Singapore legislation
Section 22
Section 22
Conduct of human biomedical research and duties of researcher
(1)
No human biomedical research can be conducted except under the supervision and control of a research institution with —
a place of business in Singapore; and
at least 2 individuals ordinarily resident in Singapore who are responsible on behalf of the research institution for the supervision and control of the biomedical research.
(2)
No person can conduct any human biomedical research unless he or she has first complied with all of the following requirements:
he or she has made the necessary contractual or other arrangements with a research institution referred to in subsection (1) for the proposed research to be conducted under the supervision and control of the research institution;
he or she has ensured that the proposed research has been —
reviewed and approved by an institutional review board appointed by the research institution referred to in paragraph (a); or
exempted from review by an institutional review board under section 17(2);
he or she has ensured that, except in such circumstances as may be prescribed, appropriate consent has been obtained in accordance with Part 3 prior to the research subject’s participation or the use of individually‑identifiable biological material or health information of the research subject in the proposed research, as the case may be;
he or she has ensured that where the human biomedical research involves human gametes or embryos, whether individually‑identifiable or not, the appropriate consent must be obtained from the research subject or donor who has capacity to give consent in person and not from a person authorised under Part 3 to give consent on the subject’s or donor’s behalf.
(3)
A researcher must ensure that —
the research does not deviate from the research proposal that has been reviewed and approved or exempted from review by an institutional review board unless the deviation —
has been reviewed and approved, or otherwise exempted from review, by the institutional review board; or
is necessary to mitigate an immediate risk of harm to a research subject and the researcher without unreasonable delay informs the institutional review board of the deviation;
any research is immediately discontinued if the institutional review board has withdrawn its approval for the research unless the immediate discontinuation will result in a risk of harm to the research subject;
the further participation of the research subject or further use of the individually‑identifiable biological material or health information of the research subject is immediately discontinued if the consent has been withdrawn or is otherwise invalid unless the immediate discontinuation will result in a risk of harm to the research subject; and
all such appropriate and necessary measures are taken to mitigate any risk of harm that has arisen under paragraph (b) or (c).
(4)
A researcher must ensure that a minor who lacks sufficient understanding and intelligence, or an adult or minor who lacks mental capacity to give consent, must not be a research subject in any biomedical research unless 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 minor or adult belongs, as the case may be.
(5)
To avoid doubt, the delegation of any obligation or duty under this Act to another person or service provider under a contract or other arrangement does not absolve or relieve the person of any of his or her obligations or duties under this Act.
(6)
Any person who contravenes subsection (1), (2), (3) or (4) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 5 years or to both.