Human Biomedical Research Act 2015
Table of Contents
Long Title
Part 1 PRELIMINARY
1 Short title
2 General interpretation
3 Meanings of "human biomedical research" and "supervision and control"
Part 2 ADMINISTRATION OF ACT
4 Administration of Act
5 Advisory committees
Part 3 CONSENT
6 Taking of appropriate consent
7 Consent for research involving adults who lack mental capacity
8 Consent for research involving minors
9 Consent for removal or use of tissue for research involving adults who lack mental capacity
10 Consent for removal or use of tissue for research from minors
11 Consent for research or removal or use of tissue for research in case of deceased persons
12 Information to be provided before taking appropriate consent
13 Waiver of appropriate consent by institutional review board
14 Withdrawal of consent
Part 4 INSTITUTIONAL REVIEW BOARDS
15 Appointment and notification of institutional review boards
16 Appointment of institutional review boards by multiple research institutions
17 Functions and duties of institutional review boards
18 Composition, quorum and proceedings of institutional review board
19 Conflicts of interest
20 Application to institutional review board for review
21 Appeal against decision of institutional review board
Part 5 REGULATION OF HUMAN BIOMEDICAL RESEARCH
22 Conduct of human biomedical research and duties of researcher
23 Functions and duties of research institutions
24 Declaration of compliance by research institution
25 Appropriate consent from research subjects
26 Compelling person to participate in research
27 Duty to protect health information and human biological material against loss, unauthorised disclosure, etc.
28 No re-identification of anonymised information or biological material without consent
29 Restrictions on disclosure of information
30 Prohibited human biomedical research
31 Restricted human biomedical research
Part 6 REGULATION OF HUMAN TISSUE ACTIVITIES AND TISSUE BANKS
32 Commercial trading of human tissue prohibited
33 Advertisements relating to commercial trading of human tissue prohibited
34 Notification of tissue bank
35 Duties of tissue bank
36 Declaration of compliance by tissue bank
37 Restrictions on activities relating to human tissue
38 Compelling person to donate tissue
39 Restrictions on disclosure of information on tissue donor
Part 7 CODES OF PRACTICE AND ETHICS
40 Codes of practice or ethics
41 Use of codes of practice or ethics
Part 8 ENFORCEMENT POWERS
42 Immediate stoppage of human biomedical research or tissue banking activity, etc.
43 Prohibiting person from conducting research or tissue banking activities
44 Review of prohibition order
45 Powers of entry, inspection and search, etc.
46 Disposal of articles or documents
47 Information and identity of informers not to be disclosed
48 Minister may appoint committee of inquiry under Inquiries Act 2007
49 Protected information
50 Enhanced penalty for corporations
51 Liability of employers for acts of employees
52 Offences by bodies corporate, etc.
53 Composition of offences
Part 9 APPEALS
54 Appeal to Minister
55 Appeals Advisory Panel
Part 10 MISCELLANEOUS
56 Act binds Government
57 Power to exempt
58 Designation of persons by Minister
59 Service of documents
60 Jurisdiction of courts
61 Protection from personal liability
62 Amendment of Schedules
63 Regulations
64 Saving and transitional provisions for legacy human biological material
65 Saving and transitional provisions
Legislative History
Abbreviations
Comparative Table