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Code of practice 2

Donation of solid organs for transplantation

Living organ donation

Types of living organ donation

27. The types of living organ donation currently offered in the UK are:

  1. Directed donation: A form of donation where a healthy person donates an organ (usually a kidney) or part organ (for example liver or lung lobe) to a specific recipient. The recipient could be known to the donor (in the case of genetically or emotionally related donation) or unknown to the donor (in the case of paired donation).
    1. genetically related donation: where the potential donor is a blood relative of the potential recipient
    2. emotionally related donation: where the potential donor has a relationship with the potential recipient, for example, spouse, partner, or close friend
    3. paired donation: where a relative, friend or partner is fit and able to donate an organ but is incompatible with the potential recipient, and they are matched with another donor and recipient in a similar situation, so that both people in need of a transplant receive a compatible organ
    4. pooled donation: a form of paired donation whereby the pair are matched with other donors and recipients from a pool of pairs in similar situations, and more than two donors and two recipients are involved in the swap, so that more than two people in need of a transplant receive a compatible organ
    5. directed altruistic donation: where there is no genetic or pre-existing emotional relationship between the donor and recipient. These cases tend to be characterised by a third party - either a person or other mechanism such a social networking website - bringing the donor and recipient together for the purpose of transplantation
  2. Altruistic non-directed donation: A form of living donation whereby an organ (usually a kidney) or part organ (for example liver or lung lobe) is donated by a healthy person who does not have a relationship with the recipient and who is not informed whom the recipient will be.
  3. Non directed altruistic donor chains: where a non-directed altruistic donor donates their organ into the paired / pooled scheme. By matching two or more donors and recipients, a chain of operations can be carried out. The remaining organ at the end of the chain is then donated to the best matched recipient on the national waiting list.

28. Domino donation is a further form of living donation where an organ or part organ is removed for the primary purpose of a person’s medical treatment. The organ/s removed may prove suitable for transplant into another person (e.g. a heart originally removed from the recipient of a heart / lung transplant).  The HTA does not regulate domino donations. While consent for use of the organ for transplantation does fall under the consent requirements of the HT Act (see paragraphs 71–75), the donation would not be subject to the same regulatory requirements as other types of living donation (see paragraphs 33– 41). This is because, although it is a living donation, the donation primarily arises from the removal of the organ as part of a patient’s treatment. Consent to treatment and examination is covered by the common law, and the legal position is set out in Department of Health’s guidance [ www.dh.gov.uk/consent ].

Requirements of the legislation

29. The HT Act governs consent for the storage and use of organs or part organs taken from a living person for the purpose of transplantation.

30. Consent for the removal of organs from living donors, whether for transplantation or otherwise, is outside the scope of the HT Act. It is instead covered by the common law and the Mental Capacity Act (MC Act) 2005 [ www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1 ] where appropriate. Trusts should have local policies in place for obtaining consent to treatment and the legal position is set out in the Department of Health’s guidance [ www.dh.gov.uk/consent ]. Guidance for healthcare professionals in Wales is available in the Welsh Assembly Government’s Reference guide to consent for examination and treatment [ www.wales.nhs.uk/consent ]. The Department of Health, Social Services and Public Safety (DHSSPS) (Northern Ireland) has published its own Reference guide to consent for examination, treatment or care [ www.dhsspsni.gov.uk/consent-referenceguide.pdf ].

31. The requirements for living donor transplantation are set out in sections 33 and 34 of the HT Act [ www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_4#pt2-pb6 ] and 9–14 of the Regulations [ www.opsi.gov.uk/si/si2006/20061659.htm ].

32. It is an offence to remove or use any organ or part organ from the body of a living person for transplantation unless the requirements of the HT Act and the Regulations are met.

33. The Regulations require that, with the exception of domino donations (see paragraph 27), all living organ donations for transplantation must be approved by the HTA before the donation can take place. 

