Human Tissue Authority

The regulator for human tissue and organs

Consent exemptions under the Human Tissue Act 2004

Consent underpins the Human Tissue Act (2004) (HT Act). This section explains the consent exemptions from the Act.

Section 9 of the HT Act indicates that existing holdings are exempt from it’s 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 pre commencement of the 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 4 on Anatomical examination.

Schedule 1, Part 2 of the HT Act details that consent is required from deceased persons during life for the following Scheduled Purposes: Clinical audit; Education or training relating to human health; Performance assessment; Public health monitoring; and Quality assurance. However, consent is not required to use or store material from the living for the these purposes.

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 Act, which do not apply to Scotland, this offence applies to the whole of the UK. Further details of ‘excepted’ purposes are given in the code of practice on Consent.

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

Research and consent exemptions

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 anonymised. Further details are given in the code of practice on Research.

The HTA encourages the taking of informed and generic consent at the outset, as the default position. This allows tissue to be used for different research projects over an unspecified period of time. It is preferable to developing complex systems for keeping the samples unlinked and mitigates the need to obtain repeat consent for each research project. More information is available in the codes of practice on Consent and Research.

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