Analysis of DNA under the HT Act
HTA regulation and enforcement
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 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.
Where are the provisions regarding DNA analysis found within the HT Act and related legislation?
S45 and Schedule 4 of the HT Act set out the provisions regarding DNA. However, where relevant material is removed from a body or stored for the purpose of DNA analysis, the scheduled purposes in Schedule 1 of the HT Act may also apply.
There are also provisions regarding analysis of DNA in circumstances where consent is not needed as a result of incapacity. These are found in regulations 5, 6 and 7 of The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659).
What is necessary for the offence under s45 to be committed?
It is necessary for someone to meet both of the following:
- be in possession of bodily material intending that DNA in the material be analysed without qualifying consent; and
- that the results of the analysis of DNA be used for something other than an excepted purpose.
As both tests must be met for the offence to be committed, this means that if one of them is not, there is no offence; for example:
- if someone has qualifying consent, then any analysis of DNA can take place and the results of that analysis can be used for any purpose;
- if there is no qualifying consent, the DNA can still be analysed and the results used, but where the use is for an excepted purpose;
- if there is no qualifying consent and the results of analysis of DNA are for something which is not an excepted purpose, then an offence is committed.
What is 'bodily material'?
Bodily material is material which:
- has come from a human body, and
- consists of or includes human cells.
DNA in itself is not bodily material so someone holding extracted DNA does not commit an offence under the Act if they analyse it and use the results.
What are the excepted purposes?
This depends on the origin of the material; the excepted purposes are found in Schedule 4 to the Act (see Appendix 1).
What is 'qualifying consent'?
This depends on whether it relates to living or deceased, adult or child and is defined in Schedule 4 (see Appendix 2).
Can existing holdings be analysed without qualifying consent?
Yes.
If the person who has the material is not in possession, and not likely to come into possession, of information from which the person from whom the material came could be identified, the results can be used for any purpose and consent is not required or if it is used for one of the excepted purposes listed below (as for imported material):
- clinical audit;
- determining the cause of death;
- education or training relating to human health;
- establishing after a person’s death the efficacy of any drug or other treatment administered to him;
- obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
- performance assessment;
- public health monitoring;
- quality assurance;
- research in connection with disorders, or the functioning, of the human body; and
- transplantation.
This means that if you have an existing holding of bodily material and hold information that allows the donor to be identified, you can only use the results of analysis for an excepted purpose, unless you seek qualifying consent from the donor.
‘Existing holding’ means bodily material held immediately before the day on which the HT Act came into force, 1 September 2006.
Do 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 DNA.
Do the Section 45 requirements in relation to non-consensual analysis of DNA apply to the analysis of DNA in cell lines?
Section 45 applies to ‘bodily material’, which is material that has come from a human body and consists of or includes human cells. However, for the purposes of the Act, material is not regarded as being from a human body if it is created outside the human body (Part 3(7). It follows that cells lines that do not contain primary cells are not bodily material and the Section 45 requirements do not apply. Cell lines containing primary cells are considered bodily material.
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 may be required. If tissues and cells are held for only a short period prior to being rendered acellular as part of the process by which DNA is obtained, then an HTA licence may not be required. Advice should be sought from the HTA.
Does DNA analysis come within the meaning of the scheduled purpose: ’Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)’?
Yes, by implication, if relevant material is removed from a body to undertake DNA analysis for a reason that falls within this scheduled purpose such as if it is to obtain scientific or medical information which may be relevant to another person.
Does use of DNA for identification (for example, in mass disasters) meet this definition?
Yes, as this is information ‘which may be relevant to any other person’. However, use of the results DNA analysis for the purposes of functions of a coroner (which includes identification of a deceased person) is use for an excepted purpose. There may be issues in relation to mass disasters overseas where there is no coroner’s jurisdiction in the UK.
Are there any exceptions to the need for qualifying consent?
Use for excepted purposes (see Appendix referred to above).
The Authority (or Court of Session in Scotland) has power to permit the use of results of analysis of DNA in the absence of consent.
For adults who lack capacity to consent (England and Wales, and Northern Ireland) or adults with incapacity (Scotland) with such an adult referred to here as “P”, the purposes for which DNA may be analysed are:
England and Wales
- any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests;
- the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations;
- the purposes of intrusive research which is carried out in accordance with the requirements of section 30(1)(a) and (b) of the Mental Capacity Act 2005 (approval by appropriate body and compliance with sections 32 and 33 of that Act);
- the purposes of intrusive research
- which is carried out on or after the relevant commencement date,
- in relation to which section 34 of the Mental Capacity Act 2005 (loss of capacity during research project) applies, and
- which is carried out in accordance with regulations made under section 34(2) of that Act; or
- research which is carried out before the relevant commencement date and which, before that date, is ethically approved within the meaning of regulation 8 of The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659).
