Part of a comprehensive analysis of the Human Biomedical Research Act 2015
All Parts in This Series
Supervision and Control of Human Biomedical Research in Singapore
The Human Biomedical Research Act 2015 (HBRA) establishes a rigorous framework to regulate human biomedical research in Singapore, ensuring ethical standards and protection of research subjects. Central to this framework is the requirement that no human biomedical research may be conducted except under the supervision and control of a research institution with a physical presence in Singapore and responsible individuals ordinarily resident in Singapore.
"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." — Section 22(1), Human Biomedical Research Act 2015
Verify Section 22 in source document →
This provision exists to ensure accountability and local oversight of research activities, preventing unregulated or foreign-controlled research that may not comply with Singapore’s ethical and legal standards. By mandating local supervision, the Act safeguards the welfare of research subjects and maintains public trust in biomedical research.
Mandatory Compliance Requirements for Researchers
Researchers are bound by stringent preconditions before conducting human biomedical research. These include contractual arrangements with a recognized research institution, obtaining institutional review board (IRB) approval, and securing appropriate consent from research subjects, especially when research involves sensitive materials such as human gametes or embryos.
"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 ... (b) he or she has ensured that the proposed research has been reviewed and approved by an institutional review board ... (c) he or she has ensured that ... appropriate consent has been obtained ... (d) he or she has ensured that where the human biomedical research involves human gametes or embryos ... the appropriate consent must be obtained from the research subject or donor who has capacity to give consent in person ..." — Section 22(2), Human Biomedical Research Act 2015
Verify Section 22 in source document →
The purpose of these requirements is to uphold ethical standards, protect the autonomy and rights of research subjects, and ensure that research proposals undergo rigorous ethical scrutiny before commencement. The special emphasis on gametes and embryos reflects the sensitive nature of such research and the need for explicit, informed consent.
Research Conduct and Risk Mitigation Obligations
Researchers must strictly adhere to the approved research proposals and immediately discontinue research activities if IRB approval is withdrawn or if consent is revoked by the participant. Additionally, researchers are obligated to take all necessary measures to mitigate any risk of harm to research subjects.
"A researcher must ensure that — (a) the research does not deviate from the research proposal that has been reviewed and approved ... (b) any research is immediately discontinued if the institutional review board has withdrawn its approval ... (c) the further participation ... is immediately discontinued if the consent has been withdrawn ... (d) all such appropriate and necessary measures are taken to mitigate any risk of harm ..." — Section 22(3), Human Biomedical Research Act 2015
This provision exists to maintain the integrity of the research process and protect participants from unforeseen risks. It ensures that any changes to the research are subject to ethical review and that participants retain the right to withdraw without penalty, reinforcing respect for individual autonomy and safety.
Responsibilities of Research Institutions
Research institutions bear significant responsibilities including submitting notifications and declarations of compliance, supervising and monitoring research activities, designating a principal person in charge, and reporting offences or serious adverse events to the Director-General.
"Every research institution must, in respect of any human biomedical research to be conducted under its supervision and control — (a) submit a notification ...; (b) submit ... a declaration of compliance ...; and (c) ensure that there is in force an approval ... issued by an institutional review board ..." — Section 23(1), Human Biomedical Research Act 2015
Verify Section 23 in source document →
These provisions ensure institutional accountability and continuous oversight of research activities. By mandating formal notifications and compliance declarations, the Act facilitates regulatory monitoring and timely intervention where necessary to protect research subjects and uphold ethical standards.
Consent Requirements and Prohibition of Coercion
Consent is a cornerstone of ethical biomedical research under the HBRA. No research may proceed without obtaining appropriate consent in accordance with Part 3 of the Act. Furthermore, the Act explicitly prohibits compelling participation or consent through coercion, intimidation, deception, or misrepresentation.
"No human biomedical research can be conducted if the appropriate consent of a person for participation as a research subject ... has not been obtained in accordance with Part 3." — Section 25, Human Biomedical Research Act 2015
Verify Section 25 in source document →
"Any person who — (a) by means of coercion or intimidation, compels another person ... to participate ...; (b) ... compels another person ... to give consent or to refrain from withdrawing consent ...; (c) by means of deception or misrepresentation, causes another person to participate ...; or (d) by means of deception or misrepresentation, causes another person to give consent or to refrain from withdrawing consent ... shall be guilty of an offence ..." — Section 26(1), Human Biomedical Research Act 2015
The emphasis on voluntary and informed consent protects the dignity and autonomy of research subjects. The prohibition of coercive or deceptive practices prevents abuse and exploitation, ensuring that participation is truly voluntary and informed.
Protection of Health Information and Biological Material
The HBRA imposes strict duties on persons handling individually-identifiable information or human biological material to protect such data against loss, unauthorized access, disclosure, or re-identification without consent.