34. Before the HTA can approve such cases, the Regulations require that the Authority must be satisfied that:

  1. no reward has been, or is to be, given
  2. consent to removal for the purpose of transplantation has been given (or removal for that purpose is otherwise lawful)
  3. an Independent Assessor (IA) (see paragraphs 60–64) has conducted separate interviews with the donor (and if different from the donor, the person giving consent) and the recipient (or the person acting on behalf of the recipient) and submitted a report of their assessment to the HTA

35. A person is qualified to conduct such an interview if:

  1. they meet the HTA’s person specification for becoming an IA and have completed the approved HTA training and enhanced training for the assessment of directed altruistic donation cases
  2. they do not have any connection to those being interviewed, or their families, of a kind which the HTA considers might raise doubts about impartiality
  3. in the case of an interview with the donor (or other person giving consent), the IA is not the same person who gave them information about the procedure and its risks.

36. The Regulations also specify the matters to be covered in the report submitted by the IA to the HTA, which are:

  1. the information given to the potential donor (or other person giving consent) as to the nature of the medical procedure and the risk involved
  2. the full name of the person who gave that information to the potential donor (or other person giving consent), and their qualification to give it
  3. the capacity of the potential donor (or other person giving consent)  to understand the nature of the medical procedure and the risk involved and that consent may be withdrawn at any time before the removal of the organ or part organ
  4. whether there is any evidence of duress or coercion affecting the decision to give consent
  5. whether there is any evidence of an offer of a reward
  6. whether there were any difficulties in communicating with the person interviewed (e.g. language, hearing), and if so, an explanation of how these difficulties were overcome

37. There are two levels of decision-making for living organ donation: the first where the HTA transplant approvals team can make the final decision on a case; and the second where a case must be assessed by an HTA panel.

38. A decision on a transplant must be made by an HTA panel:

  1. if the donor is a child
  2. if the donor is an adult who lacks capacity to consent to removal of an organ or part organ
  3. in all cases of paired and pooled donation
  4. in all cases of altruistic non-directed donation
  5. where the Authority has decided not to delegate decision making (currently adult-to-adult liver, directed altruistic, or economic dependence donation cases)

39. All other cases can be approved by the HTA transplant approvals team, although they can also refer complex or novel cases to a panel where required.

40. A donor or recipient, a person acting on behalf of either, or the registered medical practitioner who caused the matter to be referred to the HTA, may ask for a review of any decision on a case made by the HTA. The process for doing this is laid out within the Regulations [www.opsi.gov.uk/si/si2006/20061659.htm] and requires a fresh decision to be made by the HTA.

41. Further guidance on the HTA approvals process and the roles of the IA and HTA panels can be found at paragraphs 58–70.

Payment, advertising and commercial dealings

42. The HT Act [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_4#pt2-pb6] allows donors to receive reimbursement of expenses, such as travel costs and loss of earnings, which are reasonably attributable to and directly result from donation.

43. Details on the levels of reimbursement are available in the Department of Health’s guidance on Reimbursement of living donor expenses by the NHS [www.dh.gov.uk/en/Healthcare/NationalServiceFrameworks/Renal/RenalInformation/DH_4069293].

44. The HTA requires that checks are made to ensure that no other payment or reward is made and that the donor does not profit from the donation.

45. The HT Act also prohibits commercial dealings in human material, including organs or part organs, for the purposes of transplantation. A person is committing an offence if they:

  1. give, offer or receive any type of reward for the supply or offer of supply of any organ or part organ
  2. look for a person willing to supply any organ or part organ for reward
  3. offer to supply any organ or part organ for reward
  4. initiate or negotiate any arrangement involving the giving of a reward for the supply of, or for an offer to supply, any organ or part organ
  5. take part in the management or control of any type of group whose activities consist of or include the initiation or negotiation of such arrangements
  6. cause to be published or distributed, or knowingly publish or distribute, an advertisement inviting people to supply, or offering to supply, any organ or part organ for reward, or indicate that the advertiser is willing to initiate or negotiate any such arrangements. This covers all and any types of advertising

46. This offence carries the risk of a fine and up to three years imprisonment. No offence is committed, however, where payments relate to reimbursement of the donor’s expenses as discussed above, or reimbursement is for relevant expenses connected with transporting, removing, preparing, preserving, or storing human material for the purpose of transplantation.

Children – special considerations

47. Children can be considered as living organ donors only in extremely rare circumstances. In accordance with common law and the Children Act 1989 [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_1], before the removal of a solid organ or part organ from a child for donation, court approval should be obtained. Further guidance on seeking court approval can be found in Appendix A.

