Part of a comprehensive analysis of the Human Biomedical Research Act 2015
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Institutional Review Boards under the Human Biomedical Research Act 2015: Key Provisions and Their Purpose
The Human Biomedical Research Act 2015 (HBRA) establishes a comprehensive regulatory framework to ensure ethical standards and oversight in human biomedical research conducted in Singapore. Central to this framework is the appointment and operation of Institutional Review Boards (IRBs) by research institutions. This article analyses the key provisions relating to IRBs under Part 4 of the HBRA, explaining their purpose and the rationale behind each requirement.
Appointment and Notification of Institutional Review Boards
Section 15(1) mandates that:
"A research institution must appoint one or more institutional review boards for the purpose of reviewing human biomedical research conducted under the supervision and control of that research institution and in accordance with such requirements as may be prescribed." — Section 15(1), Human Biomedical Research Act 2015
Verify Section 15 in source document →
This provision ensures that every research institution has a dedicated body responsible for the ethical oversight of human biomedical research under its purview. The appointment of IRBs is fundamental to decentralizing ethical review, allowing institutions to tailor oversight mechanisms to their specific research contexts while maintaining compliance with national standards.
Further, Section 15(4) requires research institutions to notify the Director-General of Health of the appointment or revocation of IRBs, ensuring regulatory transparency and enabling governmental oversight:
"Every research institution must notify the Director-General of the appointment or revocation of an institutional review board." — Section 15(4), Human Biomedical Research Act 2015
Verify Section 15 in source document →
Failure to comply with this notification requirement attracts penalties, as detailed below, underscoring the importance of maintaining an up-to-date registry of IRBs for effective governance.
Functions and Duties of Institutional Review Boards
Section 17(1) comprehensively outlines the functions and duties of IRBs, emphasizing their role in ethical review and safeguarding research participants:
"The functions and duties of an institutional review board are — (a) to carry out a review (called in this Act an initial review) of any proposed human biomedical research (called in this section the proposed research) on ethical grounds; ... (k) if the board considers appropriate — (i) to grant its approval for the research to be conducted or continued, as the case may be; (ii) to require modifications to be made to the research proposal before granting its approval or allowing the proposed research to continue, as the case may be; or (iii) to disallow the conduct or continuation of the proposed research (as the case may be) with written justifications; and (l) to make such other assessments or carry out such other functions or duties as may be required or imposed under this Act." — Section 17(1), Human Biomedical Research Act 2015
Verify Section 17 in source document →
The IRB’s primary purpose is to conduct an initial ethical review of proposed research, ensuring that it complies with ethical principles such as respect for persons, beneficence, and justice. The board assesses the suitability of researchers, the adequacy of informed consent processes, and the risk-benefit balance of the research. The power to approve, require modifications, or disallow research ensures that only ethically sound research proceeds, protecting participants from harm.
Moreover, the IRB may perform additional assessments as mandated by the Act, reflecting the dynamic nature of biomedical research and the need for flexible oversight.
Joint Appointment of Institutional Review Boards for Collaborative Research
Section 16(1) provides for the appointment of a common IRB for collaborative research involving multiple institutions:
"One research institution to be appointed as the lead research institution for the purpose of coordinating the research." — Section 16(1), Human Biomedical Research Act 2015
Verify Section 16 in source document →
This provision facilitates efficient ethical review in multi-institutional research projects by allowing a lead institution to coordinate the review process. It prevents duplication of reviews and promotes consistency in ethical standards across collaborating institutions.
Composition, Quorum, Proceedings, and Conflict of Interest Rules
Section 18(1) requires that the composition, quorum, and proceedings of IRBs comply with regulations made under Section 63:
"The composition, quorum and proceedings of an institutional review board must be in accordance with regulations made under section 63." — Section 18(1), Human Biomedical Research Act 2015
Verify Section 18 in source document →
This ensures that IRBs operate with appropriate expertise, independence, and procedural fairness. Regulations under Section 63 typically prescribe the inclusion of members with diverse backgrounds, including scientific, ethical, and lay perspectives, to provide balanced review. Quorum requirements and conflict of interest rules safeguard the integrity of decisions and prevent undue influence.
