Consent exemptions under the Human Tissue Act 2004

Section 9 of the HT Act indicates that existing holdings are exempt from its consent provisions. An existing holding is defined as the body of a deceased person or relevant material from a human body (whether living or dead) held before the day on which the HT Act commenced (1 September 2006) for use for a Scheduled Purpose. This exemption does not apply to the storage or use of dead bodies held for anatomical examination, which are dealt with separately under Section 10 of the HT Act (see below). This means that existing holdings of, for example, pathological and former anatomical specimens can continue to be stored and used for education and training related to human health without the need for appropriate consent under the HT Act.

Section 10 of the HT Act deals with existing anatomical specimens, which are different from former anatomical specimens, and essentially comprise bodies or body parts donated for dissection in the three years prior to the commencement of the HT Act, but where the anatomical examination had not been completed by 1 September 2006. The effect of this section is that there is deemed to be appropriate consent under the HT Act for the storage and use of this material for anatomical examination where an authority exists under previous legislation. Likewise, where the authority under previous legislation extended to possession of parts of the body, appropriate consent will be deemed to exist for the storage and use of such parts for research, and education and training. Further details are given in the Code of Practice C on Anatomical examination.

Part 1 of the HT Act sets out the requirements to obtain appropriate consent for specific activities linked to the Scheduled Purposes set out in Schedule 1. Consent is required for all the purposes listed in Schedule 1, Part 1, whether the donor is a living or deceased person. However, in the case of living donors, consent is not required for the storage or use for the purposes listed in Schedule 1, Part 2. These purposes are: Clinical audit; Education or training relating to human health; Performance assessment; Public health monitoring; and Quality assurance. Consent is only required for these purposes if the donor is a deceased person.

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. Please see our frequently asked questions for more information on the analysis of DNA under the HT Act. Further details of ‘excepted’ purposes are provided in Code of Practice A.

Section 39 of the Act details that consent is not required for criminal justice purposes.

An exemption in the HT Act allows tissue and cells to be stored without a HTA licence for a research project that has appropriate ethics approval. In addition, consent is not required to store and use tissue from the living for an ethically approved research project if it has been de-identified. Further details are provided in Code of Practice E.