Northern Ireland
- any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests;
- the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or
- research which is ethically approved within the meaning of regulation 8 of The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659).
Scotland
- any purpose for which the person carrying out the analysis has obtained the consent of any person who has authority to consent to analysis of P’s DNA by virtue of
- a welfare power of attorney within the meaning of section 16(2),
- an intervention order under section 53, or
- a guardianship order under section 58,
- of the Adults with Incapacity (Scotland) Act 2000;
- a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or
- surgical, medical, nursing, dental or psychological research which is permitted under section 51 of the Adults with Incapacity (Scotland) Act 2000.
Does the legislation apply to Scotland?
Yes, the provisions of s45 do. There are some variations in relation to consent (particularly regarding children) for this purpose. However, the foregoing information in relation to removal for scheduled purposes does not apply in Scotland.
What about imported material?
Schedule 4 para 11 states that ‘Use of the results of an analysis of DNA for a purpose specified in paragraph 7 is use for an excepted purpose if the use in England and Wales, or Northern Ireland, for that purpose of the bodily material concerned is authorised by section 1(1) or (10)(c)’.
Section 1(4) of the Act makes it clear that section 1(1) (which relates to appropriate consent) of the Act does not apply to imported bodies or relevant material. Therefore, the use of the results of analysis for any of the purposes in paragraph 7 of Schedule 4 would be excepted purposes and therefore no offence would be committed if consent had not been obtained. Those purposes are:
- clinical audit;
- determining the cause of death;
- education or training relating to human health;
- establishing after a person’s death the efficacy of any drug or other treatment administered to him;
- obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
- performance assessment;
- public health monitoring;
- quality assurance;
- research in connection with disorders, or the functioning, of the human body;
- transplantation.
As stated above, this would therefore include use of the results for genetic or paternity testing. Also, import is into England, Wales and Northern Ireland so material imported from Scotland falls under this category. The HTA would always state that seeking confirmation of consent for any use in relation to imported material is good practice.
What about the police?
Tissue from the living
The consent provisions in Part 1 of the HT Act do not apply to the removal of tissue from living people for scheduled purposes, and therefore considerations about the purpose of the removal and whether consent is required are not necessary. With regard to the analysis of DNA, the s45 offence needs BOTH a lack of qualifying consent and use for something other than an excepted purpose. The excepted purposes set out in Schedule 4 include:
- the prevention and detection of a crime; and
- the conduct of a prosecution.
Therefore, police analysis of DNA for their purposes does not require the consent of the person from whom the DNA was obtained.
Tissue from the deceased
In relation to removal of tissue from the deceased and subsequent DNA analysis; the removal of the tissue falls within the scope of the consent requirements but they will not apply because (a) the removal will not be for a scheduled purpose or (b) authority will have come from HM Coroner. As above, the excepted purposes for police activities apply to the use of the results.
Does the HTA ‘police' this area?
The HTA has a statutory duty under section 15(b) to provide ‘in relation to activities within its remit such general oversight and guidance as it considers appropriate’ and under section 15(d) to provide ‘to the public, and to persons carrying on activities within its remit, such information and advice as it considers appropriate about the nature and purpose of such activities.’ The HTA has taken the approach that requests for information and guidance on the legal interpretation of DNA falls within its remit.
However, the HTA's does not have a role in enforcement or prosecution and 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.
Paternity testing
Does use of DNA for paternity testing fall within this definition?
Yes, as this is information about a living or deceased person which is relevant to another person.
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.
Does qualifying consent for DNA analysis (s45 or schedule 4) override the need for consent to remove a sample from a deceased person as in s1 of the Act?
No, the removal of relevant material from the body of a deceased person for use for a scheduled purpose needs appropriate consent (as defined in the Act and including the hierarchy of qualifying relationships).
What does this mean for paternity tests?
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:
- If it is in relation to an existing holding, paternity testing can be carried out (with or without consent or knowledge of identity, as it is use for an excepted purpose).
- If it is in relation to the living, appropriate consent is needed for the use of relevant material for paternity testing.
- If it is in relation to the deceased, appropriate consent is needed for the removal of relevant material from the deceased for use for paternity testing and for the use of the material for testing.
That means that in the situation where someone gives qualifying consent for analysis of DNA under s 45 (e.g. the adult child of a deceased person) but a person higher up the hierarchy does not give consent to the removal of relevant material from the body of the deceased, NO removal can take place, and therefore no testing can take place.
Example scenarios
I am a mortuary manager and have been asked by the partner of a deceased to obtain some bodily material from the deceased to test for paternity of the partner’s child. However, the deceased’s son has objected. Where do I stand?
