RESEARCH INVOLVING HUMAN EMBRYOS ACT 2002
Table of Provisions
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
PART 2--REGULATION--OF THE USE OF EXCESS ART EMBRYOS AND OTHER MATERIAL
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
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
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
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
PART 5--MISCELLANEOUS
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
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