Guidelines

HBRA contraventions

Singapore's Human Biomedical Research Act (HBRA) came into force on 1 Nov 2017. Researchers contravening any part of this legislation may be guilty of an offence and shall be liable on conviction to the following penalties.

Below is a summarised version to guide researchers. For full details on the relevant sections of this legislation, please refer to Singapore Statutes Online.


[Note]
Researchers who encounter any Suspected Offences and Contraventions (SOCs) should report to NTU-IRB immediately. NTU-IRB will then submit the relevant information to MOH within 7 days after knowing the event. 


List of Contraventions and Section Reference

S/NList Of Contraventions And Section Reference​Penalties
1​

Duties of researchers conducting HBR – Section 22

  • Proposed research has been reviewed and approved (or exempted) by an IRB;
  • Appropriate consent obtained from research subject.
  • Research does not deviate from approved research proposal unless (i) the deviation has been reviewed and approved by IRB, or (ii) is necessary to mitigate an immediate risk of harm to a research subject.
  • Research is immediately discontinued if IRB has withdrawn its approval for the research
  • If consent of research subject is withdrawn, the further participation of the research subject or further use of the individually-identifiable biological material or health information of the research subject should be discontinued immediately.
  • 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.

Fine:not exceeding $50,000.

Imprisonment:not exceeding 5 years.

2

Compelling person to participate in research - Section 26

  • Coercion or intimidation to compel another person against that person's will to participate or continue to participate as a research subject.

Fine:not exceeding $100,000

Imprisonment: not exceeding 10 years.

3

Duty to protect health information and human biological material against loss, unauthorised disclosure, etc. - Section 27

  • Every person who has obtained individually‑identifiable information or human biological material 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.

Fine: not exceeding $10,000

Imprisonment: not exceeding 12 months.

4

No re-identification of anonymised information or biological material without consent - Section 28

  • 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 from whom such information or material was obtained, except with the consent of the research subject.

Fine: not exceeding $20,000

Imprisonment: not exceeding 2 years.

5

Restrictions on disclosure of information - Section 29

  • Individually-identifiable information obtained from any research subject should not be disclosed, except with the consent of the research subject.

Fine: not exceeding $20,000

Imprisonment: not exceeding 2 years.

6

Prohibited human biomedical research - Section 30

  • No person can conduct any prohibited human biomedical research specified in the Third Schedule of HBRA.

Fine:not exceeding $100,000

Imprisonment: not exceeding 10 years.

7

Restricted human biomedical research - Section 31

  • No person can conduct any restricted human biomedical research specified in the Fourth Schedule except:
     -  Prior IBR approval obtained; and
     -  Prior MOH approval obtained.

Fine:not exceeding $100,000

Imprisonment: not exceeding 10 years.