The use of mitochondrial donation in Australia is regulated by a staged licensing scheme.
The use of mitochondrial donation in Australia is regulated by the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002. Recent amendments to the legislation established a mitochondrial donation licensing scheme. The Embryo Research Licensing Committee (ERLC) will be responsible for administering 3 new licences, as follows:
- mitochondrial donation pre-clinical research and training licences
- mitochondrial donation clinical trial research and training licences
- mitochondrial donation clinical trial licences.
All 3 licences permit the use of pronuclear transfer (PNT) and maternal spindle transfer (MST) mitochondrial techniques. The pre-clinical research and training licence is designed specifically to expand scientific knowledge and allows for the use of 3 additional permitted techniques.
Contact us prior to applying
We encourage you to contact the Embryo Research Licensing Team at embryo.research@nhmrc.gov.au before you start the licence application process. You may also wish to obtain independent advice to help you complete your application.
ERLC has approved standard licence conditions for mitochondrial donation licences (see Downloads section) that would apply to mitochondrial donation licences issued by ERLC.
Licence application forms
The licence application forms include instructions that will help you to complete the forms.
Forms
The following forms are available from the Downloads section (below):
- application for a pre-clinical research and training licence
- application for a clinical trial research and training licence
- application for a clinical trial licence
- application for approval to create and place an embryo using mitochondrial donation
- notification of adverse events for clinical trial licences.
Other information
The following information is available from the Downloads section (below):
- privacy and protection of your personal information
- standard licence conditions for mitochondrial donation licences.
Submitting your application
Completed application forms should be emailed to us at embryo.research@nhmrc.gov.au
Contact
To contact us about the licensing scheme, direct all enquiries to embryo.research@nhmrc.gov.au