Paternity testing falls within the definition of ‘obtaining scientific information….’ as detailed above. It is a Scheduled Purpose under the Act, and (in relation to DNA analysis) is only an Excepted Purpose if the material is an existing holding, which is not the case here.
Removal of material from the deceased for use for a Scheduled Purpose requires “appropriate consent” under s1 of the Human Tissue Act 2004. In the absence of consent of the deceased in life this would be the consent of his nominated person, or the consent of the highest-ranking person in a qualifying relationship. If a person had stated in life that he would not give consent for material to be removed for use for a scheduled purpose, then this decision cannot be overruled.
In the situation above, the partner is highest in the qualifying relationship and thus can give appropriate consent for removal of tissue for use for a Scheduled Purpose. As there is no hierarchy in the qualifying relationship when applied to the need for qualifying consent, she can also give qualifying consent for analysis of DNA under s45. The son’s objection cannot veto this, but the HTA would always suggest that discussion between family members takes place in an attempt to reach a common decision.
I have been asked by the son of a deceased patient to remove a sample of bodily material so that he can have it analysed to see if his father carried a genetic disease. However, the widow of the deceased has objected. What can I do?
The removal of bodily material for use for the Scheduled purpose of ‘obtaining scientific information . . .’ needs appropriate consent. Assuming that the consent of the deceased (or his refusal to consent) has not been recorded, and assuming he had not nominated someone to consent on his behalf, then appropriate consent would be from the highest-ranking individual in the hierarchy of qualifying relationships, in this case the widow of the deceased. If she refuses to consent then no removal for use for the scheduled purpose can take place.
If, however, the son holds some bodily material of his father, then he can give qualifying consent for that sample to be analysed and the results used for the testing he wishes to be undertaken.
Can material which has been retained under the authority of the coroner be used to determine paternity or the presence of a genetic disorder?
In the absence of qualifying consent, the results of DNA analysis can only be used for the excepted purposes detailed in Appendix 1 paragraph 5 (below). The excepted purpose of the functions of the coroner only relates to identification of the deceased and determining cause of death.
Obtaining scientific information (either in relation to paternity testing or the presence of a genetic disorder) is not an excepted purpose. If analysis to determine the presence of a genetic disorder was relevant to determining the cause of death, this would fall under the excepted purpose of the functions of a coroner, although it would be a matter for the coroner to determine whether or not he would authorise the use of the material for this purpose.
I am a museum curator and we wish to carry out genetic testing on some bodily material samples we have had for some years believed to have come from a native settlement from the 1800s. What do we need to do so as not to commit an offence?
This material may be ‘excepted material’ the definition of which is:
- material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person’s death,
- an existing holding and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified.
In either case, the offence provisions of s45 do not apply so the results of analysis could be used for any purpose.
I run a testing laboratory and have been contacted by a woman who wants a paternity test to be carried out on some hair she has taken from her husband’s hairbrush to see if he is the father of her son. Can I proceed?
This depends on circumstances. There are two genetic tests here; one on the husband and one on the child.
Husband: the client holds bodily material and she wishes to use the results of DNA analysis used to obtain ‘scientific information’ about her husband. This is not an excepted purpose and so can only be carried out with qualifying consent. If the husband is alive and competent, this would be his consent. If the husband has died, qualifying consent can be from anyone in a qualifying relationship, so she could consent and the analysis results could be used in relation to paternity testing.
Child: as above, the use of bodily material to obtain ‘scientific information’ requires appropriate consent. In the case of child, this would be the consent of the child or (if he is not competent to consent or chooses not to make a decision) someone in a parental relationship.
I am a researcher and have some samples held under an HTA licence following completion of a research project. I would like to carry out DNA analysis on them in relation to prevalence of a genetic disorder. Can I do so?
Only with qualifying consent. In the absence of qualifying consent the results of analysis of DNA can only be used for excepted purposes. Research into the disorders and functioning of the human body is not an excepted purpose. Such research can become an excepted purpose if subject to an order by the High Court or Court of Session.
However, if appropriate consent has previously been obtained to use the samples for research which includes the use of DNA or does not prohibit that use, then that would also be suitable as qualifying consent.
Also, if subsequently, recognised ethical approval was obtained again, then, provided the samples are from the living, and the researcher is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified, the use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose, and no qualifying consent would be required.
I brought some tissue samples from the deceased from the USA for a research project for which specific consent was obtained. A colleague has asked to use some of the samples to carry out analysis of DNA. Is that allowed?
Yes, because research in connection with disorders, or the functioning, of the human body is use for an excepted purpose in relation to material that has been imported, and therefore consent is not required for analysis of the DNA.
I work for a testing company and am not sure whether the bodily material I have been asked to test includes another person's DNA?
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.