HUMAN TISSUE PART 1 PRELIMINARY Citation, commencement and extent 1 1 These Regulations may be cited as the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006. 2 These Regulations shall come into force on 1st September 2006. 3 Subject to paragraphs (4) to (8), these Regulations apply in relation to England and Wales and Northern Ireland. 4 This regulation applies in relation to Scotland as well as to England and Wales and Northern Ireland. 5 Regulation 2 applies in relation to Scotland as well as to England and Wales and Northern Ireland but paragraph (b) of the definition of the clinical trials regulations applies only to England and Wales. 6 Regulations 3 and 5 apply in relation to England and Wales only. 7 Regulations 4 and 6 apply in relation to Northern Ireland only. 8 Regulation 7 applies in relation to Scotland only. Interpretation 2 In these Regulations— “ the Act ” means the Human Tissue Act 2004; “the Authority” means the Human Tissue Authority; “the clinical trials regulations” means— the Medicines for Human Use (Clinical Trials) Regulations 2004 and any other regulations replacing those regulations or amending them, and any other regulations relating to clinical trials and designated by the Secretary of State as clinical trials regulations for the purposes of section 30(5) of the Mental Capacity Act 2005 (research); “donor” and “recipient” have the meaning given by regulation 11; “intrusive research” means research of a kind that would be unlawful if it was carried out on or in relation to a person who had capacity to consent to it, but without his consent; “organ” means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy; “relevant commencement date”, in relation to any particular research, means— the date on which section 30 of the Mental Capacity Act 2005 comes into force, but if different dates are appointed for different purposes, means the date on which that section, in its application to that research, comes into force; and “transplantable material” has the meaning given by— regulation 9 for the purposes of section 34 of the Act (information about transplant operations), and regulation 10 for the purposes of section 33 of the Act (restrictions on transplants involving a live donor). PART 2 PERSONS WHO LACK CAPACITY TO CONSENT Storage and use of relevant material Deemed consent to storage and use of relevant material: England and Wales 3 1 This regulation applies in any case falling within paragraphs (a) and (b) of section 6 of the Act (storage and use involving material from adults who lack capacity to consent). 2 An adult (“P”) who lacks capacity to consent to an activity of a kind mentioned in section 1(1)(d) or (f) of the Act (storage or use of material for purposes specified in Schedule 1) which involves material from P’s body, is deemed to have consented to the activity where— a the activity is done for a purpose specified in paragraph 4 or 7 of Part 1 of Schedule 1 to the Act (the purposes of obtaining information relevant to another person and of transplantation) by a person who is acting in what he reasonably believes to be P’s best interests; b the activity is done for the purpose of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; c the activity is done on or after the relevant commencement date for the purpose of intrusive research which is carried out in accordance with the requirements of section 30(1)(a) and (b) of the Mental Capacity Act 2005 (approval by appropriate body and compliance with sections 32 and 33 of that Act); d the activity is done on or after the relevant commencement date for the purpose of intrusive research— i section 34 of the Mental Capacity Act 2005 (loss of capacity during research project) applies in relation to that research, and ii the activity is carried out in accordance with regulations made under section 34(2) of that Act; or e the activity is done before the relevant commencement date for the purpose of research which, before that date, is ethically approved within the meaning of regulation 8. Deemed consent to storage and use of relevant material: Northern Ireland 4 1 This regulation applies in any case falling within paragraphs (a) and (b) of section 6 of the Act (storage and use involving material from adults who lack capacity to consent). 2 An adult (“P”) who lacks capacity to consent to an activity of a kind mentioned in section 1(1)(d) or (f) of the Act which involves material from P’s body, is deemed to have consented to the activity where— a the activity is done for a purpose specified in paragraph 4 or 7 of Part 1 of Schedule 1 to the Act (the purposes of obtaining information relevant to another person and of transplantation) by a person who is acting in what he reasonably believes to be P’s best interests; b the activity is done for the purpose of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or c the activity is done for the purpose of research which is ethically approved within the meaning of regulation 8. Analysis of DNA Purposes for which DNA may be analysed without consent: England and Wales 5 1 This regulation applies for the purposes of paragraph 12 of Schedule 4 to the Act (excepted purposes relating to DNA of adults who lack capacity to consent). 2 In any case falling within sub-paragraph (1)(a)(i) and (b) of that paragraph (DNA manufactured by the body of a person who under the law of England and Wales lacks capacity to consent), the purposes for which DNA manufactured by the body of a person (“P”) who lacks capacity to consent to analysis of the DNA may be analysed are— a any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests; b the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; c the purposes of intrusive research which is carried out on or after the relevant commencement date in accordance with the requirements of section 30(1)(a) and (b) of the Mental Capacity Act 2005 (approval by appropriate body and compliance with sections 32 and 33 of that Act); d the purposes of intrusive research— i which is carried out on or after the relevant commencement date, ii in relation to which section 34 of the Mental Capacity Act 2005 (loss of capacity during research project) applies, and iii which is carried out in accordance with regulations made under section 34(2) of that Act; or e research which is carried out before the relevant commencement date and which, before that date, is ethically approved within the meaning of regulation 8. Purposes for which DNA may be analysed without consent: Northern Ireland 6 1 This regulation applies for the purposes of paragraph 12 of Schedule 4 to the Act (excepted purposes relating to DNA of adults who lack capacity to consent). 