48. Living donation by a child under the HT Act can only go ahead with the approval of an HTA panel (see paragraphs 69–70). The HT Act defines a child as being under 18 years old [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54]. Such cases should only be referred to the HTA for decision after court approval to the removal has been obtained.

49. The position in Scotland regarding children is somewhat different and the Scottish Government has issued guidance on these cases [www.hta.gov.uk/_db/_documents/Information_about_HT_(Scotland)_Act.pdf]. Further information on the relevant requirements under the Scottish Act can also be found at paragraphs 54–57.

Adults – special considerations

50. Where an adult lacks the capacity to consent to the removal of an organ or part organ, the case must be referred to a court for a declaration that the removal would be lawful. Donation may then only proceed if court approval has been obtained and following court approval the case is referred to, and approved by, an HTA panel (see paragraphs 69-70).

51. The HT Act does not specify the criteria for considering whether an adult has capacity to consent.

52. In determining whether a person of 16 or over has capacity, the provisions of the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] should be considered together with general principles governing capacity to consent to medical procedures. Guidance is available from the Office of Public Guardian website [www.publicguardian.gov.uk/mca/mca.htm] and in the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. There is separate guidance for Wales [http://new.wales.gov.uk/topics/health/nhswales/healthservice/mentalhealthservices/mentalcapacityact/?lang=en] and for Northern Ireland [www.dhsspsni.gov.uk/public_health_consent]. The Adults with Incapacity (Scotland) Act 2000 [www.opsi.gov.uk/legislation/scotland/acts2000/asp_20000004_en_1] governs adults who lack capacity in Scotland. See paragraphs 78–83 for further information on determining capacity and the MC Act.

53. The position in Scotland regarding adults with incapacity and living organ donation is somewhat different and the Scottish Government has issued guidance on these cases [www.hta.gov.uk/_db/_documents/Information_about_HT_(Scotland)_Act.pdf]. Further information on the relevant requirements under the Scottish Act can also be found at paragraphs 54–57 below.

Scottish legislation

54. The legal framework for living organ donation and transplantation is different in Scotland, and is set out in section 17 of the HT (Scotland) Act 2006 [www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_3#pt1-pb3]. These provisions are supplemented by the Human Organ and Tissue Live Transplants (Scotland) Regulations 2006 (the Scottish Live Transplants Regulations) [www.oqps.gov.uk/legislation/ssi/ssi2006/ssi_20060390_en_1].

55. Under Scottish legislation (see paragraph 52, above), adults without capacity to make their own decisions and children (defined as persons who have not yet reached the age of 16) are only able to donate solid organs or part of an organ which has to be removed as part of a domino organ transplant operation (see paragraph 27). Unlike other forms of living organ donation this form of donation is not regulated by the HTA. Guidance within this code is not therefore applicable to adults with incapacity or children in Scotland.

56. Scottish law covering living organ donation by adults with capacity is broadly similar to that which applies in the rest of the UK (see paragraphs 58–70), although in Scotland a person becomes an adult when they reach the age of 16.

57. Scottish Ministers have asked the HTA to regulate donation approvals on their behalf.

HTA Process

Roles of the HTA

58. As required by the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006, the HTA must assess all cases of living organ donation (except domino donations) for transplantation. The HTA undertakes this role through an independent assessment process. 

59. Before a transplant involving a living donor takes place, a donor and recipient must receive a full medical assessment to determine whether they are suitable to undergo the procedure. The decision about whether a person is medically fit and suitable as a living organ donor is a matter for the practitioners concerned.  Additionally, the Q & S Organs Regulations set out the mandatory requirements for donor and organ characterisation, and further information on this can be found in the HTA’s publication ‘The Quality and Safety of Organs Intended for Transplantation – a documentary framework’.

http://www.hta.gov.uk/_db/_documents/Organs_Intended_for_Transplantation_-_documentary_framework_July_2012.pdf ]

If the donor is deemed suitable, the clinician responsible for the donor must then make a written referral to an HTA IA. 

Independent Assessors (IAs)

60. In order to become an IA, a person must have completed the training and have been accredited by the HTA to undertake the role. Further guidance on IA accreditation can be found in the Guidance for transplant teams and Independent Assessors

http://www.hta.gov.uk/_db/_documents/Guidance_to_Transplant_Teams_and_Independent_Assessors_201208301604.pdf ].

