The definition of relevant material in the 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 embryos outside the human body, or 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.
Examples of relevant material
The fundamental concept of relevant material is that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material.
1. Specifically identified relevant material
This includes material such as bodies, organs and tissues, consisting largely or entirely of cells, and clearly identifiable.
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 an 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 considered relevant material; while plasma or serum, for example, will not be regarded as such. Plasma and serum, widely produced from blood taken for diagnostic investigations, are however examples of where ‘normal expectations’ may well need to be applied. There is more information on this in the HTA’s List of materials considered to be ‘relevant material’ under the Human Tissue Act 2004.
3. Bodily waste products (including excretions and secretions)
The HTA considers bodily waste should normally be regarded as relevant material. The Act’s wording is clear and reflects the possibility that even a single cell can be subject to an activity such as research. There will be cases where a person believes that material, intended for a scheduled purpose, is actually acellular. In such cases, the HTA can be approached for advice.
4. Cell deposits and tissue sections on microscope slides
In general, cell deposits or tissue sections on microscope slides are considered to constitute relevant material. This is because such deposits or sections are likely to contain whole cells or are intended to be representative of whole cells.
Lists of materials
To supplement the HTA's information about relevant material, a list has been produced to provide stakeholders with further guidance on whether specific materials fall within the definition of relevant material under the Act.
We have also reviewed the use of human material for the human application sector, and have provided more information in our List of materials under the 2007 Quality & Safety Regulations.
Originally issued 18 December 2008 and reviewed and revised February 2014