Human Tissue Act 2004

3 “Appropriate consent”: adults E+W+N.I.

(1) This section makes provision for the interpretation of “appropriate consent” in section 1 in relation to an activity involving the body, or material from the body, of a person who is an adult or has died an adult (“the person concerned”).

(2) Where the person concerned is alive, “appropriate consent” means his consent.

(3) Where the person concerned has died and the activity is one to which subsection (4) applies, “appropriate consent” means his consent in writing.

(4) This subsection applies to an activity involving storage for use, or use, for the purpose of—

(a) public display, or

(b) where the subject-matter of the activity is not excepted material, anatomical examination.

(5) Consent in writing for the purposes of subsection (3) is only valid if—

(a) it is signed by the person concerned in the presence of at least one witness who attests the signature,

(b) it is signed at the direction of the person concerned, in his presence and in the presence of at least one witness who attests the signature, or

(c) it is contained in a will of the person concerned made in accordance with the requirements of—

(i) section 9 of the Wills Act 1837 (c. 26), or

(ii) Article 5 of the Wills and Administration Proceedings (Northern Ireland) Order 1994 (S.I. 1994/1899 (N.I. 13)).

(6) Where the person concerned has died and the activity is not one to which subsection (4) applies, “appropriate consent” means—

(a) if a decision of his to consent to the activity, or a decision of his not to consent to it, was in force immediately before he died, his consent;

(b) if—

(i) paragraph (a) does not apply, and

(ii) he has appointed a person or persons under section 4 to deal after his death with the issue of consent in relation to the activity,

consent given under the appointment;

[F1 (ba) if neither paragraph (a) nor paragraph (b) applies and the activity is one to which subsection (6A) [F2 or (6AA)] applies, the deemed consent of the person concerned;]

(c) if neither paragraph (a) nor paragraph (b) applies [F3 and the activity is not one to which subsection (6A) [F4 or (6AA)] applies], the consent of a person who stood in a qualifying relationship to him immediately before he died.

[F5 (6A) This subsection applies to the following activities done in England unless the body is the body of an excepted adult—

(a) the storage of the body of a deceased person for use for the purpose of transplantation;

(b) the removal from the body of a deceased person, for use for the purpose of transplantation, of any permitted material of which the body consists or which it contains;

(c) the storage for use for the purpose of transplantation of any permitted material which has come from a human body;

(d) the use for the purpose of transplantation of any permitted material which has come from a human body.

[F6 (6AA) This subsection applies to the following activities done in Northern Ireland unless the body is the body of an excepted adult—

(a) the storage of the body of a deceased person for use for the purpose of transplantation;

(b) the removal from the body of a deceased person, for use for the purpose of transplantation, of any permitted material of which the body consists or which it contains;

(c) the storage for use for the purpose of transplantation of any permitted material which has come from a human body;

(d) the use for the purpose of transplantation of any permitted material which has come from a human body.]

(6B) The person concerned is to be deemed, for the purposes of subsection (6)(ba), to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented.]

(7) Where the person concerned has appointed a person or persons under section 4 to deal after his death with the issue of consent in relation to the activity, the appointment shall be disregarded for the purposes of subsection (6) if no one is able to give consent under it.

(8) If it is not reasonably practicable to communicate with a person appointed under section 4 within the time available if consent in relation to the activity is to be acted on, he shall be treated for the purposes of subsection (7) as not able to give consent under the appointment in relation to it.

[F7 (9) In subsection (6A)—

• “excepted adult” means—

  (a)

  an adult who has died and who had not been ordinarily resident in England for a period of at least 12 months immediately before dying, or

  (b)

  an adult who has died and who for a significant period before dying lacked capacity to understand the effect of subsection (6)(ba);

• “permitted material” means relevant material other than relevant material of a type specified in regulations made by the Secretary of State.

[F8 (9A) In subsection (6AA)—

• “excepted adult” means—

  (a)

  an adult who has died and who had not been ordinarily resident in Northern Ireland for a period of at least 12 months immediately before dying, or

  (b)

  an adult who has died and who for a significant period before dying lacked capacity to understand the effect of subsection (6)(ba);

• “permitted material” means relevant material of a type specified in regulations made by the Department of Health in Northern Ireland, but the regulations may not make provision dealing with a matter falling within a description specified in Schedule 3 to the Northern Ireland Act 1998 (reserved matters).]

(10) For the purposes of the definition of “excepted adult” in subsection (9) [F9 or (9A)] a significant period means a sufficiently long period as to lead a reasonable person to conclude that it would be inappropriate for consent to be deemed to be given under subsection (6)(ba).]

Textual Amendments

F1 S. 3(6)(ba) inserted (20.5.2020) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 1(2), 3(3); S.I. 2020/520, reg. 2(a)

F2 Words in s. 3(6)(ba) inserted (N.I.) (13.2.2023) by Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 (c. 10), ss. 1(2)(a), 2(2); S.R. 2023/14, art. 2

F3 Words in s. 3(6)(c) inserted (20.5.2020) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 1(3), 3(3); S.I. 2020/520, reg. 2(a)

F4 Words in s. 3(6)(c) inserted (N.I.) (13.2.2023) by Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 (c. 10), ss. 1(2)(b), 2(2); S.R. 2023/14, art. 2

F5 S. 3(6A)(6B) inserted (20.5.2020) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 1(4), 3(3); S.I. 2020/520, reg. 2(a)

F6 S. 3(6AA) inserted (N.I.) (13.2.2023) by Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 (c. 10), ss. 1(3), 2(2); S.R. 2023/14, art. 2

F7 S. 3(9)(10) inserted (1.10.2019 for specified purposes, 20.5.2020 in so far as not already in force) by Organ Donation (Deemed Consent) Act 2019 (c. 7), ss. 1(5), 3(3); S.I. 2019/1262, reg. 2(a)(b); S.I. 2020/520, reg. 2(a)

F8 S. 3(9A) inserted (N.I.) (13.2.2023) by Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 (c. 10), ss. 1(4), 2(2); S.R. 2023/14, art. 2

F9 Words in s. 3(10) inserted (N.I.) (13.2.2023) by Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 (c. 10), ss. 1(5), 2(2); S.R. 2023/14, art. 2

Commencement Information

I1 S. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)

I2 S. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)