61. IAs are professionals who are usually, but not exclusively, based in hospitals with transplant units or referring nephrology units. IAs act as a representative of both the HTA and the donor in order to help the HTA ensure the requirements of the HT Act and Regulations have been met.

62. The IA’s responsibility is to interview the donor and recipient to assess whether the requirements of the HT Act and Regulations (see paragraph 34) have been met. Separate interviews must be carried out with the donor and recipient, and IAs also interview the donor and recipient together.

63. The exceptions to this are:

  1. when the recipient is a child, the donor will be interviewed separately and the IA would attempt an interview with the child recipient.  If an interview could not be undertaken with the recipient the IA would note this in their report to the HTA.
  2. in non-directed altruistic donation, the IA would only see the donor
  3. an application is made to the HTA to suspend the requirement that donor and recipient be interviewed together, and this is approved

64. Following the interview the IA must prepare a report for the HTA which states whether they are satisfied that the relevant requirements of the HT Act and Regulations (see paragraphs 34 and 36) have been met. 

HTA approval process

65. Following submission of the IA’s report, the HTA will make a final decision on approval of the donation.

66. All straightforward directed donations where the donor and recipient are genetically or emotionally related can be assessed by the HTA transplant approvals team. However, the transplants approval team is able to refer complex cases (including those relating to newer types of organ transplant) to a panel for decision.

67. Decisions on all other donations must be made by a panel of Authority members. These include altruistic non-directed donation, paired or pooled donation, donations by children, and donations from adults who lack capacity to consent. In the rare case of donation by a child or an adult who lacks capacity, an HTA panel will consider the case only after a court declaration has been made on whether the proposed intervention is lawful. See Appendix A for requirements for court approval.

HTA Panels

68. HTA panels consist of three Authority members. A panel may ask the advice of experts; however, these advisors are not involved in the final decision-making on a donation. Panels are supported by the HTA transplant approvals team.

69. Detailed information on the referral, assessment and approval process for each type of donation is available in the Guidance for transplant teams and Independent Assessors [www.hta.gov.uk/transplantation/organ_donation/independent_assessors.cfm].

Consent

70. The HT Act requires consent be obtained to use organs or part organs from a living person for transplantation.

71. The giving of consent is a positive act. For consent to be valid, it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question.

72. Obtaining valid consent presupposes that there is a process in which individuals, including their partners, relatives or close friends where appropriate, may discuss the issue fully, ask questions and make an informed choice. Sufficient time should be allowed for questions and discussion. Surgeons should always check before surgery that the person still consents to the procedure, and be clear that consent has not been withdrawn before they proceed.

73. While the HT Act does not specify the format in which consent should be given or recorded, it is good practice to obtain written consent for significant procedures such as organ donation. When consent is obtained but is not in writing, this should be clearly documented in the patient’s records. The record should detail when consent was obtained and the purposes for which the consent was given. It is also good practice to document details of discussions held regarding the risks of the procedure
(see paragraph 90).

74. Further guidance on consent and the HT Act is available in the code of practice on Consent.

Consent – adults

75. For consent to be valid it must be given voluntarily by an appropriately informed person who has the capacity to agree to the activity in question.

76. As outlined in paragraph 51, the HT Act does not specify the criteria for considering whether an adult has capacity to consent.

77. Under the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_2#pt1-pb1-l1g1], a person aged 16 and over is unable to make a particular decision if they cannot do one or more of the following things:

  1. understand the information given to them that is relevant to the decision
  2. retain that information long enough to be able to make the decision
  3. use or weigh up the information as part of the decision-making process
  4. communicate their decision by any means

Full guidance on how the MC Act defines capacity and how it should be assessed is given in chapter 4 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm].

78. The provisions of the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] should be considered together with general principles governing capacity to consent to medical procedures. Guidance is available from the Office of Public Guardian website [www.publicguardian.gov.uk/mca/mca.htm] and in the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. There is separate guidance for Wales [http://new.wales.gov.uk/topics/health/nhswales/healthservice/mentalhealthservices/mentalcapacityact/?lang=en] and for Northern Ireland [www.dhsspsni.gov.uk/public_health_consent]. The Adults with Incapacity (Scotland) Act 2000 [www.opsi.gov.uk/legislation/scotland/acts2000/asp_20000004_en_1] governs adults who lack capacity in Scotland.

