Human Biomedical Research (Tissue Banking) Regulations 2019
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
Part 2 TISSUE BANKS GENERALLY
3 Application of this Part
4 Notification by tissue bank
5 Notification of tissue banking activity started before 1 November 2019
6 Principal person in charge designated by tissue bank
7 Change of information and particulars
8 Declaration of compliance
9 Notification under section 35(3)(a) of Act
10 Notification of serious adverse event
11 Notification by tissue bank of serious adverse event
12 Notification of untoward occurrence arising from removal of tissue under section 35(3)(c) of Act
13 Notification by tissue bank of untoward occurrence arising from removal of tissue under section 35(3)(c) of Act
14 Notification of cessation of tissue bank’s operations
15 Requirements before tissue is removed, supplied or exported
16 Protection of confidentiality of donor’s information
17 Tracking of consent and integrity of records
18 Safety and welfare of donors
19 Policy on incidental findings
Part 3 TISSUE FOR HUMAN TISSUE TRANSPLANTATION RESEARCH
20 Application of this Part
21 Documentation
22 Tracking of information relevant to safety and quality of tissue
23 Additional requirements before tissue is released, supplied or exported
24 Notification by recipient of human tissue
25 Management of tissue contamination
26 Quality and safety management systems
Part 4 MISCELLANEOUS
27 Electronic system
28 False information
29 Fees