Consent exemptions

This section explains the consent exemptions from the Human Tissue Act (2004)

Consent exemptions

The Human Tissue Act (HT Act) indicates that existing holdings are exempt from the Act'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. The 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. Essentially existing anatomical specimens are bodies or body parts donated in the three years pre commencement of HT Act but 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 if an authority exists under previous legislation. Likewise, if 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 on Anatomical examination.

The HT Act states that consent is required from deceased persons for the following Scheduled Purposes (Schedule 1 part 2):

• clinical audit;
• education or training relating to human health;
• performance assessment;
• public health monitoring;
• quality assurance. 

However consent is not required to use or store material from the living for these purposes. 

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. Further details of 'excepted' purposes are given in the code of practice on Consent.

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

Research and consent exemptions

An exemption in the HT Act (section 1 (9)) 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 taking informed and generic consent at the outset. This allows tissue to be used for different research projects over an unspecified period of time. It is preferable to developing complex systems for kepping the samples unlinked and mitigates the need to obtain repeated consent for each research project. More information is available in the codes of practices for Consent and Research.