Relevant material
This page sets out guidance on the definition of what the Human Tissue Act 2004 refers to as ‘relevant material’. The HTA intends to expand this policy frame work to provide guidance on specific examples of relevant material, and is currently discussing with stakeholders how best these might be set out.
Definition of relevant material
The definition of relevant material in the HT Act is:
Section 53: Relevant material
- In this Act, "relevant material" means material, other than gametes, which consists of or includes human cells.
- In this Act, references to relevant material from a human body do not include:
(a) embryos outside the human body, or
(b) hair and nail from the body of a living person.
The Act’s use of the words “…or includes human cells” in its explanation of the term suggests that Parliament meant it to be comprehensive. Hansard records a Ministerial statement that the term applied irrespective of the number of cells in the material. The Authority considered that a definition which reinforced this clear legislative intent was required. It noted that the Act did not attempt to limit or modify the scope of the need for consent according to the use to which the material was to be put or how it might be classified by those storing it or using it. In response to the suggestion from some commentators that bodily waste products containing cells might be exempted from relevant material status, the Authority took the view that the consent requirements stemming from relevant material status were entirely appropriate – the removal of stomach contents being a case in point.
Categories of relevant material
The Authority considers it helpful to divide potentially relevant material into three categories. While it sees such categorisation as being helpful in determining whether a sample is relevant material or not, the principle which underpins it is that, whatever the category a particular sample falls into, if there was known to be cells in the material then the normal expectation would apply if it was to be stored or research carried out on it.
The categories of relevant material are:
1. 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
but not: - cultured cells which have divided outside the human body
- artificially created embryonic stem cells
- cell lines
- extracted DNA
- plasma extracted DNA
2. Processed material
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.
3. 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.
[22 February 2007]