Relevant material under the Human Tissue Act 2004
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.
List of materials
The list is not intended as exhaustive or exclusive, but is intended to provide guidance to stakeholders in respect of a number of materials that might be considered relevant material. The HTA will review the list periodically and update it as required.
Where a material is not included within the following list, stakeholders should use the information on our website to make their own assessment about whether it is relevant material, seeking advice from us where necessary.
Materials classified in the following list as relevant material are done so subject to the following general caveat that they are relevant material except where:
- They have divided or been created outside the human body.
- They have been treated, processed or lysed through a process intended to render them acellular. This would include the freezing or thawing of cells only where that process is intended to render the material acellular.
Although cell damage can be minimised by controlling the rate of temperature change and/or by adding one or more ‘cryoprotective’ agents, freezing/thawing can cause cell damage such that no whole cells remain. Centrifugation can be used to remove residual platelets from plasma, rendering it acellular, but the effectiveness is dependent on the protocol used. In either case, sufficient validation data (either in-house or published research) should be provided if the techniques are to be relied on to render samples acellular.
- Nail (from deceased person)
- Nasal and bronchial lavage
- Bone marrow
- Non-blood, derived stem cells (i.e. derived from the body)
- Non-fetal products of conception ( i.e. the amniotic fluid, umbilical cord, placenta and membranes)
- Breast milk
- Pericardial fluid
- Buffy coat layer (interface layer between plasma and blood cells when blood is separated
- CSF (cerebrospinal fluid)
- Pleural fluid
- Cystic fluid
- Primary cell cultures (whole explant/biopsy present)
- Material relating to early pregnancy loss or termination
- Sputum (or phlegm)
- Fluid from cystic lesions
- Stomach contents
- Hair (from deceased person)
- Tumour tissue samples
- Joint aspirates
- Umbilical cord blood stem cells
- Nail (from living person)
- Breath condensates and exhaled gases
- Plasma (Please note: Depending on how plasma is prepared and processed, it may contain small numbers of platelets and other blood cells. If any of these cells are present, then the plasma must be regarded as relevant material)
- Cell lines
- Cells that have divided in culture
- Eggs (ova)
- Embryonic stem cells (cells derived from an embryo)
- Embryos (created outside the body)
- Extracted material from cells e.g. nucleic acids, cytoplasmic fractions, cell lysates, organelles, proteins, carbohydrates and lipids.
- Sperm cells (spermatozoa)
- Hair (from living person)
- Lysed cells