Human Biomedical Research Regulations 2017
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
Part 2 RESEARCH INSTITUTIONS
3 Notification by research institution
4 Notification of research started before 1 November 2017
5 Principal person in charge
6 Change of information and particulars
7 Declaration of compliance
8 Notification under section 23(3)(a) of Act
8A Definition of serious adverse event
9 Notification of serious adverse event
10 Notification of unexpected serious adverse event
10A Notification of cessation of research institution’s operations
10B Management of contamination of human biological material
10C Safety and welfare of research subjects
10D Policy on incidental findings
Part 3 INSTITUTIONAL REVIEW BOARDS
11 Appointment and composition of institutional review boards
12 Qualification of members
13 Term of office
14 Notification to Director
15 Revocation of appointment
16 Disqualification
17 Revocation of disqualification order
18 Meetings and quorum of institutional review boards
19 Conflicts of interest
20 Expedited review
21 Exempted review
22 Documentation and communications
23 Written reasons to be provided to second institutional review board
24 Reports to research institution
Part 4 MISCELLANEOUS
25 Witness to appropriate consent
26 (Deleted)
27 Procedure for appeal to Minister
28 Electronic system
29 False information
30 Fees