Human Tissue Legislation

There are two pieces of human tissue legislation that are relevant to University researchers using human tissue. In addition the Codes of Conduct set down by the Human Tissue Authority must also be adhered to in Scotland.

Human Tissue Act (Scotland) 2006

This Act sets out provisions for the research use organs, tissues and samples (including skin, hair and nails) from the deceased. For research purposes it does not regulate the use of tissues from the living.

The Acts informs that authorisation is needed in order to remove and use post mortem tissue samples unless they are existing holdings. An existing holding is defined as an organ or tissue sample removed post mortem prior to September 1st 2006.

Human Tissue Act 2004

Although the majority of this Act applies only to England, the general principles underpinning the legislation should be observed in Scotland.

For the purposes of this Act bodily material is defined as material which has come from a human body (living or dead) which contains intact human cells including hair, nails and gametes.

For more information as to what constitutes relevant material please see the section on Relevant Material.

The Human Tissue Authority (HTA)

The Human Tissue Authority (HTA) was established in 2005 as the body responsible for the implementation of the UK tissue legislation. The HTA ensures compliance by licensing and inspection. In order to provide practical guidance and to diminish uncertainties of interpretation, the HTA issued eight Codes of Conduct.

The Scottish Executive has stated that although the HTA is not a legal entity in Scotland the Codes of Conduct should be complied with by all Scottish researchers using human tissue.

These Codes of Conduct relate to the removal, storage, use and disposal of human tissue and organs. Researchers are strongly advised to consult, and be familiar with, the relevant Codes of Conduct applicable to their field of work.

The HTA also publishes an e-newsletter every two months which provides news and updates for researchers using human material.

A HTA licence is not currently required for routine research on human tissues in Scotland. However, certain laboratory standards are required by the HTA as well as the University. Please see the section on good working practice (human tissue). 

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