Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019

Human Biomedical Research Act 2015

(Section 63)

Human Biomedical Research
(Tissue Banking and Notification —
Exemption) Regulations 2019

2025 REVISED EDITION

(2 June 2025)

[1 November 2019]

Citation

1.  These Regulations are the Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019.

Exemption for tissue banking activities regulated under other legislation

2.—(1)  Sections 34, 35, 36 and 37 of the Act do not apply to an individual, body of persons or tissue bank who or which conducts any tissue banking activity solely for the purpose of the individual’s, body’s or tissue bank’s own research or own clinical trial, which falls within any of the following descriptions:

(a) national public health research as defined in and conducted in accordance with section 59A of the Infectious Diseases Act 1976;

(b) clinical trials of health products conducted in accordance with the Health Products Act 2007;

(c) clinical trials of medicinal products conducted in accordance with the Medicines Act 1975.

(2)  To avoid doubt, an individual, body of persons or tissue bank who or which conducts any tissue banking activity concurrently with, or in addition to, or which is not solely for, the purposes specified in paragraph (1) must comply with sections 34, 35, 36 and 37 of the Act in relation to that activity.