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In forceAmended2020 Revised Edition

Part 4 · Institutional Review Boards

15. Appointment and notification of institutional review boards

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Amended

Last amended by an amending law of 2023.

(1)

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.

(2)

To avoid doubt, a person may be appointed as a member concurrently of 2 or more institutional review boards appointed by the same research institution or different research institutions.

(3)

A person who is appointed as a member concurrently of 2 or more institutional review boards is not disqualified from sitting on the different boards which are reviewing proposals for human biomedical research that are part of the same research or are otherwise connected or related.

(4)

A research institution must notify the Director‑General of —

(a)

any institutional review board which it has appointed under this section or section 16; or

(b)

any institutional review board which appointment it has revoked,as the case may be.

(5)

A notification for the purposes of subsection (4) must be submitted to the Director‑General in such form and manner and within such time as the Director‑General may require, and must be accompanied by such fee as may be prescribed.

(6)

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.

(7)

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.

Report

Part 5

Regulation of Human Biomedical Research

Part 6

Regulation of Human Tissue Activities and Tissue Banks

Part 7

Codes of Practice and Ethics

Part 8

Enforcement Powers

Part 9

Appeals

Part 10

Miscellaneous

Schedules