Document ID: chunk:federal_register_of_legislation:C2024C00449:section:28j:p2
Version: federal_register_of_legislation:C2024C00449
Segment Type: section
Provision Reference: s 28J (pt 2/2)
Character Range: 63902–66025

each embryologist nominated under subsection 28H(5) has:
 (i) consented in writing to being so nominated; and
 (ii) demonstrated technical competence in the use of the technique in accordance with the protocols referred to in paragraph (a) of this subsection; and
 (iii) understands the embryologist's obligations under this Act; and
 (c) the applicant's facilities, equipment and processes for using the technique under the licence are suitable for that purpose; and
 (d) the staff, other than embryologists, who will carry out activities directly connected with the clinical trial or clinical practice (as the case requires) are appropriately qualified, trained and competent to do so; and
 (e) the applicant is likely to be able to comply with its obligations under section 28R (information about donors and children); and
 (f) the applicant has protocols in place to ensure that each donor in relation to a use of the technique is aware that any children born as a result of a pregnancy achieved by using the technique will be able to obtain information about the donor in accordance with subsections 29A(4) and (6) (disclosure of information on the Mitochondrial Donation Donor Register); and
 (g) the applicant has protocols in place to ensure that trial participants or patients (as the case requires) have been fully informed about:
 (i) the risks involved in using mitochondrial donation techniques; and
 (ii) alternatives to using mitochondrial donation techniques.
 (6) The regulations may specify:
 (a) matters that the NHMRC Licensing Committee may, must or must not have regard to when deciding whether to issue a mitochondrial donation licence; and
 (b) matters that the NHMRC Licensing Committee must be satisfied of before issuing a mitochondrial donation licence; and
 (c) procedural and other requirements that the NHMRC Licensing Committee must follow in deciding whether to issue a mitochondrial donation licence; and
 (d) requirements for demonstrating the technical competence of an embryologist in the use of a particular mitochondrial donation technique for the purposes of subparagraph (5)(b)(ii).