Consent and the use of DNA
152. The guidance in this section also applies to RNA analysis where it is to be used to provide information about DNA. Qualifying consent is required to analyse DNA, subject to certain exceptions (see paragraph 154). This means that if consent to use material has been obtained under the HT Act for a scheduled purpose, it is not necessary to obtain separate consent where that use also involves DNA analysis, but that it should be made clear to the donor that their bodily material may be used for this purpose, if that is the intention. When discussing consent, the donor should be made aware if the intended DNA analysis may reveal significant results e.g. a family genetic condition. Their decision on whether they wish such information to be made known to them should be respected in appropriate cases.
153. For more information about issues of consent and confidentiality in clinical practice in the genetics service, see the report of the Joint Committee on Medical Genetics, Consent and confidentiality in genetic practice: Guidance on genetic testing and sharing genetic information [http://www.rcplondon.ac.uk/sites/default/files/consent_and_confidentiality_2011.pdf] and Research and the Human Tissue Act - DNA Analysis.
154. In most circumstances, it is an offence to hold material with the intent of analysing DNA without qualifying consent. However, the offence does not apply if the results of the analysis are intended to be used for ‘excepted' purposes. Unlike the other parts of the HT Act, which do not apply to Scotland, this offence applies to the whole of the UK. The following are ‘excepted' purposes:
- medical diagnosis or treatment of that person
- for the purposes of the coroner (England, Wales and Northern Ireland) / Procurator Fiscal (Scotland)
- prevention/detection of crime or prosecution
- national security
- court / tribunal order or direction
- where the bodily material is from the body of a living person - use for clinical audit, education or training relating to human health, performance assessment, public health monitoring and quality assurance
- where the bodily material is an existing holding - use for clinical audit, determining the cause of death, education or training relating to human health, establishing after death the efficacy of any drug or treatment administered, obtaining scientific or medical information about a living or deceased person which may be relevant to another person (including a future person), performance assessment, public health monitoring, quality assurance, research in connection with disorders or functioning of the human body and transplantation
- obtaining scientific or medical information about the person from whose body the DNA has come where the bodily material is the subject of either a direction by the HTA or a court order under paragraph 9 Schedule 4 of the HT Act and the information may be relevant to the person for whose benefit the direction or order is made
- research in connection with disorders or functioning of the human body, provided the bodily material comes from a living person, the person carrying out the analysis is not in, and not likely to come into, possession of identifying information and the research is ethically approved. The Secretary of State may also specify the circumstances in which the High Court, or in the case of Scotland, the Court of Session may order that use of the results of DNA analysis for research purposes is an ‘excepted' purpose
- where the DNA has come from an adult lacking capacity under the law of England, Wales and Northern Ireland or is an adult with incapacity under the law of Scotland and neither a decision of that person to or not to consent is in force, use for any purposes specified in Regulations made by the Secretary of State (see above)
155. In cases where an adult dies, a person (such as a relative or friend) who was close to them at the point of death, may give consent for a DNA test. In much of the HT Act (as set out in subsection 27(4)), this operates on a hierarchical basis, but in cases relating to DNA analysis, this ranking does not apply. The person giving consent should, however, be encouraged to discuss the decision with other family members. At the time of discussing consent, it should be raised with the family whether they wish to know of any results that may have potential significance such as a genetic condition.
156. In exceptional circumstances, DNA analysis may be used for obtaining scientific or medical information about the person whose body manufactured the DNA, even if their consent has not been obtained. The HTA has established a process to permit the analysis of DNA without consent, provided that it is satisfied that certain conditions have been met [www.hta.gov.uk/guidance/non-consensual_dna_analysis.cfm].