Code A: Glossary

An advance decision is a decision made by a living person, when they had capacity, to refuse a specific type of treatment at some time in the future. To be legally binding in England and Wales, an advance decision must comply with a number of criteria which are described in the Mental Capacity Act 2005. With regard to organ and tissue donation, an advance decision could be used to exclude the possibility of donation from a living adult who lacks capacity at the time of the proposed donation.

Macroscopic examination by dissection for the purposes of teaching, studying, or researching 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 after death.

A test of a person's best interests takes into account not only the medical aspects but also the wider emotional, psychological, and social aspects of the potential medical procedure, as well as the risks.

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

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, 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.
It also refers to waste arising from medical, nursing, dental, veterinary, pharmaceutical, or similar practice, which may cause infection to any person coming into contact with it.

Coroners are independent judicial office holders, appointed by a local council. They investigate deaths that appear violent, unnatural, or of unknown cause, or occur in custody or state detention. They authorise post-mortem examinations and conduct inquests to determine who has died and how, when, and where they died.

Makes decisions on financial or welfare matters for people in England and Wales who are unable to make decisions at the time they need to be made due to a lack of mental capacity.

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 (opted out).
• Nominated a representative to decide on their behalf after death.
• 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.
• People not ordinarily resident in the relevant jurisdiction for at least 12 months 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

DNA stands for deoxyribonucleic acid, found in the nucleus of cells, containing genetic information for the development and functioning of living organisms. DNA is studied in forensics, gene therapy, relationship testing (e.g., paternity), and bioinformatics

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 already held for use for scheduled purposes when the HT Act came into force on 1 September 2006.

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

A term used to assess whether a child has the maturity to make healthcare decisions independently of parental consent and to understand the implications of those decisions. A child is legally competent when they have sufficient understanding and intelligence to fully grasp what is proposed.

Health and Social Care Trusts provide integrated health and social care services across Northern Ireland. Further details are available on the Department of Health (Northern Ireland) website.

In relation to tissue or cells, human application refers to their use on or in a human recipient, including applications outside the body, except for use in the same person within the same surgical procedure.

The movement of human tissue into England, Wales, or Northern Ireland from outside these jurisdictions.

An event or circumstance that could have resulted, or did result, in unnecessary damage, loss, or harm.

A legal document where an individual (aged 18 or over) appoints another person(s) to make decisions on their behalf if they lose capacity in the future. The appointed attorney must follow principles in the Mental Capacity Act, ensuring decisions are made in the donor's best interests. LPAs apply in England and Wales.

Certain activities, such as removing, storing, or using relevant material, require an HTA licence. Licensed establishments must meet HTA Standards.

A foetus of any gestational age born alive but dying before reaching 28 days old.

A person appointed to represent a deceased individual for activities under the Human Tissue Act requiring consent. They may give consent for removal, storage, or use of the body or tissue for scheduled purposes, excluding anatomical examination or public display.

Defined in regulations as a differentiated part of the body formed by different tissues, maintaining structure, vascularisation, and physiological functions with autonomy. Parts of organs are also considered organs if they function equivalently to the whole.

A confidential national database managed by NHS Blood and Transplant (NHSBT) holding details of people who have consented to or opted out of organ and tissue donation after death.

As defined in the Children Act 1989, a person with parental responsibility will usually be the child’s parent but can include others authorised by law

Dissection and examination of a body after death to determine the cause of death or study disease processes.

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

The relationship to the deceased of a person(s) who can give consent for the removal, storage, and use of tissue from the deceased's body for scheduled purposes. This applies if the deceased person did not express their wishes in life or appoint a nominated representative.

A programme for systematically monitoring and evaluating the various aspects of a project, service, or facility to ensure that standards of quality are being met.

Throughout the HTA Codes of Practice, the term ‘relatives’ includes a spouse or partner and, where there are no relatives, close friends of the deceased person. Decisions about consent should follow the hierarchy of qualifying relationships as outlined in the HT Act.

Defined by the HT Act as material other than gametes, consisting of or including human cells. This excludes embryos outside the human body and hair and nail from a living person. Further guidance is available on the HTA’s website.

A study addressing clearly defined questions, aims, and objectives to discover and interpret new information or gain new understanding about the structure, function, and disorders of the human body. Research includes studies that generate hypotheses and those that test them or develop practical applications.

Under the Human Tissue Act, consent is required to remove, store, or use bodies or relevant material for scheduled purposes. Licensing requirements under the HT Act also relate to scheduled purposes, divided into general and deceased-specific purposes:

• General purposes: Anatomical examination, determining the cause of death, evaluating drug efficacy, public display, research on body function or disorders, transplantation, and obtaining information relevant to others.
• Deceased-only purposes: Clinical audit, education or training related to health, performance assessment, public health monitoring, and quality assurance.

A precursor cell capable of developing into more than one type of cell. For example, early bone marrow cells can develop into red blood cells, white blood cells, or platelets.

Defined under section 41 of the Births and Deaths Registration Act 1953 as when a child issues forth from its mother after 24 weeks of pregnancy and does not, at any time, breathe or show signs of life.

Any and all constituent parts of the human body formed by cells.

The implantation of an organ, part organ, tissue, or cells, either within the same body or from one person to another.

Consent given voluntarily by an appropriately informed person with the capacity to agree to the activity in question. Further details are provided in Code A: Guiding principles and the fundamental principle of consent.

A person appointed by the Court of Protection under section 16(2)(b) of the Mental Capacity Act. Welfare Deputies are authorised to make specific decisions for individuals who lack capacity. This role applies only in England and Wales.