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Research Involving Human Embryos Act 2002
In force
Administered by
Department of Health, Disability and Ageing
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C2022C00282 (C07)
01 October 2022
-
30 May 2024
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Part 1—Preliminary
1 Short title
2 Commencement
3 Object of Act
4 Operation of Act
5 Act to bind the Crown
6 External Territories
7 Definitions
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Part 2—Regulation of the use of excess ART embryos and other material
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Division 1—Interpretation
8 Definitions
9 Meaning of excess ART embryo
Division 2—Offences
10 Offence—use of excess ART embryo
10A Offence—use of other embryos
10B Offence—certain activities involving use of human eggs
11 Offence—use of embryo that is not an excess ART embryo
11A Offence—use of material created under mitochondrial donation licence
12 Offence—breaching a general licence or mitochondrial donation licence condition
12A Person not liable for conduct purportedly authorised
Division 3—Embryo Research Licensing Committee of the NHMRC
13 Establishment of Committee
14 Functions of Committee
15 Powers of Committee
16 Membership of Committee
17 Terms of appointment
18 Annual report
19 Reports to Parliament
Division 4—General licences
20 Applying for a general licence
21 Determination of application by Committee
22 Notification of decision
23 Period of a general licence
24 Conditions of general licences
25 Variation of a general licence
26 Suspension or revocation of a general licence
27 Surrender of a general licence
28 Notification of variation, suspension or revocation of a general licence
Division 4A—Mitochondrial donation licences
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Subdivision A—Kinds of mitochondrial donation licences and what they authorise
28A Kinds of mitochondrial donation licences
28B Carrying out activities authorised by mitochondrial donation licences
28C What a pre clinical research and training licence authorises
28D What a clinical trial research and training licence authorises
28E What a clinical trial licence authorises
28F What a clinical practice research and training licence authorises
28G What a clinical practice licence authorises
Subdivision B—Applying for a mitochondrial donation licence
28H Applying for a mitochondrial donation licence
Subdivision C—Determining applications for mitochondrial donation licences
28J Determination of application by Committee
28K Notification of decision
28L Matters to be specified in a mitochondrial donation licence
28M Period of a mitochondrial donation licence
Subdivision D—Conditions of mitochondrial donation licences
28N Conditions of mitochondrial donation licences generally
28P Additional condition of clinical trial licences and clinical practice licences—Committee approval before creation or placement of embryo
28Q Other conditions of clinical trial licences and clinical practice licences
Subdivision E—Ongoing requirements for holders of mitochondrial donation licences
28R Clinical trial licences and clinical practice licences—information about donors and children
28S Clinical trial licences and clinical practice licences—requirement for ongoing monitoring protocols and to notify adverse events
28T Record keeping obligations for all holders of mitochondrial donation licences
Subdivision F—Variation, suspension, revocation and surrender
28U Variation of a mitochondrial donation licence
28V Suspension or revocation of a mitochondrial donation licence
28W Surrender of a mitochondrial donation licence
28X Notification of variation, suspension or revocation of a mitochondrial donation licence
Division 5—Protection and disclosure of information
29 NHMRC Licensing Committee to make certain information publicly available
29A Mitochondrial Donation Donor Register
30 Confidential commercial information may only be disclosed in certain circumstances
Division 6—Review provisions
31 Meaning of terms
32 Review of decisions
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Part 3—Monitoring powers
33 Appointment of inspectors
34 Identity card
35 Powers available to inspectors for monitoring compliance
36 Monitoring powers
37 Power to secure
37A Monitoring warrants
37B Details of warrant to be given to occupier etc.
37C Announcement before entry
37D Occupier entitled to be present during search
38 Inspector must produce identity card on request
39 Consent
40 Compensation for damage
41 Extended operation of Part
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Part 4—Commonwealth/State arrangements
42 Operation of State laws
43 Conferral of functions on Commonwealth officers and bodies
44 When duty imposed
45 Review of certain decisions
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Part 5—Miscellaneous
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Division 1—Arrangements relating to clinical trials of mitochondrial donation techniques
46 Arrangements relating to clinical trials of mitochondrial donation techniques
46A Terms and conditions relating to clinical trial arrangements
46B Minister or Secretary may delegate powers in relation to arrangements
46C Relationship of this Division with certain other Acts
46D Executive power of the Commonwealth
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Division 2—Other miscellaneous matters
47 Interaction with the Gene Technology Act 2000
47A Immunity from civil actions relating to mitochondrial donation licences
47B Review of operation of Act every 7 years
48 Regulations
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Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
