Use of human tissue
In medical research the use of human tissue is crucial, to increase understanding of human disease and to help develop new and improved treatments. It is also very important that the public supports the use of such tissue. To maintain public confidence and trust, all tissue used must be obtained lawfully and with appropriate consent, and be handled and used sensitively and responsibly by researchers.
On this page you will find links to key guidance documents and a Q&A summary of the requirements of the Human Tissue Act 2004.
- Key guidance
- Where does the Human Tissue Act apply?
- What tissue does the Act apply to?
- How is medical research included in the Act?
- Is consent always required to use tissue for research?
- What constitutes ‘appropriate consent’?
- Is the situation the same for DNA analysis?
- Licences for human tissue storage and use
- Human tissue and use of biological samples: operational and ethical guidance 2001 (includes Addendum to MRC 2001 guidance following the Human Tissue Act 2004)
- The Human Tissue Act 2004
- MRC Regulatory Support Centre web pages.
The Act applies in full in England, Wales and Northern Ireland, but it does not apply in full in Scotland where separate legislation has been enacted. An important part of the HT Act 2004 that applies to research in Scotland is that relating to DNA analysis (see below). In Scotland there will not be an equivalent of the Human Tissue Authority nor are licences required for storage and use of human tissue. The Scottish Human Tissue Act only applies to tissue from the deceased.
For the most part, the Act applies to all tissue that is described in the Act as ‘relevant material’. This includes any tissue that consists of or contains human cells but not cell lines or hair and nails from living people or human gametes and embryos (these are regulated under the HFE Act).
However, if conducting DNA analysis, it is an offence to have ‘bodily material’ with the intent of analysing its DNA without qualifying consent (with certain exceptions – see DNA analysis below). Bodily material is material that has come from a human body (living or deceased) and consists of or includes human cells. This includes hair and nails, and does not specifically exclude gametes. Extracted DNA (where no whole cells remain) is not classed as bodily material.
The Act requires ‘appropriate consent’ to be in place for what are described as ‘scheduled purposes’. There are two groups of purposes.
- Consent for storage and use of tissue for these purposes is required for tissue from either living or deceased persons. These purposes include ‘research in connection with disorders, or the functioning, of the human body’.
- Consent for storage and use for these purposes is required solely for tissue from deceased persons, this group includes audit, training and education.
Consent is not required to use tissue obtained from living patients if the tissue is anonymous to the researcher and the project has research ethics approval. The definition of anonymisation is included in the HTA Code of Practice on Consent which says, in section 28, that:
[anonymisation] does not mean that samples must be permanently and irrevocably unlinked – linking can be made through a third party where necessary – nor that the persons holding the samples cannot themselves carry out the research.
If members of the clinical team take part in the research, links may be retained to the relevant clinical or patient records, but they must not contain information giving direct patient information.
If a researcher or clinician involved in research can recognise a sample, research into that sample may still be permissible with the approval of a REC.
Consent can be broad in both time and scope, which means that the Act does NOT require that consent to the use of tissue in for research is project-specific. Consent can be obtained for storage and use in future research projects. This is consistent with existing MRC guidance.
Consent should be obtained from that person for the proposed purposes.
Consent should be obtained in accordance with other MRC guidance and standards. There are not specific additional requirements under the Act.
If the child has capacity in accordance with the ‘Gillick’ principles then the child can take decision themselves, although it is good practice to involve those with parental responsibility in this process. If the child has not gained capacity then consent should be obtained from the person with parental responsibility.
Consent can be given by the adult prior to death or may be given by someone after death. There is a hierarchy as to who can give such consent and this is set out in the draft code of practice on consent at paragraph 53.
Consent can be given by the child prior to death if able to take such a decision; it is good practice to involve those with parental responsibility in this process. Otherwise consent must be given by someone with parental responsibility. Consideration should be given to the views of an older child if they were known prior to death.
As the Act creates an offence of using human tissue without appropriate consent, it is now more important than ever to ensure that the consent attached to any tissue stored or used in your research is documented and tracked with the tissue; and that use of the tissue is only within the terms of that consent.
It is an offence under the Act to have bodily material (see above – What does the Act apply to?) with the intent of analysing DNA without consent, this applies to all of the UK, including Scotland. However, there are exceptions to this, which include existing holdings and material from living people if anonymised and REC approval is in place.
A licence is required to store relevant material for use in research. There is an exception where tissue is being stored for use in a specific REC approved project and is not retained after that project for unspecified future use.
What is the licence for?
The licence will allow storage for the specified activity (in this case research) to take place at the specified premises under the supervision of the designated individual (DI) named on the licence. The licence may require particular records to be kept and be made available to the HTA.
What does the HTA consider to be ‘premises’ for the licences?
A licence is required for each premise. In their guidance the HTA indicate that buildings on different streets at different postcodes may be considered separate premises but if on the same site, for example a hospital, they may be the same premises.
The licence holder can be the same as the DI or can be a different person or a corporate body. The licence holder can request that the DI on the particular licence be changed. The HTA guidance suggests that it would prefer a corporate body as licence holder to minimise name changes on the licence.
The DI carries the main responsibilities under the licence. He or she will need to ensure that suitable people carry out the activity using suitable procedures (and Standard Operating Procedures will need to be available for these). He or she also needs to ensure that any conditions attached to the licence are met.
No. Under the Human Tissue Act storing or using tissue without appropriate consent is a criminal offence but breaching other licence conditions is not. However, the HTA may revoke or alter a licence if its conditions are not met.
Yes, please see the fees and payment page on the HTA web site for a list of current fees.
Contact: Dr Catherine Elliott
Telephone: 020 7636 5422