79. The MC Act governs decision - making on behalf of adults (aged 16 and over) who lack capacity to make a particular decision because the way their mind or brain works is affected. For the purposes of the MC Act, unlike the HT Act, an adult is a person aged 16 or over. The MC Act only applies to persons aged 16 or over.

80. There are detailed provisions contained in the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] concerning decisions made on behalf of adults lacking capacity. All decisions must be made in the person’s best interests, as laid out in chapter 5 of the MC Act code of practice
[www.publicguardian.gov.uk/mca/code-of-practice.htm]. Also, certain categories of people have a legal duty to have regard to the MC Act code of practice, when working with or caring for individuals who lack or may lack capacity to make decisions for themselves, as laid out in chapter 6 [www.publicguardian.gov.uk/mca/code-of-practice.htm].

81. The MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] defines persons who lack capacity, see chapter 4 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm], and contains a set of key principles and a checklist to be used in ascertaining best interests, see chapter 5 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. The first core principle of the MC Act is that an adult must be assumed to have capacity to make a decision for themselves, unless it is established that they lack capacity to make the particular decision at the time the decision needs to be made [ www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_2 ].

82. It should therefore always be assumed that an adult has the capacity to make a decision unless there is reason to believe otherwise.

Consent – children

83. Under the HT Act, a child is defined as being under 18 years old [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54]. Under the HT (Scotland) Act, a child is defined as being under 16 years old [www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_8#pt7-l1g60] (see information relating to Scotland at paragraphs 54–57).

84. As outlined within paragraph 47, the removal of an organ or part organ from a child is governed by the common law and the Children’s Act 1989 [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_1]. Before any such procedure the approval of a court should be sought. Appendix A to this code provides further guidance on requirements for court approval.

85. The HT Act requires consent be given for the storage and use of organs for transplantation. Where a child is deemed competent to consent to that decision, the necessary consent will be their own. A person who has parental responsibility for the child can consent to the storage and use of organs for transplantation on the child’s behalf if there is no decision by the child either to, or not to, consent, and:

  1. the child is not competent to deal with the issue of consent to donation
  2. even though the child is competent to do so, they have not made a decision about consent to donation

86. A person who has parental responsibility will usually, but not always, be the child’s parent. The category of persons with parental responsibility is as set out in the Children Act 1989 [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_2].

Informing the donor

87. Potential donors must be provided with sufficient information for them to reach an informed decision about whether they wish to give consent. This information should be provided by the transplant team before the donor is interviewed by an IA.

88. All potential donors should be provided with a copy of the HTA leaflet Information about living donor transplants [http://www.hta.gov.uk/_db/_documents/Guidance_for_living_organ _donors_on_the_HTA's_Independent_Assessment_process_201209100811.pdf].

89. The following information should be explained in full to the donor:

  1. the surgical procedures and medical treatments involved for the donor and the risks involved in both the short-and long-term (this should be explained by a medical practitioner with appropriate qualifications to give this information)
  2. the chances of the transplant being successful and any possible side-effects or complications for both donor and recipient
  3. the right to withdraw consent at any time, and the implications of doing so
  4. their right to be free of any kind of coercion or threat against them or anyone else (for example, family or friends) and that consent seen to be given under any such pressure will not be validated by the IA
  5. the fact that it is an offence to seek or receive payment or any other reward for providing organs or part organs for transplantation, and that this offence is subject to significant penalties (see paragraphs 45–46)
  6. donors are able to seek reimbursement of expenses, such as travel costs and loss of earnings that are reasonably attributable to and directly result from donation (see paragraphs 42–44)

90. Information should be provided to the donor about the risks and potential complications or side effects for the recipient, as information on factors which could impact the life of the graft, or the recipient themselves, may be material to the donor’s decision-making process, and ensures fully informed consent can be given. Relevant information will vary on a case-by-case basis, and transplant teams should share information with donors following prior agreement with the potential recipient. Additional information for potential altruistic non-directed and paired organ donors

Additional information for potential altruistic non-directed and paired organ donors

91. In respect of potential altruistic non-directed and paired or pooled donors the following information should also be provided:

  1. anonymity of the donor and recipient is required before the operations, and that confidentiality must be respected
  2. how the altruistic donor, paired or pooled process works and how suitable recipient/s, or in the case of paired or pooled donation suitable matches, are identified