Code E: Glossary

Medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs are innovative, regenerative therapies which combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing or replacing damaged tissues or cells. ATMPs fall into three categories: Gene Therapies; Somatic Cell therapies; and Tissue Engineered Products.

Macroscopic examination by dissection for the purposes of teaching or studying, or researching into, the gross structure of the human body.

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. Deemed consent modifies the appropriate consent provisions in England and Wales for organs and tissue donation for donation after death.

A medical procedure that involves taking a small sample of human tissue so it can be examined under a microscope.

Bodily material is material which has come from a human body and consists of or includes human cells. It is a broader definition than 'relevant material', as it includes hair and nails from the living as well as from the deceased and gametes (human sperm and eggs). The provisions of the HT Act 2004 in relation to the analysis of DNA apply to bodily material.

A spongy tissue found in the hollow centres of some bones. It contains specialist stem cells, which produce the body's blood cells.

Individual human cells or a collection of human cells that are not bound by any form of connective tissue.

A type of clinical research that compares one treatment with another. It may involve people with specific medical conditions or healthy volunteers, or both.

The Controlled Waste Regulations 1992 define clinical waste as any waste which consists wholly or partly of: human or animal tissue; blood or other body fluids; excretions; drugs or other pharmaceutical products; swabs or dressings; or syringes, needles or other sharp instruments which, unless rendered safe, may prove hazardous to any person coming into contact with it. Clinical waste also refers to any other waste arising from medical, nursing, dental, veterinary, pharmaceutical or similar practice, investigation, treatment, teaching or research, being waste which may cause infection to any person coming into contact with it.

Deemed consent means that all individuals over 18 in England, Wales or Northern Ireland will be considered to have agreed to become an organ and tissue donor after their death, unless they made a decision not to donate their organs and/or tissue (i.e., they have opted out; they have nominated a representative to make a decision on their behalf after death about whether to donate; or are excluded from deemed consent). Deemed consent does not apply to people who lack mental capacity for a significant period before their death, children under 18 and people not ordinarily resident in the jurisdiction in which they have died for at least 12 months immediately before their death.

The person named on a licence issued by the HTA, under whose supervision licensed activities are carried out. The DI has a statutory responsibility to ensure that those carrying out licensed activities, and their practices, are suitable, and that the conditions of the licence are met.

The identification of the nature of an illness or other problem.

Samples used for diagnosis may be stored in an archive to benefit the person’s medical care. These samples can also be valuable resources for health research.

DNA stands for deoxyribonucleic acid. DNA is found in the nucleus of all cells, and contains the genetic information for the development and working of living organisms including human beings. The study of DNA is used in forensics, gene therapy, relationship (including paternity) testing and bioinformatics. Find out more information about the HTA's role with regards to DNA on this website.

The act of giving human tissue, cells, organs or part organs for a scheduled purpose, either during life or after death.

Every human source, whether living or deceased, of tissue, cells, organs or part organs.

Material from the living or deceased that was already held for use for scheduled purposes when the Human Tissue Act 2004 came into force on 1 September 2006.

The movement of human tissue from England, Wales or Northern Ireland to a place outside England, Wales and Northern Ireland.

In relation to tissue or cells, human application 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.

The movement of human tissue into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland.

Human tissue or cells made to occur in a laboratory vessel or other controlled experimental environment, rather than within a living organism or natural setting.

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes products that already have marketing authorisation, but are used or assembled (formulated or packaged) in a way different from the authorised form, or when they are used for an unauthorised indication, or when they are used to gain further information about the authorised form.

Where the licensed activity takes place.

A number of activities can only be carried out when an establishment is licensed under the Human Tissue Act by the HTA. Organisations whose activities involve the removal, storage or use of relevant material may need to work under a HTA licence. All establishments working under a HTA licence must work to specified Standards set by the HTA.

Any substance or combination of substances which:
a) is presented as having properties for treating or preventing disease in human beings; and/or 
b) may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

A foetus of any gestational age which is born alive and dies before the age of 28 days.

A body which has a role in the processes of national government, but is not a government department or part of one, and which accordingly operates to a greater or lesser extent at arm’s length from ministers.

Defined by the Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006, as amended, as a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with a significant level of autonomy. Part of an organ is also considered to be an organ if
its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirement of structure and vascularisation.

Blocks of paraffin wax in which small pieces of tissue are fixed. The blocks can be cut into thin slices for microscopic examination.

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.

The science of the causes and effects of diseases.

Peripheral blood stem cells are the source of all blood cells. They are found in the bloodstream and are formed in bone marrow. They receive signals that direct them to differentiate into all the cell types found in blood (red cells, white cells or platelets). They can be mobilised from the bone marrow into the blood stream by giving a drug, and collected with an apheresis machine.

A person working with relevant material in an establishment licensed by the HTA.

The term used by the HTA to refer to foetal tissue or products of conception resulting from pregnancy loss or termination of pregnancy, regardless of gestation. The term does not apply to stillbirths (babies born dead after the 24th week of pregnancy) and neonatal deaths.

The processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation.

This can be either 

a) a REC recognised or established by, or on behalf of, the HRA under the Care Act 2014 or any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by, or on behalf of, the Welsh Ministers or the Department of Health in Northern Ireland; or 

b) 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.

Throughout the Codes, the term ‘relatives’ should be taken to include a spouse or partner and, in cases where there are no relatives, close friends of the deceased person. Decisions regarding consent should be made according to the hierarchy of qualifying relationships as set out in the HT Act.

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.

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 or
new knowledge.

This term can encompass any collection of human tissue of any size being stored for research. Further information can be found
on the HTA's website.

‘RNA’ stands for ‘ribonucleic acid’. In human cells, RNA can be made from DNA (see Glossary definition for ‘DNA’). The structure of the RNA can be used to predict the structure of the DNA from which it is made. Analysing the RNA can therefore be a way of analysing DNA.

Under the HT Act, consent must be obtained to remove, store or use bodies or relevant material for scheduled purposes. The licensing requirements of the HT Act also refer to the scheduled purposes. Scheduled purposes are divided into those which apply generally, and those which apply to the deceased only.

• 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.

A document that se ts out the established process to be followed to complete a task.

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.

A stillbirth is defined under section 41 of the Births and Deaths Registration 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’.

The term ‘surplus tissue’ refers to material which consists of or includes human cells and which has come from a person’s body in the course of his receiving medical treatment, undergoing diagnostic testing, or participating in research, as well as to relevant material which has come from a human body, and ceases to be used, or stored for use, for a purpose specified in Schedule 1. The HT act makes provision for surplus tissue to be dealt with as waste.

Any and all constituent part/s of the human body formed by cells.

An implant of an organ or part organ, tissue or cells either from and into the same body or from one person to another.

Xenografts are cells, tissues or organs that are transplanted from one species to another.