Human Tissue Act 2004

In accordance with the Human Tissue Act 2004 (HTA), it is unlawful to conduct DNA analysis without explicit permission from the individual whose genetic material is being tested. To comply with the Human Tissue Act, we require informed consent for each participant before proceeding with testing.

Understanding the Human Tissue Act 2004
The Human Tissue Act 2004 provides a legal framework that governs practices involving human tissue in England, Wales, and Northern Ireland. This Act, overseen by the Human Tissue Authority, outlines the requirements for valid consent relating to the collection, storage, disposal, and use of human biological material. Clear guidelines are established for consent involving tissue from both living individuals and the deceased and the Act defines the specific scenarios where consent is required.

DNA Testing Under the Human Tissue Act
For DNA testing purposes, "human tissue" is defined as any biological material that originates from a human being and contains human cells. Notably, it is deemed an act of DNA 'theft' to take human tissue with the intent to analyse its DNA or genetic makeup without informed consent from the source individual. Such an offense is uniformly recognised across the United Kingdom, and infringement may result in penalties, including a maximum of three years imprisonment, fines, or both.

In the context of consent, 'informed' signifies that the individual providing the DNA must understand and agree to the specific uses of their genetic sample. In situations involving minors or those under the age of consent, a legally responsible parent or guardian must sign on their behalf. Should you be uncertain about your legal standing to consent for a minor, it is advised to either seek legal counsel or reach out to us directly for more comprehensive guidance before undertaking any tests.

We are committed to complying with the Human Tissue Act and cannot perform DNA testing without acquiring complete and appropriate consents. Any DNA samples sent to us will be put on hold pending the receipt of all necessary consent.

Regulatory Distinction in Scotland
It's important to recognise that Scotland has its own specific regulatory structure, the Human Tissue (Scotland) Act 2006. Although this Scottish legislation is constructed around the concept of 'authorisation' rather than 'consent', both terms fundamentally embrace the same underlying principle of voluntary agreement. For further information on Scotland's legislative specifics, please click here: Human Tissue (Scotland) Act 2006

Our commitment to ethical practice is not just a legal obligation but a moral one to respect the rights and privacy of all individuals participating in DNA testing processes. We appreciate your cooperation in upholding these standards.

If you have any questions or concerns about our consent policies, please do not hesitate to Contact Us. We understand that every situation is unique, and are here to assist and ensure that all of our clients understand the importance of informed consent in genetic testing whilst guiding you through the process.