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Consent and the use of DNA FAQs

Frequently asked questions about consent and the use of DNA.

Is DNA testing without consent illegal?

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 valid consent and qualifying consent (unless it is for an excepted purpose) and could lead to a fine, a term of imprisonment of up to three years, or both.

What is valid consent?

The giving of consent is a positive act.  For consent to be valid it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question. For more information see the Code of practice on Consent.

What is qualifying consent?

In relation to DNA made by the body of a person who is alive, qualifying consent is the consent of that person. There are different requirements for adults and children and for the DNA of those who have died. See Flowchart B ‘Qualifying consent' and the Code of practice on Consent.

Can children consent to DNA testing?

Yes. See Flowchart B ‘Qualifying consent' for more information.

What about DIY Paternity testing kits?

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.

What happens if you are not sure whether the bodily material you are testing includes another person's DNA?

In some cases, a third party's DNA may be found on bodily material to be tested. For instance if two people have consented to test material and they are unsure about whether there is another person's DNA within that material, then that person's consent should also be obtained.

Can consent be withdrawn, and at what stage?

Consent can be withdrawn at any time up to the point of the DNA analysis. For consent to be valid there should be a process for individuals and families to discuss the issue fully and ask any questions they may have. They should also be afforded the opportunity to change their mind/s. If it is a DIY Paternity test, consent can still be withdrawn at any point before the DNA analysis.

Does the HTA ‘police' this area?

The HTA's role is to oversee the consent provisions of the Human Tissue Act 2004 and not to enforce or prosecute. It is for police and the Crown Prosecution Service to consider whether to prosecute should they discover evidence that an offence has been committed.

What should the public do if they think the law has been broken?

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.

Does the HTA regulate DNA testing companies - do they need an HTA licence?

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 would be required.

Do all DNA testing companies need to comply with the consent requirements?

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 for DNA.

What about court directed paternity testing?

The HTA has no jurisdiction over court directed paternity tests. For information on this see the Ministry of Justice website.

See also the glossary on consent and the use of DNA.

What is the NHS Newborn Screening Programme?

There has been some recent media coverage on the NHS Newborn Blood Spot Screening Programme. Blood is taken from a newborn child for screening for a range of diseases, only after consent has been given by a parent. For information on the storage and use of screening blood spot cards, see the Programme Centre’s website.