, that donee is not authorised to give consent under subsection (1)(b)(i) to (iv); and
(c)
the donee or deputy of an adult lacking mental capacity or a person specified in subsection (1)(b)(i) to (iv) must, in determining whether to give consent under subsection (1), have regard to such matters, considerations and procedures as may be prescribed.
(3) To avoid doubt, subsections (1) and (2) apply as if there is no requirement that the removal of the tissue is primarily for a therapeutic or diagnostic purpose where the institutional review board has waived such requirement under section 37(3).
Consent for removal or use of tissue for research from minors
Open ↗10.—(1) Where the prospective tissue donor is a minor, the appropriate consent for the removal or use of human tissue must be obtained from the following persons in the following circumstances:(a)
where the minor has sufficient understanding and intelligence to enable the minor to understand what is proposed in the procedure, consent is obtained from both the minor and at least one adult parent or guardian of the minor;
(b)
where the minor does not have sufficient understanding and intelligence to enable the minor to understand what is proposed in the procedure and the removal of the tissue is primarily for a therapeutic or diagnostic purpose, consent is obtained from at least one adult parent or guardian of the minor;
(c)
where the minor lacks mental capacity and the removal of the tissue is primarily for a therapeutic or diagnostic purpose, consent is obtained from —(i)
a deputy who is authorised to give consent for the removal or use of the tissue on behalf of the minor; or
(ii)
at least one adult parent or guardian of the minor.
(2) For the purposes of subsection (1), the deputy, adult parent or guardian of a minor must, in determining whether to give consent under that subsection, have regard to such matters, considerations and procedures as may be prescribed.
(3) To avoid doubt, subsections (1)(b) and (c) and (2) apply as if there is no requirement that the removal of the tissue is primarily for a therapeutic or diagnostic purpose where the institutional review board has waived such requirement under section 37(3).
Consent for research or removal or use of tissue for research in case of deceased persons
Open ↗11.—(1) Where the prospective research subject or tissue donor is a deceased person, the appropriate consent —(a)
for the use of the deceased person’s individually‑identifiable —(i)
biological material;
(ii)
body or any part of the body; or
(iii)
health information; or
(b)
for the removal or use of human tissue for research from the deceased person,
must be obtained from any of the following persons in the order of priority stated, when persons in prior classes are not available at the time of death, and in the absence of actual notice of contrary indications by the deceased person, or actual notice of opposition of a member of the same class or a prior class:
(c)
the spouse;
(d)
an adult son or daughter;
(e)
either parent or a guardian of the deceased person at the time of the person’s death;
(f)
an adult brother or sister;
(g)
the administrator or executor of the estate of the deceased person;
(h)
any other person authorised or under obligation to dispose of the body of the deceased person.
(2) The person specified in subsection (1)(c) to (g) must, in determining whether to give appropriate consent under subsection (1), have regard to such matters, considerations and procedures as may be prescribed.
Information to be provided before taking appropriate consent
Open ↗12.—(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:(a)
the investigational nature of the biomedical research;
(b)
the purpose of the biomedical research;
(c)
the reasonably foreseeable risks, discomforts or inconveniences to a living research subject arising from this biomedical research;
(d)
the benefits which the research subject may reasonably expect from the biomedical research;
(e)
where applicable, whether there are any alternative procedures or treatments available to the research subject, and the potential benefits and risks of such alternatives;
(f)
any compensation and treatment available to the research subject in the event of injury arising from participation in the research;
(g)
any anticipated expenses the research subject is likely to incur as a consequence of participating in the biomedical research;
(h)
the extent to which information identifying the research subject will be kept confidential;
(i)
whether individually‑identifiable information obtained from the research subject will be used for future biomedical research;
(j)
where applicable, whether biological material taken from the research subject will be destroyed, discarded or stored for future biomedical research;
(k)
whether the research subject’s participation involves information in individually‑identifiable form;
(l)
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;
(m)
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;
(n)
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;
(o)
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;
(p)
such other information as the institutional review board may require;
(q)
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:(a)
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;
(b)
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;
(c)
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);
(d)
the reasonably foreseeable risks, discomforts or inconveniences to a living donor arising from the removal of the tissue;
(e)
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;
(f)
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;
(g)
any compensation and treatment available to the donor in the event of injury arising from participation in the process of tissue donation;
(h)
any anticipated expenses the donor is likely to incur as a consequence of donating tissue;
(i)
the extent to which records identifying the donor will be kept confidential;
(j)
whether individually‑identifiable information obtained from the tissue donor will be used for future research;
(k)
where applicable, whether biological material taken from the tissue donor will be destroyed, discarded or stored and used for future research;
(l)
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;
(m)
whether the tissue donation would result in the use of the donor’s tissue in an individually‑identifiable form;
(n)
whether the tissue will be used in restricted human biomedical research involving human-animal combinations;
(o)
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;
(p)
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;
(q)
whether the tissue will be exported or removed from Singapore to a place outside Singapore;
(r)
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.
Waiver of appropriate consent by institutional review board
Open ↗13.—(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 —(a)
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;
(b)
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
(c)
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 —(a)
the proposed research involves no more than minimal risk to the research subjects;
(b)
the waiver of parental consent will not adversely affect the research subject’s rights and welfare; and
(c)
the proposed research may not practicably be carried out unless there is such a waiver, and the research proposal —(i)
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;
(ii)
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
(iii)
is within the description of such circumstances as may be prescribed.
(3) To avoid doubt —(a)
subsection (1) does not apply to the waiver of consent for the removal of human tissue from a person;
(b)
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
(c)
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.
Withdrawal of consent
Open ↗14.—(1) A research subject or any person who is authorised to give consent on the subject’s behalf under this Part may, at any time, withdraw the consent to the subject’s participation in the human biomedical research.
(2) A donor of human tissue or any person who is authorised to give consent on the donor’s behalf under this Part may, at any time, withdraw the consent to the use of the donor’s tissue for research if —(a)
the tissue is individually‑identifiable and has not been used for the research; or
(b)
the tissue is individually‑identifiable and has been used for the research but it is practicable to discontinue further use of the tissue for the research.
(3) The withdrawal of consent in the circumstances specified in subsection (1) or (2)(b) does not affect the research information obtained before the consent is withdrawn and such information may be retained and used for the research.
(4) Any penalty or damages imposed solely by reason of the withdrawal of consent permitted by this section is void and unenforceable.
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
