Conduct of human biomedical research and duties of researcher
Open ↗22.—(1) No human biomedical research can be conducted except under the supervision and control of a research institution with —(a)
a place of business in Singapore; and
(b)
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:(a)
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;
(b)
he or she has ensured that the proposed research has been —(i)
reviewed and approved by an institutional review board appointed by the research institution referred to in paragraph (a); or
(ii)
exempted from review by an institutional review board under section 17(2);
(c)
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;
(d)
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 —(a)
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 —(i)
has been reviewed and approved, or otherwise exempted from review, by the institutional review board; or
(ii)
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;
(b)
any research is immediately discontinued if the institutional review board has withdrawn its approval for the research unless the immediate discontinuation will result in a risk of harm to the research subject;
(c)
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
(d)
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.
Functions and duties of research institutions
Open ↗23.—(1) Every research institution must, in respect of any human biomedical research to be conducted under its supervision and control —(a)
submit a notification in such form and manner, and within such time as may be prescribed, before the commencement of the first human biomedical research conducted under that research institution’s supervision and control;
(b)
submit, in accordance with section 24(1), a declaration of compliance in respect of all human biomedical research conducted under its supervision and control in the preceding 12 months, or such other period of time as the Director‑General may require; and[Act 11 of 2023 wef 01/05/2023]
(c)
ensure that there is in force an approval for the human biomedical research under section 17(1) issued by an institutional review board which the research institution had appointed or is an exemption under section 17(2) of the requirement for that research to be approved by the institutional review board appointed by the research institution.
(2) Every research institution must, in respect of any human biomedical research which is carried out under its supervision and control —(a)
supervise, review and proactively monitor the conduct of the research;
(b)
designate a principal person in charge to be responsible for ensuring that the research institution complies with this Act;
(c)
formulate and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the research;
(d)
establish a data and safety monitoring board if its institutional review board considers that it is necessary for the purposes of any particular research proposal;
(e)
investigate any areas of concern and take such remedial measures as appropriate;
(f)
ensure that the research —(i)
is in compliance with the requirements of this Act; and
(ii)
is conducted in accordance with its standards, policies and procedures referred to in paragraph (c);
(g)
ensure that, where the human biomedical research is conducted jointly or in collaboration with more than one research institution, there is an agreement among the research institutions for one research institution to be appointed as the lead research institution for the purpose of coordinating the research; and
(h)
perform such other functions and duties as may be prescribed by the Minister.
(3) Every research institution must notify the Director‑General, in such form and manner as may be prescribed, of —(a)
the commission of any suspected offence or contravention under this Act or the regulations;
(b)
the occurrence of any serious adverse event; and
(c)
such other matters as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(4) The designation of a principal person in charge by a research institution under subsection (2)(b) does not absolve or relieve the institution of any of its obligations or duties under this Act.
(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 research institution of any of its obligations or duties under this Act.
(6) Any person who contravenes subsection (1)(a) or (b) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(7) Any person who contravenes subsection (1)(c) 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.
(8) Any person who contravenes subsection (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Declaration of compliance by research institution
Open ↗24.—(1) The declaration of compliance that a research institution is required to submit to the Director‑General under section 23(1) for all research conducted under the supervision and control of the research institution must be in such form and submitted in such manner and within such time as may be prescribed and must be accompanied by —(a)
such particulars, information and documents as may be prescribed;
(b)
if required by the Director‑General, a statutory declaration by the research institution verifying any information contained in or related to the declaration of compliance; and[Act 11 of 2023 wef 01/05/2023]
(c)
such fee as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(2) A research institution must notify the Director‑General —(a)
of any change in the information submitted under subsection (1)(a), within 30 days after the occurrence of the change or such longer period as the Director‑General may allow in any particular case; and[Act 11 of 2023 wef 01/05/2023]
(b)
of its intention to cease operating as a research institution at least 30 days before the cessation of operation or such shorter period as the Director‑General may allow in any particular case.[Act 11 of 2023 wef 01/05/2023]
(3) Any person who, in submitting a declaration of compliance referred to in subsection (1) or any notification referred to in subsection (2) —(a)
makes any statement or furnishes any document which he or she knows to be false or does not believe to be true; or
(b)
by the intentional suppression of any material fact, furnishes information which is misleading,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
(4) Any person who contravenes subsection (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
Appropriate consent from research subjects
Open ↗25. No human biomedical research can be conducted if the appropriate consent of a person for participation as a research subject, including the use of his or her biological material or individually‑identifiable health information, has not been obtained in accordance with Part 3.
