Consent, DNA Testing and the Human Tissue Act

Human Tissue Act

What is the Human Tissue Act and how does the HTA impinge on DNA tests, such as home paternity tests?

The UK Human Tissue Act: what you need to know

When we talk about tissue we refer to any amount, no matter how small or large, of cells with a similar structure. If you are based in the UK and plan on carrying out a paternity test within the UK, awareness of the Human Tissue Act (HTA) of 2004 is extremely important. The law lays out a legal framework for regulating the use and storage of human tissue and has implications on relationship and parental testing since carrying out such tests entails the analysis of human tissue. The Human Tissue Act of 2004 covers England, Wales and Northern Ireland.

Consent and the Human Tissue Act

Consent is central to understanding the Human Tissue Act. No tissue sample can be tested unless the person from whom that tissue sample has been taken gives their explicit consent. The law even eliminates possible shades of grey by outlining that an absence of consent or a non-refusal does not signify consent. The type of consent required is referred to as “appropriate consent”. Consent must be given freely and without coercion. Moreover, the person from which the sample has been taken must be made fully aware of how their sample will be used and what will happen once the sample is tested.

How do DNA testing companies comply with this Act?

Any UK-based DNA testing company or laboratory will be aware of the Human Tissue Act and both the person requesting the test and the testing company or laboratory could be liable to being fined or a prison sentence for failure to adhere to the provisions and regulations set out in the HTA. It is important to reiterate the no DNA sample can be collected in order to carry out a DNA test without the person from whom the sample was collected giving their consent for the analysis to take place. Many DNA testing companies such as Who’zTheDaddy?™ and homeDNAdirect will actually highlight the importance of consent in context of the Human Tissue Act on their website. Serious companies would make sure to inform clients of all implications of the law in relations to DNA testing. Such companies understand that they and/or their clients could be legally liable if they fail to meet all requirements of the Human Tissue Act. In cases where a paternity test is carried out, consent would be needed from all people who have provided samples for the test; normally, the child, mother and the alleged father. If a child is under the legal age of consent, a legal parent or guardian may provide consent on their behalf. The same applies for people with a mental disability.

If the sample is collected from a deceased person then the relatives of that person would need to give their consent.

What does the Human Tissue Act do?

The Human Tissue Act regulates the removal, storage and use of human tissue. The Act refers to any type of human cell sample as “relevant material”. The amount of human cell material is irrelevant; even a sample containing a single cell is classified as “relevant material”. Bones, blood, breast milk, bone marrow, bile and even DNA is specifically listed on the list of “relevant materials” on the Human Tissue Act website (see here).

The Human Tissue Act makes the following illegal with a maximum sentence of three years in prison:

  • The storage and retention of human tissue without consent
  • Taking any sample of human tissue for testing (something referred to as “DNA theft”) without consent
  • Organ trafficking

Are there exceptions to the Human Tissue Act?

Consent is not always required under the HTA. There are some exceptions which include:

  • Human Tissue which was already collected and stored before 1st September 2006. This is referred to as an “existing holding”
  • Human Tissue which has been collected from a living person but the research is unable to identify the person and the research has been approved by the Research Ethics Committees, REC.
  • Any tissue that has been imported from outside the UK is exempt from the Human Tissue Act.

The Human Tissue Act for Scotland, implemented in 2006, has a separate legislation which departs from the 2004 Human Tissue Act which applies to England, Wales and Northern Ireland. The Human Tissue Act for Scotland differs on the issue of consent and concerns itself with organ transplantation but essentially is based on the same principles.

The Alder Hey scandal

The Human Tissue Act came about as a result of the Alder Hey Children’s Hospital organs’ retention scandal. The scandal took place in Alder Hay hospital, Liverpool, between 1988 and 1996. The scandal involved the unauthorised removal of organs from around 850 babies that died at the hospital during that period – the removal of organs was entirely non-consensual and unknown to the parents of the children. Although the scandal was not the only impetus behind the drafting and implementation of the law, it played a considerable role. Besides hundreds of organs removed post mortem, unbeknown to the parents, the hospital also retained hundreds of foetuses. Alder Hey also sold Thymus glands removed from children during heart operations to pharmaceutical companies. Parents sometimes buried their children not knowing that their organs had been removed only to have to deal with the heartache and emotional turmoil of another funeral when the scandal came to light, once the hospital started handing back children’s organs to the families to which they belonged. The fact that other hospitals within the NHS were retaining organs without consent from living relatives remained unknown to the general public until an inquiry was launched into Alder Hay. The Human Tissue Act 2004 came into force on 1 September 2006.

Caroline Hughes is an online writer specializing in writing about genetics. The author regularly contributes to many online blogs and websites delving into various, related topics including forensic testing, genetic illnesses and heredity as well as pharmacogenetics.