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

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Deemed consent and appropriate consent – general provisions

10. (1) For the purposes of this Part, where deemed consent applies in respect of a deceased adult in accordance with section 18 and there is no objection to transplantation activities by the designated family member—

(a) the designated family member shall confirm in writing, in the presence of a witness who shall attest the designated family member’s confirmation, that he or she has no objection to such transplantation activities, or

(b) in a case where the family member concerned cannot provide confirmation in writing for any reason, that confirmation may be given orally by the person in the presence of two witnesses each of whom shall attest that the person has no objection.

(2) (a) For the purposes of this Part, “appropriate consent” means consent provided without duress or coercion—

(i) in relation to a deceased adult who is not registered on the Register and in respect of whom deemed consent does not apply, by the designated family member in accordance with section 19 ,

(ii) in relation to a deceased child, by a parent or guardian in accordance with section 21 ,

(iii) in relation to the donation of an organ by a living adult donor or a non directed altruistic donor, by the donor and, in the case of a non-directed altruistic donor, with the approval of the Panel in accordance with section 29 ,

(iv) in relation to the donation of tissues and cells by a living adult donor, by the donor,

(v) in relation to the donation of regenerative tissues and cells by a living child, by a parent or guardian, with the approval of a Panel in accordance with section 31 ,

(vi) in relation to the donation of regenerative tissues and cells by a living adult who lacks capacity, by the specified person concerned in accordance with section 25 , with the approval of the Panel in accordance with section 30 ,

(vii) in relation to a case to which section 25 (2) applies, by the specified person concerned, or

(viii) in relation to a case to which section 26 (2) applies, by a parent or guardian of the child.

(b) For the purposes of this Part—

(i) appropriate consent shall be in writing and shall be signed by the person giving the consent in the presence of a witness who shall attest the person’s signature, or

(ii) in a case where the person cannot provide appropriate consent in writing that consent may be given orally by the person in the presence of two witnesses each of whom shall attest that the person gave consent.

(3) A copy of a confirmation referred to in subsection (1) or a copy of an appropriate consent referred to in subparagraphs (i) to (viii) of subsection (2)(a) shall be—

(a) retained with the medical records of the donor for a period of 30 years, and

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

(4) Prior to any importation of an organ into the State for the purpose of transplantation activities, a transplantation centre shall satisfy itself that—

(a) the consent required for such transplantation activities has been obtained by the appropriate person in the country of origin where procurement of the organ took place, and

(b) the procurement of the organ meets the legal requirements of the country of origin in relation to the transplantation activities concerned.

(5) Prior to any importation of any tissues and cells into the State for the purpose of transplantation activities, a tissue establishment or an importing tissue establishment shall satisfy itself that—

(a) the consent required for such transplantation activities has been obtained by the appropriate person in the country of origin where procurement of the tissues and cells took place, and

(b) the procurement of the tissues and cells meets the legal requirements of the country of origin in relation to the transplantation activities concerned.

(6) A person who contravenes—

(a) subsection (3),

(b) subsection (4), or

(c) subsection (5),

shall be guilty of an offence.

(7) In this section, “country of origin” means the country from which the organ or tissues and cells, as the case may be, was or were procured before being imported into the State.