2 In any case falling within sub-paragraph (1)(a)(i) and (b) of that paragraph (DNA manufactured by the body of a person who under the law of Northern Ireland lacks capacity to consent), the purposes for which DNA manufactured by the body of a person (“P”) who lacks capacity to consent to analysis of the DNA may be analysed are— a any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests; b the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or c research which is ethically approved within the meaning of regulation 8. Purposes for which DNA may be analysed without consent: Scotland 7 1 This regulation applies for the purposes of paragraph 12 of Schedule 4 to the Act. 2 In any case falling within sub-paragraph (1)(a)(ii) and (b) of that paragraph (DNA manufactured by the body of a person who under the law of Scotland is an adult with incapacity), the purposes for which DNA manufactured by the body of an adult (“P”) with incapacity may be analysed are— a any purpose for which the person carrying out the analysis has obtained the consent of any person who has authority to consent to analysis of P’s DNA by virtue of— i a welfare power of attorney within the meaning of section 16(2), ii an intervention order under section 53, or iii a guardianship order under section 58, of the Adults with Incapacity (Scotland) Act 2000; b a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or c surgical, medical, nursing, dental or psychological research which is permitted under section 51 of the Adults with Incapacity (Scotland) Act 2000 . Ethical approval Ethical approval for the purposes of regulations 3 to 6 8 1 Research is ethically approved within the meaning of this regulation if approval is given by a research ethics authority in the circumstances specified in paragraph (2). 2 The circumstances are that— a the research is in connection with disorders, or the functioning, of the human body, b there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the research has to be confined to, or relate only to, persons who have capacity to consent to taking part in it, and c there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out in circumstances such that the person carrying out the research is not in possession, and not likely to come into possession, of information from which the person from whose body the defined material has come can be identified. 3 “Defined material”— a in relation to ethical approval for the purposes of regulations 3(2)(e) and 4(2)(c), means the relevant material involved in an activity of a kind mentioned in section 1(1)(d) or (f) of the Act, and b in relation to ethical approval for the purposes of regulations 5(2)(e) and 6(2)(c), means the bodily material in relation to which an analysis of DNA is to be carried out. 4 “Research ethics authority” has the meaning given by regulation 2 of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 . PART 3 TRANSPLANTS Meaning of transplantable material for the purposes of section 34 of the Act 9 For the purposes of section 34 of the Act (information about transplant operations) “transplantable material” means— a the whole or part of any of the following organs if it is to be used for the same purpose as the entire organ in the human body— i kidney, ii heart, iii lung or a lung lobe, iv pancreas, v liver, vi bowel, vii larynx; b face, or c limb. Meaning of transplantable material for the purposes of section 33 of the Act 10 1 Subject to paragraphs (2) and (3), for the purposes of section 33 of the Act (restriction on transplants involving a live donor), “transplantable material” means— a an organ, or part of an organ if it is to be used for the same purpose as the entire organ in the human body, b bone marrow, and c peripheral blood stem cells, where that material is removed from the body of a living person with the intention that it be transplanted into another person. 2 The material referred to in paragraph (1)(a) is not transplantable material for the purposes of section 33 of the Act in a case where the primary purpose of removal of the material is the medical treatment of the person from whose body the material is removed. 3 The material referred to in paragraph (1)(b) and (c) is transplantable material for the purposes of section 33 of the Act only in a case where the person from whose body the material is removed is— a an adult who lacks the capacity, or b a child who is not competent, to consent to removal of the transplantable material. Cases in which restriction on transplants involving a live donor is disapplied 11 1 Section 33(1) and (2) of the Act (offences relating to transplants involving a live donor) shall not apply in any case involving transplantable material from the body of a living person (“the donor”) if the requirements of paragraphs (2) to (6) are met. 2 A registered medical practitioner who has clinical responsibility for the donor must have caused the matter to be referred to the Authority. 3 The Authority must be satisfied that— a no reward has been or is to be given in contravention of section 32 of the Act (prohibition of commercial dealings in human material for transplantation), and b when the transplantable material is removed— i consent for its removal for the purpose of transplantation has been given, or ii its removal for that purpose is otherwise lawful. 4 The Authority must take the report referred to in paragraph (6) into account in making its decision under paragraph (3). 5 The Authority shall give notice of its decision under paragraph (3) to— a the donor of the transplantable material or any person acting on his behalf, b the person to whom it is proposed to transplant the transplantable material (“ the recipient”) or any person acting on his behalf, and c the registered medical practitioner who caused the matter to be referred to the Authority under paragraph (2). 6 Subject to paragraph (7), one or more qualified persons must have conducted separate interviews with each of the following— a the donor, b if different from the donor, the person giving consent, and c the recipient, and reported to the Authority on the matters specified in paragraphs (8) and (9). 7 Paragraph (6) does not apply in any case where the removal of the transplantable material for the purpose of transplantation is authorised by an order made in any legal proceedings before a court. 