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Glossary

Anatomical examination: Examination by dissection for the purpose of teaching, studying or conducting research into the structure of the human body.

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.

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.

Bodily material: Defined by the HT Act as material which has come from a human body and consists of or includes human cells. Unlike relevant material this includes gametes, embryos outside the human body and hair and nail from the body of a living person.

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.

Clinical audit: A process to review explicit criteria and the implementation of change to continuously improve patient care and outcomes.

Designated Individual (DI): The individual designated on the licence to supervise the licensable activities being carried out. DIs are trained by the HTA to carry out this important role and they have statutory responsibilities they must fulfil.

Diagnosis: A process where a disease is identified.

DNA (deoxyribonucleic acid): A polymer made up of a series of repeating units. DNA encodes the instructions required to assemble cells and regulate processes in living cells. The instructions are contained within sections of DNA which are known as genes.

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.

Existing holdings: The body of a deceased person, or any relevant material which has come from the human body, held immediately prior to 1st September 2006.

Gillick competent (or Fraser competent): In the case of Gillick v West Norfolk and Wisbech Area Health Authority [1986] 1 AC 112 the court found that a child below 16 years of age will be competent to consent to medical treatment if they have sufficient intelligence and understanding to make decisions regarding their own healthcare.

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.

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.

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-identifiable: Ensuring that if human tissue is removed from a human body, all necessary steps are taken to prevent the person from whose body the material has come from being identified.

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.

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.

Performance assessment: This term is intended to encompass use of material in the evaluation and assessment of in vitro diagnostic kits. This is to make it quite clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent.

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.

Public health monitoring: Using population-based or epidemiological techniques to ascertain the prevalence, spread and pattern of an established disease or condition in the community, and relating its occurrence to public health programmes and activities.

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.

Quality assurance: A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

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:

RNA (ribonucleic acid): A type of nucleic acid present in the nucleus, and occasionally in the cytoplasm. Cellular forms include ribosomal RNA, messenger RNA and transfer RNA. Messenger RNA can be used to obtain genetic information.

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.

Stillbirth: A stillbirth is defined under section 41 of the Registration of Births and Deaths Act 1953 as "where a child issues forth from its mother after the 24 week of pregnancy, and which did not at any time after being completely expelled from its mother, breathe or show any signs of life."

Surplus tissue: Includes material which has come from a person's body in the course of his receiving medical treatment, undergoing diagnostic testing, or participating in research; or material that is relevant material that has come from a human body and ceases to be used, or stored for use, for scheduled purposes.

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.

Valid consent: Consent which has been given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question.