Human Tissue Act 2004
Human Tissue Act 2004
A UK Parliamentary Act which repealed, replaced and streamlined several Acts: Human Tissue Act 1961, Anatomy Act 1984 and Human Organ Transplants Act 1989 as they relate to England and Wales. It also repealed and replaced the Northern Ireland (NI) Human Tissue Act 1962, Human Organ Transplants Order 1989 and Anatomy Order 1992. Relevant law approved by Scottish Parliament is known as Human Tissue (Act) Scotland 2006. Consent is required for virtually every use of tissue from the living or, with even more restrictions, for use of tissues from the deceased. The Human Tissue Act prohibits the use of postmortem tissue for audit, education, EQA, performance assessment or training without express consent from the deceased’s family.The HTA 2004 was introduced as a response to the public enquiries into Bristol Regional Infirmary Inquiry, the Royal Liverpool Children’s Hospital organ and tissue retention scandal, the Isaacs report and Human Genetics Commission concerns about DNA “theft”. The HTA 2004 regulates removal, storage and use of human tissue (“relevant material”); makes consent a fundamental principle underpinning removal, use (“scheduled purposes”) and storage of human tissues; and establishes a Human Tissue Authority to advise on and oversee compliance with the Act. The HTA 2004 makes it a punishable offence to be in possession of any human tissue on which DNA is analysed without consent. The Law minimises the steps that must be taken to preserve the organs of a deceased while consent is sought from next-of-kin to removing them for transplantation. The Act gives specified museums discretionary power to move human remains out of their collections.
Human Tissue Act, consent for use of tissue is not required
Living
Residual/surplus material taken—e.g., during surgery—can potentially be used for audit, QA, education, training and general public health purposes or for research purposes, where it is unlikely that the tissue donor is or will be identified, and where ethical approval has been granted by an appropriate body.
Dead
Under a coroner’s authority
(1) The deceased’s material is already held for an approved scheduled purpose defined by the Act; or
(2) The person died over 100 years ago.
In Scotland, storage of blocks and slides from Procurator Fiscal PMs for audit or for diagnostic review.
Exemptions to the Act
Hair, nails, cell lines, gametes—which are not defined by the Act as human tissues—and blood products and derivatives (for transfusion purposes), unless these materials are undergoing DNA analysis, in which case consent is required (coroners are largely exempt from consent issues).
Human Tissue Act, objectives
• Provides safeguards and penalties to prevent a recurrence of the distress caused by retention of tissue and organs without proper consent;
• Will help improve public confidence so that people will be more willing to agree to valuable uses of tissue and organs;
• Will improve professional confidence so that properly authorised supplies of tissue for research, education and transplantation can be maintained or improved.