The Human Tissue Act: implications for clinical biochemistry.

The Human Tissue Act sets out a new legal framework for the use and retention of tissues from living persons as well as the removal, retention and use of tissue and organs from the deceased. The Human Tissue Authority (HTA) has been established as the regulatory body in relation to the Act and also to give advice and guidance initially through the publication of Codes of Practice. The HTA will also license activities within the remit of the Act and will inspect to ensure compliance with the Act and licence conditions. The Act establishes consent as the essential requirement for the lawful retention and use of tissues and organs; failure to comply could result in penalties that include a custodial sentence. In addition to solid organs and tissues, the Act applies to the use of other specimens including body fluids if they contain cells. Tissue can be stored and used without consent for a number of purposes on the basis that these are integral to the general provision of clinical and diagnostic services. These include clinical audit, education or training relating to human health, performance assessment and quality assurance. In the case of research, the Act allows tissue to be used without consent, provided that the tissue is anonymized so that the researcher cannot identify from whom the material came. Linking with medical records is allowed, provided patient-identifying information is not obtained. There is a requirement to respect the wishes of any patient who specifies that they do not wish diagnostic or therapeutic samples to be kept or used for additional purposes.