Part of a comprehensive analysis of the Human Biomedical Research Act 2015
All Parts in This Series
Director-General’s Powers to Halt Research and Tissue Banking Activities Under Section 42
Section 42 of the Human Biomedical Research Act 2015 empowers the Director-General to order the immediate cessation of any human biomedical research or tissue banking activity under specific circumstances. This provision exists to safeguard public health and uphold ethical standards in biomedical research by enabling swift intervention when serious risks or breaches occur.
"Where the Director‑General is of the opinion that any human biomedical research or tissue banking activity — (a) has given rise or is likely to give rise to a serious adverse event or to such other matter as may be prescribed; (b) is in contravention of — (i) any provision of this Act; or (ii) any relevant code of practice or code of ethics issued or approved under section 40; (c) is not being or has not been properly reviewed by an institutional review board appointed by the research institution; or (d) is contrary to the public interest, the Director‑General may, in writing, order the researcher and other persons conducting the human biomedical research or tissue banking activity to immediately stop all activities..." — Section 42, Human Biomedical Research Act 2015
Verify Section 42 in source document →
This provision exists to prevent harm arising from research activities that may cause serious adverse events, violate statutory or ethical requirements, lack proper oversight, or threaten public interest. By granting the Director-General this power, the Act ensures that research institutions remain accountable and that potentially dangerous or unethical research can be promptly halted.
Failure to comply with such an order attracts severe penalties, reflecting the importance of adherence to regulatory oversight.
Prohibition Orders Against Persons Under Section 43
Section 43 authorizes the Director-General to prohibit individuals from conducting human biomedical research or tissue banking activities based on specific grounds such as criminal convictions, reputational concerns, or medical reasons. This provision serves to protect the integrity of biomedical research and the safety of research participants by restricting access to research activities for unsuitable persons.
"The Director-General may, by written notice, prohibit any person from conducting human biomedical research or tissue banking activity if the Director-General is satisfied that the person— (a) has been convicted of an offence involving dishonesty or fraud; (b) is not a fit and proper person to conduct such research or activity having regard to the person's reputation, character or conduct; or (c) is medically unfit to conduct such research or activity." — Section 43, Human Biomedical Research Act 2015
Verify Section 43 in source document →
This provision exists to ensure that only qualified and trustworthy individuals engage in sensitive biomedical research, thereby maintaining public confidence and protecting research subjects from potential harm or exploitation.
Contravention of a prohibition order is a serious offence, punishable by fines and imprisonment, underscoring the critical nature of this safeguard.
Inspection and Search Powers of Authorised Officers Under Section 45
Section 45 grants authorised officers the power to enter premises, inspect, search, and seize articles or documents to investigate compliance with the Act and related offences. This provision is essential for effective enforcement, enabling regulatory authorities to gather evidence and ensure adherence to legal and ethical standards.
"An authorised officer may, at any reasonable time and on producing the officer’s authorisation, enter any premises or place where the officer has reason to believe that human biomedical research or tissue banking activity is being or has been conducted for the purposes of— (a) inspecting the premises or place; (b) examining any article or document; (c) seizing any article or document that may be relevant to an investigation; and (d) exercising any other power conferred by this Act." — Section 45(1), Human Biomedical Research Act 2015
Verify Section 45 in source document →
The provision also includes safeguards against interference or obstruction:
"Any person who, without the authorised officer’s permission— (a) interferes, tampers with, removes or otherwise disposes of the article or document; (b) alters, counterfeits, defaces, destroys, erases or removes any mark, seal or label placed by the authorised officer under subsection (5)(c)(i); or (c) opens, breaks or otherwise tampers with the lock or seal placed by the authorised officer on the whole or part of any premises or place under subsection (5)(c)(ii), 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 45(6), Human Biomedical Research Act 2015
Verify Section 45 in source document →
"Any person who— (a) obstructs, hinders or impedes an authorised officer in the exercise of the officer’s powers under this section; or (b) without reasonable excuse, fails to comply with any order or requirement of an authorised officer under this section or to produce any book, document, record, electronic material, article or thing which that person is required by or under this Act to produce to an authorised officer, 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 45(9), Human Biomedical Research Act 2015
These powers and penalties exist to ensure that investigations can be conducted effectively without obstruction, thereby promoting compliance and accountability.
Protection of Confidential Information Under Section 49
Section 49 safeguards the confidentiality of information obtained under the Act, recognizing the sensitive nature of biomedical research data. This provision protects research participants, institutions, and the integrity of the research process by preventing unauthorized disclosure of protected information.
"Any person who contravenes subsection (1) 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 49(2), Human Biomedical Research Act 2015
Verify Section 49 in source document →
"“protected information” means information the disclosure of which would, or could reasonably be expected to disclose confidential information or to adversely affect a person or a research institution in relation to the research being conducted or to be conducted." — Section 49(3)(b), Human Biomedical Research Act 2015
Verify Section 49 in source document →
This provision exists to balance transparency and accountability with the need to maintain confidentiality, thereby fostering trust in the research environment and encouraging participation.
