What does the Human Tissue Act cover?

The Human Tissue Act 2004 followed concerns about organs and tissue being retained without families’ knowledge or consent. It sets out when consent is needed to store and use human tissue for specified purposes, and established the Human Tissue Authority (HTA).

Most of the Act applies in England, Wales and Northern Ireland. Scotland has separate human tissue legislation, but the Act’s offence relating to non-consensual DNA analysis also applies in Scotland.

The rules depend on the material, its intended use and whether it comes from a living or deceased person. Collecting a sample, storing it and analysing its DNA are related steps, but they do not all have identical legal requirements.

Complying with the Act is also different from holding an HTA licence. A DNA testing company does not automatically need one: the activities it carries out and the material it stores determine whether licensing is required. The HTA’s guidance on DNA analysis explains these distinctions.

Can someone arrange a DNA test without consent?

For an ordinary paternity or relationship test, do not assume you can submit another person’s sample simply because you have access to it. A mouth swab, a hairbrush or a used toothbrush can contain DNA belonging to someone else.

Section 45 of the Act concerns possession of bodily material with the intention of analysing its DNA without qualifying consent, where the results are intended for a purpose outside the statutory exceptions. It is often described as the law against DNA ‘theft’. The exceptions matter, so it is misleading to say that every DNA analysis without consent is automatically an offence.

Our DNA testing services normally use cheek swabs. Before arranging a test, make sure the consent requirements have been established for each participant. Permission to use a sample for one purpose should not be assumed to cover a different test.

Who can consent for a child or someone who has died?

The answer depends on the circumstances. A child’s ability to understand the test matters, as does parental responsibility. A parent’s request does not provide consent on behalf of every other person taking part.

Testing involving a deceased person needs particular care. Permission to remove a sample and qualifying consent for DNA analysis are separate questions. Do not collect or send an alternative sample before discussing the case with our team.

If an adult cannot make the relevant decision, do not assume a relative can simply sign for them. Ask us about the proposed test before booking; the appropriate legal arrangements will need to be established.

Does the Human Tissue Act apply to workplace drug testing?

A drug test and a DNA test answer different questions. Urine, saliva or hair testing for drugs does not ordinarily involve analysing someone’s DNA. Using a biological sample does not, on its own, make a drug test a DNA test or bring it within section 45.

Consent still matters. Employees must consent to workplace screening, and the employer needs a clear reason for testing and a policy explaining the arrangements. GOV.UK’s workplace drug testing guidance explains the basic requirements.

Agreeing to provide a sample does not, by itself, settle the employer’s data protection responsibilities. Results and relevant medication information need appropriate confidentiality, security and access arrangements. The ICO’s guidance on workers’ health information is a useful starting point.

When arranging workplace drug and alcohol testing, tell our team about your policy, the roles involved and any site or industry specification. We can explain the collection options and testing process. Our best-practice policy support is separate from legal advice.