Compelling person to participate in research
Open ↗26.—(1) Any person who —(a)
by means of coercion or intimidation, compels another person against that person’s will to participate or continue to participate as a research subject in any human biomedical research;
(b)
by means of coercion or intimidation, compels another person (A) against A’s will to give A’s consent or to refrain from withdrawing A’s consent for the participation of another person (B) as a research subject in any human biomedical research;
(c)
by means of deception or misrepresentation, causes another person to participate or continue to participate as a research subject in any human biomedical research; or
(d)
by means of deception or misrepresentation, causes another person (A) to give A’s consent or to refrain from withdrawing A’s consent for the participation of another person (B) as a research subject in any human biomedical research,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
(2) It is a defence to a prosecution under subsection (1)(c) if the defendant proves all of the following:(a)
the deception or misrepresentation was a necessary requirement of the human biomedical research;
(b)
the possibility of the deception or misrepresentation was disclosed to the research subject;
(c)
the research was conducted in accordance with the research proposal approved by the reviewing authority.
Duty to protect health information and human biological material against loss, unauthorised disclosure, etc.
Open ↗27.—(1) Every person who has obtained individually‑identifiable information or human biological material for the purposes of human biomedical research must take all reasonable steps and safeguards as may be necessary, including rendering information or material non‑identifiable, to protect such information or material against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification.
(2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(3) In this section and section 28, the act of rendering information or material non‑identifiable means the removal of identifying details from the information or material so that the identity of the research subject from whom the information or material was obtained cannot be readily discovered or ascertained by a person who subsequently accesses or receives the information or material.
No re-identification of anonymised information or biological material without consent
Open ↗28.—(1) This section applies to any information or human biological material —(a)
relating to human biomedical research; and
(b)
which was individually‑identifiable but which has been rendered non-identifiable within the meaning of section 27(3).
(2) No person who is in possession of or in contact with any information or human biological material referred to in subsection (1) can take any action to identify the person from whom such information or material was obtained except —(a)
with the consent of the research subject or the person authorised under Part 3 to give consent on the research subject’s behalf, as the case may be;
(b)
when it is necessary to do so in connection with the administration or execution of anything under this Act;
(c)
when ordered to do so by a court;
(d)
where the information on the identity is publicly available;
(e)
for the purpose of providing the identity to any person or class of persons to whom, in the opinion of the Director‑General, it is in the public interest that the information be disclosed;[Act 11 of 2023 wef 01/05/2023]
(f)
where it is permitted or provided for under this Act or any other written law or rule of law; or
(g)
in such other circumstances and to such persons as may be prescribed.
(3) Any person who contravenes subsection (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Restrictions on disclosure of information
Open ↗29.—(1) No person may disclose any individually-identifiable information of any research subject which has come to his or her knowledge in the course of discharging his or her functions or duties under this Act, or by virtue of his or her conduct or review of the human biomedical research (as the case may be) except —(a)
with the consent of the research subject or the person authorised under Part 3 to give consent on his or her behalf, as the case may be;
(b)
when it is necessary to do so in connection with the administration or execution of anything under this Act;
(c)
when ordered to do so by a court;
(d)
where the information is publicly available;
(e)
to any person or class of persons to whom, in the opinion of the Director‑General, it is in the public interest that the information be disclosed;[Act 11 of 2023 wef 01/05/2023]
(f)
where any other right of disclosure arises under this Act or any other written law or rule of law; or
(g)
in such other circumstances and to such persons as may be prescribed.
(2) No person receiving any individually-identifiable information or human biomedical material of a research subject, may disclose any individually-identifiable information of the research subject, if at the time when the person received the information or material, the person knew or had reasonable grounds to believe that it had been communicated or supplied to him or her in contravention of this Act or any other written law or rule of law.
(3) Any person who contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Prohibited human biomedical research
Open ↗30.—(1) Despite anything in this Act, no research institution or person can conduct, supervise or control any prohibited human biomedical research specified in the Third Schedule.
(2) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
Restricted human biomedical research
Open ↗31.—(1) No research institution or person can conduct, supervise or control any restricted human biomedical research specified in the Fourth Schedule except in accordance with such requirements as the Minister may prescribe and such prescribed requirements are in addition to and not in lieu of the requirements in this Act.
(2) Without limiting subsection (1), the additional requirements which may be prescribed for the purposes of subsection (1) may include the following:(a)
that the Director‑General should be notified of the conduct of such restricted human biomedical research;[Act 11 of 2023 wef 01/05/2023]
(b)
that the restricted human biomedical research should be carried out only under, and in accordance with the conditions of approval obtained from the Director‑General or a public officer authorised by the Minister;[Act 11 of 2023 wef 01/05/2023]
(c)
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;
(d)
that the restricted human biomedical research should be conducted only by certain specified persons;
(e)
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;
(f)
that the restricted human biomedical research should be carried out only at certain specified premises;
(g)
that the restricted human biomedical research should or should not be conducted in any specified manner.
(3) No person can use any human tissue in restricted human biomedical research unless —(a)
one of the following types of consent for the tissue to be used for the particular restricted human biomedical research has been obtained:(i)
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;
(ii)
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;
(iii)
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
(b)
the use is in accordance with any conditions or restrictions specified as part of the consent.
(4) Any person who contravenes subsection (1) or (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