Liabilities and Penalties for Corporations, Employers, and Officers Under Sections 50-52
The Act imposes strict penalties for offences committed by corporations and their officers to ensure corporate accountability in biomedical research. Sections 50 to 52 clarify the scope of liability and enhance penalties to deter corporate misconduct.
"Where a body corporate is convicted of an offence under this Act, the penalty that the court may impose shall be a fine not exceeding 2 times the maximum amount that the court could, but for this section, impose as a fine for that offence." — Section 50, Human Biomedical Research Act 2015
Verify Section 50 in source document →
"In this section — “body corporate” includes a limited liability partnership which has the meaning given by section 2(1) of the Limited Liability Partnerships Act 2005; “officer” — (a) in relation to a body corporate, means any director, partner, member of the committee of management, chief executive, manager, secretary or other similar officer of the body corporate and includes any person purporting to act in any such capacity; or (b) in relation to an unincorporated association (other than a partnership), means the president, the secretary, or any member of the committee of the unincorporated association, or any person holding a position analogous to that of president, secretary or member of a committee and includes any person purporting to act in any such capacity; “partner” includes a person purporting to act as a partner." — Section 52(5), Human Biomedical Research Act 2015
These provisions exist to ensure that corporations cannot evade responsibility for breaches of the Act and that individuals in positions of authority within these entities are held accountable for compliance.
Composition of Offences Under Section 53
Section 53 empowers the Director-General or authorised officers to compound offences under the Act. This mechanism allows for efficient resolution of minor breaches without resorting to formal prosecution, thereby conserving resources and encouraging compliance.
"The Director-General or an authorised officer may, with the consent of the Attorney-General, compound any offence under this Act by accepting from the person reasonably suspected of having committed the offence a sum of money not exceeding the amount of the fine that may be imposed for the offence." — Section 53, Human Biomedical Research Act 2015
Verify Section 53 in source document →
This provision exists to provide flexibility in enforcement, enabling regulatory authorities to address offences proportionately and expediently.
Cross-References to Other Legislation
The Human Biomedical Research Act 2015 integrates with other statutes to provide a comprehensive regulatory framework. Key cross-references include:
- Section 40: Codes of practice or ethics issued or approved under this section guide ethical conduct in research.
- Section 4(6): Authorisation of persons by the Director-General to assist in exercising powers.
- Criminal Procedure Code 2010, Section 364(1): Governs handling of articles or documents produced in criminal trials, ensuring proper legal procedures.
- Inquiries Act 2007, Section 9(1): Minister’s power to appoint committees of inquiry into serious adverse events or contraventions.
- Limited Liability Partnerships Act 2005, Section 2(1): Definition of limited liability partnerships, relevant for defining “body corporate.”
"any relevant code of practice or code of ethics issued or approved under section 40;" — Section 42(1)(b)(ii), Human Biomedical Research Act 2015
Verify Section 42 in source document →
"an authorised officer may be accompanied and assisted by a person authorised by the Director‑General under section 4(6) for the purposes of facilitating the exercise of such powers and duties." — Section 45(3), Human Biomedical Research Act 2015
Verify Section 45 in source document →
"Any article or document produced, detained or seized under section 45 must — (a) where the article or document is produced in any criminal trial, be dealt with in accordance with section 364(1) of the Criminal Procedure Code 2010;" — Section 46(1)(a), Human Biomedical Research Act 2015
Verify Section 46 in source document →
"the Minister may in writing appoint a committee of inquiry under that section and direct the committee to inquire into — (a) any actual or suspected serious adverse event that has occurred; or (b) any contravention or suspected contravention of the requirements of this Act or any relevant code of practice or code of ethics, issued or approved under section 40, by a research institution, an institutional review board, a tissue bank or a researcher, as the case may be." — Section 48, Human Biomedical Research Act 2015
Verify Section 48 in source document →
"“body corporate” includes a limited liability partnership which has the meaning given by section 2(1) of the Limited Liability Partnerships Act 2005;" — Section 52(5), Human Biomedical Research Act 2015
Verify Section 52 in source document →
These cross-references ensure that the Human Biomedical Research Act operates cohesively within Singapore’s broader legal framework, facilitating effective governance and enforcement.
Conclusion
The provisions analysed herein collectively establish a robust regulatory framework for human biomedical research and tissue banking in Singapore. The Director-General’s powers to halt research and prohibit unsuitable persons, the inspection and search authorities granted to authorised officers, the protection of confidential information, and the imposition of stringent penalties all serve to uphold ethical standards, protect public health, and ensure accountability. Cross-references to other legislation further reinforce the Act’s effectiveness by embedding it within Singapore’s comprehensive legal system.
Sections Covered in This Analysis
- Section 40
- Section 42
- Section 43
- Section 45
- Section 46
- Section 48
- Section 49
- Section 50
- Section 52
- Section 53
- Section 4(6)
- Criminal Procedure Code 2010, Section 364(1)
- Inquiries Act 2007, Section 9(1)
- Limited Liability Partnerships Act 2005, Section 2(1)
Source Documents
For the authoritative text, consult SSO.