Singapore – Sections Of The New Human Biomedical Research Act In Effect As Of 1 July 2016.

Section

Brief description of section

Sections 1 – 3; Sections 4 and 5 (Preliminary; Administration of the Act)

• Definitions

• Administration of the HBRA and establishment of advisory committees

Sections 40 – 41 (Codes of Practice and Ethics)

• Power of the Director to issue and/or approve codes of practice and codes of ethics for the purposes of providing guidance in relation to compliance with the HBRA

• Liability under any criminal proceedings for failure to observe codes of practice or codes of ethics

Sections 42 – 53 (Enforcement Powers)

• Enforcement powers of the Director; the power to immediately require stoppage of human biomedical research or tissue banking activity and issue directions to institutional review boards to suspend human biomedical research etc

• Powers of authorised officers to enter premises and search the same to investigate, among other things, contravention of provisions of the HBRA

• Protection of informers and information identifying informers

• Disclosure of “protected information”

• Penalties (including enhanced penalties for corporations) and offences

Section

Brief description of section

Sections 54 – 55 (Appeals)

• Procedure for appeal

• Establishment of Appeals Advisory Panel

Sections 56 – 63 (Miscellaneous)

• Provision that Government is bound by the HBRA

• Power of the Minister to exempt persons, institutions or

  tissue banks etc

• Administrative issues such as the service of documents, jurisdiction of the courts and the power of the Minister to make regulations

Sections 66 and 67 (Miscellaneous)

• Related amendments to the Health Products Act and the Medicines Act

First Schedule

• Specifies human biological material which is excluded from the definition of “human tissue”

Second Schedule

• Specifies research studies and matters which are excluded from the definition of “human biomedical research”