Human Tissue Act 2004
Act governing the removal, storage and use of human tissue and organs. Changes in the law were prompted by the Alder Hey scandal where children's organs were retained at autopsy without consent. Came into effect September 2006.
A more digestable interpretation of the Act is here.
Entire act available here. Divided into 3 parts:
- Removal, storage and use of human organs and other tissue for scheduled purposes
- Includes: list of scheduled purposes, issues around consent (nominated representatives, those unable to consent, when consent can be dispensed with), restriction of activities in donated material and existing holdings.
- Regulation of activities involving human tissue
- Includes: Human Tissue Authority, licensing (including designated individual), Codes of Practice, anatomical specimens outside licenced premises, trafficking and transplantation.
- Miscellaneous and general
- Miscellaneous: HTA assisting other public authorities, preservation for transplantation, surplus tissue, non-consensual analysis of DNA
- General: Powers of inspection, corporate offences, prosecutions, etc.
Part 1 of the Act
Schedule 1 - Scheduled Purposes
Scheduled purposes refers to activities for which consent is required. Part 1 includes purposes that apply to both living and deceased patients and some purposes that require consent during life for purposes in death. Part 2 concerns material from deceased purposes for which consent is required (consent for part 2 purposes in the living are not required).
Outside of certain part 1 purposes, the Act does not apply to tissue from the living, which is subject to consent under common law (i.e. consent for bloods, surgical procedures, research, etc.).
Part 1 of Schedule 1: PURPOSES REQUIRING CONSENT: GENERAL
- Anatomical examination [refers to anatomical dissection, typically but not exclusively, in the medical school setting; see also body donation]
- Determining the cause of death [generally refers to consented hospital autopsy; coronial post mortem do not need consent]
- Establishing after a person's death the efficacy of any drug or other treatment administered to him [generally refers to autopsy]
- Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) [may refer to genetic testing]
- Public display [see definition; e.g. museums; requires witnessed consent prior to death; a microscope slide viewed under a microscope needs consent, but an photomicrograph does not]
- Research in connection with disorders, or the functioning, of the human body.
Part 2 of Schedule 1: PURPOSES REQUIRING CONSENT: DECEASED PERSONS
- Clinical audit
- Education or training relating to human health
- Performance assessment
- Public health monitoring
- Quality assurance
- For the purposes of anatomical examination and/or public display, consent must have been given during life and suitably documented.
- Where appropriate, consent while alive and competent holds following death.
- Children can do so if Gillick competent or, if not, those with parental responsibility. The same caveats apply to anatomical examination/public display.
- If wishes not made explicit during life, the deceased may have a nominated representative who can give consent (including potentially over-riding family's/relative's wishes).
- In the absence of previously stated wishes or a nominated representative, consent can be given by those in a qualifying relationship with the deceased. The hierarchy of relationships is here and consent from the highest rank should be sought.
- Material already held in storage prior to 1 September 2006 is exempt from the requirements for consent.
- Excepted material includes:
- Material from a body of a deceased who died at least 100 years prior to the Act
- Existing holdings (as above)
- Embryo outside human body (governed by HFEA).
Part 2 of the Act
Designated individual is the term given to an individual in an organisation with ultimate responsibility for compliance with the HTA.