8 The matters that must be covered in the report of each interview under paragraph (6) are— a any evidence of duress or coercion affecting the decision to give consent, b any evidence of an offer of a reward, and c any difficulties of communication with the person interviewed and an explanation of how those difficulties were overcome. 9 The following matters must be covered in the report of the interview with the donor and, where relevant, the other person giving consent— a the information given to the person interviewed as to the nature of the medical procedure for, and the risk involved in, the removal of the transplantable material, b the full name of the person who gave that information and his qualification to give it, and c the capacity of the person interviewed to understand— i the nature of the medical procedure and the risk involved, and ii that the consent may be withdrawn at any time before the removal of the transplantable material. 10 A person shall be taken to be qualified to conduct an interview under paragraph (6) if— a he appears to the Authority to be suitably qualified to conduct the interview, b he does not have any connection with any of the persons to be interviewed, or with a person who stands in a qualifying relationship to any of those persons, which the Authority considers to be of a kind that might raise doubts about his ability to act impartially, and c in the case of an interview with the donor or other person giving consent, he is not the person who gave the information referred to in paragraph (9)(a). Decisions of the Authority: procedure for certain cases 12 1 In any case to which paragraph (2), (3) or (4) applies, the Authority’s decision as to the matters specified in regulation 11(3) shall be made by a panel of no fewer than 3 members of the Authority. 2 A case falls within this paragraph if— a the donor of the transplantable material is a child, and b the material is an organ or part of an organ if it is to be used for the same purpose as an entire organ in the human body. 3 A case falls within this paragraph if— a the donor of the transplantable material is an adult who lacks capacity to consent to removal of the material, and b the material is an organ or part of an organ if it is to be used for the same purpose as an entire organ in the human body. 4 A case falls within this paragraph if— a the donor of the transplantable material is an adult who has capacity to consent to removal of the material, and b the case involves— i paired donations, ii pooled donations, or iii a non-directed altruistic donation. 5 In this regulation— “non-directed altruistic donation” means the removal (in circumstances not amounting to a paired or pooled donation) of transplantable material from a donor for transplant to a person who is not genetically related to the donor or known to him; “paired donations” means an arrangement under which— transplantable material is removed from a donor (“D”) for transplant to a person who is not genetically related or known to D, and transplantable material is removed from another person for transplant to a person who is genetically related or known to D; and “pooled donations” means a series of paired donations of transplantable material, each of which is linked to another in the same series (for example, transplantable material from D is transplanted to the wife of another person (“E”), transplantable material from E is transplanted to the partner of a third person (“F”) and transplantable material from F is transplanted to D’s son). Right to reconsideration of Authority’s decision 13 1 The Authority may reconsider any decision made by it under regulation 11(3) if it is satisfied that— a any information given for the purpose of the decision was in any material respect false or misleading, or b there has been any material change of circumstances since the decision was made. 2 A specified person may in any case require the Authority to reconsider any decision made by it under regulation 11(3). 3 “Specified persons”, in relation to such a decision, are— a the donor of the transplantable material or any person acting on his behalf, b the recipient of the material or any person acting on his behalf, and c the registered medical practitioner who caused the matter to be referred to the Authority under regulation 11(2). 4 The right under paragraph (2 ) is exercisable by giving to the Authority, in such manner as it may direct, notice of exercise of the right. 5 A notice under paragraph (4) shall contain or be accompanied by such other information as the Authority may reasonably require. 6 On receipt of the information required by paragraph (5), the Authority shall provide to the person requiring the reconsideration— a a copy of each report made under regulation 11(6) of the interviews that were conducted in the case, and b a statement of the Authority’s reasons for its decision. 7 Paragraphs (1) to (6) do not apply to a decision made by the Authority on reconsideration in pursuance of a notice under this regulation. Procedure on reconsideration 14 1 Reconsideration shall be by way of fresh decision made at a meeting of the Authority. 2 The meeting shall take place as soon as reasonably practicable after the provision of the reports and statement required by regulation 13(6), having regard to the need to allow time for the information contained in that material to be taken into account. 3 Where a member of the Authority has taken part in the making of a decision subject to reconsideration (whether under regulation 12 or otherwise), he is disqualified from participating in the Authority’s reconsideration of it. 4 On reconsideration under regulation 13(2)— a the person (“A”) by whom the reconsideration is required under regulation 13(2) shall be entitled to require that he or his representative be given an opportunity to appear before and be heard at the meeting of the Authority at which the decision is reconsidered, and b the members of the Authority in attendance at the meeting at which the decision is reconsidered shall consider any such written representations and comments. 5 The Authority shall give a notice of its decision to A. 6 If on reconsideration the Authority upholds the previous decision, the notice under paragraph (5) shall include a statement of the reasons for the Authority’s decision. 7 “Reconsideration” means reconsideration in pursuance of a notice under regulation 13. Rosie Winterton Minister of State, Department of Health 22nd June 2006