Human Tissue Act 2004 and university approval

Contacts and resources

The Human Tissue Act (2004)

The Human Tissue Act (2004) was fully implemented on 1 September 2006. The Act covers the use of tissue (relevant material) for a number of ‘Scheduled Purposes’ which include research, clinical diagnosis and teaching. The Act makes consent the fundamental principle underpinning the lawful storage and use of human tissue from the living or the deceased for specified health-related purposes and public display. This includes `residual´ tissue remaining following clinical and diagnostic procedures. It also covers the removal of such material from the deceased.

The Human Tissue Authority is the regulatory body for all matters concerning the removal, storage, use and disposal of human tissue (excluding gametes and embryos) for Scheduled Purposes. The Authority has issued good practice guidance in its Codes of Practice and answers to Frequently Asked Questions are available. The HTA also licences a number of activities under the Act, one of which is the storage of tissue for research.

What is relevant material?

Relevant material as defined in the Human Tissue Act (2004, section 53) is:

  1. Material other than gametes, which consists of or includes human cells.
  2. 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.

Examples of relevant material (obtained from the Human Tissue Authority website 8 December 2020)

The key concept of relevant material is that if a sample is known to contain even a single cell that has come from the 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.