Application and Appeal Procedures
Section 20 mandates that applications for ethical review be submitted by researchers responsible for the research:
"Every application to an institutional review board for the review of human biomedical research must be made by one or more researchers responsible for the conduct and supervision of the research in accordance with such requirements as may be prescribed." — Section 20, Human Biomedical Research Act 2015
Verify Section 20 in source document →
This provision ensures accountability by requiring that those with direct responsibility for the research seek ethical approval.
Section 21(1) provides an avenue for appeal against IRB decisions:
"Any researcher who, having submitted an application to an institutional review board for initial review, is aggrieved by the decision of the institutional review board ... may within 30 days after the decision of the first board, submit an appeal to the research institution which appointed the first board." — Section 21(1), Human Biomedical Research Act 2015
Verify Section 21 in source document →
The appeal mechanism promotes fairness and transparency, allowing researchers to challenge decisions they consider unjust, while maintaining institutional oversight.
Penalties for Non-Compliance
The HBRA imposes strict penalties to ensure compliance with IRB-related obligations. Section 15(6) addresses failure to notify the Director-General of appointments or revocations:
"Any person who contravenes subsection (4)(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." — Section 15(6), Human Biomedical Research Act 2015
Verify Section 15 in source document →
This penalty underscores the importance of regulatory oversight and accurate record-keeping of IRBs.
Section 15(7) further penalizes false or misleading notifications:
"Any person who, in submitting a notification for the purposes of subsection (4) — (a) makes any statement or furnishes any document which that person 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." — Section 15(7), Human Biomedical Research Act 2015
Verify Section 15 in source document →
These stringent penalties deter misconduct and promote integrity in the administration of IRBs.
Definitions and Cross-References
While Part 4 does not explicitly define all terms, it uses key terms with contextual meaning. For example, "lead research institution" is defined in Section 16(1) as:
"One research institution to be appointed as the lead research institution for the purpose of coordinating the research." — Section 16(1), Human Biomedical Research Act 2015
Verify Section 16 in source document →
"Initial review" is defined in Section 17(1)(a) as:
"A review ... of any proposed human biomedical research ... on ethical grounds." — Section 17(1)(a), Human Biomedical Research Act 2015
Verify Section 17 in source document →
Additionally, the Act references other regulatory frameworks, such as regulations made under Section 63 and requirements in Part 3 of the Fifth Schedule, to ensure comprehensive governance:
"The composition, quorum and proceedings of an institutional review board must be in accordance with regulations made under section 63." — Section 18(1), Human Biomedical Research Act 2015
Verify Section 18 in source document →
"To assess that the requirements in Part 3 of the Fifth Schedule are fulfilled before approving any proposed emergency research;" — Section 17(1)(f), Human Biomedical Research Act 2015
Verify Section 17 in source document →
These cross-references integrate the IRB provisions within the broader regulatory landscape, ensuring consistency and adherence to detailed procedural and ethical standards.
Conclusion
The provisions relating to Institutional Review Boards under the Human Biomedical Research Act 2015 establish a robust framework for ethical oversight of human biomedical research in Singapore. By mandating the appointment of IRBs, defining their functions, ensuring procedural fairness, and imposing penalties for non-compliance, the Act safeguards the rights and welfare of research participants while promoting responsible research conduct. The inclusion of appeal mechanisms and provisions for collaborative research further enhance the effectiveness and adaptability of the regulatory regime.
Sections Covered in This Analysis
- Section 15(1), (4), (6), (7)
- Section 16(1)
- Section 17(1)(a), (f), (k), (l)
- Section 18(1)
- Section 20
- Section 21(1)
- Section 63 (referenced)
- Part 3 of the Fifth Schedule (referenced)
Source Documents
For the authoritative text, consult SSO.