28EWhat a clinical trial licence authorises

28E What a clinical trial licence authorises

(1) A clinical trial licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in conducting a clinical trial to determine whether the permitted technique specified in the licence is sufficiently safe and effective to use in a clinical practice setting: (a) creating a human embryo for a trial participant, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease; (b) placing the embryo in the body of the trial participant for the purposes of achieving her pregnancy. (2) The activities are as follows: (a) 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; (b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence: (i) by fertilisation of a human egg by a human sperm outside the body of a woman; or (ii) other than by the fertilisation of a human egg by a human sperm; and use of such embryos; (c) alteration of the genome of a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered; (d) placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence: (i) a human embryo created by a process other than the fertilisation of a human egg by human sperm; (ii) a human embryo that contains genetic material provided by more than 2 persons; (iii) a human embryo that contains a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered; (e) use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence. (3) A clinical trial licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.