HTA Regulations and Guidance
Within the Human Tissue Act, human tissue is referred to as ‘relevant material’ and this is defined as ‘material that has come from a human body and consists of, or includes, human cells’. Under the Act, "relevant material" means material, other than gametes, which consists of or includes human cells.
References to relevant material in the Act do not include:
(a) embryos outside the human body, or
(b) hair and nail from the body of a living person.
The Human Tissue Authority has furthered defined ‘relevant material’ and has divided tissues into three categories as follows:
Specifically identified relevant material
This includes material like bodily organs and tissues, consisting largely or entirely of cells, and clearly identifiable and regarded as such. This category of relevant material includes human bodies, internal organs and tissues, skin and bone; and specifically the following:
• stem cells created inside the human body
• embryonic stem cells
• non blood derived stem cells
• umbilical cord blood stem cell
• bone marrow
• primary human cell cultures
• cultured cells which have divided outside the human body
• artificially created embryonic stem cells
• cell lines
• extracted DNA
• plasma extracted DNA
Where a processed material is generally agreed – as a result of the process – to leave it always either cellular or acellular, then the presumption should be that all examples should be regarded as such. The HTA would rely on the stakeholders’s assurance that the process in question had been carried out. Under this category plastinated tissue and plastinated body parts (where the cellular structure is retained by the plastination process) are to be regarded generically as relevant material; while plasma or serum, for example, will be regarded as not. The two latter processed materials, widely produced from blood taken for treatment, are however examples of where ‘normal expectations’ may well need to be exercised.
Bodily waste products (including excretions and secretions)
Bodily waste is a less well characterised group of material. Nevertheless the Authority considers it important to provide a framework of guidance. The Authority considers bodily waste should normally be regarded as relevant material: the Act cannot be denied on this point. The Act’s wording is clear and reflects the possibility that even a single cell can be subject to research. While acknowledging the views of stakeholders who have argued for greater individual discretion, it would be inappropriate to encourage people to grant themselves an exemption on the basis of their own interpretation of the Act. However the Authority may be able to offer nuanced advice in specific instances. There will be cases where a stakeholder believes that material, intended for a scheduled purpose, is actually acellular. In such cases the stakeholder would need to consult the Authority, and we would then refer the case for advice to a members’ panel if necessary.