Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

Application to Panel for donation of regenerative tissue and cells by living child

31. (1) Where a donation of regenerative tissue and cells from a living child is proposed in accordance with section 26 (3), the tissue establishment or procurement organisation, as the case may be, with clinical responsibility for the removal of the regenerative tissue and cells shall, apply to the Panel for approval for such proposed donation.

(2) An application under subsection (1) shall be made in such form and manner as may be specified by the Panel.

(3) On receipt of an application under subsection (1), the Panel shall appoint a suitably qualified professional, who shall not be a member of the Panel, to prepare a report as to whether appropriate consent has been provided for the purposes of such donation.

(4) The person appointed under subsection (3) shall prepare a report in accordance with that subsection and furnish the report to the Panel not later than 15 days after his or her appointment.

(5) The Panel shall take into account the report prepared in accordance with subsection (3) when making any decision regarding an application under subsection (1).

(6) The Panel may approve an application under subsection (1) where it is satisfied that—

(a) having taken account of the report prepared in accordance with subsection (3), appropriate consent has been provided in accordance with section 10 ,

(b) subject to subsection (7), consent has been given to the proposed donation by at least one parent or guardian,

(c) the opinion of the child the subject of the application, having regard to his or her age, degree of maturity and decision-making competence in relation to making a decision in respect of the donation and that he or she does not object to the proposed donation,

(d) the parent or guardian, or where applicable the child, the subject of the application has been given sufficient information,

(e) the proposed recipient is a parent (including a parent who has not yet attained 18 years), child or sibling of the donor and there is no other compatible donor with the capacity to consent available,

(f) there is no alternative therapeutic intervention of comparable effectiveness, and

(g) the donation of the regenerative tissue and cells by the donor has been clinically assessed by a registered medical practitioner as having the potential to be life-saving for the recipient.

(7) Where a parent or guardian objects in writing to the consent given by the other parent or guardian, the consent given by the first-mentioned parent or guardian shall have no effect and shall be deemed invalid for the purposes of this section.

(8) The Panel shall refuse an application under subsection (1) where it is not satisfied that the conditions specified in subsection (6) are met.

(9) In considering an application under subsection (1), the Panel shall have regard to—

(a) the report under subsection (3), and

(b) the views of the proposed donor, the subject of the application.

(10) The Panel shall give notice in writing of a decision to approve an application under subsection (6) or refuse an application under subsection (8), as the case may be, to—

(a) the parent or guardian of the child the subject of the application, and

(b) the tissue establishment or procurement organisation, as the case may be, who caused the matter to be referred to the Panel under subsection (1).

(11) A copy of the report provided in accordance with subsection (3)

(a) shall be retained with the medical records of the child donating the regenerative tissue and cells, for a period of not less than 30 years, by the tissue establishment or procurement organisation, as the case may be, which carried out the procedure, and

(b) shall be offered to the person providing consent and shall, on his or her request, be given to that person.