Document ID: chunk:federal_register_of_legislation:C2022A00026:clause:1_28r:p1
Version: federal_register_of_legislation:C2022A00026
Segment Type: clause
Provision Reference: sch 1 cl 28R (pt 1/3)
Character Range: 47646–50289

28R  Clinical trial licences and clinical practice licences—information about donors and children
 (1) The holder of a clinical trial licence or a clinical practice licence must collect the following information for the donor in relation to each use of a mitochondrial donation technique under the licence:
 (a) the donor's full name;
 (b) the donor's residential address at the time the donor gave the proper consent required by paragraph 28N(1A)(a) to the use of the donor's egg;
 (c) the donor's date and place of birth;
 (d) any other information the donor gives the licence holder, for the purposes of inclusion on the Mitochondrial Donation Donor Register under section 29A, at the time referred to in paragraph (b) of this subsection;
 (e) any other information about the donor prescribed by the regulations for the purposes of this paragraph.
 (2) If a particular use of a mitochondrial donation technique results in the creation of a zygote that:
 (a) has nuclear DNA from a woman and a man; and
 (b) contains mitochondria from a human egg of a different woman;
the woman mentioned in paragraph (b) is the donor in relation to that use of the technique.
 (3) A person who is or was the holder of a clinical trial licence or a clinical practice licence must use the person's best endeavours to collect the following information for each child born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence:
 (a) the child's full name;
 (b) the child's sex;
 (c) the child's date of birth;
 (d) any other information about the child prescribed by the regulations for the purposes of this paragraph.
 (4) A person who is or was the holder of a clinical trial licence or a clinical practice licence must keep records of information the person collects as required by subsection (1) or (3) for the period prescribed by the regulations for the purposes of this subsection.
 (5) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware that a child has been born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence, the person must:
 (a) as soon as practicable after the birth of the child, notify the Secretary and the NHMRC Licensing Committee of that fact, in the form (if any) approved by the Secretary; and
 (b) give the Secretary, in the form (if any) approved by the Secretary:
 (i) the information collected as required by subsection (1) for the donor in relation to the particular use of the technique that achieved the pregnancy, as soon as practicable after the birth of the child; and