"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 ... to protect such information or material against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification." — Section 27(1), Human Biomedical Research Act 2015
Verify Section 27 in source document →
"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." — Section 27(3), Human Biomedical Research Act 2015
Verify Section 27 in source document →
These provisions exist to safeguard privacy and confidentiality, which are fundamental ethical principles in biomedical research. By defining “non-identifiable” information, the Act clarifies standards for anonymization to prevent unauthorized re-identification and misuse of sensitive data.
Regulation of Prohibited and Restricted Human Biomedical Research
The Act categorically prohibits certain types of human biomedical research specified in the Third Schedule and tightly regulates restricted research listed in the Fourth Schedule, requiring compliance with additional ministerial requirements.
"No research institution or person can conduct, supervise or control any prohibited human biomedical research specified in the Third Schedule." — Section 30(1), Human Biomedical Research Act 2015
Verify Section 30 in source document →
"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 ..." — Section 31(1), Human Biomedical Research Act 2015
Verify Section 31 in source document →
These provisions ensure that ethically sensitive or potentially harmful research is either banned outright or subject to enhanced regulatory scrutiny. This protects public interest and aligns Singapore’s research practices with international ethical norms.
Penalties for Non-Compliance
The HBRA imposes significant penalties for breaches of its provisions, reflecting the seriousness with which Singapore treats ethical biomedical research. Penalties range from fines to imprisonment, depending on the nature and gravity of the offence.
- Contravention of supervision and control requirements or researcher duties: up to $50,000 fine and/or 5 years imprisonment — Section 22(6)
- Failure to submit notification or declaration by research institution: up to $10,000 fine and/or 12 months imprisonment — Section 23(6)
- Contravention of approval requirements by research institution: up to $50,000 fine and/or 5 years imprisonment — Section 23(7)
- Failure to notify offences or serious adverse events: up to $20,000 fine and/or 2 years imprisonment — Section 23(8)
- False or misleading declarations: up to $20,000 fine and/or 2 years imprisonment — Section 24(3)
- Compelling participation by coercion, intimidation, deception or misrepresentation: up to $100,000 fine and/or 10 years imprisonment — Section 26(1)
- Failure to protect health information or biological material: up to $10,000 fine and/or 12 months imprisonment — Section 27(2)
- Re-identification of anonymised information without consent: up to $20,000 fine and/or 2 years imprisonment — Section 28(3)
- Unauthorized disclosure of individually-identifiable information: up to $20,000 fine and/or 2 years imprisonment — Section 29(3)
- Conducting prohibited human biomedical research: up to $100,000 fine and/or 10 years imprisonment — Section 30(2)
- Conducting restricted human biomedical research without compliance: up to $100,000 fine and/or 10 years imprisonment — Section 31(4)
These penalties serve as a deterrent against unethical conduct and reinforce the importance of compliance with the Act’s provisions to protect research subjects and maintain public confidence.
Cross-References to Other Legal Provisions
The HBRA integrates with other legal frameworks to ensure comprehensive regulation. Notably, it references Part 3 of the Act for consent requirements and acknowledges other written laws or rules of law for permitted disclosure or re-identification of information.
"appropriate consent has been obtained in accordance with Part 3 prior to the research subject’s participation ..." — Section 22(2)(c), Human Biomedical Research Act 2015
Verify Section 22 in source document →
"No human biomedical research can be conducted if the appropriate consent ... has not been obtained in accordance with Part 3." — Section 25, Human Biomedical Research Act 2015
Verify Section 25 in source document →
"No person who is in possession of or in contact with any information or human biological material ... can take any action to identify the person ... except ... (c) when ordered to do so by a court; ... (f) where it is permitted or provided for under this Act or any other written law or rule of law;" — Section 28(2), Human Biomedical Research Act 2015
Verify Section 28 in source document →
"No person may disclose any individually-identifiable information ... except ... (c) when ordered to do so by a court; ... (f) where any other right of disclosure arises under this Act or any other written law or rule of law;" — Section 29(1), Human Biomedical Research Act 2015
Verify Section 29 in source document →
These cross-references ensure that the HBRA operates harmoniously within Singapore’s broader legal system, allowing for lawful disclosures and actions under court orders or other statutes, while maintaining strict protections for research subjects.
Conclusion
The Human Biomedical Research Act 2015 establishes a comprehensive regulatory regime to govern human biomedical research in Singapore. Its key provisions emphasize local supervision, ethical review, informed consent, protection of personal data, and strict prohibitions on unethical research practices. The Act’s detailed penalties underscore the importance of compliance and the protection of research subjects. By integrating with other legal frameworks, the HBRA ensures a robust and coherent approach to regulating biomedical research, balancing scientific advancement with ethical responsibility.
Sections Covered in This Analysis
- Section 22(1), (2), (3), (6)
- Section 23(1), (6), (7), (8)
- Section 24(3), (4)
- Section 25
- Section 26(1)
- Section 27(1), (2), (3)
- Section 28(2), (3)
- Section 29(1), (3)
- Section 30(1), (2)
- Section 31(1), (3), (4)
Source Documents
For the authoritative text, consult SSO.