Donation of solid organs for transplantation
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 to the recipient.
Appropriate consent: Defined in the HT Act by reference to the person who may give consent. This is broadly either the consent of the person concerned, their nominated representative or (in the absence of either of these) that of a person in a qualifying relationship to them immediately before they died.
Autologous: Cells, tissue or organs removed from and applied or transplanted into the same person.
Best interests: A test of a person's best interests takes into account not only the medical but also the wider emotional, psychological and social aspects of the potential procedure, as well as the risks.
Bone marrow: The soft, spongy tissue found in the centre of most large bones that produces the cellular components of blood: white cells, red cells and platelets.
Cells: Individual human cells or a collection of human cells when not bound by any form of connective tissue. For establishments licensed for human application this includes cell lines grown outside the human body but not gametes, embryos outside the human body, or blood and blood components.
Directed donation: A form of donation where a healthy person donates an organ (usually a kidney) or part of an organ (e.g. 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 / pooled donation).
Domino donation: A 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 or lung transplant).
Donation: The act of donating human tissue, cells, organs or part organs for a scheduled purpose either during life or after death.
Donor: Every human source, whether living or deceased, of tissue, cells, organs or part organs.
Emotionally related donation: Where the potential donor has a relationship with the potential recipient, for example, spouse, partner or close friend.
Genetically related donation: Where the potential donor is genetically related to the potential recipient.
Heartbeating donors: Patients diagnosed with brain stem death that continue to be ventilated. This keeps the heart beating and blood circulating after death, until donation takes place.
Human application: In relation to tissue or cells, means use on or in a human recipient, including use in applications situated or occurring outside the body, but not including use when tissue and cells are removed from and applied in the same person within the same surgical procedure.
Independent Assessor: A person trained and accredited by the HTA to act as a representative of both the donor and the HTA to ensure the relevant requirements of the HT Act and HT Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 are met, for certain types of living organ transplantations.
Intraperitoneal cooling: A method of surface cooling of organs by infusing cold fluid into the abdominal cavity to aid preservation after death of the donor for the purposes of transplantation.
Licensing: A number of activities can only be carried out where the establishment is licensed under the HT Act by the HTA. Organisations whose activities involve the removal, storage or use of relevant material may need to work under an HTA licence. All establishments working under an HTA licence must work to specified standards set by the HTA.
Licensed premises: Where the licensed activity takes place. If the licensed activity will take place at more than one place, a separate licence will be issued for each place. Premises in different streets or with different postal codes are considered as being in different places. In contrast, different buildings on a hospital site could be regarded as the same place.
Living donor: The person donating tissue, cells or organs for transplantation. The most common forms are live kidney donation (where one kidney is removed), or live bone marrow donation.
Lymphocytes: White blood cells that fight infection and disease.
Nominated representative: A person appointed to represent someone after their death who is empowered to consent to the removal, storage and use of the body or tissue for any of the scheduled purposes, other than anatomical examination or public display.
Non-heartbeating donation: A form of donation in circumstances where the deceased donor was not ventilated at the time of death. Donation therefore occurs once death is certified following cardiorespiratory arrest (i.e. the donor’s heart has stopped beating). This is described as controlled when treatment has been actively withdrawn within a hospital setting; or uncontrolled where a patient has experienced an unexpected cardiac arrest from which they cannot be resuscitated.
Organ: Defined by the HT Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006. 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.
Organ Donor Register: A confidential, computerised database managed by NHS Blood and Transplant (NHSBT), which holds details of people who have signed up to become organ donors in the event of their death. The register is used after a person has died to help establish whether they wanted to donate and if so, which organs.
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.
Parental responsibility: 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.
Part organ: For the purposes of the HT Act and the HT Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006, material is part of an organ if it is to be used for the same purpose as the entire organ in the human body.
Perfusion: A method of treating organs to preserve them before transplantation. In the deceased donor this will take place after death, and in the living donor after the organ has been removed.
Pooled donation: A form of paired donation whereby the donor and recipient are incompatible and so are matched with other donors and recipients from a pool of pairs in similar situations. More than two donors and two recipients are involved in the exchange, so that more than two people in need of a transplant receive a compatible organ.
Post-mortem examination: Dissection and examination of a body after death, principally in order to determine the cause of death or the presence of disease processes. A hospital post-mortem examination is carried out with appropriate consent to gain a fuller understanding of the deceased person’s illness or the cause of death, and to enhance future medical care. Coroners’ post-mortem examinations are carried out under the authority of the coroner and without consent to assist coroners in carrying out their functions.
Processing: All operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human application.
Procurement: The processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation.
Qualifying relationship: Person/s who can give consent for the deceased person if the deceased person has not indicated their consent nor appointed a nominated representative.
Relevant material: Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person. See policy guidance on how to apply this definition on the HTA’s website [www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm].
Research: A study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications of new knowledge.
Recognised Research Ethics Committee:
- a Research Ethics Committee (REC) established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments [www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727]; or
- an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004 [www.opsi.gov.uk/si/si2004/20041031.htm].
Scheduled purposes: Under the provision of the HT Act consent must be obtained to remove, store or use bodies or relevant material for scheduled purposes. The purposes are divided into 2 parts:
Part 1: Purposes requiring consent: General – anatomical examination; determining the cause of death; establishing after a person’s death the efficacy of any drug or other treatment administered to him; obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person); public display; research in connection with disorders; or the functioning; of the human body, transplantation.
Part 2: Purposes requiring consent: Deceased persons – clinical audit, education or training relating to human health, performance assessment, public health monitoring, quality assurance.
Stem cell: A precursor cell that can develop into more than one kind of cell. For example, early bone marrow cells can develop into red blood cells, white blood cells or platelets.
Tissue: Any and all constituent part/s of the human body formed by cells.
Transplantation: An implant of an organ or part organ, tissue or cells either from and into the same body or from one person to another.
Transplant coordinator: A person who helps a potential transplant recipient to understand the transplant process and also coordinates the transplant evaluation between the dialysis unit, transplant surgeon, and tissue typing laboratory. After a transplant operation, the transplant coordinator provides a communication link between the recipient and the transplant doctors for post-transplant care.
Valid consent: Consent which has been given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question.