What is the Human Tissue Act and how does it affect people wishing to carry out a DNA test within the UK? In the UK, there are certain laws or rather provisions with respect to activities involving human tissue which one must be aware of in order to avoid infringement of the law and the harsh penalties which could ensue. This set of provisions fall under what is known as the Human Tissue Act. The Human Tissue Act applies to England, Wales and Northern Ireland. When it comes to Scotland, only certain provisions of the Human Tissue Act apply (namely those related to DNA testing). The non-departmental public body (NDPB) in charge of this storage and regulation is known as the Human Tissue Authority.
What is Human Tissue?
When we talk about human tissue we refer to anything that contains human cells. Every part of our body from our bones to our hair to our nails contains human cells. The human body consists of trillions of cells and most of these constantly regenerate to replace cells which die off.
Across the world, individuals are collecting samples of human tissue for various reasons, perhaps for a DNA home paternity test, a prenatal paternity test or a genetic test. But the use and trade of Human Tissue clearly goes beyond the ambit of DNA testing – pharmaceutical companies and medical research require samples of human tissue to conduct their research and carry out their tests. Without access to such samples, the development of new medicines and our understanding of disease would come to a halt.
The problem with collecting human tissue and DNA
Collecting Human Tissue is collecting a very personal piece of data which can be used to help somebody but also to their detriment. From our DNA, scientists can discover whether we are in good genetic health, perhaps have an idea of what we disease could die of, determine biological links with other human beings, establish the extent or risks children born to that person might have based upon the genetic profile of the mother or father, learn our ancestral origins, find out whether a woman will have the menopause early or later in life and the list goes on and on. A person’s identity can be said to be encoded in their DNA and the Human Tissue Act ensures to retain, protect and preserve a person’s personal data and their genetic identity.
DNA theft and gene theft are terms which have been coined over the recent years, making their way into law journals and books and becoming parts of accepted legal terminology. The Human Tissue Act ensures this does not happen in the UK where non-consensual DNA sample collection and analysis by private third parties is criminalized. However, most jurisdictions, including the USA, do not recognise DNA theft as a crime. It is a completely unregulated market where there is an uncontrolled exchange of human tissue samples.
So what is DNA theft? DNA theft is the non-consensual collection of DNA samples or human tissue and the notion of consent is an integral part of the Human Tissue Act. We can thus, sum up the HTA in one simple sentence: consent is required by the person from whom the sample has been collected in order for that sample to undergo any type of testing. The Human Tissue Act website states this clearly in the following way:
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.
However, whilst this sentence pretty much says it all, the Human Tissue Act goes into much more detail.
DNA testing companies provide sample submission forms which need to be filled in and signed by all test participants. In this way, they try to curb the risk of DNA theft and the chance of non-consensual testing. Children who are under the legal age of consent can have their legal parent or guardian sign on their behalf.
DNA theft is rampant, especially when it comes to people requiring a DNA test. This is because in many cases people wish to carry out the test in a discreet or covert manner. Companies offer what they call discreet or secret DNA testing in order to meet this new trend in consumer DNA testing needs. For example, a father may doubt he is the biological father of his child and wish to establish the truth with a DNA test. In some instances, he may collect a sample from the child and send this off for testing along with a sample of his own. Further to paternity tests and relationship tests, there is a huge demand for infidelity DNA testing. An individual might find a suspicious stain or item which they think might contain the genetic proof of marital infidelity – they can send this sample off for testing to determine whether there is male or female DNA, whether the sample contains multiple profiles belonging to different people or request more in-depth analyses which could help confirm or disprove their suspicions. So, in order to quench their doubts, people scout around for samples they can use for DNA tests, snooping secretly amongst other people’s belongings, or even in trash cans to find something that might be suitable for analysis; a used tissue, a band aid, a condom or a few nail clippings to mention very few.
More about consent and the Human Tissue Act
The issue of consent is not as straight forward as it sounds when it comes to the Human Tissue Act (sometimes abbreviated as HTA). We have already established that the person from whom the tissue sample has been collected must give their consent for the collection of that sample. Under the Human Tissue Act, the term “appropriate consent” is used to refer to the authorisation needed for the collection of a human tissue sample from somebody other than oneself. Consent must be explicit and can only be valid if that person to which the sample belongs, has been made aware of how their sample will be used and stored. They must be made aware of any risks entailed and how results will be used. It is also important to note that refusal or absence of consent cannot be taken as consent and that moreover, consent must be done out of one’s own volition and people giving their DNA sample must have the capacity to agree. The HTA makes provisions for both tissue samples collected from the living as well as those collected from the dead.
What happens in cases of Non consensual DNA analysis in the UK?
If anyone attempts to have a sample of human tissue tested in a paternity test, maternity test, sibling test etc without appropriate consent, they are committing a serious offence. A prison sentence of up to 3 years may be incurred or a fine – in some cases both.
Consent is not required during forensic testing in criminal investigations or people who have been dead for more than 100 years prior to the implementation of the law; there are some other exceptions which will not be discussed here.
Human Tissue Act in New Zealand
The UK is the only country that has a Human Tissue Act which is aimed at tightly controlling the use of human tissue. New Zealand also has a Human Tissue Act but the scope of this is very different to that of the UK Human Tissue Act as we shall see hereunder.
The New Zealand Tissue Act is however, worth mentioning since New Zealand is one of the very few countries that implement a law that regulates how human tissue is stored – it does not, however, regulate how DNA samples are used and has no implications on DNA testing.
The New Zealand Human Tissue Act differs on one main account: it only applies to the use and consent of human tissue from dead bodies. This is principally applicable to organ donation and essentially details on who may or may not give consent for the removal of tissue, including organs, post-mortem. When drivers in New Zealand fill out a request for a new driving license, they are asked to tick whether to not they wish their organs to be removed in the event of death. By ticking “yes”, a New Zealander gives consent for the removal of their organs. The family of a deceased person can nevertheless, override the decision of the deceased to have their organs removed if the family deem the removal will cause anxiety and undue stress. If the deceased has not given consent, the law views them as a potential donor. The wishes of the deceased will in this case be discussed with the family to determine whether the deceased had in fact discussed the issue and given request for the removal of their organs in the event of death.