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Anyone holding bodily material without the consent of the person/s concerned, intending to analyse the DNA and to use the results, could be breaking the law. It is an offence to analyse DNA without qualifying consent (unless it is for an excepted purpose) and could lead to a fine, a term of...
The consent requirements for DIY Paternity testing kits are the same as those for any other kind of DNA analysis. As long as the consent requirements of the Human Tissue Act 2004 are met, the sale of DNA testing kits and their effectiveness are not matters for the HTA.
Paternity tests fall within the definition of ‘obtaining scientific information….’ as detailed above. This is NOT an excepted purpose, EXCEPT in relation to existing holdings. In relation to any other material it is a scheduled purpose. Therefore:
DNA testing companies may not always need an HTA licence. This is because DNA is not ‘relevant material' (which consists of or includes human cells). If establishments hold material (tissues and cells) from which DNA comes, then an HTA licence may be required.
All companies providing DNA testing kits or DNA testing services must comply with the provisions of the Human Tissue Act 2004 relating to consent and the holding of bodily material with the intent to analyse DNA.
Issued 11 May 2007Introduction
In most circumstances it is an offence to analyse DNA without what the Human Tissue Act (HT Act) calls ‘qualifying consent’.
In some cases, it may be possible that a third party's DNA may be found on bodily material to be tested. Where that is known to be a possibility, that person's consent should also be obtained for the testing to take place.
Both consent and a licence are needed to store any tissue or cells for the purpose of genetic testing. A licence is not required to store DNA if it is not associated with cells.
In most cases it is illegal to carry out DNA testing, including paternity testing, without consent. Members of the public should contact the police if they suspect the law has been broken.