Research Involving Human Embryos Act 2002

A clinical trial research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a particular clinical trial:

developing protocols for using the technique safely and effectively, in a clinical trial setting, for the purpose of minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols;

ensuring that the holder’s facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical trial setting.

The activities are as follows:

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence;

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

A clinical trial research and training licence does not authorise any use of a human embryo that would:

result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or

involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman.