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3 Mar 2022

What is the Human Tissue Act 2004?

The Human Tissue Act 2004 covers England, Wales, and Northern Ireland. It established the Human Tissue Authority (HTA) to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation. Different consent requirements apply when dealing with tissue from the deceased and the living. The services we offer are regulated by the HTA. As a result, consent is a critical component for all our testing services.

DNA theft

Why was the Human Tissue Act 2004 established?

The legislation was enacted and the HTA set up in 2005 following events in the 1990s that revealed a culture in hospitals of removing and retaining human organs and tissue without consent. The legislation not only addressed this issue but also updated and brought together other laws that relate to human tissue and organs.

How does the Human Tissue Act 2004 affect drug testing?

We collect a variety of biological samples for the purpose of drug testing. These include urine, saliva, hair and blood. The definition of human tissue is material that has come from a human body and consists of, or includes, human cells. As a result, all of our drug tests require consent from the person we are taking the samples from. Or, in the case of a child or incapacitated person, an individual that has official parental or legal responsibility.

How does the Human Tissue Act 2004 affect DNA testing?

Likewise, the same applies to DNA testing. In most cases, we acquire DNA samples from individuals using mouth swabs. The mouth swabs collect cells from the inside of a person's cheek, and the cells contain the DNA we require for analysing and determining biological relationships. As a result, we must obtain consent for all individuals taking part in the DNA test to comply with the requirements of the Human Tissue Act.

In addition, in some circumstances, we require alternative samples for DNA analysis other than mouth swabs. For example, this would be in the case of a deceased person where either hair, nail, or deep tissue samples are required to perform the required DNA test.

The Human Tissue Act 2004 also created an offence of DNA ‘theft’. It is unlawful to have human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came. As a result, it is important that we obtain consent for children taking part in a DNA test from an individual with parental responsibility.

What are the key points from the Human Tissue Act 2004?

In relation to our services, we must comply with the following three points of the Human Tissue Act 2004:

  • Removing, storing, or using human tissue for Scheduled Purposes without appropriate consent.
  • Storing or using human tissue donated for a Scheduled Purpose for another purpose.
  • Having human tissue, including hair, nail, and gametes, with the intention of its DNA being analysed without the consent of the person from whom the tissue came or of those close to them if they have died.

There is separate legislation in Scotland - the Human Tissue (Scotland) Act 2006. While provisions of the Human Tissue (Scotland) Act 2006 are based on authorisation rather than consent, these are essentially both expressions of the same principle.